Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methyldopa (anhydrous)
The Boots Company Plc
C02AB01
Methyldopa (anhydrous)
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050200
PATIENT INFORMATION LEAFLET METHYLDOPA TABLETS BP 250MG & METHYLDOPA TABLETS BP 500MG 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 further questions, please ask your doctor or pharmacist (chemist). 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. In the entire leaflet Methyldopa Tablets BP 250mg & Methyldopa Tablets BP 250mg will be referred as Methyldopa tablets. WHAT IS IN THIS LEAFLET 1. What your Methyldopa tablets are and what it is 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 YOUR METHYLDOPA TABLETS ARE AND WHAT IT IS USED FOR The active substance is called methyldopa. This belongs to a group of medicines called ‘antihypertensives’. Methyldopa is changed inside your body to a natural substance that lowers blood pressure. Your doctor has prescribed Methyldopa to treat high blood pressure (hypertension). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHYLDOPA TABLETS DO NOT TAKE METHYLDOPA TABLETSIF YOU HAVE: ever had liver disease ever had a bad reaction, such as an allergy to Methyldopa or any of the ingredients in the tablets (listed in section 6) ever had depression been taking a type of medicine called a monoamine oxidase inhibitors (MAOIs) high blood pressure due to a tumour near your kidney called phaeochromocytoma or paraganglioma porphyria (a rare, inherited blood disorder) Do not take Methyldopa tablets if any of the above applies to Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Methyldopa Tablets 500mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains methyldopa BP 500mg. Excipient with known effect FD&C Yellow 5 [Tartrazine (E 102)] For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Yellow coloured , capsule shaped , biconvex, film coated tablets , plain on both sides with an approximate dimensions of 19.10mm X 8.60mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults:_ Initial dosage: Usually 250 mg 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 3 g. 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 500 mg 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 500 mg of methyldopa is added to 50 mg of hydrochlorothiazide, the two agents may be given together once daily. _Paediatric population_ Ini Read the complete document