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Allegron® 25mg Tablets Paxtibi® 25mg Tablets Nortriptyline Hydrochloride 25mg Tablets

(nortriptyline hydrochloride)

Your medicine is known by the above names, but will be referred to as Allegron tablets throughout this:

Patient Information Leaflet

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

1)    What Allegron tablets is and what is it used for?

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

Allegron tablets 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 tablets 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 tablets 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.

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 tablets 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.

Important information about some of the ingredients of Allegron tablets

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

3) How to 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 25mg three or four times daily or the dose may be given once a day, usually at night.

The dose should begin at a low level, 10mg, 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 10mg three times a day.

Adolescent patients:

The usual dose is 30 to 50mg/day in divided doses.

Treatment may start with 10mg 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	44-55	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 tablets

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 or feel generally unwell.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4) 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 hearing things (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 (ECG) 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

•    peculiar taste

•    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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5)    How to store Allegron tablets

•    Keep all medicines out of the sight and reach of children.

•    Do not take your medicine after the expiry date printed on the carton, and blister label.

•    If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

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

6)    Further information What Allegron tablets contain:

The active substance is nortriptyline hydrochloride.

Each film-coated tablet contains the active ingredient nortriptyline hydrochloride equivalent to 25mg nortriptyline base.

The other ingredients are: lactose, calcium phosphate, maize starch, magnesium stearate, sunset yellow lake (E110), hypromellose, ethylcellulose and glycerol.

What Allegron tablets looks like and contents of the pack

The tablets are round, orange, film-coated with a scoreline on one side and plain on the other.

Allegron tablets are available as blister packs of 25 and 100 tablets.

PL 10383/1821 Allegron 25mg Tablets    _i_

Paxtibi 25mg Tablets    POM|

Nortriptyline Hydrochloride 25 mg Tablets.

Who makes and repackages your medicine?

Your medicine is manufactured by Laboratorios Biomed S.L., C/Licorers, 169170 Nave 14, Poligono Ca'n Robiols, E07141 Marratxi (Islas Baleares),

Spain. Procured from within the EU and repackaged by Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Leaflet date: 22.05.2014

Allegron® is a registered trademark of King Pharmaceuticals Ltd., Ireland.