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Document: leaflet MAH GENERIC_PL 21880-0151 change

• leaflet MAH GENERIC_PL 20046-0305
• leaflet MAH GENERIC_PL 21880-0151
• leaflet MAH GENERIC_PL 43945-0012

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PATIENT INFORMATION LEAFLET

Nortriptyline 10mg Film-coated tablets Nortriptyline 25mg Film-coated tablets

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 Nortriptyline Tablets are and what they are used for

2.    Before you take Nortriptyline Tablets

3.    How to take Nortriptyline Tablets

4.    Possible Side effects.

5.    How to store Nortriptyline Tablets

6.    Contents of pack and other information

1.    WHAT NORTRIPTYLINE TABLETS ARE AND WHAT THEY ARE USED FOR

This medicine contains nortriptyline.

Nortriptyline Tablets are used in the treatment of symptoms of depression. Nortriptyline Tablets may also be used for the treatment of bedwetting in children 6 years and older.

2.    BEFORE YOU TAKE NORTRIPTYLINE TABLETS:

Do not take Nortriptyline if you are:

•    you are allergic (hypersensitive) to Nortriptyline or any of the other ingredients of Nortriptyline 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 Nortriptyline Tablets

•    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 Nortriptyline 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 Nortriptyline 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:

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 these points 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 Nortriptyline 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 Nortriptyline Tablets. Your doctor will be able to decide what is suitable for you.

Driving and using machines

Nortriptyline 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 Nortriptyline Tablets affect your ability to drive or use machines, tell your doctor immediately.

Important information about some of the ingredients of Nortriptyline Tablets

Nortriptyline Tablets contain lactose. If you are lactose intolerant, contact your doctor before taking this medicine. Nortriptyline 25 mg Tablets contain sunset yellow (E 110), which may cause allergic reactions

3. How to take Nortriptyline Tablets

Always take Nortriptyline 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).

If you forget to take Nortriptyline 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 Nortriptyline 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, Nortriptyline 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

•    co-ordination 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)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system 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 NORTRIPTYLINE 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.

6. CONTENTS OF PACK AND OTHER INFORMATION What Nortriptyline Tablets contain:

The active substance is nortriptyline hydrochloride. Each tablet contains the equivalent to 10mg or 25mg of nortriptyline base.

The other ingredients are:

Nortriptyline 10 mg

Lactose Monohydrate, Anhydrous Calcium Hydrogen Phosphate, Maize Starch, Magnesium Stearate, Hypromellose (HPMC E-5), Macrogol (PEG 6000).

Nortriptyline 25 mg

Lactose Monohydrate, Anhydrous Calcium Hydrogen Phosphate, Maize Starch, Magnesium Stearate, Hypromellose (HPMC E-5), Macrogol (PEG 6000), Sunset Yellow Lake (E-110) and Titanium dioxide (E-171).

What Nortriptyline Tablets looks like and contents of the pack

Nortriptyline 10 mg Tablets are white to off coloured, round biconvex, film-coated tablets, debossed with ‘N’ on one side and 10 on other side.

Nortriptyline 25 mg Tablets are orange coloured, round biconvex, film-coated tablets, debossed with ‘N25’ on one side and scored on other side.

The Tablets are available in PVC/aluminium blister packs of 10s, 30s, 100s.

The Tablets are available in HDPE container with Polypropylene screw on cap pack size: 100 tablets.

Discard 60 days after first opening the container

Nortriptyline 10mg tablets: PL 21880/0150 Nortriptyline 25mg tablets: PL 21880/0151

This leaflet was last revised on March 2015 0150-0151/PIL/0001/I

IPOMI

Marketing Authorisation Holder and Manufacturer:

MMEDREICH PLC

Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK E-mail : info@medreich.co.uk

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