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PATIENT INFORMATION LEAFLET

NORTRIPTYLINE 25MG 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.
■	This product is also available in the 10mg strength
In this leaflet:
1.	What Nortriptyline 25mg Tablets are and what they are used for
2.	Before you take Nortriptyline 25mg Tablets
3.	Howto take Nortriptyline 25mg Tablets
4.	Possible side effects
5.	How to store Nortriptyline 25mg Tablets
6.	Further information

1. WHAT NORTRIPTYLINE 25MG TABLETS ARE AND WHAT THEY ARE USED FOR

Nortriptyline 25mg Tablets contain the active ingredient nortriptyline hydrochloride, which is a tricyclic antidepressant. Nortriptyline 25mg Tablets relieve the symptoms of depression.

Nortriptyline 25mg Tablets may also be used for the treatment of bed-wetting in children 6 years and older.

2. BEFORE YOU TAKE NORTRIPTYLINE

25MG TABLETS

Do not take Nortriptyline 25mg Tablets if

■    you are allergic (hypersensitive) to nortriptyline hydrochloride or any of the other ingredients of Nortriptyline 25mg 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 25mg

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 Nortriptyline 25mg 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 25mg Tablets unless your doctor tells you to.

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

It may still be all right for you to be given Nortriptyline 25mg Tablets. Your doctor will be able to decide what is suitable for you.

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 Nortriptyline 25mg 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);

Driving and using machines

Nortriptyline 25mg 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 25mg Tablets affect your ability to drive or use machines, tell your doctor immediately.

Important information about some of the ingredients of Nortriptyline 25mg Tablets

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

3. HOW TO TAKE NORTRIPTYLINE 25MG TABLETS

Always take Nortriptyline 25mg 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.

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 Nortriptyline 25mg 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 Nortriptyline 25mg 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 25mg 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 25mg 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

■    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.qov.uk/vellowcard.

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

5. HOW TO STORE NORTRIPTYLINE 25MG TABLETS

Keep out of the sight and reach of children.

Do not use the drug after the date indicated on the carton. If your tablets show signs of deterioration or discolouration, 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 protect the environment.

6. FURTHER INFORMATION

What Nortriptyline 25mg tablets contain

The active substance is Nortriptyline hydrochloride. Each tablet contains 25mg Nortriptyline (as the hydrochloride).The other ingredients are: Lactose, calcium phosphate, starch, magnesium stearate, hydroxypropylmethylcellulose, ethylcellulose, glycerin, sunset yellow E110

What Nortriptyline 25mg tablets look like and contents of the pack

Your medicine is called Nortriptyline 25mg Tablets. Each round, orange film-coated tablet has a breakline on one side and is plain on the reverse. Nortriptyline 25mg Tablets are available as packs of 100 tablets.

Manufacturer

Nortriptyline 25mg Tablets are manufactured by Laboratorios BIOMED, S.L. Cl Licorers, 169-170 Nave 14 Poligon Ca’n Robiols, E-07141 Marratxi (Islas Baleares), Spain and is procured from within the EU by Product Licence Holder: PilsCo Ltd, 10-16 Colvilles Place, East Kilbride,

G75 OSN.

Repackaged by Cross Healthcare, Bandeath Industrial Estate, Thorsk, Stirling, FK7 7NP Leaflet revision date: 18/06/2015 PL 39467/0039