Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Verapamil hydrochloride
Accord-UK Ltd
C08DA01
Verapamil hydrochloride
120mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060200; GTIN: 5012617009777
350x210 Leaflet Reel Fed Profile Landscape (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Verapamil BP Tablets 40, 80, 120, 160mg x 25, 56, 84 (UK) 350x210 (Reel Fed) 50995430 Leaflet for Blisters 5778 T. Hull 26/10/20 page 1 page 4 * 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. EU-Artwork-Support@accord-healthcare.com VERAPAMIL ALL STRENGTHS 28, 56, 84 TABLETS PIL - UK Black Profile BBBA9696 M.Doak 17/11/2020 23/12/2020 M.Doak 350 x 210mm 9 pt Accord Barnstaple N/A N/A 2 Version 7 12.02.2020 German GTIN 14 (incorporating PZN): N/A Cartons and label leaflets only (labels only when specified) 50995430 BBBA9696 VERAPAMIL 40MG, 80MG, 120MG AND 160MG TABLETS Package leaflet: Information for the patient 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 t Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT VERAPAMIL TABLETS BP 120mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 120mg Verapamil Hydrochloride PhEur. Excipient with known effect Sunset yellow aluminium lake (E110) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Yellow film-coated tablets. Yellow, circular, biconvex film-coated tablets, impressed “C” on one face and the identifying letters “VT” on the reverse. Tablet diameter: 8.55-9.45mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1) The management of mild to moderate hypertension and renal hypertension, used alone or in combination with other antihypertensive therapy (see section 4.3 for warning regarding concomitant administration with beta-blockers). 2) For the management and prophylaxis of angina pectoris (including variant angina). 3) The treatment and prophylaxis of paroxysmal supraventricular tachycardia and the reduction of the ventricular rate in atrial fibrillation/flutter. Verapamil should not be used for atrial fibrillation/flutter in patients with Wolff- Parkinson-White syndrome (see section 4.4). _4.2 _ _POSOLOGY AND METHOD OF ADMINISTRATION _ Posology _Adults: _ _Hypertension:_ 240mg verapamil daily. For patients new to verapamil therapy, the physician should consider halving the initial dose to 120mg. Most patients respond to 240mg daily given as a single dose. If control is not achieved after a period of at least one week, the dosage may be increased to a maximum of 480mg (in divided doses of 240mg in the morning and 240mg in the evening, at an interval of about twelve hours). A further reduction in blood pressure may be acheived by combining verapamil with other antihypertensive agents, in particular diuretics. 120mg may be used for dose titration purposes. _ _ _Angina pectoris:_ 120mg twice daily. A small number of patients respond to a lower dose and where indictaed, adjustment down to 120mg daily could be made. 120mg may be used for dose titration purposes. _ Read the complete document