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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Modalim Tablets 100mg (2007)

Εκδότης

Εκδότης Winthrop Pharmaceuticals UK Ltd
Διεύθυνση One Onslow Street, Guildford, Surrey, GU1 4YS, UK
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Περιεχόμενα

Name of the medicinal product

Modalim Tablets 100 mg.

Qualitative and quantitative composition

Each tablet contains 100mg ciprofibrate as the active ingredient. For excipients, see 6.1

Pharmaceutical form

Tablet.

Therapeutic indications

Modalim tablets are recommended for the treatment of primary dyslipoproteinaemias, including types IIa, ...

Posology and method of administration

Adults The recommended dosage is one tablet (100mg ciprofibrate) per day. This dose should not be exceeded ...

Contraindications

Severe hepatic impairment. Severe renal impairment. Pregnancy and lactation. Concurrent use with another ...

Special warnings and precautions for use

Special warnings Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency ...

Interaction with other medicinal products and other forms of interaction

Contra-indicated combination Other fibrates: As with other fibrates, the risk of rhabdomyolysis and myoglobinuria ...

Use during pregnancy and lactation

There is no evidence that ciprofibrate is teratogenic but signs of embryotoxicity were observed at high ...

Effects on ability to drive and use machines

Dizziness, drowsiness, and tiredness have only rarely been reported in association with ciprofibrate. ...

Undesirable effects

Cutaneous disorders Cutaneous reactions mainly allergic have been reported: rashes, urticaria and pruritus, ...

Overdose

Overdosage with ciprofibrate has been rarely reported. Associated adverse events reflect those seen in ...

Pharmacodynamic properties

Pharmacotherapeutic group: Serum lipid reducing agents fibrates. ATC Code: C10A B08 Ciprofibrate is ...

Pharmacokinetic properties

Ciprofibrate is readily absorbed in man, with maximum plasma concentrations occurring mainly between ...

Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included ...

List of excipients

Maize starch Lactose monohydrate Microcrystalline cellulose Hypromellose Powdered vegetable stearine ...

Incompatibilities

Not applicable.

Shelf life

5 years when packed in blister strips.

Special precautions for storage

There are no special storage precautions.

Nature and contents of container

Clear PVC / Aluminium blister strips in packs of 28 tablets.

Special precautions for disposal and other handling

None stated.

Marketing authorization holder

Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS

Marketing authorization number(s)

PL 11723/0050

Date of first authorization / renewal of the authorization

13 June 2002

Date of revision of the text

October 2006
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.