SUMMARY CMI

ALLEGRON^®

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 ALLEGRON?

ALLEGRON contains the active ingredient nortriptyline hydrochloride. ALLEGRON is used to treat depression.

For more information, see Section 1. Why am I using ALLEGRON? in the full CMI.

2. What should I know before I use ALLEGRON?

Do not use if you have ever had an allergic reaction to ALLEGRON 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 ALLEGRON? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ALLEGRON 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 ALLEGRON?

• Your doctor will tell you how much ALLEGRON you need to take each day.
• The usual adult dose for ALLEGRON is 75 to 100mg daily, in 3 or 4 divided doses.
• For elderly patients 25 to 50mg daily in divided doses is recommended. Your doctor may increase or decrease your dose depending on your condition.

More instructions can be found in Section 4. How do I use ALLEGRON? in the full CMI.

5. What should I know while using ALLEGRON?

For more information, see Section 5. What should I know while using ALLEGRON? in the full CMI.

6. Are there any side effects?

Common side effects: drowsiness, weakness, headache, blurred vision, constipation, diarrhoea and stomach pain, vomiting, dizziness or light-headedness (especially on standing rapidly), nausea, difficulty passing urine, dry mouth. Serious side effects include: body temperature changes (low and high), difficulty in breathing, increased heartbeat (palpitations) or irregular heartbeats, hallucinations, feeling anxious, restless or confused, tingling or numbness of the hands or feet, larger breast than normal (in men and women), yellowing of the eyes or skin (jaundice).

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

ALLEGRON^®

Active ingredient(s): nortriptyline hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using ALLEGRON. 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 ALLEGRON.

Where to find information in this leaflet:

1. Why am I using ALLEGRON?
2. What should I know before I use ALLEGRON?
3. What if I am taking other medicines?
4. How do I use ALLEGRON?
5. What should I know while using ALLEGRON?
6. Are there any side effects?
7. Product details

1. Why am I using ALLEGRON?

ALLEGRON contains the active ingredient nortriptyline hydrochloride. ALLEGRON is used to treat depression. There are many different types of medicines used to treat depression.

ALLEGRON belongs to a group of medicines called tricyclic antidepressants (TCAs). TCAs are thought to work by their action on brain chemicals called amines which are involved in controlling mood. Your doctor may have prescribed ALLEGRON for another reason.

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

2. What should I know before I use ALLEGRON?

Warnings

Tell your doctor if you have any of the following conditions or if you have ever experienced any of these conditions.

Do not use ALLEGRON if:

• you have had an allergic reaction to any medicines containing nortriptyline or to any of the ingredients listed at the end of this leaflet (see 'Product Description').
  Signs of an allergic reaction may include rash, itching of the skin, shortness of breath and swelling of the tongue or face.
• If you are taking another medicine for depression called a monoamine oxidase inhibitor (MAOI), or have been taking a MAOI within the last 14 days. Check with your doctor or pharmacist if you are unsure as to whether or not you are taking a MAOI.
• If you are taking another medicine for sedation or anxiety. If you take both medicines together, you may have an allergic reaction.
• If you have an irregular heart beat or have had a heart attack within the previous eight weeks.
• If the expiry date on the pack has passed.
• If the packaging is torn or shows signs of tampering.
• Be careful to avoid exposure to sunlight while you are taking ALLEGRON, as symptoms of sunburn may occur more quickly than normal.
• Some people may suffer symptoms such as nausea, headache or malaise if ALLEGRON is stopped suddenly. Your doctor may decide to reduce your dose, or the interval of your dose over 1 or 2 weeks.

Check with your doctor if you:

• have any other medical conditions especially the following:
  - heart or blood vessel problems
  - diabetes
  - glaucoma (increased pressure in the eye)
  - difficulty in urinating
  - thyroid problems
  - epilepsy or seizures
  - mental illness such as mania or schizophrenia
  - family history of suicide or mania
  - psychiatric disorder such as suicidal thoughts

Tell your doctor if you plan to have surgery.

Tell your doctor about these things before you take ALLEGRON.

There is no specific information available to recommend the use of ALLEGRON in children or adolescents under 18 years of age.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

ALLEGRON is not recommended to be used during pregnancy. Your doctor will discuss the risks and benefits of using ALLEGRON if you are pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known whether ALLEGRON passes into breast milk.

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 affect the way ALLEGRON works.

These include:

• cimetidine, a medicine used to treat ulcers and gastric reflux.
• fluoxetine, a medicine used to treat depression.
• quinidine, a medicine used to treat heart disease.
• chlorpropamide, a medicine used to treat diabetes.
• carbamazepine, a medicine used to treat epilepsy.
• medicines used to treat high blood pressure.
• medicines used to treat thyroid problems
• selective serotonin reuptake inhibitors (SSRIs), a group of medicines used to treat depression and other mental illnesses, such as fluoxetine, sertraline and paroxetine. This could result in "serotonin syndrome". This condition may include feeling agitated or restless, confused, loss of muscle coordination or twitching muscles and shivering
• anticholinergics, found in some medicines used to relieve stomach cramps, travel sickness, hayfever and allergies. This could result in high fever, particularly during hot weather. If you take these medicines together, you may feel drowsier and experience dry mouth, constipation, and dizziness for a longer period of time. Also, you may be more at risk of developing seizures and neuroleptic malignant syndrome. Neuroleptic malignant syndrome may include sudden increase in body temperature, sweating, fast heartbeat, muscle stiffness, high blood pressure and convulsions.

Your doctor or pharmacist will be able to tell you what to do when taking ALLEGRON with other medicines

4. How do I use ALLEGRON?

How much to take

• Your doctor will tell you how much ALLEGRON you need to take each day.
• The usual adult dose for ALLEGRON is 75 to 100mg daily, in 3 or 4 divided doses.
• For elderly patients 25 to 50mg daily in divided doses is recommended. Your doctor may increase or decrease your dose depending on your condition.

When to take ALLEGRON

• ALLEGRON can be taken with or without food.

How to take ALLEGRON

• Tablets should be swallowed whole with a glass of water.

How long to take ALLEGRON

• For depression, the length of treatment will depend on how quickly your symptoms improve. Most antidepressants take time to work so don't be discouraged if you do not feel better right away. While some symptoms will be relieved sooner than others, ALLEGRON commonly takes two to four weeks before improvement is really apparent.
• Continue taking ALLEGRON for as long as your doctor recommends.
  If you do not start to feel better in about four weeks, check with your doctor.

If you forget to use ALLEGRON

Take it as soon as you remember, and then go back to taking it as you would normally.

Do not take an extra dose.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not try to make up for missed doses by taking more than one dose at a time.

If you use too much ALLEGRON

Taking too much ALLEGRON at once can be dangerous and may cause death.

If you think that you have used too much ALLEGRON, 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.

If you have taken too much ALLEGRON you may exhibit the following signs:- confusion, blurred vision, drowsiness, hallucinations, agitation, vomiting, dizziness, body temperature changes (low and high), difficulty in breathing and increased or irregular heartbeat.

5. What should I know while using ALLEGRON?

Things you should do

Remind any doctor, dentist or pharmacist you visit that you are using ALLEGRON.

Before you start any new medicine, tell your doctor or pharmacist that you are taking ALLEGRON.

Watch carefully for signs that your depression or anxiety is getting worse, especially in the first few weeks of treatment.

Call your doctor straight away if you experience any of the following symptoms, especially if they are severe, you have not had these symptoms before or they happen very suddenly

• anxiety or agitation
• panic attacks
• difficulty sleeping
• hostility or impulsiveness
• restlessness
• overactivity or uninhibited behaviour
• thoughts of suicide

Tell your doctor immediately if you have any thoughts about suicide or doing harm to yourself.

The symptoms of depression or other psychiatric conditions may include thoughts of harming yourself or committing suicide. These symptoms may continue or get worse during the first one to two months of treatment until the full antidepressant effect of the medicine becomes apparent. This is more likely to occur in children, adolescents and young adults ages 18 to 24.

Warning signs of suicide:

• All thoughts or talk about suicide or violence are serious. If you or someone you know is showing the following warning signs, either contact your doctor or a mental health advisor right away or go to the nearest hospital for treatment.
• Thoughts or talk about death or suicide
• Thoughts or talk about self-harm or doing harm to others
• Any recent attempts of self-harm
• An increase in aggressive behaviour, irritability or agitation

Tell your doctor if you develop a skin rash or hives while taking ALLEGRON.

Tell your doctor if you become pregnant while taking ALLEGRON.

Visit your doctor regularly so your progress can be checked.

Tell your doctor if your mouth feels dry and this lasts for more than 2 weeks.

ALLEGRON causes dry mouth.

Things you should not do

• Do not stop taking ALLEGRON or lower the dose without first checking with your doctor. Suddenly stopping ALLEGRON may cause unwanted side effects.
• Do not drive or operate machinery until you know how ALLEGRON affects you.
• Do not give ALLEGRON to anyone else. Your doctor has prescribed it specifically for you and your condition.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how ALLEGRON affects you.

ALLEGRON may cause drowsiness in some people.
Make sure you know how you react to ALLEGRON before you drive a car or operate any machinery

Drinking alcohol

Be careful when drinking alcohol while taking ALLEGRON. Combining ALLEGRON and alcohol can make you more sleepy, dizzy or light-headed. Your doctor may suggest that you avoid alcohol while you are being treated with ALLEGRON.

Looking after your medicine

• Keep your tablets in a cool dry place where the temperature stays below 25°C.
• Keep your tablets in the blister pack until it is time to take them. If you take your tablets out of the blister pack, they may not keep as well.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

There will be an expiry date (month, year) on your ALLEGRON carton. The medicine should not be taken after this date because it may have lost some of its strength.

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.

ALLEGRON may cause some unwanted side effects. These are likely to vary from patient to patient. Some side effects may be related to the dose of ALLEGRON, so it is important that you never exceed the stated dose.

It is important that you tell your doctor as soon as possible about any unwanted effects. Your doctor may then decide to adjust the dose of ALLEGRON you are taking.

Less serious/Common side effects

Serious side/rare effects

These side effects are uncommon but may be serious and need urgent medical attention. There are other rare 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 ALLEGRON contains

Do not take this medicine if you are allergic to any of these ingredients.

What ALLEGRON looks like

ALLEGRON 10mg tablets are plain, round, white tablets. (Aust R 14619).

ALLEGRON 25mg tablets are orange round tablets with a scoreline on one side. (Aust R 53747).

ALLEGRON 10 mg and 25 mg tablets are available in blister pack of 50 tablets.

Who distributes ALLEGRON

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne VIC 3121
www.arrotex.com.au

This leaflet was prepared in January 2025.

Published by MIMS April 2025

1 Name of Medicine

Nortriptyline hydrochloride.

2 Qualitative and Quantitative Composition

Allegron 10 mg and 25 mg tablets contain 10 mg and 25 mg nortriptyline (present as the hydrochloride) as the active ingredient, respectively.

Excipients with known effect.

3 Pharmaceutical Form

Allegron 10 mg tablets are plain, round, white tablets.
Allegron 25 mg tablets are orange round tablets with a scoreline on one side.

4 Clinical Particulars

4.1 Therapeutic Indications

Allegron is indicated for the treatment of major depression.

4.2 Dose and Method of Administration

Allegron is not recommended for children.
Allegron is administered orally in the form of tablets. Lower than usual dosages are recommended for elderly patients and adolescents. The dosage for outpatients should also be lower than that for hospitalised patients who will be under close supervision. The physician should initiate dosage at a low level and increase it gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission.
If a patient develops minor adverse reactions, the dosage should be reduced. The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur.

Usual adult dose.

Use in children and adolescents (< 18 years).

Elderly patients.

Plasma levels.

4.3 Contraindications

The use of Allegron or other tricyclic antidepressants concurrently with a monoamine oxidase (MAO) inhibitor is contraindicated. Hyperpyretic crises, severe convulsions and fatalities have occurred when similar tricyclic antidepressants were used in such combinations. It is advisable to have discontinued the MAO inhibitor for at least two weeks before treatment with Allegron is started.
Patients hypersensitive to Allegron should not be given the drug.
Cross sensitivity between Allegron and other dibenzazepines is a possibility.
Allegron is contraindicated during the acute recovery period after myocardial infarction.

4.4 Special Warnings and Precautions for Use

Clinical worsening and suicide risk associated with psychiatric disorders.

Bipolar disorder and activation of mania/hypomania.

Impairment of motor coordination.

Other precautions.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Steady-state serum concentrations of the tricyclic antidepressants are reported to fluctuate significantly as cimetidine is either added or deleted from the drug regimen. Serious anticholinergic symptoms (severe dry mouth, urinary retention, blurred vision) have been associated with elevations in the serum levels of the tricyclic antidepressant when cimetidine is added to the drug regimen. In addition, higher than expected steady-state serum concentrations of the tricyclic antidepressant have been observed when therapy is initiated in patients already taking cimetidine. Alternatively, decreases in the steady-state serum concentration of the tricyclic antidepressant have been reported in well controlled patients on concurrent therapy, on discontinuance of cimetidine. The therapeutic efficacy of the tricyclic antidepressant may be compromised in these patients as cimetidine is discontinued. Several of the tricyclic antidepressants have been cited in these reports.
There have been greater than twofold increases in previously stable plasma levels of other antidepressants, including nortriptyline, when Prozac 20 (fluoxetine hydrochloride) has been administered in combination with these agents. Fluoxetine and its active metabolite, norfluoxetine, have a long half-life (4 to 16 days for norfluoxetine) which might affect strategies during conversion from one drug to the other.
Administration of reserpine during therapy with a tricyclic antidepressant has been shown to produce a "stimulating" effect in some depressed patients. Close supervision and careful adjustment of the dosage are required when Allegron is used with other anticholinergic drugs and sympathomimetic drugs.
A case of significant hypoglycaemia has been reported in a type 2 diabetic patient maintained on chlorpropamide (250 mg/day) after the addition of nortriptyline (125 mg/day).
The concomitant administration of quinidine and nortriptyline may result in a significantly longer plasma half-life, higher AUC and lower clearance of nortriptyline.
Guanethidine and similar agents, thyroid medication, alcohol (see Section 4.4 Special Warnings and Precautions for Use).

Drugs metabolised by P450IID6.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Included in the following list are a few adverse reactions that have not been reported with this specific drug. However, the pharmacologic similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when nortriptyline is administered.

Cardiovascular.

Psychiatric.

Neurological.

Anticholinergic.

Allergic.

Haematologic.

Gastrointestinal.

Endocrine.

Other.

Withdrawal symptoms.

Reporting suspected adverse effects.

4.9 Overdose

Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As the management is complex and changing, it is recommended that the physician contact a poison control centre for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose; therefore, hospital monitoring is required as soon as possible.

Manifestations.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Allegron 10 mg and 25 mg tablets contain maize starch, magnesium stearate, lactose monohydrate, calcium phosphate, glycerol and hypromellose. Allegron 25 mg tablets also contain sunset yellow FCF aluminium lake as the colouring agent.

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

Store below 25°C, protect from light.

6.5 Nature and Contents of Container

Allegron 10 mg and 25 mg tablets are available in blister pack (PVC/Aluminium) of 50 tablets.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4: Prescription Only Medicine.

Summary Table of Changes