Riik: Malta
keel: inglise
Allikas: Medicines Authority
AMITRIPTYLINE HYDROCHLORIDE
Pinewood Laboratories Ltd BALLYMACARBRY, CLONMEL, CO. TIPPERARY, Ireland
N06AA09
AMITRIPTYLINE HYDROCHLORIDE 25 mg/5ml
ORAL SOLUTION
AMITRIPTYLINE HYDROCHLORIDE 25 mg/5ml
POM
PSYCHOANALEPTICS
Withdrawn
2010-07-21
Page 1 of 11 PACKAGE LEAFLET: INFORMATION FOR THE USER Amitriptyline Hydrochloride 25mg/5ml oral solution Amitriptyline Hydrochloride 50mg/5ml oral solution READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE 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, please 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 Amitriptyline Oral Solution is and what it is used for 2. What you need to know before you take Amitriptyline Oral Solution 3. How to take Amitriptyline Oral Solution 4. Possible side effects 5. How to store Amitriptyline Oral Solution 6. Contents of the pack and other information 1. WHAT AMITRIPTYLINE ORAL SOLUTION IS AND WHAT IT IS USED FOR Amitriptyline Oral Solution 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. T h i s 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 ORAL SOLUTION DO NOT TAKE AMITRIPTYLINE ORAL SOLUTION IF YOU: are allergic to amitriptyline or to any of the other ingredients of this medicine (listed in section 6) if you recently have had a heart attack (myocar Lugege kogu dokumenti
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amitriptyline Hydrochloride 25mg/5ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of solution contains 25mg amitriptyline hydrochloride. Excipients with known effect Each 5ml of solution contains: 1mg propyl hydroxybenzoate (E216) 6mg methyl hydroxybenzoate (E218) 100mg propylene glycol 3.35g liquid maltitol Approximately 10.5mg ethanol For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. A clear colourless to yellow solution with an orange/tangerine odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. Page 2 of 14 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 Lugege kogu dokumenti