Ref: 0505/040315/2/F

Allegron 25mg Tablets

(nortriptyline hydrochloride)

Patient Information Leaflet

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:

^ What Allegron tablets are and what they are used for Before you take Allegron tablets How to take Allegron tablets [4) Possible side effects

How to store Allegron tablets Further information

[1) What Allegron tablets are and what they are used for

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

Allegron tablets may also be used for the treatment of bed-wetting in children 6 years and older.

[2) Before you take Allegron tablets

Do not take Allegron tablets if

*    you are allergic (hypersensitive) to nortriptyline hydrochloride 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.

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 25mg tablets contain sunset yellow (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)

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.

Patient Information Leaflet (continued)

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.

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 (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.

*    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

Expiry date

Do not use this medicine after the expiry date shown on the blister label or carton label. If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to. If your tablets becomes discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.

Storing your medicine

*    Keep out of the sight and reach of children

_*    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.

Important

Remember this medicine is for you. It can only be prescribed by a doctor. Never give your medicine to other people.

It may harm them, even if their symptoms are the same as yours. This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. He/she will have addtional information about this medicine and will be able to advise you.

Further information

What Allegron tablets contain:

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

The inactive ingredients are magnesium stearate, lactose, calcium phosphate, Sunset yellow lake E110, maize starch, ethylcellulose, hypromellose, glycerol.

What Allegron tablets looks like and contents of the pack

Your medicine is called Allegron 25mg Tablets but will be referred to as Allegron throughout this leaflet. They are round orange film-coated tablets with a scoreline on one side and plain on the other.

Allegron tablets comes in blister packs of 25 and 100 tablets.

Manufacturer and Licence Holder

The tablets are manufactured by Laboratorios BIOMED S.L. C/Licorers, 169-170 Nave 14, Poligon Ca'n Robiols, E-07141 Marratxi, Spain and procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM PL Number: 15184/0505

Allegron is a registered trademark of King Pharmaceuticals Ltd. Revision date: 04/03/15

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Patient Information Leaflet

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:

What Paxtibi tablets are and what they are used for Before you take Paxtibi tablets ^ How to take Paxtibi tablets ^ Possible side effects ^ How to store Paxtibi tablets

*    6^ Further information

What Paxtibi tablets are and what they are used for

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

Paxtibi tablets may also be used for the treatment of bed-wetting in children 6 years and older.

[2) Before you take Paxtibi tablets

Do not take Paxtibi tablets if

*    you are allergic (hypersensitive) to nortriptyline hydrochloride or any of the other ingredients of Paxtibi 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 Paxtibi 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 Paxtibi 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 Paxtibi 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 Paxtibi 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 Paxtibi tablets. Your doctor will be able to decide what is suitable for you.

Driving and using machines

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

Important information about some of the ingredients of Paxtibi tablets

Paxtibi tablets contain lactose. If you are lactose intolerant contact your doctor before taking this medicine.

Paxtibi 25mg tablets contain sunset yellow (E110), which may cause allergic reactions.

[3) How to take Paxtibi tablets

Always take Paxtibi 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)

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.

Patient Information Leaflet (continued)

If you take more Paxtibi 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 Paxtibi 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 Paxtibi 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.

Possible side effects

Like all medicines, Paxtibi 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 (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.

_*    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.

[0 How to store Paxtibi tablets

Expiry date

Do not use this medicine after the expiry date shown on the blister label or carton label. If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to. If your tablets becomes discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.

Storing your medicine

*    Keep out of the sight and reach of children

_*    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.

Important

Remember this medicine is for you. It can only be prescribed by a doctor. Never give your medicine to other people.

It may harm them, even if their symptoms are the same as yours. This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. He/she will have addtional information about this medicine and will be able to advise you.

[m Further information

What Paxtibi tablets contain:

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

The inactive ingredients are magnesium stearate, lactose, calcium phosphate, Sunset yellow lake E110, maize starch, ethylcellulose, hypromellose, glycerol.

What Paxtibi tablets looks like and contents of the pack

Your medicine is called Paxtibi 25mg Tablets but will be referred to as Paxtibi throughout this leaflet.

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

Paxtibi tablets comes in blister packs of 25 and 100 tablets.

Manufacturer and Licence Holder

The tablets are manufactured by Laboratorios BIOMED S.L. C/Licorers, 169-170 Nave 14, Poligon Ca'n Robiols, E-07141 Marratxi, Spain and procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

| POM | PL Number: 15184/0505

Paxtibi is a registered trademark of King Pharmaceuticals Ltd.

Revision date: 04/03/15

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Nortriptyline Hydrochloride 25mg Tablets

Ref: 0505/040315/3/F

Patient Information Leaflet

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:

What Nortriptyline Hydrochloride tablets are and what they are used for Before you take Nortriptyline Hydrochloride tablets How to take Nortriptyline Hydrochloride tablets [4) Possible side effects

How to store Nortriptyline Hydrochloride tablets .6^ Further information

What Nortriptyline Hydrochloride tablets are and what they are used for

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

Nortriptyline Hydrochloride tablets may also be used for the treatment of bed-wetting in children 6 years and older.

^ Before you take Nortriptyline Hydrochloride tablets

Do not take Nortriptyline Hydrochloride tablets if

*    you are allergic (hypersensitive) to nortriptyline hydrochloride or any of the other ingredients of Nortriptyline Hydrochloride 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 Hydrochloride 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 Hydrochloride 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 Hydrochloride 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 Nortriptyline Hydrochloride 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 Hydrochloride tablets. Your doctor will be able to decide what is suitable for you.

Driving and using machines

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

Important information about some of the ingredients of Nortriptyline Hydrochloride tablets

Nortriptyline Hydrochloride tablets contain lactose. If you are lactose intolerant contact your doctor before taking this medicine.

Nortriptyline Hydrochloride 25mg tablets contain sunset yellow (E110), which may cause allergic reactions.

How to take Nortriptyline Hydrochloride tablets

Always take Nortriptyline Hydrochloride 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)

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.