Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2007 Publisher: Sanofi-aventis, One Onslow Street, Guildford, Surrey GU1 4YS
Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
CPK levels should be assessed immediately in patients reporting these symptoms. Treatment should be discontinued if CPK levels are greater than ten times the upper limit of the normal range, if levels rise progressively or if there is other evidence of myopathy.
Use with caution in patients with impaired hepatic function.
Periodic hepatic function tests are recommended. Modalim treatment should be discontinued if significant transaminases abnormalities persist or if cholestatic liver injury is evidenced.
Secondary causes of dyslipidaemia, such as hypothyroidism, should be excluded or corrected prior to commencing any lipid lowering drug treatment.
Association with oral anticoagulant therapy: concomitant oral anticoagulant therapy should be given at reduced dosage and adjusted according to INR (see section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction).
If after a period of administration lasting several months, a satisfactory reduction in serum lipid concentrations has not been obtained, additional or different therapeutic measures must be considered.
Other fibrates: As with other fibrates, the risk of rhabdomyolysis and myoglobinuria may be increased if ciprofibrate is used in combination with other fibrates (see section 4.3 Contra-indications and section 4.4.1 Special warnings).
HMG CoA reductase inhibitors: As with other fibrates, the risk of myopathy, rhabdomyolysis and myoglobinuria may be increased if ciprofibrate is used in combination with HMG CoA reductase inhibitors (see section 4.4.1 Special warnings). The benefits of combined use should be carefully weighed against the risks. Physicians contemplating concomitant therapy with HMG CoA reductase inhibitors should consult the SPC of the relevant HMG CoA reductase inhibitor as some higher doses are contraindicated/not recommended with fibrates.
Oral anticoagulant therapy: Ciprofibrate is highly protein bound and therefore likely to displace other drugs from plasma protein binding sites. Ciprofibrate has been shown to potentiate the effect of warfarin, indicating that concomitant oral anticoagulant therapy should be given at reduced dosage and adjusted according to INR (see section 4.4.2 Special precautions for use).
Oral hypoglycaemics: A possible interaction should be considered.
Oestrogens: Oestrogens can raise lipid levels. Although a pharmacodynamic interaction may be suggested, no clinical data are currently available.
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 on the use of the drug in human pregnancy or lactation. Therefore the use of ciprofibrate is contraindicated during pregnancy and in nursing mothers.
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.
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 has been reported.
As with other fibrates, elevation of serum creatine phosphokinase (CPK), myalgia and myopathy including myositis and rare cases of rhabdomyolysis have been reported. In the majority of cases muscle toxicity is reversible when treatment is withdrawn (see section 4.4 Special Warnings and Special Warnings for Use).
Occasional reports of headache, vertigo.
Dizziness, drowsiness have only rarely been reported in association with ciprofibrate.
As with other drugs of this class, a low occurrence of impotence has been reported.
There have been occasional reports of gastrointestinal symptoms including nausea, vomiting, diarrhoea, dyspepsia, and abdominal pain. Generally, these side effects were mild to moderate in nature and occurred early on, becoming less frequent as treatment progressed.
As with other fibrates, abnormal liver function tests have been observed occasionally. Very rare cases of cholestasis or cytolysis have been reported (see section 4.4 Special Warnings and Special Precautions for Use). Exceptional cases with chronic evolution have been observed.
Isolated cases of pneumonitis or pulmonary fibrosis have been reported.
Tiredness has only rarely been reported in association with ciprofibrate.
Not applicable.
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