MODALIM Tablet (2007)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Winthrop Pharmaceuticals UK Ltd |
|---|---|
| Διεύθυνση | One Onslow Street, Guildford, Surrey, GU1 4YS, UK |
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Name of the medicinal product
Modalim Tablets 100 mg.
Pharmaceutical form
Tablet.
Therapeutic indications
Modalim tablets are recommended for the treatment of primary dyslipoproteinaemias, including types IIa, IIb, III and IV (hypercholesterolaemia, hypertriglyceridaemia and combined forms) - refractory to ...
Interaction with other medicinal products and other forms of interaction
Contra-indicated combination <u>Other fibrates:</u> As with other fibrates, the risk of rhabdomyolysis and myoglobinuria may be increased if ciprofibrate is used in combination with other fibrates (see ...
Special warnings and precautions for use
Special warnings Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine. Myalgia/myopathy Patients ...
Qualitative and quantitative composition
Each tablet contains 100mg ciprofibrate as the active ingredient. For excipients, see 6.1
Posology and method of administration
Adults The recommended dosage is one tablet (100mg ciprofibrate) per day. This dose should not be exceeded (see Precautions). Elderly Patients As for adults, but see Precautions and Warnings. Use in Case ...
Contraindications
Severe hepatic impairment. Severe renal impairment. Pregnancy and lactation. Concurrent use with another fibrate. Hypersensitivity to the active substance or to any component of the product.
Incompatibilities
Not applicable.
Marketing authorization holder
Sanofi-aventis, One Onslow Street, Guildford, Surrey GU1 4YS
Date of revision of the text
October 2006
Use during pregnancy and lactation
There is no evidence that ciprofibrate is teratogenic but signs of embryotoxicity were observed at high doses in animals. Ciprofibrate is excreted in the breast milk of lactating rats. There are no data ...
Undesirable effects
Cutaneous disorders Cutaneous reactions mainly allergic have been reported: rashes, urticaria and pruritus, and very rarely photosensitivity. As with other drugs in this class, a low occurrence of alopecia ...
Marketing authorization number(s)
PL 11723/0050
Pharmacokinetic properties
Ciprofibrate is readily absorbed in man, with maximum plasma concentrations occurring mainly between one and four hours following an oral dose. Following a single dose of 100mg, in volunteers, maximum ...
Nature and contents of container
Clear PVC / Aluminium blister strips in packs of 28 tablets.
List of excipients
Maize starch Lactose monohydrate Microcrystalline cellulose Hypromellose Powdered vegetable stearine Sodium laurilsulfate
Special precautions for disposal and other handling
None stated.
Effects on ability to drive and use machines
Dizziness, drowsiness, and tiredness have only rarely been reported in association with ciprofibrate. Patients should be warned that if they are affected they should not drive or operate machinery.
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Pharmacodynamic properties
Pharmacotherapeutic group: Serum lipid reducing agents fibrates. ATC Code: C10A B08 Ciprofibrate is a new derivative of phenoxyisobutyric acid which has a marked hypolipidaemic action. It reduces both ...
Date of first authorization / renewal of the authorization
13 June 2002
Special precautions for storage
There are no special storage precautions.
Shelf life
5 years when packed in blister strips.
Overdose
Overdosage with ciprofibrate has been rarely reported. Associated adverse events reflect those seen in routine use. There are no specific antidotes to ciprofibrate. Treatment of overdosage should be symptomatic. ...