B How to store Amitriptyline tablets

Keep this medicine out of the sight and reach of chi Idren. Store below 25°C in a dry place, protected from light.

Do not use AmitriptyI ine tablets after the expiry date stated on the carton. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicine you no longer use. These measures will help protect the environment.

B Contents of the pack and other information

What Amitriptyline tablets contain

The active substance is amitriptyline hydrochloride.

Each tablet contains either 10mg, 25mg or 50mg of the active ingredient.

The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), maize starch, colloidal anhydrous silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol.

The 10mg tablet also contains: indigo carmine (E132).

The 25mg tablet also contains: talc (E553b), quinoline yellow (E104), iron oxide (E172), sunset yellow (E110), indigo carmine (El 32).

The 50mg tablet also contains: talc (E553b), quinoline yellow (E104), iron oxide (E172).

What Amitriptyline tablets look like and contents of the pack

Amitriptyline 10mg tablets are blue film-coated tablets.

Amitriptyline 25mg tablets are yellow, circular, biconvex,film-coated tablets impressed 'Con one face and the identifying letters AB'on the reverse.

Amitriptyline 50mg tablets are tan film-coated tablets.

Pack sizes are 28 tablets

Marketing Authorisation Holder and Manufacturer: Accord, Barnstaple, EX32 8NS, UK.

This leaflet was last revised in March 2021

If you would like a leaflet with larger text, please contact 01271 385257.

Package leaflet: Information for the patient

Amitriptyline lOmg, 25mg and 50mg tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• Ifyou have anyfurtherques­tions.askyour doctor or pharmacist
• This medicine has been prescribed foryou only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• Ifyou get any side effects, talk to your doctor or pharmacist This includes any possible side effects not listed in this leaflet See section 4.

What is in this leaflet

• □ What Amitriptyline tablets are and what they are used for

H

What you need to know before you take Amitriptyline tablets

e] how to take amitriptyline tablets

□ possible side effects

B How to store Amitriptyline tablets

0 Contents of the pack and other information

• □ What Amitriptyline tablets are and what they are used for

Amitriptyline belongs toa group of medicines called tricyclic antidepressant drugs. This medicine is used to treat: ♦ Depression in adults (major depressive episodes) ♦ Neuropathic pain in adults

• ♦ Chronic tension type headache prophylaxis in adults

• ♦ Migraine prophylaxis in adults

• ♦ Bed-wetting at night in children aged 6 years and above, only when organic causes, such as spina bifida and related disorders, have been excluded and no response has been achieved to a II other non-drug and drug treatments, including muscle relaxants and desmopressin.This medicine should only be prescribed by doctors with expertise in treating patients with persistent bed-wetting.

H What you need to know before you take Amitriptyline tablets

Do nottake Amitriptyline tablets ifyou or your child (if they are the patient):

• ♦ are allergic to amitriptyline or any of the other ingredients of this medicine (listed in section 6)

• ♦ recently have had a heart attack (myocardial infarction)

• ♦ have heart problems such as disturbances in heart rhythm which are seen on an electrocardiogram (ECG), heart block, or coronary artery disease

• ♦ are taking medicines known as monoamine oxidase inhibitors (MAOIs)

• ♦ have taken MAOIs within the last 14 days. Ifyou are treated with Amitriptyline tablets you have to stop taking this medicine and wait for 14 days before you start treatment with a MAOI

• ♦ have taken moclobemide the day before

• ♦ have a severe liver disease.

This medicine should not be used for children below 6 years of age.

Warnings and precautions

Ta Ik to your doctor or pharmacist before taking Amitriptyline tablets.

Heart rhythm disorders and hypotension may occur if you receive a high dosage of amitriptyline. This might also occur in usual doses ifyou have pre-existing heart disease.

The use of Buprenorphine together with Amitriptyline tablets can lead to serotonin syndrome, a potentially life threatening condition (see'Other medicinesand Amitriptyline tablets').

Prolonged QT interval

A heart problem called „prolonged QTinterval“(which is shown on your electrocardiogram, ECG) and heart rhythm disorders (rapid or irregular heart beat) have been reported with Amitriptyline tablets. Tell your doctor ifyou: ♦ have slow heart rate

• ♦ have or had a problem where your heart cannot pump the blood around your body as well as it should (a condition called heart failure)

• ♦ are taking any other medication that may cause heart problems

• ♦ have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood

• ♦ have a surgery planned as it might be necessary to stop the treatment with amitriptyline before you are given anaesthetics. In the case of acute surgery, the anaesthetist should be informed about the treatment of amitriptyline

• ♦ have an over-active thyroid gland or receive thyroid medication.

Thoughts of suicide and worsening of your depression

Ifyou are depressed, 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:

• ♦ Ifyou have previously had thoughts about killing or harming yourself.

• ♦ Ifyou are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.

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

You may find it helpful to tell a relative or close friend that you are depressed, 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.

Episodes of mania

Some patients with manic-depressive illness may enter into a manic phase. This is characterised by profuse and rapidly changing ideas, exaggerated gaiety a nd excessive physical activity. In such cases, it is important to contact your doctor who probably will change your medication.

Tell your doctor ifyou have, or have had in the past, any medical problems, especially ifyou have:

• ♦ narrow angle glaucoma (loss of vision due to abnormally high pressure in the eye)

• ♦ epilepsy, a history of convulsions orfits

• ♦ difficulty in passing urine

• ♦ enlarged prostate

• ♦ thyroid disease

• ♦ bi polar disorder _. .

Continued over page

• ♦ schizophrenia

• ♦ severe heart disease

• ♦ severe liver disease

• ♦ pylorus stenosis (narrowing of the gastric outlet) and paralytic ileus (blocked intestine)

• ♦ diabetes, as you might need an adjustment of your antidiabetic medicine

• ♦ phaeochromocytoma (a rare tumour of the adrenal gland).

If you use antidepressants such as SSRIs,your doctor might consider changing the dose of your medicine (see also section 2'Other medicines and Amitriptyli ne tablets'and section 3 ‚How to take Amitriptyline tablets‘)

The elderly are more likely to suffer from certain side effects, such as dizziness when you stand up due to low blood pressure (see also section 4'Possible side effects').

Children and adolescents

Depression, neuropathic pain, chronic tension type headache and migraine prophylaxis

Do not give this medicine to children and adolescents aged below 18 years for these treatments, as safety a nd efficacy have not been established in this age group.

Bed-wetting at night

• ♦ An ECG should be performed prior to initiating therapy with amitriptyline to exclude long QT syndrome

• ♦ This medicine should not be taken at the same time as an anticholinergic drug (seealso section 2'Other medicines and Amitriptyline tablets')

• ♦ Suicidal thoughts and behaviours may also develop during early treatment with a ntidepressants for disorders other than depression; the same precautions observed when treating patients with depression should therefore be followed when treating patients with enuresis.

Other medicines and Amitriptyline tablets

Some medicines may affect the action of other medicines and this can sometimes cause serious side effects.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, such as:

• ♦ monoamine oxidase inhibitors (MAOIs) e.g. phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine (used to treat depression) or selegiline (used to treat Parkinson's di­sease). These should not be taken at the same time as Amitriptyline tablets (see section 2'Do not take Amitriptyline tablets')

• ♦ ad renal Ine, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (these may be present in cough or cold medicine, and in some anaesthetics)

• ♦ medicine to treat high blood pressure, for example calcium-channel blockers (e.g.diltiazem and verapamil), guanethidine, betanidine,clo­nidine, reserpine and methyldopa

• ♦ anticholinergic­drugs such ascertain medicines to treat Parkinson's disease and gastrointestinal disorders (e.g. atropine, hyoscyamine)

• ♦ thioridazine (used to treat schizophrenia)

• ♦ nefopam,tramadol and morphine (painkillers)

• ♦ buprenorphine (a drug used for severe pain or opioid drug addiction). This medicine may interact with amitriptyline and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms

• ♦ medicines to treat fungal infections (e.g. fluconazole, terbinafine, ketoconazole, and itraconazole)

• ♦ sedatives (e.g. barbiturates)

• ♦ antidepressants (e.g. SSRIs (fluoxetine, paroxetine, fluvoxamine),and bupropion)

• ♦ medicines for certain heart conditions (e.g. beta blockers and antiarrhythmics)

• ♦ cimetidine (used to treat stomach ulcers)

• ♦ methylphenidate (used to treat ADHD)

• ♦ ritonavir (used to treat HIV)

• ♦ oral contraceptives

• ♦ rifampicin (to treat infections)

• ♦ phenytoin and carbamazepine (used to treat epilepsy)

• ♦ St. John's Wort (Hypericum perforatum] -a herbal remedy used for depression

• ♦ thyroid medication

• ♦ baclofen (muscle relaxant)

• ♦ nitrate tablets placed under the tongue, such as glyceryl trinitrate, used to treat angina

• ♦ valproic acid.

You should also tell your doctor if you take or have recently taken medicine that may affect the heart's rhythm, such as: ♦ medicines totreat irregular heartbeats (e.g. quinidine and sotalol)

• ♦ asternizole and terfenadine (used totreat allergies and hayfever)

• ♦ medicines used to treat some mental illnesses (e.g. pimozide and sertindole)

• ♦ cisapride (used to treat certain types of indigestion)

• ♦ halofantrine (used totreat malaria)

• ♦ methadone (used to treat pain and for detoxification)

• ♦ diuretics ("water tablets"e.g.fu­rosemide).

If you are going to have an operation and receive general or local anaesthetics, you should tel I your doctor that you a re taking this medicine.

Likewise, you should tell your dentist that you take this medicine if you are to receive a local anaesthetic.

Amitriptyline tablets with alcohol

It is not advised to drin k alcohol d uring treatment with this medicine as it might increase the sedative effect.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Amitriptyline is not recommended during pregnancy unless your doctor considers it clearly necessary and only after careful consideration of the benefit and risk. If you have taken this medicine during the last part of the pregnancy, the newborn may have withdrawal symptoms such as irritability, increased muscle tension, tremor, irregular breathing, poor drinking, loud crying, urinary retention, and constipation.

Your doctor will advise you whether to start, continue or stop breast-feeding,or stop using this medicine taking into account the benefit of breast-feeding foryour child and the benefit of therapy for you.

Driving and using machines

This medicine may cause drowsiness and dizziness, especially in the beginning of the treatment. Do not drive or work with tools or machinery if you are affected.

Amitriptyline tablets contain lactose and sunset yellow

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.

The 25mg tablets also contain a colour called'sunset yellow' which may cause allergic reactions.

0 How to take Amitriptyline tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Not all dosage schemes can be achieved with all the pharmaceutical forms/strengths. The appropriate formulation/ strength should be selected for the starting doses and any subsequent dose increases.

Depression Adults

The recommended initial dose is 25mg two times daily.

Depending on the response to the medicine, your doctor may gradually increase the dose to 150mg per day divided in two doses.

Elderly (above 65 years of age) and patients with cardiovascular disease

The recommended initial dose is 10mg – 25mg daily.

Depending on your response to the medicine, yourdoctor may gradually increase the dose to a total daily dose of 10Omg divided in two doses.

If you receive doses in the range of 10Omg –150mg, your doctor may need to do more frequent fol lew-ups with you.

Use in children and adolescents

This medicine should not be given to children or adolescents for treatment of depression. Forfurther information please see section 2 ‚Do not take Amitriptyli ne tablets.‘

Neuropathic pain, chronic tension type headache and migraine prophylaxis

Your doctor will adjust the medication according to your symptoms and your response to the treatment.

Adults

The recommended initial dose is 10mg –25mg in the evening.

The recommended daily dose is 25mg-75mg.

Depending on your response to the medicine, your doctor may gradually increase the dose. If you receive doses above 1OOmg daily, your doctor may need to do more frequent follow-ups with you. Your doctor will instruct you whether to take the doses once daily or divide into two doses.

Elderly (above 65 years of age) and patients with cardiovascular disease

The recommended initial dose is 10mg –25mg in the evening.

Depending on your response to the medicine, your doctor may gradually increase the dose. If you receive doses above 75mg daily, your doctor may need to do more frequent fol low-ups with you.

Use in children and adolescents

This medicine should not be given to children or adolescents for treatments of neuropathic pain, chronic tension type headache prophylaxis and migraine prophylaxis. Forfurther information please see section 2'Do not take Amitriptyline tablets!

Bed-wetting at night

Use in children and adolescents

The recommended doses for children:

• ♦ aged below 6 years: see section 2'Do not take Amitriptyline tablets'

• ♦ aged 6 to 10 years: 10mg – 20mg daily. A suitable dosage form should be used for this age group.

• ♦ aged 11 years and above: 25mg – 50mg.

The dose should be increased gradually.

Take this medicine 1 –11/2 hours before bedtime.

Before starting treatment, your doctor wil I conduct an ECG of your heart to check for signs of an unusual heartbeat.

Your doctor wil I re-evaluate your treatment after 3 months and if needed perform a new ECG. Do not stop the treatment without consulting your doctor first.

Patients with special risks

Patients with liver diseases or people known as „poor metabolisers“ usually receive lower doses. Your doctor may take blood samples to determine the level of amitriptyline in the blood (see also section 2).

How and when to take Amitriptyline tablets

This medicine can be taken with or without food.

Swallow the tablets with a drink of water. Do not chew them.

Duration of treatment

Do not change the dose of the medicine or stop taking the medicine without consulting your doctorf irst.

Depression

As with other medicines for the treatment of depression, it may take a few weeks before you feel any improvement.

In treating depression, the duration of treatment is individual, and is usually at least 6 months. The duration of treatment is decided by your doctor.

Continue to take this medicine for as long as your doctor recommends.

The underlying illness may persistfora long time. If you stop your treatment too soon, your symptoms may return.

Neuropathic pain, chronic tension type headache and migraine prophylaxis

It might take a few weeks before you feel any improvement of your pain.

Talk to your doctor about the duration of your treatment and continue to take this medicine for as long as your doctor recommends.

Bed-wetting at night

Yourdoctor will evaluate if the treatment should be continued after 3 months.

If you take more Amitriptyline tablets than you should

Contact your doctor or nearest hospital casualty department immediately. Do this even if there are no signs of discomfort or poisoning. Take the container of this medicine with you if you go to a doctor or hospital.

Symptoms of overdose include dilated pupils, fast or irregular heartbeats, difficulties passing water, dry mouth and tongue, intestinal blockage,fits,fe­ver,agitation,con­fusion, hallucinations, uncontrolled movements, low blood pressure, weak pulse, pallor, difficulty breathing, blue discolouration of the skin, decreased heart rate, drowsiness, loss of consciousness, coma, various cardiac symptoms such as heart block, heart fa il ure, ca rd iogenic shock, metabolic acidosis, hypokalaemia, hyponatraemia.

If you forget to take Amitriptyline tablets

Take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amitriptyline tablets

Your doctor will decide when and how to stop your treatment to avoid any unpleasant symptoms that might occur if it is stopped abruptly (e.g. headache,feeling unwell, sleeplessness and irritability).

If you have anyfurtherques­tionson the use of this medicine, ask your doctor or pharmacist.

□ possible side effects

B How to store Amitriptyline tablets

0 Contents of the pack and other information

• □ What Amitriptyline tablets are and what they are used for

Amitriptyline belongs toa group of medicines called tricyclic antidepressant drugs. This medicine is used to treat: ♦ Depression in adults (major depressive episodes) ♦ Neuropathic pain in adults

• ♦ Chronic tension type headache prophylaxis in adults

• ♦ Migraine prophylaxis in adults

• ♦ Bed-wetting at night in children aged 6 years and above, only when organic causes, such as spina bifida and related disorders, have been excluded and no response has been achieved to a II other non-drug and drug treatments, including muscle relaxants and desmopressin.This medicine should only be prescribed by doctors with expertise in treating patients with persistent bed-wetting.

H What you need to know before you take Amitriptyline tablets

Do nottake Amitriptyline tablets ifyou or your child (if they are the patient):

• ♦ are allergic to amitriptyline or any of the other ingredients of this medicine (listed in section 6)

• ♦ recently have had a heart attack (myocardial infarction)

• ♦ have heart problems such as disturbances in heart rhythm which are seen on an electrocardiogram (ECG), heart block, or coronary artery disease

• ♦ are taking medicines known as monoamine oxidase inhibitors (MAOIs)

• ♦ have taken MAOIs within the last 14 days. Ifyou are treated with Amitriptyline tablets you have to stop taking this medicine and wait for 14 days before you start treatment with a MAOI

• ♦ have taken moclobemide the day before

• ♦ have a severe liver disease.

This medicine should not be used for children below 6 years of age.

Warnings and precautions

Ta Ik to your doctor or pharmacist before taking Amitriptyline tablets.

Heart rhythm disorders and hypotension may occur if you receive a high dosage of amitriptyline. This might also occur in usual doses ifyou have pre-existing heart disease.

The use of Buprenorphine together with Amitriptyline tablets can lead to serotonin syndrome, a potentially life threatening condition (see'Other medicinesand Amitriptyline tablets').

Prolonged QT interval

A heart problem called „prolonged QTinterval“(which is shown on your electrocardiogram, ECG) and heart rhythm disorders (rapid or irregular heart beat) have been reported with Amitriptyline tablets. Tell your doctor ifyou: ♦ have slow heart rate

• ♦ have or had a problem where your heart cannot pump the blood around your body as well as it should (a condition called heart failure)

• ♦ are taking any other medication that may cause heart problems

• ♦ have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood

• ♦ have a surgery planned as it might be necessary to stop the treatment with amitriptyline before you are given anaesthetics. In the case of acute surgery, the anaesthetist should be informed about the treatment of amitriptyline

• ♦ have an over-active thyroid gland or receive thyroid medication.

Thoughts of suicide and worsening of your depression

Ifyou are depressed, 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:

• ♦ Ifyou have previously had thoughts about killing or harming yourself.

• ♦ Ifyou are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.

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

You may find it helpful to tell a relative or close friend that you are depressed, 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.

Episodes of mania

Some patients with manic-depressive illness may enter into a manic phase. This is characterised by profuse and rapidly changing ideas, exaggerated gaiety a nd excessive physical activity. In such cases, it is important to contact your doctor who probably will change your medication.

Tell your doctor ifyou have, or have had in the past, any medical problems, especially ifyou have:

• ♦ narrow angle glaucoma (loss of vision due to abnormally high pressure in the eye)

• ♦ epilepsy, a history of convulsions orfits

• ♦ difficulty in passing urine

• ♦ enlarged prostate

• ♦ thyroid disease

• ♦ bi polar disorder _. .

Continued over page

• ♦ schizophrenia

• ♦ severe heart disease

• ♦ severe liver disease

• ♦ pylorus stenosis (narrowing of the gastric outlet) and paralytic ileus (blocked intestine)

• ♦ diabetes, as you might need an adjustment of your antidiabetic medicine

• ♦ phaeochromocytoma (a rare tumour of the adrenal gland).

If you use antidepressants such as SSRIs,your doctor might consider changing the dose of your medicine (see also section 2'Other medicines and Amitriptyli ne tablets'and section 3 ‚How to take Amitriptyline tablets‘)

The elderly are more likely to suffer from certain side effects, such as dizziness when you stand up due to low blood pressure (see also section 4'Possible side effects').

Children and adolescents

Depression, neuropathic pain, chronic tension type headache and migraine prophylaxis

Do not give this medicine to children and adolescents aged below 18 years for these treatments, as safety a nd efficacy have not been established in this age group.

Bed-wetting at night

• ♦ An ECG should be performed prior to initiating therapy with amitriptyline to exclude long QT syndrome

• ♦ This medicine should not be taken at the same time as an anticholinergic drug (seealso section 2'Other medicines and Amitriptyline tablets')

• ♦ Suicidal thoughts and behaviours may also develop during early treatment with a ntidepressants for disorders other than depression; the same precautions observed when treating patients with depression should therefore be followed when treating patients with enuresis.

Other medicines and Amitriptyline tablets

Some medicines may affect the action of other medicines and this can sometimes cause serious side effects.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, such as:

• ♦ monoamine oxidase inhibitors (MAOIs) e.g. phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine (used to treat depression) or selegiline (used to treat Parkinson's di­sease). These should not be taken at the same time as Amitriptyline tablets (see section 2'Do not take Amitriptyline tablets')

• ♦ ad renal Ine, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (these may be present in cough or cold medicine, and in some anaesthetics)

• ♦ medicine to treat high blood pressure, for example calcium-channel blockers (e.g.diltiazem and verapamil), guanethidine, betanidine,clo­nidine, reserpine and methyldopa

• ♦ anticholinergic­drugs such ascertain medicines to treat Parkinson's disease and gastrointestinal disorders (e.g. atropine, hyoscyamine)

• ♦ thioridazine (used to treat schizophrenia)

• ♦ nefopam,tramadol and morphine (painkillers)

• ♦ buprenorphine (a drug used for severe pain or opioid drug addiction). This medicine may interact with amitriptyline and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms

• ♦ medicines to treat fungal infections (e.g. fluconazole, terbinafine, ketoconazole, and itraconazole)

• ♦ sedatives (e.g. barbiturates)

• ♦ antidepressants (e.g. SSRIs (fluoxetine, paroxetine, fluvoxamine),and bupropion)

• ♦ medicines for certain heart conditions (e.g. beta blockers and antiarrhythmics)

• ♦ cimetidine (used to treat stomach ulcers)

• ♦ methylphenidate (used to treat ADHD)

• ♦ ritonavir (used to treat HIV)

• ♦ oral contraceptives

• ♦ rifampicin (to treat infections)

• ♦ phenytoin and carbamazepine (used to treat epilepsy)

• ♦ St. John's Wort (Hypericum perforatum] -a herbal remedy used for depression

• ♦ thyroid medication

• ♦ baclofen (muscle relaxant)

• ♦ nitrate tablets placed under the tongue, such as glyceryl trinitrate, used to treat angina

• ♦ valproic acid.

You should also tell your doctor if you take or have recently taken medicine that may affect the heart's rhythm, such as: ♦ medicines totreat irregular heartbeats (e.g. quinidine and sotalol)

• ♦ asternizole and terfenadine (used totreat allergies and hayfever)

• ♦ medicines used to treat some mental illnesses (e.g. pimozide and sertindole)

• ♦ cisapride (used to treat certain types of indigestion)

• ♦ halofantrine (used totreat malaria)

• ♦ methadone (used to treat pain and for detoxification)

• ♦ diuretics ("water tablets"e.g.fu­rosemide).

If you are going to have an operation and receive general or local anaesthetics, you should tel I your doctor that you a re taking this medicine.

Likewise, you should tell your dentist that you take this medicine if you are to receive a local anaesthetic.

Amitriptyline tablets with alcohol

It is not advised to drin k alcohol d uring treatment with this medicine as it might increase the sedative effect.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Amitriptyline is not recommended during pregnancy unless your doctor considers it clearly necessary and only after careful consideration of the benefit and risk. If you have taken this medicine during the last part of the pregnancy, the newborn may have withdrawal symptoms such as irritability, increased muscle tension, tremor, irregular breathing, poor drinking, loud crying, urinary retention, and constipation.

Your doctor will advise you whether to start, continue or stop breast-feeding,or stop using this medicine taking into account the benefit of breast-feeding foryour child and the benefit of therapy for you.

Driving and using machines

This medicine may cause drowsiness and dizziness, especially in the beginning of the treatment. Do not drive or work with tools or machinery if you are affected.

Amitriptyline tablets contain lactose and sunset yellow

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.

The 25mg tablets also contain a colour called'sunset yellow' which may cause allergic reactions.

0 How to take Amitriptyline tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Not all dosage schemes can be achieved with all the pharmaceutical forms/strengths. The appropriate formulation/ strength should be selected for the starting doses and any subsequent dose increases.

Depression Adults

The recommended initial dose is 25mg two times daily.

Depending on the response to the medicine, your doctor may gradually increase the dose to 150mg per day divided in two doses.

Elderly (above 65 years of age) and patients with cardiovascular disease

The recommended initial dose is 10mg – 25mg daily.

Depending on your response to the medicine, yourdoctor may gradually increase the dose to a total daily dose of 10Omg divided in two doses.

If you receive doses in the range of 10Omg –150mg, your doctor may need to do more frequent fol lew-ups with you.

Use in children and adolescents

This medicine should not be given to children or adolescents for treatment of depression. Forfurther information please see section 2 ‚Do not take Amitriptyli ne tablets.‘

Neuropathic pain, chronic tension type headache and migraine prophylaxis

Your doctor will adjust the medication according to your symptoms and your response to the treatment.

Adults

The recommended initial dose is 10mg –25mg in the evening.

The recommended daily dose is 25mg-75mg.

Depending on your response to the medicine, your doctor may gradually increase the dose. If you receive doses above 1OOmg daily, your doctor may need to do more frequent follow-ups with you. Your doctor will instruct you whether to take the doses once daily or divide into two doses.

Elderly (above 65 years of age) and patients with cardiovascular disease

The recommended initial dose is 10mg –25mg in the evening.

Depending on your response to the medicine, your doctor may gradually increase the dose. If you receive doses above 75mg daily, your doctor may need to do more frequent fol low-ups with you.

Use in children and adolescents

This medicine should not be given to children or adolescents for treatments of neuropathic pain, chronic tension type headache prophylaxis and migraine prophylaxis. Forfurther information please see section 2'Do not take Amitriptyline tablets!

Bed-wetting at night

Use in children and adolescents

The recommended doses for children:

• ♦ aged below 6 years: see section 2'Do not take Amitriptyline tablets'

• ♦ aged 6 to 10 years: 10mg – 20mg daily. A suitable dosage form should be used for this age group.

• ♦ aged 11 years and above: 25mg – 50mg.

The dose should be increased gradually.

Take this medicine 1 –11/2 hours before bedtime.

Before starting treatment, your doctor wil I conduct an ECG of your heart to check for signs of an unusual heartbeat.

Your doctor wil I re-evaluate your treatment after 3 months and if needed perform a new ECG. Do not stop the treatment without consulting your doctor first.

Patients with special risks

Patients with liver diseases or people known as „poor metabolisers“ usually receive lower doses. Your doctor may take blood samples to determine the level of amitriptyline in the blood (see also section 2).

How and when to take Amitriptyline tablets

This medicine can be taken with or without food.

Swallow the tablets with a drink of water. Do not chew them.

Duration of treatment

Do not change the dose of the medicine or stop taking the medicine without consulting your doctorf irst.

Depression

As with other medicines for the treatment of depression, it may take a few weeks before you feel any improvement.

In treating depression, the duration of treatment is individual, and is usually at least 6 months. The duration of treatment is decided by your doctor.

Continue to take this medicine for as long as your doctor recommends.

The underlying illness may persistfora long time. If you stop your treatment too soon, your symptoms may return.

Neuropathic pain, chronic tension type headache and migraine prophylaxis

It might take a few weeks before you feel any improvement of your pain.

Talk to your doctor about the duration of your treatment and continue to take this medicine for as long as your doctor recommends.

Bed-wetting at night

Yourdoctor will evaluate if the treatment should be continued after 3 months.

If you take more Amitriptyline tablets than you should

Contact your doctor or nearest hospital casualty department immediately. Do this even if there are no signs of discomfort or poisoning. Take the container of this medicine with you if you go to a doctor or hospital.

Symptoms of overdose include dilated pupils, fast or irregular heartbeats, difficulties passing water, dry mouth and tongue, intestinal blockage,fits,fe­ver,agitation,con­fusion, hallucinations, uncontrolled movements, low blood pressure, weak pulse, pallor, difficulty breathing, blue discolouration of the skin, decreased heart rate, drowsiness, loss of consciousness, coma, various cardiac symptoms such as heart block, heart fa il ure, ca rd iogenic shock, metabolic acidosis, hypokalaemia, hyponatraemia.

If you forget to take Amitriptyline tablets

Take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amitriptyline tablets

Your doctor will decide when and how to stop your treatment to avoid any unpleasant symptoms that might occur if it is stopped abruptly (e.g. headache,feeling unwell, sleeplessness and irritability).

If you have anyfurtherques­tionson the use of this medicine, ask your doctor or pharmacist.

□ possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you getany of the following symptoms you should see your doctor immediately: ♦ Signsofa severe allergic reaction (anaphylaxis), such as difficulty breathing or swelling of your face, I ips, throat or tongue. Not known,frequency cannot be estimated from the available data.

• ♦ Attacks of intermittent blurring of vision, rainbow vision, and eye pain. You should immediately have an eye examination before the treatment with this medicine can be continued. This condition may be signs of acute glaucoma. Very rare, may affect up to 1 in 10,000 people.

• ♦ A heart problem called „prolonged QT interval“ (which is shown on your electrocard iogram, ECG). Com mon, may affect up to 1 in 10 people.

• ♦ Bad constipation, a swollen stomach,fever and vomiting. These symptoms may be due to parts of the intestine becoming paralysed. Rare, may affect up to 1 in 1,000 people.

• ♦ Any yellowing of the skin and the white in the eyes (jaundice). Your liver may be affected. Rare, may affect up to 1 in 1,000 people.

• ♦ Bruising, bleeding, pallor or persistent sore throat and fever. These symptoms can be the first signs that your blood or bone marrow may be affected. Effects on the blood could be a decrease in the number of white cells (which help to fight infection) and platelets (which help with clotting). Rare, may affect up to 1 in 1,000 people.

• ♦ Suicidal thoughts or behaviour. Rare, may affect up to 1 in 1,000 people.