SUMMARY CMI
MIRTANZA ODT
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
1. Why am I using MIRTANZA ODT?
MIRTANZA ODT contains the active ingredient mirtazapine. MIRTANZA ODT is used to treat depression including relapse prevention.
For more information, see Section 1. Why am I using MIRTANZA ODT? in the full CMI.
2. What should I know before I use MIRTANZA ODT?
Do not use if you have ever had an allergic reaction to MIRTANZA ODT or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use MIRTANZA ODT? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with MIRTANZA ODT and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How do I use MIRTANZA ODT?
- The usual starting dose is 15 mg per day. Your doctor may slowly increase this dose depending on how you respond to MIRTANZA ODT.
- The effective dose for most people is usually between 30 mg and 45 mg per day.
More instructions can be found in Section 4. How do I use MIRTANZA ODT? in the full CMI.
5. What should I know while using MIRTANZA ODT?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Drinking alcohol |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using MIRTANZA ODT? in the full CMI.
6. Are there any side effects?
Common side effects: lethargy, drowsiness or sleepiness, headache, tiredness, dry mouth, diarrhoea, constipation, increase in appetite and weight gain, nausea, vomiting. Serious side effects: skin rashes, itching or hives; swelling of the face, lips, or tongue which may cause difficulty breathing, severe skin reactions.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
FULL CMI
MIRTANZA ODT
Active ingredient(s): Mirtazapine
Consumer Medicine Information (CMI)
This leaflet provides important information about using MIRTANZA ODT. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using MIRTANZA ODT.
Where to find information in this leaflet:
1. Why am I using MIRTANZA ODT?
2. What should I know before I use MIRTANZA ODT?
3. What if I am taking other medicines?
4. How do I use MIRTANZA ODT?
5. What should I know while using MIRTANZA ODT?
6. Are there any side effects?
7. Product details
1. Why am I using MIRTANZA ODT?
MIRTANZA ODT medicine contains the active ingredient Mirtazapine. This medicine corrects this chemical imbalance and may help relieve the symptoms of depression.
MIRTANZA ODT is used to treat depression including relapse prevention. 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.
2. What should I know before I use MIRTANZA ODT?
Warnings
Do not use MIRTANZA ODT if:
- You are allergic to mirtazapine, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
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. - you are taking another medicine for depression called monoamine oxidase inhibitor (MAOI) or have been taking it within the last 14 days. If you stop taking MIRTANZA ODT, do not take MAOI during the next two weeks either.
Taking MIRTANZA ODT with an MAOI may cause serious reactions 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.
Check with your doctor if you:
- have any other medical conditions like:
- 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 a certain medicine that may affect the hearts rhythm
- any mental illness (e.g., schizophrenia, maniac depression)
- diabetes
- glaucoma (increased pressure in the eye)
- problems in urinating due to an enlarged prostate
- unexplainable high fever, sore throat and mouth ulcers
- glucose-galactose malabsorption
- galactose intolerance
- sucrose-isomaltose insufficiency
- phenylketonuria - take medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Do not take MIRTANZA ODT if you are pregnant or intend to become pregnant.
Tell your doctor if you become pregnant while taking this medicine. Do not stop taking your tablets until you have spoken to your doctor.
Like most medicines of this kind, this medicine is not recommended to be used during pregnancy. Your doctor will discuss the risks and benefits of taking this medicine when pregnant.
If you use MIRTANZA ODT until, or shortly before birth, your baby should be supervised for possible adverse effects.
Do not take MIRTANZA ODT if you are breastfeeding or intend to breastfeed.
It is not known whether this medicine passes into breast milk.
Use in Children
Do not give this medicine to a child or adolescent.
The safety of this medicine in patients under 18 years has not been established.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may be affected by MIRTANZA ODT or may affect how well it works. These include:
- other medicines (e.g., 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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect MIRTANZA ODT.
4. How do I use MIRTANZA ODT?
How much to take / use
- The usual starting dose is 15 mg per day. Your doctor may slowly increase this dose depending on how you respond to MIRTANZA ODT.
- The effective dose for most people is usually between 30 mg and 45 mg 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.
When to take / use MIRTANZA ODT
MIRTANZA ODT should be used at 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, MIRTANZA ODT 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
MIRTANZA ODT 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 ten 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
- Continue taking your medicine for as long as your doctor tells you.
- For depression, the length of treatment depends 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 symptoms may improve in 1 to 2 weeks, but it can take up to 2 to 4 weeks to feel the full benefit of the medicine.
- It is important to keep taking your medicine even if you feel well, usually for about 4 to 6 months or even longer, to make sure the benefits will last.
If you forget to use MIRTANZA ODT
Once daily dosing
If you forget to take the tablet before you go to bed, do not take the missed dose the next morning. This medicine may cause drowsiness or sleepiness during the day. Continue treatment in the evening with your usual dose and continue to take it as you would normally.
Twice dosing daily
- 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 use too much MIRTANZA ODT
If you think that you have used too much MIRTANZA ODT, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre (by calling 13 11 26), or
- contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too many MIRTANZA ODT 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.
5. What should I know while using MIRTANZA ODT?
Things you should do
- If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking MIRTANZA ODT.
- Tell your doctor if 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.
- Keep all of your doctor's appointments so that your progress can be checked. Your doctor may do some blood tests from time to time. This helps to prevent unwanted side effects.
Call your doctor straight away if you:
- develop fever, chills, sore throat, or mouth ulcers or other signs of frequent infections. Stop taking MIRTANZA ODT 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 MIRTANZA ODT can cause a temporary shortage of white blood cells (granulocytopenia). In rare cases MIRTANZA ODT 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 2-6 weeks of treatment. - 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. - you or someone you know is showing warning signs of suicide-related behavior while taking MIRTANZA ODT, 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 self-harm, 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.
Remind any doctor, dentist, or pharmacist you visit that you are using MIRTANZA ODT.
Things you should not do
- Do not stop using this medicine suddenly or lower the dose without first checking with your doctor.
Your doctor may want to gradually reduce the amount of MIRTANZA ODT you are taking before stopping completely. - 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.
- Do not stop taking MIRTANZA ODT even if you feel better. unless advised by your doctor.
Suddenly stopping MIRTANZA ODT may cause nausea, headache, dizziness, anxiety, agitation. - Do not let yourself run out of medicine over the weekend or on holidays.
- Do not use MIRTANZA ODT to treat any other condition unless your doctor tells you to do.
Driving or using machines
Do not drive or operate machinery until you know how MIRTANZA ODT affects you.
MIRTANZA ODT may cause dizziness, drowsiness, or sleepiness in some people and affect alertness and concentration in some people. If any of these occur, do not drive, operate machinery or anything that could be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
Combining MIRTANZA ODT and alcohol can make you sleepier and less alert. Your doctor may suggest you avoid alcohol while being treated with this medicine.
Looking after your medicine
- 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.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where young children cannot reach it.
A locked cupboard at least one-and -a half meters above the ground is a good place to store medicines.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
Less serious side effects | What to do |
General disorders
*These maybe symptoms of depression Others
| Speak to your doctor if you have any of these less serious side effects and they worry you. They are generally mild and do not cause patients to stop taking MIRTANZA ODT. |
Serious side effects
Serious side effects | What to do |
Mood or psychiatric related
| Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What MIRTANZA ODT contains
Active ingredient (main ingredient) | Mirtazapine |
Other ingredients (inactive ingredients) | Crospovidone Mannitol Microcrystalline cellulose Aspartame* Colloidal anhydrous silica Magnesium stearate Strawberry Guarana 586997 AP0551 (HF82) N&A Peppermint FL SD # 517 |
Potential allergens | n/a |
What MIRTANZA ODT looks like
MIRTANZA ODT 15, 30 and 45 mg tablets are presented in a blister pack of 30 or 90 tablets*.
*not marketed
MIRTANZA ODT 15 mg (AUST R 183404)
White, round tablets debossed with ‘36’ on one side and ‘A’ on the other side with an embossed circular edge.
MIRTANZA ODT 30 mg (AUST R 183405)
White, round tablets debossed with ‘37’ on one side and ‘A’ on the other side with an embossed circular edge.
MIRTANZA ODT 45 mg (AUST R 183406)
White, round tablets debossed with ‘38’ on one side and ‘A’ on the other side with an embossed circular edge.
Who distributes MIRTANZA ODT
Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121
www.arrotex.com.au
This leaflet was prepared in August 2024.
Published by MIMS October 2024