מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methyldopa (anhydrous)
Accord-UK Ltd
C02AB01
Methyldopa (anhydrous)
125mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050200; GTIN: 5012617009487
148x210 Leaflet Reel Fed Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Methyldopa ,125, 250 & 500 mg, 56 Tablets - UK 148x210 (Reel Fed) 50991367 Leaflet for Blisters 2132 RH 21-05-20 * 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. METHYLDOPA ALL STRENGTHS TABLETS JOINT PIL - UNITED KINGDOM Black Profile BBBA8282 NM 28/05/2020 23/06/2020 NM 148x210 7.5pts Accord Barnstaple N/A 04 Version 7 12.02.2020 EU-Artwork-Support@accord-healthcare.com German GTIN 14 (incorporating PZN): Cartons and label leaflets only (labels only when specified) METHYLDOPA 125MG, 250MG AND 500MG TABLETS _Continued top of next column_ _Continued over page_ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR 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 METHYLDOPA TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHYLDOPA TABLETS 3 HOW TO TAKE METHYLDOPA TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE METHYLDOPA TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT METHYLDOPA TABLETS ARE AND WHAT THEY ARE USED FOR Methyldopa belongs to a group of medicines called antihypertensives, which l קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT METHYLDOPA TABLETS BP 125mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Methyldopa PhEur equivalent to anhydrous methyldopa 125mg. Excipient with known effect: Each tablet contains 0.002mg of Sunset yellow (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 “MA” on the reverse. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1) Treatment of hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ _Use in adults and children over 12 years _ _Initial dosage:_ Usually 250mg two or three times a day, for two days. _Adjustment: _Usually adjusted at intervals of not less than two days, until an adequate response is obtained. The maximum recommended daily dosage is 3g. Many patients experience sedation for two or three days when therapy with Methyldopa is started or when the dose is increased. When increasing the dosage, therefore, it may be desirable to increase the evening dose first. Withdrawal of Methyldopa is followed by return of hypertension, usually within 48 hours. This is not complicated generally by an overshoot of blood pressure. _Patients with renal impairment_ Methyldopa is largely excreted by the kidney, and patients with impaired renal function may respond to smaller doses. _Other antihypertensives _ Therapy with Methyldopa may be initiated in most patients already on treatment with other antihypertensive agents by terminating these antihypertensive medications gradually, as required. Following such previous antihypertensive therapy, Methyldopa should be limited to an initial dose of not more than 500mg daily and increased as required at intervals of not less than two days. When Methyldopa is given to patients on other antihypertensives the dose of these agents may need to be adjusted to effect a smooth transition. When 500mg of Methyldopa קרא את המסמך השלם