DOPAMET Film-coated tablet (2015)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Dopamet 250 mg film-coated tablet.
2. Qualitative and quantitative composition
Each tablet contains methyldopa sesquihydrate equivalent to 250mg anhydrous methyldopa.
3. Pharmaceutical form
Film-coated tablets. Round, biconvex, yellow immediate release film-coated tablet.
4.1. Therapeutic indications
Methyldopa is an antihypertensive agent indicated for the treatment of hypertension.
4.2. Posology and method of administration
General considerations Methyldopa is largely excreted by the kidney, and patients with impaired renal function may respond to smaller doses. Withdrawal of methyldopa is followed by return of hypertension, ...
4.3. Contraindications
Active hepatic disease, such as acute hepatitis and active cirrhosis. Hypersensitivity (including hepatic disorders associated with previous methyldopa therapy) to the active substance or to any of the ...
4.4. Special warnings and precautions for use
Acquired haemolytic anaemia has occurred rarely. Haemoglobin and/or haematocrit determinations should be made if symptoms suggest anaemia. If anaemia is confirmed, haemolysis tests should be done. Dopamet ...
4.5. Interaction with other medicinal products and other forms of interaction
Lithium Patients should be monitored carefully for symptoms of lithium toxicity when methyldopa and lithium are given concomitantly. Other antihypertensive drugs When methyldopa is used with other antihypertensive ...
4.6. Fertility, pregnancy and lactation
Methyldopa has been used under close medical supervision for the treatment of hypertension during pregnancy. There was no clinical evidence that methyldopa caused fetal abnormalities or affected the neonate. ...
4.7. Effects on ability to drive and use machines
Dopamet may cause sedations, usually transient, during the initial period of therapy or whenever the dose is increased. If affected, patients should not carry out activities where alertness is necessary, ...
4.8. Undesirable effects
The following reactions have been reported; frequency not known (cannot be estimated from the available data): <u>Cardiac disorders:</u> Bradycardia, aggravation of angina pectoris, myocarditis, pericarditis. ...
4.9. Overdose
Acute overdosage may produce acute hypotension with other responses attributable to brain and gastro-intestinal malfunction (excessive sedation, weakness, bradycardia, dizziness, light-headedness, constipation, ...
5.1. Pharmacodynamic properties
<b>Pharmacoterapeutic group:</b> Antiadrenergic agents, centrally acting <b>ATC code:</b> C02AB01 It appears that several mechanisms of action account for the clinically useful effects of methyldopa and ...
5.2. Pharmacokinetic properties
Absorption of oral methyldopa is variable and incomplete. Bioavailability after oral administration averages around 25%. Peak concentrations in plasma occur at two to three hours, and elimination of the ...
5.3. Preclinical safety data
No relevant information.
6.1. List of excipients
Maize starch Citric acid anhydrous Sodium calcium edetate Povidone K25 Microcrystalline cellullose Sodium starch glycolate Purified talc Magnesium stearate <u>Coating ingredients:</u> Opadry yellow OY-F-6022 ...
6.2. Incompatibilities
No known incompatibilities.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C, in the original package.
6.5. Nature and contents of container
PVC-Al blisters in packs of 30 &100, boxes of 1000 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
8707
9. Date of first authorization / renewal of the authorization
12.02.1983 / 16.09.2010
10. Date of revision of the text
10/2015
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