Nortriptyline 10 Mg Tablets

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Document: leaflet MAH BRAND_PL 14385-0001 change

Package leaflet: Information for the user

Allegron tablets

Nortriptyline hydrochloride

Read all of this leaflet carefully before you start taking this medicine.

■ Keep this leaflet. You may need to read it again.

■ If you have any further questions, ask your doctor or pharmacist.

■ This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

■ If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Allegron tablets are and what they are used for

2. Before you take Allegron tablets

3. How to take Allegron tablets

4. Possible side effects

5. How to store Allegron tablets

6. Further information

What Allegron tablets are and what they are used for

Allegron tablets contain the active ingredient nortriptyline hydrochloride, which is a tricyclic antidepressant. Allegron relieves the symptoms of depression.

Allegron may also be used for the treatment of bedwetting in children 6 years and older.

2 Before you take Allegron tablets

Do not take Allegron tablets if

■ you are allergic (hypersensitive) to nortriptyline or any of the other ingredients of Allegron tablets (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue;

■ you have had a recent heart attack or heartbeat disorder;

■ you have severe liver disease;

■ you suffer from mania (abnormally raised mood);

■ you are breast-feeding;

■ the child is under 6 years of age;

■ you are taking, or have taken in the last two weeks, monoamine oxidase inhibitors (another type of antidepressant);

■ you are taking adrenaline-like drugs including ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine. These drugs are often contained in cough and cold remedies.

Take special care with Allegron tablets If

■ you feel suicidal or aggressive - tell your doctor;

■ you are agitated, overactive, or suffer from schizophrenia;

■ you have heart disease;

■ you have a thyroid condition;

■ you have a history of epilepsy;

■ you have high pressure in the eyes (glaucoma);

■ you have an enlarged prostate;

■ your child taking Allegron has a change in behaviour;

■ you are going to have electroconvulsive therapy (electric shock);

■ you are diabetic;

■ you are going to receive an anaesthetic, e.g. for an operation - tell your doctor;

■ you have had an allergic reaction to another tricyclic antidepressant in the past;

■ you are pregnant, think you might be pregnant or planning to become pregnant or breast-feeding you should not take Allegron unless your doctor tells you to.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this:

■ If you have previously had thoughts about killing or harming yourself;

■ If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to hospital straight away.

You may find it helpful to tell a relative or close friend

that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

If any of the above apply to you, tell your doctor or pharmacist.

Taking other medicines

You should tell your doctor if you are taking or have taken any medicines, including medicines obtained without a prescription.

The following medicines may interact with your Allegron tablets:

■ guanethidine, debrisoquine, bethanidine, clonidine

(used to treat high blood pressure);

■ barbiturates (used for anxiety or to make you feel sleepy);

■ alcohol (you should not drink alcohol);

■ fluoxetine (another antidepressant);

■ cimetidine (for heartburn and ulcers);

■ phenothiazines (for mental illness);

■ carbamazepine (for epilepsy);

■ propafenone, flecainide, encainide, quinidine (for heartbeat disorders).

It may still be all right for you to be given Allegron tablets. Your doctor will be able to decide what is suitable for you.

Driving and using machines

Allegron may affect alertness. Use caution when driving or operating heavy machinery until you're aware of how this drug affects you. If you feel Allegron tablets affect your ability to drive or use machines, tell your doctor immediately.

Allegron tablets contain lactose. If you are lactose intolerant, contact your doctor before taking this medicine. Allegron 25mgtablets contain sunset yellow (E110), which may cause allergic reactions.

3 Howto take Allegron tablets

Always take Allegron tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage

Adults:

The usual adult dose is 25mgthree orfourtimes daily orthe dose may be given once a day, usually at night. The dose should begin at a low level, lOmg, 3-4 times daily, for example and be increased gradually as required. The maximum dose is 150mg per day.

The elderly:

The usual dose is 30 to 50mg/day in divided doses. Treatment may start with lOmg three times a day. Adolescent patients:

The usual dose is 30 to 50mg/day in divided doses. Treatment may start with lOmg three times a day. Lower dosages are recommended for outpatients than for patients in hospital who will be under close supervision. Following remission maintenance treatment may be needed longer term. This should be at the lowest dose that stops the symptoms of depression coming back. Children (for bed-wetting only)

Age (years)	Weight kg	lb	Dose (mg)
6-7	20-25	44-5 5	10
8-11	25-35	55-77	10-20
Over 11	35-54	77-119	25-35

The dose should be given thirty minutes before bedtime. The maximum length of treatment should be three months. Another course of treatment should not be started until a full physical examination has been made.

If you take more Allegron tablets than you should

Go to the nearest casualty department or contact your doctor immediately. Take the tablet carton with you.

If you forget to take Allegron tablets

If you miss a dose, take one as soon as you can. If you have missed several doses, tell your doctor. Do not take a double dose to make up for a forgotten dose.

If you stop taking Allegron

Do not stop taking the tablets or reduce the dose without telling your doctor first.

If you suddenly stop taking the tablets you may feel sick (nausea), have a headache orfeel generally unwell. If you have anyfurther questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Allegron tablets can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

All medicines can cause allergic reactions, although serious allergic reactions are very rare.

Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching, especially affecting your whole body.

The following side effects have been reported:

■ low or high blood pressure

■ fast or irregular heartbeat

■ palpitations

■ heart attack (myocardial infarction)

■ stroke

■ oedema (swelling of the ankles)

■ confusion (especially in the elderly) with seeing or hearingthings (hallucinations)

■ not knowing where you are (disorientation)

■ false beliefs (delusions)

■ anxiety, restlessness, agitation

■ not sleeping (insomnia)

■ nightmares

■ panic

■ long-lasting abnormal mood

■ worsening of mental illness

■ numbness, tingling, pins and needles in the hands or feet

■ coordination problems

■ tremors

■ abnormal movements

■ fits (seizures)

■ altered brainwave (EEG) patterns

■ ringing in the ears (tinnitus)

■ dry mouth

■ rarely, inflamed glands under the tongue or inflammation of the gums (gingivitis)

■ blurred vision, difficulty in focusing, dilated pupils

■ constipation, blockage of the digestive tract

■ unable to urinate or delayed urination

■ rash

■ itching

■ light sensitivity

■ swelling (oedema)

■ fever

■ reaction to other similar drugs

■ blood disorders which may cause you to bruise easily, become anaemic or be unable to fight off infections

■ feeling sick (nausea) and vomiting

■ not eating (anorexia)

■ indigestion

■ diarrhoea

■ constipation

■ peculiartaste

■ inflamed mouth

■ abdominal cramps

■ black tongue

■ development of breasts in men, breast enlargement and milk production in women

■ increased or decreased sex drive

■ failure to have an erection (impotence)

■ swollen testicles

■ altered blood sugar levels

■ yellow eyes and skin (jaundice)

■ altered liver function

■ inflamed liver (hepatitis) and liver damage

■ weight gain or loss

■ sweating

■ flushing

■ urinating often and at night

■ sleepiness

■ dizziness

■ weakness

■ tiredness

■ headache

■ swollen glands

■ hair loss (alopecia)

■ An increased risk of bone fractures has been observed in patients taking this type of medicine.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Howto store Allegron tablets

Keep out of the sight and reach of children.

Do not use the drug after the date indicated on the carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. These measures will help to protect the environment.

Maize Starch, Magnesium Stearate, Lactose Monohydrate, Calcium Phosphate, Purified Water, Sunset Yellow (El 10) - 25mgtablets only.

What Allegron tablets looks like and contents of the pack

Tablets lOmg are white, film-coated, unscored and marked 'KING'.

Tablets 2 5mg are orange, film-coated, scored and marked 'KING'.

Blister strips of 25 tablets or plastic bottles contain 500 or 100 x lOmg or 25mg tablets Not all pack sizes may be marketed.

Marketing Authorisation Holder

King Pharmaceuticals Ltd Donegal Street Ballybofey County Donegal

Manufacturer

Dales Pharmaceuticals Snaygill Industrial Estate Keighley Road Skipton

North Yorkshire BD23 2RW

This leaflet was last revised in

June 2010

6 Further information

What Allegron tablets contain

The active substance is nortriptyline hydrochloride. Each tablet contains the equivalent of lOmg or 25mg nortriptyline base.