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METHYLDOPA Film coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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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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