देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amitriptyline hydrochloride
Crescent Pharma Ltd
N06AA09
Amitriptyline hydrochloride
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100; GTIN: 5017123313028
PATIENT INFORMATION LEAFLET AMITRIPTYLINE 25 MG TABLETS AMITRIPTYLINE HYDROCHLORIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. IT CONTAINS IMPORTANT INFORMATION. • Keep this leaflet. You may want to read it again. • If you have any other questions, or if there is something you do not understand, please ask your doctor or pharmacist. • This medicine has been prescribed for you only. Never give it to someone else. It may not be the right medicine for 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 Amitriptyline is and what it is 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 IS AND WHAT IT IS USED FOR : • Amitriptyline belongs to a group of drugs called tricyclic antidepressants (TCADs). It prolongs the effect of noradrenaline and serotonin levels (substances which transmit nerve impulses) in the brain to relieve the symptoms of depression. • Amitriptyline is used to treat depression. It is also used to treat night bedwetting in children aged 6 years and above as third line therapy only. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMITRIPTYLINE TABLETS DO NOT TAKE THIS MEDICINE IF YOU: • have previously suffered an ALLERGIC REACTION to a medicine containing Amitriptyline or other anti-depressant medicines • are allergic to any of the other ingredients of this tablet (See section 6 further information) • suffer from any severe LIVER DISEASE • or the patient is under 6 years of age • suffer from HEART PROBLEMS (e.g. abnormal heart beats, coronary artery disease) • have suffered a HEART ATTACK within the last three months • are taking or have you recently taken (within the last 14 days) an पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amitriptyline Tablets BP 25mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25.00 mg of amitriptyline hydrochloride Excipient with known effect Each tablet contains 75 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Amitriptyline Tablets 25 mg are presented as yellow, film-coated, round normal convex tablets engraved with the company logo on one side and A313 on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amitriptyline tablets are 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 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 the clinical response and any evidence of intolerability. _Adults _ Initially 25 mg 2 times daily (50 mg daily). If necessary, the dose can be increased by 25 mg every other day up to 150 mg daily divided into two doses. The maintenance dose is the lowest effective dose. _Elderly patients over 65 years of age and patients with cardiovascular disease _ Initially 10 mg – 25 mg daily. The daily dose may be पूरा दस्तावेज़ पढ़ें