Consumer medicine information

Remeron SolTab



Brand name

Remeron SolTab

Active ingredient





Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Remeron SolTab.

What is in this leaflet

This leaflet answers some common questions about Remeron SolTab. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Remeron SolTab against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Remeron SolTab is used for

Remeron SolTab is used in the treatment of depression

Depression is longer lasting or more severe than "low moods" everyone has from time to time due to the stress of everyday life. It is thought to be caused by a chemical imbalance in parts of the brain. This affects your whole body and can cause emotional and physical symptoms such as feeling low in spirit, loss of interest in activities, unable to enjoy life, poor appetite or overeating, disturbed sleep, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing.

This medicine corrects this chemical imbalance and may help relieve the symptoms of depression.

Your doctor, however, may prescribe it for another purpose.

Ask your doctor if you have any questions about why it has been prescribed for you.

This medicine is only available with a doctor's prescription.

Remeron SolTab is not addictive.

Before you take Remeron SolTab

When you must not take it

Do not take Remeron SolTab:

  • if you are allergic to medicines containing mirtazapine
  • if you are allergic to any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips, mouth, throat or other parts of the body, shortness of breath, wheezing or trouble breathing.

Do not take Remeron SolTab if you are taking another medicine for depression called a monoamine oxidase inhibitor (MAOI) or have been taking an MAOI within the last 14 days. If you stop taking Remeron SolTab, do not take MAOI during the next two weeks either.

Taking Remeron SolTab with an MAOI may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and severe convulsions.

Examples of this type of medicine include phenelzine, tranylcypromine and selegiline.

Ask your doctor or pharmacist if you are not sure if you are or if you have been taking a MAOI medicine.

Do not take Remeron SolTab if the packaging is torn or shows signs of tampering.

Do not take Remeron SolTab if the expiry date printed on the pack has passed.

If you are not sure whether you should start taking Remeron SolTab, talk to your doctor.

Before you start to take it

Do not give Remeron SolTab to a child or adolescent. The safety of Remeron SolTab in patients under 18 years has not been established.

Tell your doctor if:

  1. you are allergic to any other medicines, foods, dyes or preservatives
  2. you are pregnant or plan to become pregnant.
Like most medicines of this kind, Remeron SolTab is not recommended to be used during pregnancy. Your doctor will discuss the risks and benefits of taking Remeron SolTab when pregnant.
  1. you are breastfeeding or wish to breastfeed.
It is not known whether Remeron SolTab passes into breast milk.
  1. if you have or have had any medical conditions, especially the following:
  • thoughts of suicide or self-harm
  • epilepsy (fits or convulsions)
  • liver disease such as jaundice
  • kidney disease
  • heart disease
  • low blood pressure
  • certain kinds of heart conditions that may change your heart rhythm, a recent heart attack, heart failure, or take certain medicines that may affect the heart's rhythm.
  • any mental illness (e.g. schizophrenia, manic depression)
  • diabetes
  • glaucoma (increased pressure in the eye)
  • problems in urinating due to an enlarged prostate
  • unexplainable high fever, sore throat and mouth ulcers
  • galactose intolerance
  • glucose-galactose malabsorption

If you have not told your doctor about any of the above, tell them before you take Remeron SolTab.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may be affected by Remeron SolTab or may affect how well it works. These include:

  • other medicines (eg. SSRIs, venlafaxine, L-tryptophan, nefazodone) for depression, anxiety, obsessive compulsive disorders or pre-menstrual dysphoric disorder
  • Monoamine Oxidase Inhibitors (such as tranylcypromine, phenelzine, and selegiline)
  • medicines containing St. John's Wort (hypericum perforatum)
  • phenytoin or carbamazepine, medicines used to treat epilepsy
  • benzodiazepines, medicines used to treat anxiety and sleeping problems
  • lithium, a medicine used to treat some psychiatric conditions
  • methylene blue (used to treat high levels of methemoglobin in the blood)
  • tramadol, a pain killer
  • morphine, a medicine for severe pain
  • cetirizine, a medicine for allergies
  • warfarin, a medicine used to prevent blood clotting
  • linezolid or erythromycin, both antibiotics
  • rifampicin, a medicine used to treat tuberculosis
  • medicines used to treat fungal infections such as ketoconazole
  • HIV/AIDS medications
  • cimetidine, a medicine used to treat reflux and stomach ulcers
  • triptans such as sumatriptan, naratriptan and zolmitriptan, medicines used to treat migraine
  • medicines that may affect the heart's rhythm such as certain antibiotics and some anti-psychotics.

Your doctor will tell you what to do if you are taking any of these medicines.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking Remeron SolTab.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

How to take Remeron SolTab

Follow all directions given to you by your doctor and pharmacist. They may differ from the information contained in this leaflet.

How much to take

Your doctor will tell you how much Remeron SolTab to take each day. Take exactly the amount your doctor tells you.

The usual starting dose is 15mg per day. Your doctor may slowly increase this dose depending on how you respond to Remeron SolTab. The effective dose for most people is usually between 30mg and 45mg per day.

Your doctor may have prescribed a different dose.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

When to take it

Take Remeron SolTab at about the same time each day.

Your doctor will tell you when to take your tablets.

The tablet(s) should be taken at the same time each day, preferably as a single night-time dose before going to bed; if recommended by your doctor, Remeron SolTab may be taken in sub-doses equally divided over the day (once in the morning and once at night-time before going to bed).

How to take it

REMERON SolTab can be taken with or without water.

Please read the following instructions carefully.

  • To prevent crushing the tablet, do not push against the tablet pocket.
  • Each blister contains six tablet pockets, which are separated by perforations (dotted lines). Bend the strip several times along the dotted lines, and then tear off one tablet pocket.
  • Carefully peel off the lidding foil, starting in the corner indicated by the arrow.
  • Take out the tablet with dry hands and place it on the tongue. The tablet will rapidly disintegrate and can be swallowed with or without water.

Take the tablet immediately after it is removed from the tablet pocket. Once removed it cannot be stored.

How long to take it

Keep taking Remeron SolTab until your doctor tells you to stop.

For depression, the length of treatment will depend on how quickly your symptoms improve. Most antidepressants take time to work, so do not be discouraged if you don't feel better right away. Some of your symptoms may improve in 1 to 2 weeks but it can take up to 2 - 4 weeks to feel the full benefit of the medicine.

Even when you feel well, you will usually have to take Remeron SolTab for 4 to 6 months or even longer to make sure the benefits will last.

If you forget to take it


If you forget to take the tablet before you go to bed, do not take the missed dose next morning. It may cause drowsiness or sleepiness during the day. Continue treatment in the evening with your normal dose.


  • Morning dose forgotten - simply take it together with your evening dose.
  • Evening dose forgotten - do not take it with the next morning dose. Continue treatment with your normal morning and evening doses.
  • Both doses forgotten - do not try to make up for the missed tablets. Continue with your usual morning and evening dose the next day.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at your nearest hospital if you think you or anyone else may have taken too much Remeron SolTab. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too many Remeron SolTab tablets, you may feel drowsy, dizzy, confused, and agitated.

You may also have changes to your heart rhythm (fast, irregular heartbeat) and/or fainting which could be symptoms of a life-threatening condition known as Torsades de Pointes.

While you are taking Remeron SolTab

Things you must do

Tell your doctor immediately if you develop fever, chills, sore throat or mouth ulcers or other signs of frequent infections. Stop taking Remeron SolTab and consult with your doctor for a blood test.

In rare cases mirtazapine can cause disturbances in the production of blood cells (bone marrow depression). Some people become less resistant to infection because Remeron SolTab can cause a temporary shortage of white blood cells (granulocytopenia). In rare cases Remeron SolTab can also cause a shortage of red and white blood cells, as well as blood platelets (aplastic anaemia), a shortage of blood platelets (thrombocytopenia) or an increase in the number of white blood cells (eosinophilia). While rare, these symptoms most commonly appear after 4-6 weeks of treatment.

Tell your doctor immediately or go to the nearest hospital for treatment if you have any suicidal thoughts or other mental/mood changes.

Occasionally, the symptoms of depression or other psychiatric conditions may include thoughts of harming yourself or committing suicide. Until the full antidepressant effect of your medicine becomes apparent, it is possible these symptoms may increase in the first few weeks of treatment.

Information from clinical trials have shown an increased risk of suicidal behaviour in young adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you or someone you know is showing warning signs of suicide-related behaviour while taking Remeron SolTab, contact your doctor or a mental health professional right away or go to the nearest hospital for treatment. These signs include:

  • thoughts or talk about death or suicide
  • thoughts or talk of self-harm or harm to others
  • any recent attempts of self-harm
  • increase in aggressive behaviour, irritability or agitation.

All mentions of suicide or violence must be taken seriously.

You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Tell your doctor if you become pregnant while taking this medicine. Do not stop taking your tablets until you have spoken to your doctor.

If you use Remeron SolTab until, or shortly before birth, your baby should be supervised for possible adverse effects.

Ask your doctor whether you can breast-feed, while taking Remeron SolTab.

Tell your doctor if for any reason you have not taken your medicine exactly as prescribed. Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.

Tell your doctor if you feel the tablets are not helping your condition.

Be sure to keep all of your appointments with your doctor so that your progress can be checked. You may need to have blood tests from time to time.

Before starting any new medicine, tell your doctor or pharmacist that you are taking Remeron SolTab.

Tell all doctors, dentists and pharmacists who are treating you that you are taking Remeron SolTab.

Things you must not do

Do not drive or operate machinery until you know how Remeron SolTab affects you. Remeron SolTab may cause drowsiness, dizziness or sleepiness in some people and affect alertness and concentration. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.

Do not suddenly stop taking Remeron SolTab, or lower the dose, without first checking with your doctor.

Do not let yourself run out of medicine over the weekend or on holidays.

Do not stop taking Remeron SolTab, even if you feel better, unless advised by your doctor.

Suddenly stopping Remeron SolTab may cause nausea, headache, dizziness, anxiety, agitation.

Your doctor may want to gradually reduce the amount of Remeron SolTab you are taking before stopping completely.

Do not use Remeron SolTab to treat any other conditions unless your doctor tells you to.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours or if they have the same condition as you.

Things to be careful of

You are advised not to drink any alcohol while taking Remeron SolTab. Combining Remeron SolTab and alcohol can make you more sleepy and less alert. Your doctor may suggest you avoid alcohol while being treated with this medicine.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Remeron SolTab.

Remeron SolTab helps most people with depression, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist any questions you may have.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor if you notice any of the following and they bother you:

  • lethargy, drowsiness or sleepiness
  • headache
  • tiredness
  • increase in appetite and weight gain
  • dry mouth
  • nausea, vomiting
  • diarrhoea
  • constipation
  • dizziness
  • dizziness or faintness when getting up quickly from a lying or sitting position (low blood pressure)
  • abnormal sensations in the mouth sensations of numbness in the mouth or swelling in the mouth
  • aggression
  • swollen ankles or feet as a result of fluid accumulation (oedema)
  • rash or skin eruptions
  • nightmares/vivid dreams
  • tingling fingers or toes
  • painful joints
  • back pain
  • muscle aches and pains
  • restless legs
  • abnormal sensation in the skin for example burning, stinging, tickling or tingling
  • urge to move
  • difficulty in passing urine (urinary retention)
  • speech disorders
  • anxiety, insomnia. These may be symptoms of depression
  • increased prolactin hormone levels in blood (hyperprolactinaemia, including symptoms such as enlarged breasts and/or milky nipple discharge)
  • sleepwalking

Tell your doctor immediately, or go to the Accident and Emergency at your nearest hospital if you notice any of the following:

  • suicidal ideation or behaviour
  • epileptic attack (seizures)
  • shaking or tremors
  • sudden muscle contractions (myoclonus)
  • attack of excessive excitability (mania)
  • agitation
  • confusion
  • hallucinations
  • changes to your heart rhythm
  • fainting
  • yellow colouring of eyes or skin; this may suggest disturbance in liver function
  • abdominal pain and nausea; this may suggest inflammation of the pancreas
  • generalised fluid retention with weight gain
  • skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty breathing
  • signs of infection such as sudden unexplainable high fever, sore throat and mouth ulcers
  • a combination of symptoms such as fever, sweating, increased heart rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes unconsciousness and increased salivation (serotonin syndrome)
  • muscle pain, stiffness and/or weakness, darkening or discolouration of the urine (rhabdomyolysis)

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

Ask your doctor or pharmacist if you don't understand anything in this list.

After taking Remeron SolTab


Keep your tablets in their blister pack until it is time to take them. The tablets may not keep as well if you take them out of the blister pack.

Store below 30°C in a dark, dry place.

Do not store Remeron SolTab, or any other medicine, in a bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep this medicine where young children cannot reach it. A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.


Return any unused medicine to your pharmacist.

Medicines should not be disposed of via waste water or household waste.

Product Description

What it looks like

Remeron SolTab is available in three strengths: 15 mg, 30 mg and 45 mg.

They are round, white, flat faced bevelled edge tablets marked with a code on one side (15 mg "TZ" and "1", 30 mg "TZ" and "2", 45 mg "TZ" and "4") and an orange odour.

The medicine is packed in child-resistant blisters.

Pack size:

A starter pack of 6 tablets is available for Remeron SolTab 15 mg and 30 mg.

A trade pack of Remeron SolTab contains 30 tablets.


Remeron SolTab contains 15mg or 30 mg or 45 mg of mirtazapine as the active ingredient.

Remeron SolTab also contains the following inactive ingredients:

  • sugar spheres# (containing sucrose and starch)
  • hypromellose
  • povidone
  • Eudragit E 100
  • magnesium stearate
  • mannitol (E421)
  • crospovidone
  • sodium bicarbonate
  • citric acid
  • microcrystalline cellulose
  • aspartame (E951)##
  • orange flavour SN 027512

# Remeron SolTab contains sugar spheres containing sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

## Aspartame may be harmful for people with phenylketonuria.


Remeron SolTab is supplied in Australia by:

Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A,
26 Talavera Road
Macquarie Park, NSW 2113

Australian Registration Numbers

AUST R 90436 (15 mg)

AUST R 90437 (30 mg)

AUST R 90438 (45 mg)

This leaflet was updated in:
April 2019


Published by MIMS June 2019


Brand name

Remeron SolTab

Active ingredient





1 Name of Medicine


6.7 Physicochemical Properties

Mirtazapine is a white to creamy white crystalline powder which is slightly soluble in water.
Mirtazapine - INN name.
Molecular formula: C17H19N3.
Molecular mass: 265.36.
Chemical name: (±)-1,2,3,4,10,14b-hexahydro-2-methyl- pyrazino[2,1-a]pyrido[2,3-c][2]benzazepine.
Mirtazapine is a tetracyclic piperazinoazepine analogue of mianserin, a chemical structure unrelated to tricyclic antidepressants, monoamine oxidase inhibitors or selective serotonin reuptake inhibitors.

Chemical structure.

CAS number.


2 Qualitative and Quantitative Composition

Each tablet contains 15 mg, 30 mg or 45 mg of mirtazapine.

Excipients with known effect.

Sugar Spheres NF (25/30 Mesh) PI (4780), aspartame.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Remeron SolTab tablets are round, white, flat faced bevelled-edge tablets marked with a code on one side, with a characteristic orange odour.
The codes are: 15 mg (code TZ/1); 30 mg (code TZ/2); 45 mg (code TZ/4).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Remeron SolTab is an antidepressant, which can be given as treatment for episodes of major depression. Mirtazapine is an antagonist of central α2-auto and heteroadrenoceptors which causes an increase in both noradrenaline and serotonin release. The effect of released serotonin is exerted specifically via 5HT1 type receptors, because 5HT2 and 5HT3 type receptors are specifically blocked by mirtazapine. Mirtazapine is accordingly a noradrenergic and specific serotonergic antidepressant. The α2, 5HT2 and 5HT3 antagonistic effects all contribute to the antidepressant profile of mirtazapine. The presentation of mirtazapine is as a racemate. The two enantiomers contribute differently to its pharmacological profile. The α2 and 5HT2 receptor blocking activity is contained in the (S)+ enantiomer, whereas the 5HT3 receptor blocking activity is contained in the (R)- enantiomer. The presence of both enantiomers is therefore considered to be essential for the antidepressant activity of mirtazapine. In one study, there was no efficacy difference indicated between the two enantiomers, despite their different receptor affinities.
Mirtazapine is generally well tolerated. The histamine H1-antagonistic activity of mirtazapine may cause a degree of sedation in the first weeks of treatment. It has practically no anticholinergic activity. Mirtazapine has been associated with acute postural hypotension in healthy volunteer studies but this occurred rarely in patient studies (see Section 4.8 Adverse Effects (Undesirable Effects)).

Clinical trials.

Several placebo controlled double blind studies have demonstrated that mirtazapine is statistically significantly more effective than placebo in the short-term treatment of a major depressive episode; the efficacy is maintained during continuation treatment with mirtazapine.

Active controlled studies.

The efficacy of mirtazapine has been found to be comparable to several standard antidepressant agents (amitriptyline, doxepin, clomipramine). In addition, eleven 6 or 8 week studies and a 24 week study have been performed in moderately to severely depressed patients in which efficacy and tolerability of mirtazapine were compared to SSRIs (4 vs fluoxetine, 3 vs paroxetine, 2 vs sertraline, 2 vs fluvoxamine and 1 vs citalopram). The primary efficacy parameters in these studies were:
change from baseline on HAM-D total score (Hamilton depression rating scale, 17 items). 7 studies;
proportion or number of HAM-D 50% responders. 3 studies;
change from baseline on MADRAS total score (Montgomery-Asberg depression rating scale, 10 items). 1 study;
VAMRS 6 items (Visual Analogue Mood Rating Scale). 1 study. Change in HAM-D (12 items) total score was a secondary parameter in this study.
On an intention to treat basis, a total of 1402 patients were treated with mirtazapine and 1405 patients were treated with the comparator. In all 12 studies, mirtazapine proved to be at least comparable in efficacy to the SSRIs. In 11 of these studies, statistically significant greater reductions in HAM-D or MADRS total scores and more responders were observed in the mirtazapine groups at one or more timepoints in the first 4 weeks.
A meta-analysis of these 12 studies provides further comparison of the onset of efficacy of mirtazapine relative to the SSRIs studied. The primary efficacy parameter for this meta-analysis was time to first 50% reduction on recalculated HAM-D total score (17 items) or recalculated MADRS total score (10 items). There were also a number of secondary parameters which are identified in Tables 2 and 3. Table 2 provides an analysis of the relative event rates (estimated hazard ratios) for various depression parameters limited to the first 3 treatment weeks for the occurrence of the event and the entire 6-8 week study period to define whether the event was sustained or not. The increased hazard ratios demonstrate that the probability at any time t of first response (50% or more score reduction), remission, sustained response or sustained remission was consistently and significantly greater among mirtazapine treated than SSRI treated patients, indicating an earlier onset of efficacy. The statistically earlier onset of action observed with mirtazapine may not necessarily translate in to a meaningful clinical benefit for an individual patient. Table 3 presents the proportions of HAM-D responders and HAM-D/MADRS remitters at the various time points during treatment. At most time points there were significantly more responders and remitters among mirtazapine treated patients than among SSRI treated patients.
Some secondary parameter results have been excluded from Table 3. These were number of:
50% Bech responders;
50% HAM-D factor I "anxiety/ somatisation" responders;
50% HAM-D factor V "retardation" responders;
50% HAM-D factor VI "sleep disturbance" responders;
HAM-D item "depressed mood" responders (= 0 or < 2);
HAM-D item "suicide" or MADRS item "suicidal thoughts" (= 0 or < 2).
Statistically significant differences favouring mirtazapine were observed for HAM-D factors V and VI at week 1 to 6 timepoints. Statistically significant differences favouring mirtazapine were observed for HAM-D factor I at week 1 to 4 timepoints. A statistically significant difference was observed in favour of mirtazapine for Bech responders at the week 2 timepoint. There were no other statistically significant differences.
An eight week comparative study was performed to compare the antidepressant efficacy and tolerability of mirtazapine and venlafaxine in the treatment of 157 hospitalised patients with severe depression with melancholic features (HAM-D total score > 25). In this study, mirtazapine and venlafaxine were equally effective in reducing symptoms of depression and improving quality of life during treatment.


The efficacy and tolerability in elderly patients was investigated in three randomised controlled trials. In two six week trials with a total of 270 patients aged over 55 years (mean age 70 and 62 years respectively), mirtazapine was at least as effective as amitriptyline and all treatments were well tolerated. In an eight week study in 255 patients aged 65 and over (mean age 72 years) comparing mirtazapine with paroxetine, mean HAM-D scores were similar at endpoint but lower for mirtazapine in the first 3 weeks, although only at day 14 was the difference statistically significant. Total discontinuation rates were similar (22.7% for mirtazapine versus 31.0% for paroxetine), although discontinuation due to adverse events was lower with mirtazapine than paroxetine (14.8% versus 26.2%) and discontinuation due to lack of efficacy higher (3.9% versus 0%).

5.2 Pharmacokinetic Properties


After oral administration of Remeron SolTab tablets, the active substance mirtazapine is rapidly and well absorbed (bioavailability ≈ 50%), reaching peak plasma levels after about 2 hours. Food intake has no clinically significant influence on the pharmacokinetics of mirtazapine.


Binding of mirtazapine to plasma proteins is approx. 85%. The half-life of elimination ranged from 20-40 hours; longer half-lives, up to 65 hours, have occasionally been recorded and shorter half-lives have been seen in young men. The half-life of elimination is sufficient to justify once a day dosing. Steady state is reached after 3-6 days, after which there is no further accumulation. Mirtazapine displays linear pharmacokinetics within the recommended dose range.


In vitro data from human liver microsomes indicate that cytochrome P450 enzymes CYP2D6 and CYP1A2 are involved in the formation of the 8-hydroxy metabolite of mirtazapine, whereas CYP3A4 is considered to be responsible for the formation of the N-demethyl and N-oxide metabolites.
The presentation of mirtazapine is as a racemate. It is not known whether first-pass extraction of the drug is stereoselective but it is known that the clearance of the two enantiomers is by different metabolic processes.


Mirtazapine is extensively metabolized and its metabolites are eliminated via the urine and faeces within four days. Major pathways of biotransformation are demethylation and oxidation, followed by conjugation. The demethyl metabolite is pharmacologically active and appears to have the same pharmacokinetic profile as the parent compound.

Special populations.

Renal and/or hepatic impairment.

The clearance of mirtazapine may be decreased as a result of renal or hepatic insufficiency. Mirtazapine is substantially excreted by the kidney (75%) and the risk of decreased clearance of this drug is greater in patients with impaired renal function (see Section 4.2 Dose and Method of Administration).


The recommended dosage regimen is the same as for adults. Increases should be monitored carefully (see Section 4.2 Dose and Method of Administration).

Children and adolescents.

The safety and effectiveness of mirtazapine has not been established in children and adolescents and therefore should not be prescribed in these patient groups (see Section 4.4 Special Warnings and Precautions for Use).


The half-life of elimination of mirtazapine ranged from 20-40 hours, longer half-lives up to 65 hours have occasionally been recorded and shorter half-lives have been seen in young men.


There is no information available regarding the effect of race on the pharmacokinetics of mirtazapine.

5.3 Preclinical Safety Data


Since the only tumours found in carcinogenicity studies with mice and rats were considered to be species-specific, non-genotoxic responses associated with long term treatment with hepatic enzyme inducers, mirtazapine is not expected to possess carcinogenic potential at therapeutic dosages in the clinic. Mirtazapine was not genotoxic in a series of tests for gene mutation and chromosomal and DNA damage.


An eighteen month carcinogenicity study in mice showed an increase in the development of hepatic tumours in males after mirtazapine treatment at oral doses of 20 mg/kg/day and above. In a two year carcinogenicity study in rats, oral doses of mirtazapine greater than 20 mg/kg/day were associated in males with an increased incidence of thyroid follicular cell adenomas and carcinomas.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of major depression.

4.3 Contraindications

Hypersensitivity to mirtazapine or to any of the excipients.
MAO inhibitors as concomitant therapy. It is recommended that Remeron SolTab not be used in combination with MAO inhibitors, or within 14 days of initiating or discontinuing therapy with a MAO inhibitor (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

4.4 Special Warnings and Precautions for Use

Clinical worsening and suicide risk.

The risk of suicidality (suicidal ideation and suicidal behaviours) is inherent in depression and may persist until significant remission occurs. This risk must be considered in all depressed patients. Patients with depression may experience worsening of their depressive symptoms and/or the emergence of suicidal ideation and/or behaviours whether or not they are taking antidepressant medication, and this risk may persist until significant remission occurs. Suicide is a known risk in depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of a course of treatment, or at the time of dose changes, either increases or decreases. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or whose emergent suicidality is severe, abrupt in onset, or was not part of the patient's presenting symptoms. Patients (and caregivers of patients) should be alerted about the need to monitor for any worsening of their condition and/or the emergence of suicidal ideation or behaviour or thoughts of harming themselves and to seek medical advice immediately if these symptoms present. Patients with comorbid depression associated with other psychiatric disorders being treated with antidepressants should be similarly observed for clinical worsening and suicidality.
Pooled analysis of short-term placebo controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increased the risk of suicidal ideation and/or behaviours in children, adolescents, and young adults (aged 18-24 years) with major depressive disorder (MDD) and other psychiatric disorders during the initial treatment (generally the first one to two months). Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond the age of 24 years; there was a reduction with antidepressants compared to placebo in adults aged 65 years and older.
The pooled analyses of placebo controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials (4 to 16 weeks) of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in the risk of suicidality among drugs, but a tendency towards an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across different indications, with the highest incidence in MDD trials. The risk differences (drug vs placebo), however, were relatively stable within age strata and across indications.
No suicides occurred in any of the paediatric trials. There were few suicides in the adult trials, but the number was not sufficient to reach any conclusion about the effect of antidepressants on suicide. It is unknown whether suicidality risk extends to longer-term use, i.e. beyond several months. However, there is substantial evidence from placebo controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
Symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness), impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adults, adolescents and children being treated with antidepressants for major depressive disorders as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either worsening of depression and/or emergence of suicidality impulses has not been established, there is concern that such symptoms may be precursors of emerging suicidality.
Families and caregivers of children and adolescents being treated with antidepressants for MDD or for any other condition (psychiatric or nonpsychiatric) should be informed about the need to monitor these patients for the emergence of agitation, irritability, unusual changes in behaviour, and other symptoms described above, as well as the emergence of suicidality and to report such symptoms immediately to health care providers. It is particularly important that monitoring be undertaken during the initial few months of antidepressant treatment or at times of dose increase or decrease.
Prescriptions for Remeron SolTab should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Conditions which need supervision.

Careful dosing as well as regular and close monitoring is necessary in patients with:

Hepatic impairment.

Epilepsy and organic brain syndrome.

See Section 4.8 Adverse Effects (Undesirable Effects). Remeron SolTab should be introduced cautiously in patients who have a history of seizures. Treatment should be discontinued in any patient who develops seizures, or where there is an increase in seizure frequency.

Renal insufficiency.

Mirtazapine is substantially excreted by the kidney (75%) and the risk of decreased clearance of this drug is greater in patients with impaired renal function.

Cardiac diseases.

Such as conduction disturbances, angina pectoris and recent myocardial infarct, where normal precautions should be taken and concomitant medicines carefully administered.

Low blood pressure.

And conditions that would predispose patients to hypotension (dehydration, hypovolemia and treatment with antihypertensive medication).

Diabetes mellitus.

In patients with diabetes, antidepressants may alter glycemic control. Insulin and/or oral hypoglycemic dosage may need to be adjusted and close monitoring is recommended.
Like with other antidepressants, the following should also be taken into account.
Worsening of psychotic symptoms can occur when antidepressants are administered to patients with schizophrenia or other psychotic disturbances; paranoid thoughts can be intensified.
A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed that treating such an episode with an antidepressant alone can increase the likelihood of precipitation of a mixed/ manic episode in patients at risk of bipolar disorder. Prior to initiating treatment with an antidepressant, patients should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder and depression. When the depressive phase of the bipolar disorder is being treated, it can transform into the manic phase. Patients with a history of mania/ hypomania should be closely monitored. Remeron SolTab should be discontinued in any patient entering a manic phase.
Care should be taken in patients with micturition disturbances like prostate hypertrophy (although problems are not to be expected because mirtazapine possesses only very weak anticholinergic activity).
Acute narrow angle glaucoma and increased intraocular pressure (however mirtazapine has weak anticholinergic activity).
Akathisia/ psychomotor restlessness. The use of antidepressants have been associated with the development of akathisia, characterized by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental.
The effect of mirtazapine on QTc interval was assessed in a randomized, placebo and moxifloxacin controlled clinical trial involving 54 healthy volunteers using exposure response analysis. This trial revealed that both 45 mg (therapeutic) and 75 mg (supratherapeutic) doses of mirtazapine did not affect the QTc interval to a clinically meaningful extent. During the postmarketing use of mirtazapine, cases of QT prolongation, torsades de pointes, ventricular tachycardia, and sudden death, have been reported. The majority of reports occurred in association with overdose or in patients with other risk factors for QT prolongation, including concomitant use of QTc prolonging medicines (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 4.9 Overdose). Caution should be exercised when Remeron SolTab is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products thought to prolong the QTc interval.
Remeron SolTab is not addictive. Postmarketing experience shows that abrupt termination of treatment after long-term administration may sometimes result in withdrawal symptoms. The majority of withdrawal reactions are mild and self limiting. Among the various reported withdrawal symptoms, dizziness, agitation, anxiety, headache and nausea are the most frequently reported. Even though they have been reported as withdrawal symptoms, it should be realised that these symptoms may be related to underlying disease. As advised, see Section 4.2 Dose and Method of Administration, it is recommended to discontinue treatment with Remeron SolTab gradually.


Treatment should be discontinued if jaundice occurs.


Hyponatremia has been reported very rarely with the use of mirtazapine. Caution should be exercised in patients at risk, such as elderly patients or patients concomitantly treated with medications known to cause hyponatremia.

Serotonin syndrome.

Development of serotonin syndrome may occur in association with treatment with SSRIs and SNRIs, particularly when given in combination with MAOIs (see Section 4.3 Contraindications; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions) or other serotonergic agents (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). Symptoms and signs of serotonin syndrome include rapid onset of neuromuscular excitation (hyper-reflexia, incoordination, myoclonus, tremor), altered mental status (confusion, agitation, hypomania) and autonomic dysfunction (diaphoresis, diarrhoea, fever, shivering and rapidly fluctuating vital signs). Treatment with Remeron SolTab should be discontinued if such events occur and supportive symptomatic treatment initiated. From postmarketing experience it appears that serotonin syndrome occurs very rarely in patients treated with mirtazapine alone (see Section 4.8 Adverse Effects (Undesirable Effects)).


Phenylketonuric patients should be informed that Remeron SolTab contains aspartame, a source of phenylalanine. Each tablet with 15 mg, 30 mg and 45 mg mirtazapine corresponds to 2.6 mg, 5.2 mg and 7.8 mg phenylalanine respectively. It may be harmful for patients with phenylketonuria.
Remeron SolTab contains sugar spheres containing sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

Neutropenia, agranulocytosis.

Bone marrow depression, usually presenting as granulocytopenia or agranulocytosis, has been reported during treatment with mirtazapine. The symptoms mostly appear after 2-6 weeks of treatment. The bone marrow depression is, in general, reversible after termination of treatment. However in very rare cases agranulocytosis can be fatal. Reversible agranulocytosis has been reported as a rare occurrence in clinical studies with mirtazapine. In the postmarketing period with Remeron SolTab very rare cases of agranulocytosis have been reported, mostly reversible, but in some cases fatal. All fatal cases concerned patients over 65 years. Postmarketing data indicate that the rate of occurrence of agranulocytosis and agranulocytosis-like disorders (whether or not causally related) amongst mirtazapine users is no greater than that in the background population. One should be alert for symptoms like fever, sore throat, stomatitis or other signs of infections. If such symptoms occur the treatment should be stopped and blood counts taken.

Use in hepatic impairment.

See Conditions which need supervision, above; Section 4.2 Dose and Method of Administration; Section 5.2 Pharmacokinetic Properties, Special populations, Renal and/or hepatic impairment.

Use in renal impairment.

See Conditions which need supervision, above; Section 4.2 Dose and Method of Administration; Section 5.2 Pharmacokinetic Properties, Special populations, Renal and/or hepatic impairment.

Use in the elderly.

Elderly patients are often more sensitive, especially with regard to the undesirable effects of antidepressants. During clinical research with mirtazapine, undesirable effects have not been reported more often in elderly patients than in other age groups (see Section 5.1 Pharmacodynamic Properties, Clinical trials; Section 4.2 Dose and Method of Administration).

Paediatric use.

Remeron SolTab should not be used to treat children and adolescents under the age of 18 years. Suicide related behaviors (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behavior and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken; the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioral development are lacking.

Effects on laboratory tests.

For adverse effects related to laboratory tests, see Section 4.8 Adverse Effects (Undesirable Effects).

4.5 Interactions with Other Medicines and Other Forms of Interactions

Pharmacokinetic interactions.

Mirtazapine is extensively metabolised by CYP2D6 (resulting in the 8-hydroxy metabolite) and CYP3A4 (N-demethyl and N-oxide metabolites) and to a lesser extent by CYP1A2. An interaction study with healthy volunteers showed no influence of paroxetine, a CYP2D6 inhibitor, on mirtazapine pharmacokinetics in steady state.
Coadministration of the potent inhibitor of CYP3A4, ketoconazole, in healthy male volunteers increased mirtazapine peak plasma concentration levels and AUC by approximately 40% and 50% respectively.
When cimetidine (weak inhibitor of CYP1A2, CYP2D6 and CYP3A4) is administered with mirtazapine, the mean plasma concentration of mirtazapine may increase more than 50%. The mirtazapine dose may have to be decreased when concomitant treatment with cimetidine is started or increased when cimetidine treatment is ended. Caution should be exercised and the dose may have to be decreased when coadministering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, ketoconazole, erythromycin, cimetidine or nefazodone.
Carbamazepine and phenytoin, inducers of CYP3A4, increased mirtazapine clearance about twofold, resulting in a decrease in mirtazapine plasma levels of 45-60%. When carbamazepine, phenytoin or another inducer of drug metabolism (such as rifampicin) is added to mirtazapine therapy, the mirtazapine dose may have to be increased. If treatment with an inducer is stopped, mirtazapine dose may have to be decreased.
In in vivo interaction studies, mirtazapine did not influence the pharmacokinetics of paroxetine (CYP2D6 substrates), carbamazepine or phenytoin (CYP3A4 inducers), amitriptyline or cimetidine.
In a mirtazapine and lithium interaction study, the steady-state pharmacokinetics of lithium was not affected by coadministration of a single oral dose of 30 mg of mirtazapine. Correspondingly, the single dose pharmacokinetics of mirtazapine was not affected by the lithium steady state.

Pharmacodynamic interactions.

Mirtazapine should not be administered concomitantly with MAO inhibitors or within two weeks after discontinuation of MAO inhibitor therapy. In the opposite way about two weeks should pass before patients treated with mirtazapine should be treated with MAO inhibitors (see Section 4.3 Contraindications). In addition, as with SSRIs, coadministration with other serotonergic active substances (L-tryptophan, triptans, tramadol, linezolid, methylene blue, SSRIs, venlafaxine, lithium and St. John's wort (Hypericum perforatum) preparations) may lead to an incidence of serotonin associated effects (see Section 4.4 Special Warnings and Precautions for Use). Caution should be advised and a closer clinical monitoring is required when these active substances are combined with mirtazapine.
Mirtazapine may potentiate the sedative effects of benzodiazepines and other sedatives (especially antipsychotics, antihistamine H1-antagonists, opioids). Caution should be taken when these drugs are prescribed together with mirtazapine.
Mirtazapine may potentiate the central nervous dampening action of alcohol; patients using mirtazapine should therefore be advised to avoid alcohol during tasks which require concentration and alertness.
Mirtazapine dosed at 30 mg daily caused a small but statistically significant increase of the INR in subjects treated with warfarin. Both at continuing stable doses and higher doses of mirtazapine, a more pronounced effect cannot be excluded. It is advisable to monitor the prothrombin time more carefully in case of concomitant treatment of warfarin with mirtazapine.
The risk of QT prolongation and/or ventricular arrhythmias (e.g. torsades de pointes) may be increased with concomitant use of medicines which prolong the QTc interval (e.g. some antipsychotics and antibiotics) and in case of mirtazapine overdose.
From postmarketing experience it appears that serotonin syndrome occurs very rarely in patients treated with mirtazapine in combination with SSRIs or venlafaxine. If the combination is considered therapeutically necessary, dosage changes should be made with caution and there should be adequate close monitoring for early signs of serotonergic overstimulation.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

In a fertility study in rats, mirtazapine was given at doses up to 100 mg/kg [ca. 20 times the recommended human dose of 45 mg on a mg/m2 basis]. The drug did not affect mating and conception, but oestrus cycling was disrupted at doses that were 3 or more times the recommended human dose of 45 mg on a mg/m2 basis.
(Category B3)
There are insufficient clinical data to assess the possible effect of mirtazapine on pregnancy.
Oral dosing of pregnant rats with mirtazapine at 100 mg/kg/day was associated with a reduction in survival of the offspring, and an increased incidence of postnatal mortality. Mirtazapine was not teratogenic in rats at these dose levels, or in rabbits at oral doses up to 40 mg/kg/day.
Although studies in animals have not shown any teratogenic effects of toxicological significance the safety of Remeron SolTab in human pregnancy has not been established. Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Although no studies have investigated the association of PPHN to mirtazapine treatment, this potential risk cannot be ruled out taking into account the related mechanism of action (increase in serotonin concentrations). Remeron SolTab should be used during pregnancy only if it is clearly needed. Women of childbearing potential should employ an adequate method of contraception if taking Remeron SolTab.
Although animal experiments show that mirtazapine is excreted only in very small amounts in the milk, postnatal mortality was increased when lactating rats were given mirtazapine orally at 100 mg/kg/day.
The use of Remeron SolTab in breastfeeding mothers is not recommended since no human data in breast milk are available.

4.8 Adverse Effects (Undesirable Effects)

Clinical trials.

Depressed patients display a number of symptoms that are associated with the illness itself. It is therefore sometimes difficult to ascertain which symptoms are a result of the illness itself and which are a result of treatment with mirtazapine. See Table 1.

Postmarketing reports.

Skin and subcutaneous tissue disorders.

Stevens-Johnson syndrome, dermatitis bullous, erythema multiforme, toxic epidermal necrolysis, rash (including erythematous and maculopapular), rare cases of increased sweating, alopecia, pruritus and urticaria.

Musculoskeletal connective tissue and bone disorders.

Back pain, arthralgia, myalgia, rhabdomyolysis.

Nervous system disorders.

Lethargy, dysarthria, serotonin syndrome, somnolence (i.e. drowsiness, sedation), impaired concentration, dizziness, paraesthesia, headache, hyperkinesia, rare cases of cerebrovascular disorder, convulsions, tremor and myoclonus, movement disorders**. Very rare cases of oral paraesthesia.

Psychiatric disorders.

Suicidal ideation***, suicidal behaviour***, confusion, agitation, aggression, paroniria, less common or rare occurrences of nightmares/ vivid dreams, hallucination, mania, depression, anxiety*, insomnia*, psychomotor restlessness** and somnambulism.

Gastrointestinal disorders.

Constipation, vomiting, pancreatitis, increased salivation, nausea, diarrhoea, dry mouth, less common or rare cases of stomatitis, very rare cases of oral hypoaesthesia and mouth oedema.

Hepatobiliary disorders.

Hepatic function abnormal, elevated hepatic enzymes or transaminases, rare cases of jaundice, hepatitis.

Metabolism and nutrition disorders.

Hyponatraemia, increased appetite, rare cases of hypercholesterolaemia, hyperlipidaemia.

Cardiac disorders.

Tachycardia, palpitations, rare; arrhythmia, myocardial infarction, chest pain.

Vascular disorders.

Hypotension, dependent oedema, hypertension, orthostatic hypotension, rare cases of thromboembolic disorder, pulmonary embolism.

Blood and lymphatic system disorders.

Leukopenia, granulocytopoenia, rare cases of agranulocytosis (see Section 4.4 Special Warnings and Precautions for Use), rare cases of thrombocytopenia, pancytopenia, anaemia, aplastic anaemia, eosinophilia and coagulation disorder.

Endocrine disorders.

Hyperprolactinaemia (and related symptoms e.g. galactorrhea and gynaecomastia).

Renal and urinary disorders.

Rare cases of urinary retention.

General disorders and administration site conditions.

Oedema including generalised, peripheral and face oedema; fatigue/ asthenia, rare cases of pyrexia, syncope, chest pain and drug withdrawal symptoms.


Increases in gamma-glutamyltransferase levels, hypertriglyceridaemia, weight gain, increased creatine kinase.

Eye disorders.

Very rare cases of glaucoma.
* Upon treatment with antidepressants in general, anxiety and insomnia (which may be symptoms of depression) can develop or become aggravated. Under mirtazapine treatment, development or aggravation of anxiety and insomnia has been reported very rarely.
** Including akathisia, hyperkinesia.
*** Cases of suicidal ideation and suicidal behaviours have been reported during mirtazapine therapy or early after treatment discontinuation (see Section 4.4 Special Warnings and Precautions for Use).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at

4.2 Dose and Method of Administration

The tablets should be taken orally, if necessary with fluid, and swallowed without chewing.


Treatment should begin with 15 mg daily. The dosage generally needs to be increased to obtain an optimal clinical response. The effective daily dose is usually between 30 and 45 mg, but responses have been observed at 60 mg per day.


The recommended dose is the same as that for adults. In elderly patients an increase in dosing should be done under close supervision to elicit a satisfactory and safe response.
The clearance of mirtazapine may be decreased in patients with renal or hepatic insufficiency. This should be taken into account when prescribing Remeron SolTab to this category of patients (see Section 5.2 Pharmacokinetic Properties).
Mirtazapine has a half-life of 20-40 hours and therefore Remeron SolTab is suitable for once a day administration. It should be taken preferably as a single night time dose before going to bed. Remeron SolTab may also be given in subdoses equally divided over the day (once in the morning and once at night time).
Treatment should preferably be continued until the patient has been completely symptom free for 4-6 months. After this, treatment can be gradually discontinued to avoid withdrawal symptoms (see Section 4.4 Special Warnings and Precautions for Use). Mirtazapine begins to exert its effect in general after 1-2 weeks of treatment. Treatment with an adequate dose should result in a positive response within 2-4 weeks. With an insufficient response, the dose can be increased up to the maximum dose. If there is no response within a further 2-4 weeks, then treatment should be stopped.

Children and adolescents (< 18 years of age).

In placebo controlled trials, safety and efficacy of Remeron SolTab in the treatment of children and adolescents under the age of 18 years with major depressive disorder have not been established. Safety and efficacy in this population cannot be extrapolated from adult data. Therefore Remeron SolTab should not be used in children and adolescents under the age of 18 years.

4.7 Effects on Ability to Drive and Use Machines

Remeron SolTab may impair concentration and alertness (more commonly in the initial phase of treatment). Patients treated with Remeron SolTab should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that the treatment does not affect them adversely.

4.9 Overdose

Postmarketing experience concerning overdose with Remeron SolTab alone indicates that symptoms are usually mild. The symptoms of overdose are an exaggeration of the pharmacological action of mirtazapine and may include symptoms such as dizziness, impaired consciousness (confusion, disorientation, stupor, coma), agitation, tremor, tachycardia and hyper- and hypotension. As with all overdose attempts, the possibility of multiple drug ingestion should be borne in mind. As with antidepressants in general, serious outcomes, including fatalities, are possible at dosages much higher than the therapeutic dose, especially with mixed overdoses. In these cases QT prolongation and torsades de pointes have also been reported.

Overdose management.

Cases of overdose should receive appropriate symptomatic and supportive therapy for vital functions. ECG monitoring should be undertaken.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)


6 Pharmaceutical Particulars

6.1 List of Excipients

Remeron SolTab 15 mg, 30 mg and 45 mg tablets contain: Sugar Spheres NF (25/30 Mesh) PI (4780), starch, hypromellose, povidone, Eudragit E100, magnesium stearate, mannitol, crospovidone, sodium bicarbonate, citric acid, microcrystalline cellulose, aspartame, and orange flavour SN 027512.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Remeron SolTab should be stored in the dark and dry below 30°C.

6.5 Nature and Contents of Container

Remeron SolTab tablets are packed in a child-resistant, peel-to-open, rigid perforated blister, formed from a laminate of aluminium foil and plastic films sealed to a paper-based laminate of aluminium foil coated with a heat seal lacquer. Tablet pockets in the strip are separated by perforations.
The following packages are available:
15 mg: 12, 30, 48 and 90 tablets in peel to open blisters.
30 mg: 12, 30, 48 and 90 tablets in peel to open blisters.
45 mg: 12, 30, 48 and 90 tablets in peel to open blisters.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste should be disposed of by taking to your local pharmacy.

Summary Table of Changes