Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
AMITRIPTYLINE HYDROCHLORIDE
Wockhardt UK Limited
N06AA; N06AA09
AMITRIPTYLINE HYDROCHLORIDE
25 mg/5ml
Oral solution
Product subject to prescription which may not be renewed (A)
Non-selective monoamine reuptake inhibitors; amitriptyline
Not marketed
2010-11-26
Customer Pinewood Healthcare Item Code Description Component Type Dimensions Language Market Pharma Code No. Paper GSM Proof By Proof No. Date Colours Used WARNING! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client’s brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT. 2082 45gsm 23LF01569PW Black Keyline (Non-Printing) Text Free Area (Non-Printing) Amitriptyline Hydrochloride 25mg/5ml oral solution Leaflet 190 x 420mm English DBO 1 05/10/2018 UK Customer Pinewood Healthcare Item Code Description Component Type Dimensions Language Market Pharma Code No. Paper GSM Proof By Proof No. Date Colours Used WARNING! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client’s brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT. 2082 45gsm 23LF01569PW Black Keyline (Non-Printing) Text Free Area (Non-Printing) Amitriptyline Hydrochloride 25mg/5ml oral solution Leaflet 190 x 420mm English DBO 1 05/10/2018 UK Lees het volledige document
Health Products Regulatory Authority 14 February 2019 CRN008T5S Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amitriptyline Hydrochloride 25 mg/ 5 ml 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Health Products Regulatory Authority 14 February 2019 CRN008T5S 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 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. Lees het volledige document