Country: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methyldopa (anhydrous)
A A H Pharmaceuticals Ltd
C02AB01
Methyldopa (anhydrous)
125mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050200; GTIN: 5025903009238
148x210 Leaflet Reel Fed Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Methyldopa Tablets 125, 250, 500mg x 56’s (UK) 148x210 (Reel Fed) 50971964 Leaflet for Blisters 4751 T. Hull 05/07/19 * 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 UK-Eire-Artwork-Support@accord-healthcare.com 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. FMD info NA (not a carton) No Yes Details METHYLDOPA 125MG, 250MG & 500MG 56 TABLETS - UK Black Profile BBBA5440 S.Anson 12.07.19 23.07.19 S.Anson 148 x 210 7.5pt Accord Barnstaple n/a n/a 3 Version 2 01.11.2017 _Continued top of next column_ _Continued over page_ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. INDEX 1 WHAT METHYLDOPA TABLETS ARE AND WHAT THEY ARE USED FOR 2 BEFORE YOU TAKE 3 HOW TO TAKE 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE 6 FURTHER INFORMATION 1 WHAT METHYLDOPA TABLETS ARE AND WHAT THEY ARE USED FOR Methyldopa belongs to a group of medicines called antihypertensives, which lower blood pressure. Methyldopa tablets are used to treat high blood pressure (hypertension). 2 BEFORE YOU TAKE DO NOT TAKE Methyldopa tablets and TELL your doctor if you: • are ALLERGIC (hypersensitive) to methyldopa or any of the other ingredients (see section 6) • have LIVER DISEASE • have HIGH BLOOD PRESSURE due to a TUMOUR NEAR THE KIDNEY (phaeochromocytoma) • suffer from DEPRESSION • are ta Lestu allt skjalið
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 _ Since methyldopa is largely excreted by the kidneys, patients with impaired renal function may respond to comparatively low doses. Withdrawal of methyldopa which is followed by return of hypertension, usually within 48 hours, is not complicated generally by an overshoot of blood pressure. Therapy with methyldopa may be initiated in most patients already on treatment with other antihypertensive agents by terminating these antihypertensive medications gradually if required (see manufacturers recommendations on stopping these drugs). 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. A thiazide may be added at any time during methyldopa therapy and is recommended if therapy has not been started with a thiazide or if effective control of blood pressure cannot be maintained on 2g of methyldopa daily. Methyldopa may also be used concomitantly with the combination of amiloride hydrochloride and hydrochlorothiazide or beta-blocking agents, such as timolol maleate. When methyldopa is given to patients on other antihypertensives the dose of these agents may need to be adjusted to effect a smooth transition. _ADULTS AND CHILDREN OVER 12 YEARS: _Initially 250mg two or three times a day, for two days. Thereafter, usually increased Lestu allt skjalið