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.

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, IIb, III and IV (hypercholesterolaemia, hypertriglyceridaemia and combined forms) - refractory to ...

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.

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 ...

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 ...

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 ...

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.

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 ...

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. ...

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 ...

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 ...

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.

List of excipients

Maize starch Lactose monohydrate Microcrystalline cellulose Hypromellose Powdered vegetable stearine Sodium laurilsulfate

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