Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methyldopa (anhydrous)
A A H Pharmaceuticals Ltd
C02AB01
Methyldopa (anhydrous)
250mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050200; GTIN: 5025903004431
Artwork No. Customer Description Market Language Size Min. Font Size Page No. Version No. Date Software 300519/1 Ennogen Methyldopa Leaflet UK English 160 x 360 mm 9 pt 1 of 1 17 21-01-20 Coreldraw 12 Packaging Development Quality Assurance (QA) Quality Control (QC) Production e-mail : prasad.pdp@gmail.com Ph : +91-09845156610 Colours Used Black Keyline METHYLDOPA 125MG, 250MG AND 500MG TABLETS PACKAGE LEAFLET: INFORMATION FOR THE USER ! Liver problems DO NOT TAKE METHYLDOPA TABLETS IF: ! You have pheochromocytoma or paraganglioma (a rare tumour of the adrenal gland which causes high blood pressure) ! You are allergic to methyldopa or any of the other ingredients of this medicine (listed in section 6) ! You have ever had liver disease ! You are taking monoamine oxidase inhibitors (MAOI) – a type of antidepressant ! You have porphyria (a rare inherited blood disorder). OTHER MEDICINES AND METHYLDOPA TABLETS ! Other medicines for high blood pressure (antihypertensives) WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Methyldopa Tablets if you have: ! Fever ! Dialysis 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHYLDOPA TABLETS ! Any abnormal movements (involuntary). ! You suffer from depression ! A blood disorder called haemolytic anaemia ! An operation ! A blood transfusion. Your doctor may do blood tests to check how your liver is working during the first 6-12 weeks. He or she may use similar tests if you have a fever at any time while you are taking this medicine. Check with your doctor while taking this medicine if you are going to have: Tell your doctor you are taking this medicine if you have a laboratory test where a urine or blood sample is taken. This is because methyldopa may affect the results of some types of tests. Rarely, in patients taking this medicine urine may darken when it is exposed to air after voiding. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Methyldopa Tablets. TESTS YOU MAY HAVE WHILE TAKING METHY Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Methyldopa 250mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 283.00mg of methyldopa equivalent to 250mg anhydrous methyldopa Excipient with known effect: Each tablet contains sunset yellow (E110) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Yellow biconvex film coated tablets with an approximate diameter of 10.5mm either plain or coded MYD 250 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clinical indications: Methyldopa is indicated for hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY General considerations _Patients with renal impairment _ Methyldopa is largely excreted by the kidney, and the patients with impaired renal function may respond to smaller doses. 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 on treatment with other hypertensive agents _ 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 500 mg daily and increased as required at intervals of not less than two days. When methyldopa is given to patients on other antihypertensive the dose of these agents may need to be adjusted to effect a smooth transition. _Addition of a thiazide _ When 500 mg of methyldopa is added to 50 mg of hydrochlorothiazide, the two agents may be given together once daily. 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. _Adults_ _ _ _Initial dosage:_ Usually 250mg two or three times a day, for two days, increased at i Citiți documentul complet