Side effects listed below have been reported in the following • hepatitis (inflammation of the liver) with signs such as dark frequencies: urine, weight loss and jaundice Very common (may affect more than 1 in 10 people): • hot flush • sleepiness/drowsiness • dry eyes Package leaflet: Information for the patient • shakiness of hands or other body parts • stomach pain, sore mouth • dizziness, headache, dizziness when you stand up due to • itching. Amitriptyline 10mg, 25mg low blood pressure (orthostatic hypotension) An increased risk of bone fractures has been observed in • irregular, hard, or rapid heartbeat patients taking this type of medicine. and 50mg tablets • dry mouth, constipation, nausea When used for the treatment of bed wetting in children, the • excessive sweating side effects are less frequent. The most common side effects Read all of this leaflet carefully before you start Warnings and precautions • weight gain are drowsiness, blurred vision, dilated pupils, constipation, Talk to your doctor or pharmacist before taking • slurred or slow speech taking this medicine because it contains important sweating, itching and dry mouth. Changes in behaviour have information for you. Amitriptyline tablets. • aggression also occurred in children receiving amitriptyline. • congested nose. • Keep this leaflet. You may need to read it again. Heart rhythm disorders and hypotension may occur if Reporting of side effects • If you have any further questions, ask your doctor or you receive a high dosage of amitriptyline. This might Common: (may affect up to 1 in 10 people): If you get any side effects, talk to your doctor, pharmacist or also occur in usual doses if you have pre-existing heart • confusion nurse. This includes any possible side effects not listed in this pharmacist. disease. • sexual disturbances (decreased sex-drive, problems with leaflet. You can also report side effects directly via the Yellow • This medicine has been prescribed for you only. Do not erection) The use of Buprenorphine together with Amitriptyline Card Scheme at www.mhra.gov.uk/yellowcard or search for pass it on to others. It may harm them, even if their tablets can lead to serotonin syndrome, a potentially • disturbance in attention MHRA Yellow Card in the Google Play or Apple App Store. signs of illness are the same as yours. • changes in taste life threatening condition (see ‘Other medicines and Amitriptyline tablets’). • numbness or tingling in the arms or legs By reporting side effects, you can help provide more • If you get any side effects, talk to your doctor or • disturbed coordination information on the safety of this medicine pharmacist. This includes any possible side effects not Prolonged QT interval • dilated pupils listed in this leaflet. See section 4. A heart problem called “prolonged QT interval” (which is • heart block 5 How to store Amitriptyline tablets shown on your electrocardiogram, ECG) and heart rhythm • fatigue What is in this leaflet disorders (rapid or irregular heart beat) have been reported • low sodium concentration in the blood Keep this medicine out of the sight and reach of children. 1 What Amitriptyline tablets are and what with Amitriptyline tablets. Tell your doctor if you: • agitation Store below 25°C in a dry place, protected from light. • have slow heart rate • urination disorders Do not use Amitriptyline tablets after the expiry date stated on they are used for • have or had a problem where your heart cannot pump the • feeling thirsty. the carton. The expiry date refers to the last day of that month. 2 What you need to know before you take blood around your body as well as it should (a condition called heart failure) Uncommon (may affect up to 1 in 100 people): Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away Amitriptyline tablets • are taking any other medication that may cause heart • excitement, anxiety, difficulties sleeping, nightmares problems • convulsions medicine you no longer use. These measures will help protect 3 How to take Amitriptyline tablets the environment. 4 • have a problem that gives you a low level of potassium or • tinnitus Possible side effects magnesium, or a high level of potassium in your blood • increased blood pressure 5 How to store Amitriptyline tablets • have a surgery planned as it might be necessary to stop • diarrhoea, vomiting 6 Contents of the pack and other 6 Contents of the pack and other the treatment with amitriptyline before you are given • skin rash, nettle rash (urticaria), swelling of the face and information anaesthetics. In the case of acute surgery, the anaesthetist tongue What Amitriptyline tablets contain information should be informed about the treatment of amitriptyline • difficulties passing urine The active substance is amitriptyline hydrochloride. • increased production of breast milk or breast milk outflow • have an over-active thyroid gland or receive thyroid Each tablet contains either 10mg, 25mg or 50mg of the active 1 What Amitriptyline tablets are and what medication. without breast feeding ingredient. • increased pressure in the eyeball they are used for The other ingredients are lactose monohydrate, Amitriptyline belongs to a group of medicines called tricyclic Thoughts of suicide and worsening of your • collapse conditions microcrystalline cellulose (E460), maize starch, colloidal antidepressant drugs. This medicine is used to treat: depression • worsening of cardiac failure anhydrous silica, magnesium stearate, hypromellose (E464), • Depression in adults (major depressive episodes) If you are depressed, you can sometimes have thoughts of • liver function impairment (e.g. cholestatic liver disease). titanium dioxide (E171), macrogol. • Neuropathic pain in adults harming or killing yourself. These may be increased when first Rare (may affect up to 1 in 1,000 people): The 10mg tablet also contains: indigo carmine (E132). • Chronic tension type headache prophylaxis in adults starting antidepressants, since these medicines all take time to • decreased appetite The 25mg tablet also contains: talc (E553b), quinoline yellow • Migraine prophylaxis in adults work, usually about two weeks but sometimes longer. • delirium (especially in elderly patients), hallucinations (E104), iron oxide (E172), sunset yellow (E110), indigo carmine • Bed-wetting at night in children aged 6 years and above, You may be more likely to think like this: • abnormality in the heart’s rhythm, or heartbeat pattern (E132). only when organic causes, such as spina bifida and related • If you have previously had thoughts about killing or harming • swelling of the salivary glands The 50mg tablet also contains: talc (E553b), quinoline yellow disorders, have been excluded and no response has been yourself. • hair loss (E104), iron oxide (E172). achieved to all other non-drug and drug treatments, • If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young • increased sensitivity to sunlight What Amitriptyline tablets look like and contents of the including muscle relaxants and desmopressin. This medicine • breast enlargement in men should only be prescribed by doctors with expertise in adults (less than 25 years old) with psychiatric conditions pack who were treated with an antidepressant. • fever Amitriptyline 10mg tablets are blue film-coated tablets. treating patients with persistent bed-wetting. • weight loss Amitriptyline 25mg tablets are yellow, circular, biconvex, film- If you have thoughts of harming or killing yourself at any time, • abnormal results of liver function tests. coated tablets impressed ‘C’ on one face and the identifying 2 What you need to know before you take contact your doctor or go to a hospital straight away. Very rare (may affect up to 1 in 10,000 people): letters ‘AB’ on the reverse. Amitriptyline tablets You may find it helpful to tell a relative or close friend that you • heart muscle disease Amitriptyline 50mg tablets are tan film-coated tablets. are depressed, and ask them to read this leaflet. You might Do not take Amitriptyline tablets if you or your child (if they • feeling of inner restlessness and a compelling need to be in Pack sizes are 28 tablets ask them to tell you if they think your depression or anxiety constant motion are the patient): • is getting worse, or if they are worried about changes in your • disorder of the peripheral nerves Marketing Authorisation Holder and Manufacturer: are allergic to amitriptyline or any of the other ingredients of behaviour. • acute increase of pressure in the eye Accord, Barnstaple, EX32 8NS, UK. this medicine (listed in section 6) • particular forms of abnormal heart rhythm (so called This leaflet was last revised in March 2021 • recently have had a heart attack (myocardial infarction) Episodes of mania torsades de pointes) • have heart problems such as disturbances in heart rhythm Some patients with manic-depressive illness may enter into • allergic inflammation of the lung alveoli and of the lung which are seen on an electrocardiogram (ECG), heart block, a manic phase. This is characterised by profuse and rapidly tissue. If you would like a leaflet or coronary artery disease changing ideas, exaggerated gaiety and excessive physical • are taking medicines known as monoamine oxidase activity. In such cases, it is important to contact your doctor Not known (frequency cannot be estimated from the inhibitors (MAOIs) who probably will change your medication. available data): with larger text, please • have taken MAOIs within the last 14 days. If you are treated Tell your doctor if you have, or have had in the past, any • absent sensation of appetite with Amitriptyline tablets you have to stop taking this • elevation or lowering of blood sugar levels contact 01271 385257. medical problems, especially if you have: medicine and wait for 14 days before you start treatment • narrow angle glaucoma (loss of vision due to abnormally • paranoia with a MAOI • movement disorders (involuntary movements or decreased high pressure in the eye) • have taken moclobemide the day before • epilepsy, a history of convulsions or fits movements) • have a severe liver disease.