AMITRIPTYLINE 25 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

AMITRIPTYLINE

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.

• - If you have any further questions, ask your doctor or pharmacist.

• - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their sign of illness are the same as yours.

• - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

THIS LEAFLET CONTAINS

• 1. What Amitriptyline tablets are and what they are used for

2. What you need to know before you take Amitriptyline tablets

3. How to take Amitriptyline tablets

4. Possible side effects

5. How to store Amitriptyline tablets

6. Contents of the pack and other information

1. WHAT AMITRIPTYLINE TABLETS ARE AND WHAT THEY ARE USED FOR ,

Amitriptyline belongs to a group of medicines called tricyclic antidepressants.

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 all 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMITRIPTYLINE TABLETS

Do not take Amitriptyline tablets if you or your child (if they are the patient):

• are allergic to amitriptyline, other tricyclic antidepressants, or any of the other ingredients of this medicine (listed in section 6 of this leaflet)
• 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. If you 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

Talk to your doctor or pharmacist before taking Amitriptyline tablets.

armacoeHeart rhythm disorders and hypotension may occur if you receive a high dosage of amitriptyline. This might also occur in usual doses if you 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 medicines and Amitriptyline tablets’).

Prolonged QT interval

A heart problem called “prolonged QT interval” (which is shown on your electrocardiogram, ECG) and heart rhythm disorders (rapid or irregular heart beat) have been reported with amitriptyline. Tell your doctor if you:

• have slow heart rate.
• have or had a problem where your heart cannot pump the blood round your body as well as it should (a condition called heart failure).
• are taking any other medication that may cause heart problems, or
• 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

If you are depressed, you can sometimes have thoughts of harming or killing themselves. 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 a 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.

Episodes of mania

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

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

• narrow angle glaucoma (loss of vision due to abnormally high pressure in the eye
• epilepsy, a history of convulsions or fits
• difficulty in passing urine
• enlarged prostate
• thyroid disease
• bipolar disorder
• schizophrenia
• severe liver disease
• severe heart disease
• pylorus stenosis (narrowing of the gastric outlet) and paralytic ileus (blocked intestine)
• diabetes as you might need and 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 Amitriptyline 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 and 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 (see also section 2 Other medicines and Amitriptyline)
• Suicidal thoughts and behaviours may also develop during early treatment with antidepressants 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, or have recently taken 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)
• adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (these may be present in cough or cold medicine, and in some anaesthetics)
• medicines to treat high blood pressure for example calcium-channel blockers (e.g. diltiazem and verapamil), guanethidine, betanidine, clonidine, reserpine and methyldopa
• anticholinergic drugs such as certain medicines to treat Parkinson’s disease and gastrointestinal disorders (e.g. atropine, hyoscyamine)
• thioridazine (used to treat schizophrenia)
• nefopam, tramadol and morphine (painkiller)
• 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. babiturates)
• antidepressants (e.g. SSRIs (fluoxetine, paroxetine, fluvoxamine), duloxetine 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
• 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. e.g.:

• medicines to treat irregular heartbeats (e.g. quinidine and sotalol)
• astemizole and terfenadine (used to treat allergies and hayfever)
• medicines used to treat some mental health illnesses (e.g. pimozide and sertindole)
• cisapride (used to treat certain types of indigestion)
• halofantrine (used to treat 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 tell your doctor that you are taking Amitriptyline.

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 drink alcohol during 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/ stop breast-feeding, or stop using this medicine taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.

Driving and using machinery

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 10 mg Film-coated tablets contains lactose If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine.

Amitriptyline 25 mg Film-coated tablets contains lactose and sunset yellow

If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine. Amitriptyline 25 mg Film-coated Tablets also contain a colour ‘sunset yellow’ which may cause allergic reactions.

3. 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 25 mg two times daily.

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

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

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

Depending on your response to the medicine, your doctor may gradually increase the dose to a total daily dose of 100 mg divided in two doses.

If you receive doses in the range of 100 mg – 150 mg, your doctor may need to do more frequent follow-up with you.

Use in children and adolescents

This medicine should not be given to children or adolescents for treatment of depression. For further information please see section 2 ‘Do not take Amitriptyline 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 10 mg – 25 mg in the evening.

The recommended daily dose is 25 mg – 75 mg.

Depending on your response to the medicine, your doctor may gradually increase the dose. If you receive doses above 100 mg daily, your doctor may need to do more frequent follow-up 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 10 mg – 25 mg in the evening. Depending on your response to the medicine, your doctor may gradually increase the dose. If you receive doses above 75 mg daily, your doctor may need to do more frequent follow-up 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. For further information please see section 2.

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: 10 mg – 20 mg daily. A suitable dosage form should be used for this age group.
• aged 11 years and over: 25 mg to 50 mg.

The dose should be increased gradually.

Take this medicine 1–1% hours before bedtime.

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

Your doctor will 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 doctor first.

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 persist for a 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 your 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

Your doctor 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 an overdose may include:

• dilated pupils
• fast or irregular heartbeats
• difficulties passing water
• dry mouth and tongue
• intestinal blockage harmacode fits
• agitation
• confusion
• hallucinations
• uncontrolled movement
• slow 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 failure, hypotension, cardiogenic shock, metabolic acidosis, hypokalemia.

Overdose with amitriptyline in children could have serious consequences. Children are especially susceptible to coma, cardiac symptoms, difficulty in breathing, seizures, low blood sodium level, lethargy, drowsiness, nausea, vomiting and high blood sugar level.

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

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any of the following symptoms you should see your doctor immediately:

• Signs of a severe allergic reaction (anaphylaxis), such as difficulty breathing or swelling of your face, lips, 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 side effect, may affect up to 1 in 10,000 people.

• A heart problem called “prolonged QT interval” (which is shown on your electrocardiogram, ECG). Common side effect, 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 side effect, 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 side effect, 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 red cells (which carry oxygen around the body), white cells (which help to fight infection) and platelets (which help with clotting). Rare side effect, may affect up to 1 in 1,000 people.

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

Side effects listed below have been reported in the following frequencies:

Very common: may affect more than 1 in 10 people

• sleepiness/drow­siness
• shakiness of hands or other body parts
• dizziness, headache, dizziness when you stand up due to low blood pressure (orthostatic hypotension)
• irregular, hard, or rapid heartbeat
• dry mouth
• constipation
• nausea
• excessive sweating
• weight gain
• lurred or slow speech
• aggression
• congested nose.

Common: may affect up to 1 in 10 people

• confusion
• sexual disturbances (decreased sex-drive, problems with erection)
• disturbance in attention
• changes in taste
• numbness or tingling in the arms or legs
• disturbed coordination
• mydriasis (dilated pupils)
• heart block
• fatigue
• low sodium concentration in the blood
• agitation
• urination disorders
• feeling thirsty.

Uncommon: may affect up to 1 in 100 people

• excitement, anxiety, difficulties sleeping, nightmares
• convulsions
• tinnitus
• increased blood pressure
• hypertension
• diarrhoea, vomiting, tongue oedema
• skin rash, nettle rash (urticarial), swelling of the face and tongue, face oedema
• difficulties passing urine
• increased production of breast milk or breast milk outflow without breast feeding
• increased pressure in the eye ball
• collapse conditions
• worsening of cardiac failure
• liver function impairment (e.g. cholestatic liver disease).

Rare: may affect up to 1 in 1,000 people

• bone marrow depression, agranulocytosis, leucopenia, eosinophilia, thrombocytopenia
• decreased appetite
• delirium (especially in elderly patients), hallucinations, suicidal thoughts or behaviour
• abnormality in the heart's rhythm, or heartbeat pattern
• swelling of the salivary glands
• alopecia (hair loss)
• photosensitivity reaction (increased sensitivity to sunlight)
• breast enlargement in men
• jaundice
• fever
• weight loss
• abnormal results of liver function tests, transaminases increased.

Very rare: may affect up to 1 in 10,000 people

• heart muscle disease
• feeling of inner restlessness and a compelling need to be in constant motion
• disorder of the peripheral nerves
• acute increase of pressure in the eye
• particular forms of abnormal heart rhythm (so called torsades de pointes)
• allergic inflammation of the lung alveoli and of the lung tissue.

Not known: frequency cannot be estimated from the available data

• absent sensation of appetite
• elevation or lowering of blood sugar levels, anorexia
• paranoia
• movement disorders (involuntary movements or decreased movements)
• hypersensitivity inflammation of heart muscle
• hepatitis (inflammation of the liver) with signs such as dark urine, weight loss and jaundice
• hot flush
• dry eyes
• stomach pain, sore mouth
• itching
• breast enlargement in women
• anaphylaxis
• angioedema
• epigastric
• distress
• stomatitis.

5. how to store amitriptyline tablets

Keep this medicine out of the sight and reach of children.

Store below 25°C and away from light. Store in the original package or container and keep the container tightly closed.

Do not use this medicine after the expiry date, which is stated on the label after EXP. 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 medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Amitriptyline Film-coated Tablets contain

The active ingredient in Amitriptyline 10 mg and 25 mg Film-coated Tablets is amitriptyline hydrochloride.

The other ingredients are lactose monohydrate, calcium hydrogen phosphate dihydrate, maize starch, microcrystalline cellulose, colloidal anhydrous silica, stearic acid, magnesium stearate, hypromellose 5cps, ethylcellulose 10cps, diethyl phthalate, hydroxypropyl cellulose (E463) and titanium dioxide (E171).

The 10 mg tablets also contain indigo carmine (E132). The 25 mg tablets also contain quinoline yellow (E104) and sunset yellow (E110).

What Amitriptyline Film-coated Tablets look like and contents of the pack

Amitriptyline 10 mg Film-coated Tablets are round, blue, film-coated tablets with the marking MP49 on one side.

Amitriptyline 25 mg Film-coated Tablets are round, yellow, film-coated tablets with the marking MP50 on one side and 25 mg on the other.

The tablets come in blister packs of 28 tablets and containers of 28, 100 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Genethics Europe Limited,

41 – 43 Klimentos, Klimentos Tower, Nicosia 1061, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

84 Pembroke Road, London, W8 6NX, UK

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 01/2022

GE0029–0030/O/PIL/GE5