Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methyldopa (anhydrous)
Aspen Pharma Trading Ltd
C02AB01
Methyldopa (anhydrous)
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050200; GTIN: 6001390118294
PACKAGE LEAFLET: INFORMATION FOR THE USER ALDOMET ® Film-coated Tablets 250 mg ALDOMET ® Film-coated Tablets 500 mg (Methyldopa) 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, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4. What is in this leaflet: 1. What Aldomet is and what it is used for 2. What you need to know before you take Aldomet 3. How to take Aldomet 4. Possible side effects 5. How to store Aldomet 6. Contents of the pack and other information 1. What Aldomet is and what it is used for Aldomet contains the active substance 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 Aldomet to treat high blood pressure (hypertension). 2. What you need to know before you take Aldomet Do not take Aldomet if you have: • ever had a bad reaction, such as an allergy to methyldopa, or to any of the other ingredients (listed in section 6) • ever had liver disease • ever had depression • high blood pressure due to a tumour near your kidney called ‘phaeochromocytoma’ or ‘paraganglioma’. • been taking a type of medicine called a ‘monoamine oxidase inhibitor’ (MAO inhibitor) • porphyria (a rare, inherited blood disorder) Do not take Aldomet if any of the above applies to you. If you are not sure talk to your doctor or pharmacist before taking Aldomet. Take special care with Aldomet Talk to your doctor or pharmacist before tak Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ALDOMET® Tablets 500 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ‘Aldomet’ Tablets 500 mg, contain methyldopa equivalent to 500 mg anhydrous methyldopa. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Yellow, film-coated tablets. ‘Aldomet’ Tablets 500 mg are marked ‘ALDOMET on one side and 500 on the other side’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ _ _ _Use in 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 ‘Aldomet’ 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 ‘Aldomet’ 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 ‘Aldomet’ 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, ‘Aldomet’ 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 ‘Aldomet’ is added to 50 mg of hydrochlorothiazide, the two agents may be given together once daily. _ _ _P Read the complete document