Страна: Мальта
Язык: английский
Источник: Medicines Authority
AMITRIPTYLINE HYDROCHLORIDE
Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus
N06AA09
AMITRIPTYLINE HYDROCHLORIDE 10 mg
FILM-COATED TABLET
AMITRIPTYLINE HYDROCHLORIDE 10 mg
POM
PSYCHOANALEPTICS
Authorised
2007-02-28
cy-pl-amirol-fc-tabs-a7 page 1 OF 11 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMIROL 10 MG FILM-COATED TABLETS AMIROL 25 MG FILM-COATED TABLETS Amitriptyline hydrochloride 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 signs 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. WHAT IS IN THIS LEAFLET 1. What Amirol is and what it is used for 2. What you need to know before you take Amirol 3. How to take Amirol 4. Possible side effects 5. How to store Amirol 6. Contents of the pack and other information 1. WHAT AMIROL IS AND WHAT IT IS USED FOR Amirol belongs to a group of medicines known as 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 AMIROL DO NOT TAKE AMIROL: • if you are allergic to amitriptyline or any of the other ingredients of this medicine (listed in section 6). • if you recently have had a heart attack (myocardial infarction). • if you have heart problems such as disturbances in heart rhythm which are seen on an electrocardiogram (ECG), heart block, or co Прочитать полный документ
mt-spc-amirol-fc-tabs-v08-r00-a0 Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amirol 10 mg film-coated tablets Amirol 25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Amirol 10 mg film-coated tablets: Each film-coated tablet contains Amitriptyline Hydrochloride 10mg. Amirol 25 mg film-coated tablets: Each film-coated tablet contains Amitriptyline Hydrochloride 25mg Excipient with known effect Amirol 10 mg film-coated tablets: Each film-coated tablet contains 58,4 mg of lactose monohydrate. Amirol 25 mg film-coated tablets: Each film-coated tablet contains 96,6 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Amirol 10 mg film-coated tablets: Light blue, round, film-coated tablets. Amirol 25 mg film-coated tablets: Yellow, round, film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amirol is indicated for: • the treatment of major depressive disorder in adults • the treatment of neuropathic pain in adults • the prophylactic treatment of chronic tension type headache (CTTH) in adults • the prophylactic treatment of migraine in adults • the treatment of nocturnal enuresis in children aged 6 years and above when organic pathology, including spina bifida and related disorders, have been excluded and no response has been achieved to all other non-drug and drug treatments, including antispasmodics and vasopressin-related products. This medicinal product should only be prescribed by a healthcare professional with expertise in the management of persistent enuresis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology mt-spc-amirol-fc-tabs-v08-r00-a0 Page 2 of 16 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 increments. _Major depressive disorder _ Dosage should be initiated at a low level and increased gradually, noting carefully Прочитать полный документ