Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Verapamil hydrochloride
Sandoz Ltd
C08DA01
Verapamil hydrochloride
120mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060200
148x210 Leaflet Reel Fed Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Verapamil Film-coated Tablets 40, 80, 120, 160mg x 28, 56, 84 (UK) 148x210 (Reel Fed) 50987309 Leaflet for Blisters 3927 T. Hull 23/01/2020 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. GTIN 13 (Belgium & Slovenia): EU-Artwork-Support@accord-healthcare.com VERAPAMIL ALL STRENGTHS 28, 56, 84 TABLETS PIL - UK Black Profile BBBA7483 C Fox 05/04/2020 08/04/2020 T. Hull 148 x 210 7pt Accord Barnstaple N/A N/A 4 Version 6 12.12.2019 German GTIN 14 (incorporating PZN): Cartons and label leaflets only (labels only when specified) 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 VERAPAMIL TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE VERAPAMIL TABLETS 3 HOW TO TAKE VERAPAMIL TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE VERAPAMIL TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT VERAPAMIL TABLETS ARE AND WHAT THEY ARE USED FOR Verapamil belongs to a group of medicines called calcium- channel blockers which interfere with the electrical signals Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Verapamil 120mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains verapamil hydrochloride 120 mg Excipients with known effect Lactose Sunset yellow E110 For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Pale yellow, convex, film-coated tablets, diameter approximately 9.5 mm, engraved MP70 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. The prophylaxis and treatment of angina pectoris. 2. Prophylaxis and treatment of supraventricular paroxysmal tachycardia; atrial fibrillation and premature supraventricular contractions; atrial fibrillation and flutter and supraventricular paroxysmal tachycardia of the reciprocating type, associated with the Wolff-Parkinson-White Syndrome. 3. Treatment either alone or in conjunction with other anti-hypertensive therapy of mild to moderate hypertension (including renal hypertension). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: ANGINA _Adults: _ 120 mg three times a day is recommended. 80 mg three times a day can be completely satisfactory in some patients with angina of effort. Less than 120 mg three times a day is not likely to be effective in angina at rest and variant angina. _Children: _ Not applicable _Elderly_: As for adults, unless liver or renal function is impaired. SUPRAVENTRICULAR PAROXYSMAL TACHYCARDIA _Adults: _ 40-120 mg three times a day according to the severity of the condition. _Children: _ Up to 2 years: 20 mg 2-3 times daily. 2 years and above: 40-120 mg 2-3 times daily. _Elderly: _ It is recommended to commence with lowest dose and adjust as required. HYPERTENSION _Adults: _ The usual dose range is 80-160 mg three times a day. The dose should be increased from 80 mg three times a day at weekly intervals according to response, either alone or in conjunction with other antihypertensive therapy. A further reduction in blood pressure may be obtained by combining verapamil with other antihypertensive agents, e.g Prečítajte si celý dokument