Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Zentiva Pharma UK Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom Trading as: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Severe hepatic impairment.
Severe renal impairment.
Pregnancy and lactation, or when pregnancy is suspected.
Concurrent use with another fibrate.
Hypersensitivity to the active substance or to any component of the product.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
Patients should be advised to report unexplained muscle pain, tenderness or weakness immediately.
CPK levels should be assessed immediately in patients reporting these symptoms. Therapy should be discontinued if myopathy is diagnosed or if markedly elevated CPK levels (levels exceeding 5 times the normal range) occur.
Doses of 200mg ciprofibrate per day or greater have been associated with a high risk of rhabdomyolysis. Therefore the daily dose should not exceed 100mg.
The risk of myopathy may be increased in the presence of the following predisposing factors:
As with other fibrates, the risk of rhabdomyolysis and myoglobinuria may be increased if ciprofibrate is used in combination with other fibrates or HMG CoA reductase inhibitors (see sections 4.3 and 4.5).
Use with caution in patients with impaired hepatic function.
Periodic hepatic function tests are recommended (every 3 months for the first 12 months of treatment). Ciprofibrate treatment should be discontinued in case of increased AST and ALT levels to more than 3 times the upper limit of normal 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).
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 should be considered.
As with other fibrates, the risk of rhabdomyolysis and myoglobinuria may be increased if ciprofibrate is used in combination with other fibrates (see sections 4.3 and 4.4).
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). 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.
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).
Although ciprofibrate may potentiate the effect of oral hypoglycaemics, available data do not suggest that such an interaction may be clinically significant.
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 toxicity at high doses were observed in teratogenicty tests in animals. As there are no data on its use in human pregnancy ciprofibrate is contraindicated during pregnancy.
Ciprofibrate is excreted in the breast milk of lactating rats. As there are no data on its use in lactation, ciprofibrate is contraindicated in nursing mothers.
Dizziness, somnolence, and fatigue 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.
The adverse reactions observed in clinical studies and reported in post-marketing experience are detailed below. Post-marketing adverse reactions are designated with a frequency “not known”.
Adverse reactions frequency is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Not known: Thrombocytopenia
Common: Headache, Dizziness, Somnolence, Vertigo
Not known: Pneumonitis, Pulmonary fibrosis
Common: Nausea, Vomiting, Diarrhoea, Dyspepsia, Abdominal pain
Not known: Liver function test abnormal, Cholestasis, Cytolysis, Cholelithiasis
Common: Rash, Alopecia
Not known: Urticaria, Pruritis, Photosensitivity reaction, Eczema
Common: Myalgia
Not known: Elevation of serum creatine phosphokinase, Myopathy, Myositis, Rhabdomyolysis
Not known: Erectile dysfunction
Common: Fatigue
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
Not applicable.
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