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Home , Amitriptyline, Clonidine, Cold medicine, Guanethidine, Nefopam, Pimozide

Side effects listed below have been reported in the following • hepatitis (inflammation of the ) with signs such as dark frequencies: , 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 • pain, sore mouth • dizziness, , dizziness when you stand up due to • itching. 10mg, 25mg low pressure (orthostatic ) An increased risk of fractures has been observed in • irregular, hard, or rapid heartbeat patients taking this type of . 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. 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 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 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 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 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 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 •   Possible side effects , 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 Thoughts of suicide and worsening of your • collapse conditions microcrystalline cellulose (E460), maize starch, colloidal . 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. • 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 , since these medicines all take time to • decreased appetite The 25mg tablet also contains: talc (E553b), quinoline yellow • prophylaxis in adults work, usually about two weeks but sometimes longer. • delirium (especially in elderly patients), (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. • (E104), iron oxide (E172). achieved to all other non- 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. • 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 () Episodes of ) • 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 changing ideas, exaggerated gaiety and excessive physical • are taking medicines known as 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 levels contact 01271 385257. medical problems, especially if you have: medicine and wait for 14 days before you start treatment • narrow angle (loss of vision due to abnormally • paranoia with a MAOI • movement disorders (involuntary movements or decreased high pressure in the eye) • have taken the day before • , a history of convulsions or fits movements) • have a severe liver disease. • hypersensitivity inflammation of heart muscle • difficulty in passing urine This medicine should not be used for children below 6 years • enlarged of age. • thyroid disease Continued top of next column • 50998850 BBBB0886 Continued top of next column Continued over page

296x210 Leaflet Reel Fed Bi Fold Profile (BST) page 4 page 1 Amitriptyline 10, 25 & 50 mg Tablet PIL - UK Amitriptyline, Film-coated Tablets, 10, 25, 50mg, 28s - UK approved for print/date Item number: BBBB0886 Colours Non Printing Colours 1. Black 1. Profile JDE No.: 50998850 Originator: RH Dimensions: 296x210 Origination Date: 09-03-21 Min Body Text Size: 7pt 2. 2. Dimensions: 296x210 (Reel Fed) Revision Date: 10-03-21 Supplier: Accord Barnstaple 3. 3. Component: Leaflet for Blisters Revised By: RH 4. Pharmacode: 1029 5. Proof Round n/a Technical Date sent: 6. Date Sent: 19-02-21 03 Approval Date received: n/a Technologist: RH [email protected] Technically Approved Cartons and label leaflets only  (labels only when specified) German GTIN 14 (incorporating PZN): * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.02.2020 • •  (to treat ) Depending on your response to the medicine, your doctor The underlying illness may persist for a long time. If you stop • severe heart disease •  and (used to treat epilepsy) may gradually increase the dose to a total daily dose of 100mg your treatment too soon, your symptoms may return. • severe liver disease • St. John´s Wort () – a herbal remedy divided in two doses. Neuropathic pain, chronic tension type headache and • pylorus stenosis (narrowing of the gastric outlet) and used for depression If you receive doses in the range of 100mg – 150mg, your migraine prophylaxis paralytic (blocked intestine) • thyroid medication doctor may need to do more frequent follow-ups with you. It might take a few weeks before you feel any improvement • diabetes, as you might need an adjustment of your •  () of your pain. antidiabetic medicine • nitrate tablets placed under the tongue, such as glyceryl Use in children and adolescents • phaeochromocytoma (a rare tumour of the adrenal gland). trinitrate, used to treat angina This medicine should not be given to children or adolescents Talk to your doctor about the duration of your treatment • valproic acid. for treatment of depression. For further information please see and continue to take this medicine for as long as your doctor If you use antidepressants such as SSRIs, your doctor might section 2 ‘Do not take Amitriptyline tablets’. recommends. consider changing the dose of your medicine (see also section You should also tell your doctor if you take or have recently 2 ‘Other medicines and Amitriptyline tablets’ and section 3 taken medicine that may affect the heart´s rhythm, such as: Neuropathic pain, chronic tension type headache and Bed-wetting at night ‘How to take Amitriptyline tablets’) • medicines to treat irregular heartbeats (e.g. and migraine prophylaxis Your doctor will evaluate if the treatment should be continued ) Your doctor will adjust the medication according to your after 3 months. The elderly are more likely to suffer from certain side effects, symptoms and your response to the treatment. such as dizziness when you stand up due to low blood •  and (used to treat allergies and If you take more Amitriptyline tablets than you pressure (see also section 4 ‘Possible side effects’). hayfever) Adults should • medicines used to treat some mental illnesses (e.g. The recommended initial dose is 10mg - 25mg in the evening. Contact your doctor or nearest hospital casualty department Children and adolescents and ) The recommended daily dose is 25mg – 75mg. immediately. Do this even if there are no signs of discomfort Depression, neuropathic pain, chronic tension type •  (used to treat certain types of ) Depending on your response to the medicine, your doctor or poisoning. Take the container of this medicine with you if headache and migraine prophylaxis •  (used to treat ) may gradually increase the dose. If you receive doses above you go to a doctor or hospital. Do not give this medicine to children and adolescents aged •  (used to treat pain and for detoxification) 100mg daily, your doctor may need to do more frequent below 18 years for these treatments, as safety and •  (“water tablets” e.g. ). follow-ups with you. Your doctor will instruct you whether to Symptoms of overdose include dilated pupils, fast or have not been established in this age group. take the doses once daily or divide into two doses. irregular heartbeats, difficulties passing water, dry mouth and If you are going to have an operation and receive general or tongue, intestinal blockage, fits, fever, agitation, confusion, Bed-wetting at night local anaesthetics, you should tell your doctor that you are Elderly (above 65 years of age) and patients with hallucinations, uncontrolled movements, low blood pressure, • An ECG should be performed prior to initiating with taking this medicine. cardiovascular disease weak , pallor, difficulty breathing, blue discolouration amitriptyline to exclude long QT syndrome Likewise, you should tell your dentist that you take this The recommended initial dose is 10mg – 25mg in the evening. of the skin, decreased heart rate, drowsiness, loss of • This medicine should not be taken at the same time as an medicine if you are to receive a local anaesthetic. consciousness, coma, various cardiac symptoms such as heart drug (see also section 2 ‘Other medicines and Depending on your response to the medicine, your doctor Amitriptyline tablets with may gradually increase the dose. If you receive doses above block, heart failure, cardiogenic shock, metabolic acidosis, Amitriptyline tablets’) hypokalaemia, hyponatraemia. • Suicidal thoughts and behaviours may also develop during It is not advised to drink alcohol during treatment with this 75mg daily, your doctor may need to do more frequent follow- early treatment with antidepressants for disorders other than medicine as it might increase the effect. ups with you. If you forget to take Amitriptyline tablets depression; the same precautions observed when treating and breast-feeding Use in children and adolescents Take the next dose at the usual time. Do not take a double patients with depression should therefore be followed when If you are pregnant or breast-feeding, think you may be This medicine should not be given to children or adolescents dose to make up for a forgotten dose. treating patients with . pregnant or are planning to have a baby, ask for treatments of neuropathic pain, chronic tension type If you stop taking Amitriptyline tablets your doctor for advice before taking this medicine. headache prophylaxis and migraine prophylaxis. For further Your doctor will decide when and how to stop your treatment Other medicines and Amitriptyline tablets information please see section 2 ‘Do not take Amitriptyline Some medicines may affect the action of other medicines and to avoid any unpleasant symptoms that might occur if it is Amitriptyline is not recommended during pregnancy unless tablets’. this can sometimes cause serious side effects. your doctor considers it clearly necessary and only after careful stopped abruptly (e.g. headache, feeling unwell, sleeplessness Bed-wetting at night Tell your doctor or pharmacist if you are taking, have recently consideration of the benefit and risk. If you have taken this and irritability). Use in children and adolescents taken or might take any other medicines, such as: medicine during the last part of the pregnancy, the newborn If you have any further questions on the use of this medicine, The recommended doses for children: • monoamine oxidase inhibitors (MAOIs) e.g. , may have withdrawal symptoms such as irritability, increased ask your doctor or pharmacist. • aged below 6 years: see section 2 ‘Do not take Amitriptyline , , or muscle tension, , irregular breathing, poor drinking, tablets’ (used to treat depression) or (used to treat loud crying, , and constipation. • aged 6 to 10 years: 10mg – 20mg daily. A suitable dosage 4   Possible side effects Parkinson’s disease). These should not be taken at the same Your doctor will advise you whether to start, continue or stop form should be used for this age group. time as Amitriptyline tablets (see section 2 ‘Do not take Like all medicines, this medicine can cause side effects, breast-feeding, or stop using this medicine taking into account • aged 11 years and above: 25mg – 50mg. Amitriptyline tablets’) the benefit of breast-feeding for your child and the benefit of although not everybody gets them. If you get any of the • , , , noradrenaline, therapy for you. The dose should be increased gradually. following symptoms you should see your doctor immediately: • Signs of a severe allergic reaction (anaphylaxis), such as and (these may Take this medicine 1-1½ hours before bedtime. be present in or , and in some Driving and using machines difficulty breathing or swelling of your face, lips, throat or anaesthetics) This medicine may cause drowsiness and dizziness, especially Before starting treatment, your doctor will conduct an ECG of tongue. Not known, frequency cannot be estimated from • medicine to treat high blood pressure, for example in the beginning of the treatment. Do not drive or work with your heart to check for signs of an unusual heartbeat. the available data. -channel blockers (e.g. and ), tools or machinery if you are affected. Your doctor will re-evaluate your treatment after 3 months • Attacks of intermittent blurring of vision, rainbow vision, and , betanidine, , and Amitriptyline tablets contain lactose and and if needed perform a new ECG. Do not stop the treatment eye pain. You should immediately have an eye examination sunset yellow without consulting your doctor first. before the treatment with this medicine can be continued. • anticholinergic drugs such as certain medicines to treat If you have been told you have an intolerance to some , This condition may be signs of acute glaucoma. Very rare, Patients with special risks may affect up to 1 in 10,000 people. Parkinson’s disease and gastrointestinal disorders (e.g. contact your doctor before taking this medicine. Patients with liver diseases or people known as “poor , ) The 25mg tablets also contain a colour called ‘sunset yellow’ • A heart problem called “prolonged QT interval” (which is metabolisers” usually receive lower doses. Your doctor may shown on your electrocardiogram, ECG). Common, may •  (used to treat schizophrenia) which may cause allergic reactions. take blood samples to determine the level of amitriptyline in • , and (painkillers) affect up to 1 in 10 people. the blood (see also section 2). • Bad constipation, a swollen stomach, fever and vomiting. • buprenorphine (a drug used for severe pain or drug 3 addiction). This medicine may interact with amitriptyline   How to take Amitriptyline tablets How and when to take Amitriptyline tablets These symptoms may be due to parts of the intestine and you may experience symptoms such as involuntary, Always take this medicine exactly as your doctor has told you. This medicine can be taken with or without food. becoming paralysed. Rare, may affect up to 1 in 1,000 people. • Any yellowing of the skin and the white in the eyes rhythmic contractions of muscles, including the muscles Check with your doctor if you are not sure. Swallow the tablets with a drink of water. Do not chew them. that control movement of the eye, agitation, hallucinations, (jaundice). Your liver may be affected. Rare, may affect up to Not all dosage schemes can be achieved with all the coma, excessive sweating, tremor, exaggeration of reflexes, Duration of treatment 1 in 1,000 people. pharmaceutical forms/strengths. The appropriate formulation/ increased muscle tension, body temperature above 38°C. Do not change the dose of the medicine or stop taking the • Bruising, bleeding, pallor or persistent sore throat and fever. strength should be selected for the starting doses and any Contact your doctor when experiencing such symptoms medicine without consulting your doctor first. These symptoms can be the first signs that your blood or subsequent dose increases. • medicines to treat fungal infections (e.g. , Depression bone marrow may be affected. Effects on the blood could be , , and ) Depression As with other medicines for the treatment of depression, it a decrease in the number of white cells (which help to fight •  (e.g. ) Adults may take a few weeks before you feel any improvement. ) and (which help with clotting). Rare, may • antidepressants (e.g. SSRIs (, , The recommended initial dose is 25mg two times daily. affect up to 1 in 1,000 people. In treating depression, the duration of treatment is individual, • Suicidal thoughts or behaviour. Rare, may affect up to 1 in ), and ) Depending on the response to the medicine, your doctor • medicines for certain heart conditions (e.g. beta blockers and and is usually at least 6 months. The duration of treatment is 1,000 people. may gradually increase the dose to 150mg per day divided in decided by your doctor. antiarrhythmics) two doses. •  (used to treat stomach ulcers) Continue to take this medicine for as long as your doctor •  (used to treat ADHD) Elderly (above 65 years of age) and patients with recommends. •  (used to treat HIV) cardiovascular disease • oral contraceptives The recommended initial dose is 10mg – 25mg daily. Continued top of next column Continued over page Continued top of next column Continued over page

296x210 Leaflet Reel Fed Bi Fold Profile (BST) page 2 page 3 Amitriptyline 10, 25 & 50 mg Tablet PIL - UK Amitriptyline, Film-coated Tablets, 10, 25, 50mg, 28s - UK approved for print/date Item number: BBBB0886 Colours Non Printing Colours 1. Black 1. Profile JDE No.: 50998850 Originator: RH Dimensions: 296x210 Origination Date: 09-03-21 Min Body Text Size: 7pt 2. 2. Dimensions: 296x210 (Reel Fed) Revision Date: 10-03-21 Supplier: Accord Barnstaple 3. 3. Component: Leaflet for Blisters Revised By: RH 4. Pharmacode: 1029 5. Proof Round n/a Technical Date sent: 6. Date Sent: 19-02-21 03 Approval Date received: n/a Technologist: RH [email protected] Technically Approved Cartons and label leaflets only  (labels only when specified) German GTIN 14 (incorporating PZN): * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.02.2020 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 () 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 , 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. • hypersensitivity inflammation of heart muscle • difficulty in passing urine This medicine should not be used for children below 6 years • enlarged prostate of age. • thyroid disease Continued top of next column • bipolar disorder 50998850 BBBB0886 Continued top of next column Continued over page

296x210 Leaflet Reel Fed Bi Fold Profile (BST) page 4 page 1 Amitriptyline 10, 25 & 50 mg Tablet PIL - UK Amitriptyline, Film-coated Tablets, 10, 25, 50mg, 28s - UK approved for print/date Item number: BBBB0886 Colours Non Printing Colours 1. Black 1. Profile JDE No.: 50998850 Originator: RH Dimensions: 296x210 Origination Date: 09-03-21 Min Body Text Size: 7pt 2. 2. Dimensions: 296x210 (Reel Fed) Revision Date: 10-03-21 Supplier: Accord Barnstaple 3. 3. Component: Leaflet for Blisters Revised By: RH 4. Pharmacode: 1029 5. Proof Round n/a Technical Date sent: 6. Date Sent: 19-02-21 03 Approval Date received: n/a Technologist: RH [email protected] Technically Approved Cartons and label leaflets only  (labels only when specified) German GTIN 14 (incorporating PZN): * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.02.2020