THERAPEUTIC INDICATIONS

Treatment of primary dyslipoproteinaemias, including types IIa, IIb, III and IV (hypercholesterolemia, hypertriglyceridemia and combined forms) – refractory to appropriate dietary treatment. Dietary measures should be continued during therapy.

POSOLOGY AND METHOD OF ADMINISTRATION

Adults : The recommended dosage is one tablet (100 mg ciprofibrate) per day. This dose should not be exceeded. Elderly Patients: As for adults, but see Precautions and Warnings. Impaired Renal Function: In moderate renal impairment it is recommended that dosage be reduced to one tablet every other day. Patients should be carefully monitored. Do not be used in severe renal impairment.
Children: Not recommended (safety and efficacy has not been established). Modalim tablets are for oral administration only.

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

Patients with galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine. Discontinue therapy if myalgia/myopathy is diagnosed or elevated CPK level (>5x normal range) occur. Increased risk of myopathy with impaired renal function, hypoalbuminaemia, hypotiroidism, alcohol abuse. Risk of rhabdomyolysis for dose of 200 mg. Increased risk of rhabdomyolisis & myoglobinuria when coadministered with other fibrates or HMG CoA reductase inhibitors. Use with caution in impaired hepatic function, periodic hepatic function tests are recommended, discontinue therapy if AST & ALT levels>3x normal upper limit or cholestatic liver injury is evidenced. Secondary causes of dyslipidaemia (e.q hypothyroidism) should be corrected prior to treatment. Concomitant oral anticoagulant therapy should be given at reduced dosage and adjusted according to INR.

INTERACTIONS

Contra indicated combination: other fibrates. Not recommended combinations: HMG CoA reductase inhibitors. Combination requiring caution: Oral anticoagulant therapy (potentiate effect of warfarin). Combination to be taken into account: Oral hypoglycaemics, estrogens (can raise lipid levels).

PREGNANCY AND LACTATION

No evidence that ciprofibrate is teratogenic but signs of toxicity were observed at high doses in animals. Ciprofibrate is excreted in the breast milk of lactating rats. There are no data on the use of the drug in human pregnancy or lactation. Therefore the use of ciprofibrate is contraindicated during pregnancy and in nursing mothers.

UNDESIRABLE EFFECTS

Common: headache, dizziness, somnolence, vertigo, nausea, vomiting, diarrhea, dyspepsia, abdominal pain, rash, alopecia, myalgia, fatigue. Not known: Pneumonitis, Pulmonary fibrosis, Liver function test abnormal, cholestasis, cytolysis, cholelithiasis, urticaria, pruritis, photosensitivity reaction, eczema, myopathy, myositis, rhabdomyolysis, erectile dysfunction.

OVERDOSAGE

It has been rarely reported. No specific antidotes to ciprofibrate. Treatment of overdosage should be symptomatic. Gastric lavage and appropriate supportive care may be instituted if necessary. Ciprofibrate is non-dialysable.

PHARMACODYNAMIC PROPERTIES

ATC Code: C10AB08, Serum lipid reducing agents –fibrates.

Presentation

Box of 2 blister packs of 14 caplets (Reg No.: DKL1321205604A1)

Manufactured by

PT. Aventis Pharma, Jakarta, Indonesia

More detailed Information on request

PT Aventis Pharma Jl. Jend. Ahmad Yani, Pulomas, Jakarta 13210 (021) 4892208 – 4895608

Date of revision

2-Jan-2018 (based on BPOM approval 19-Dec-2017

This information is intended for Health Care Professional only. See local product information for full details information

MODALIM