ALLEGRON®

nortriptyline hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet is designed to provide you with answers to some common questions about this medicine. It does not contain all the available information and does not take the place of talking with your doctor.

All medicines have risks and benefits.

Your doctor has more information about this medicine than is contained in this leaflet. Also, your doctor has had the benefit of taking a full and detailed history from you and is in the best position to make an expert judgement to meet your individual needs.

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

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

What ALLEGRON is used for

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.

Before taking ALLEGRON

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

When you must not take ALLEGRON

Do not take 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 you take this medicine after the expiry date has passed, it may not work as well.
• if the packaging is torn or shows signs of tampering.

Before you start taking ALLEGRON

Tell your doctor if you have allergies to any other medicines, including other medicines used to treat your current condition, or other substances such as foods, preservatives or dyes.

Tell 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.

Tell your doctor if you are breast-feeding or plan to breast-feed. It is not known whether ALLEGRON passes into breast milk.

Tell your doctor if you have or have had any medical conditions, especially the following:

• heart disease
• diabetes
• glaucoma (increased pressure in the eye)
• difficulty in urinating
• thyroid problems
• epilepsy or seizures
• mental illnesses such as mania or schizophrenia

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.

Taking other medicines

Tell your doctor if you are taking any other medicines including any that you have bought from a 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

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

How to take 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.

How to take it

Tablets should be swallowed whole with a glass of water.

When to take it

ALLEGRON can be taken with or without food.

How long do I take it

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 take it

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 take too much

Immediately telephone your doctor or Poisons Information Centre (13 11 26) or go to casualty at your nearest hospital, if you think you or anyone else has taken too much ALLEGRON. 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, dizziness, body temperature changes (low and high), difficulty in breathing and increased heart beat.

While you are taking ALLEGRON

Things you must do

Tell all doctors and pharmacists who are treating you that you are taking 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.

Tell your doctor immediately 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
• diffulty 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.

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 must 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.

Things to be careful of

Be careful driving or operating machinery 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.

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.

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.

Side effects

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

Like other medicines, 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.

Tell your doctor if you notice any of the following side effects and they worry you.

These are common side effects of tricyclic antidepressants.

• drowsiness
• blurred vision
• constipation
• diarrhoea and stomach pain
• vomiting
• dizziness or light-headedness (especially on standing rapidly)
• nausea
• difficulty passing urine
• dry mouth

Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following:

• body temperature changes (low and high)
• difficulty in breathing
• increased heart beat (palpitations)

These side effects are uncommon but may be serious and need urgent medical attention.

There are other rare side effects.

Tell your doctor if you notice any unusual symptoms or if you are concerned about any aspect of your health, even if you think the problems are not connected with this medicine and are not referred to in this leaflet.

After taking ALLEGRON

Storage

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.

Keep your tablets in a cool dry place where the temperature stays below 25 degrees C.

All medicines should be kept where young children cannot reach them.

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.

Disposal

If your doctor tells you to stop taking ALLEGRON or you find that this medicine has passed its expiry date, ask your pharmacist what to do with any remaining tablets.

Product description

What it looks like

ALLEGRON tablets are available in 2 strengths, 10mg and 25mg.

ALLEGRON tablets are available in packs of 50.

The 10mg tablets are round and white. The 25mg tablets are round and orange with a scoreline on one side.

Ingredients

Active Ingredient - 10mg or 25mg nortriptyline.

Inactive Ingredients - maize starch, magnesium stearate, lactose, calcium phosphate, glycerol and hypromellose.

The 25mg tablet also contains Sunset Yellow FCF CI15985.

Supplier

ALLEGRON is distributed by:

Arrow Pharma Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121

Australian Registration Numbers:
10 mg: AUST R 14619
25 mg: AUST R 53747

This leaflet was revised in October 2016.