METHYLDOPA Film coated tablets (2019)
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Περιεχόμενα
Name of the medicinal product
Methyldopa Tablets BP 250mg.
Qualitative and quantitative composition
Active: Methyldopa Ph.Eur. Per Tablet: 281.960 mg equivalent to methyldopa anhydrous 250mg. Excipient(s) with known effect: Each tablet contains 33 mg of lactose (as monohydrate). For the full list of ...
Pharmaceutical form
Round, yellow film coated biconvex tablet.
Therapeutic indications
Treatment of moderate to severe hypertension.
Posology and method of administration
Adults 250mg 2-3 times daily for 2 days, adjusted at intervals of 2 days until adequate response is obtained. Maximum dose 3g daily (increase evening dose first). Usual effective dose 500mg to 2g daily. ...
Contraindications
Methyldopa tablets are contraindicated in patients with: Hypersensitivity to methyldopa or to any of the excipients listed in section 6 (including hepatic disorders associated with previous methyldopa ...
Special warnings and precautions for use
Acquired haemolytic anaemia has occurred rarely; should symptoms suggest anaemia, haemoglobin and/or haematocrit determinations should be made. If anaemia is confirmed, tests should be done for haemolysis. ...
Interaction with other medicinal products and other forms of interaction
Lithium When methyldopa and lithium are given concomitantly the patient should be monitored carefully for symptoms of lithium toxicity. Other antihypertensive drugs When methyldopa is used with other antihypertensive ...
Pregnancy and lactation
Pregnancy Methyldopa has been used under close medical supervision for the treatment of hypertension during pregnancy. There is no clinical evidence of foetal abnormalities or effect on the neonate. Published ...
Effects on ability to drive and use machines
Caution should be observed when driving or operating machinery, as methyldopa therapy may result in drowsiness, dizziness, light headedness, involuntary choreoathetotic movements in patients with severe ...
Undesirable effects
The following convention has been utilised for the classification of frequency: Very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (< ...
Overdose
Symptoms of overdose may include acute hypotension, sedation, weakness, bradycardia, dizziness, gastrointestinal disturbances, light-headedness, constipation, distension, flatus, diarrhoea, nausea and ...
Pharmacodynamic properties
Methyldopa is an antihypertensive agent acting centrally by stimulating alpha adrenergic receptors. It inhibits the decarboxylation of dopa to dopamine but this action is not responsible for the hypotensive ...
Pharmacokinetic properties
Methyldopa is incompletely absorbed from the gastrointestinal tract. Methyldopa is extensively metabolised through pathways common to the catecholamines utilising dopa decarboxylates and dopamine B-hydroxylase. ...
Preclinical safety data
None.
List of excipients
Lactose monohydrate Maize starch Citric acid Talc Magnesium stearate Stearic acid Hypromellose Macrogol 400 Titanium dioxide (E171) Iron oxide yellow (E172)
Incompatibilities
None known.
Shelf life
Shelf life: 30 months in Blister strips.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light.
Nature and contents of container
Aluminium/PVC (opaque) blister strips of 14 tablets in cartons containing 28 or 56 tablets.
Special precautions for disposal and other handling
No special instruction necessary.
Marketing authorization holder
Intrapharm Laboratories Limited, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berkshire, SL6 6PT
Marketing authorization number(s)
PL 17509/0035
Date of first authorization / renewal of the authorization
05/03/2011
Date of revision of the text
14<sup>th</sup> January 2019
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