Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ciprofibrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for The name of your medicine is Ciprofibrate 100mg Tablets (called ciprofibrate throughout this leaflet). This belongs to a group of medicines commonly known as 'fibrates'. These medicines are used to lower the level of fats (lipids) in the blood. For example the fats known as triglycerides. Ciprofibrate is used alongside a low fat diet and other non-medical treatments such as exercise and weight loss, to lower levels of fats in the blood. 2. Before you take ciprofibrate Do not take ciprofibrate if:
Take special care with ciprofibrate. Check with your doctor or pharmacist before taking ciprofibrate if you:
Important information about some of the ingredients of ciprofibrate Ciprofibrate 100mg tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product. This medicine contains less than 1mmol sodium (23mg) per dose, that is to say essentially 'sodium free'.
ciprofibrate Always take ciprofibrate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Taking this medicine
Like all medicines, ciprofibrate can cause side effects, although not everybody gets them. Stop taking your medicine and see a doctor or go to a hospital straight away – you may need urgent medical treatment.
You may also have a fever and feel or be sick. This could be a sign of biliary colic or gallstones. Other side effects are: Common (may affect up to 1 in 10 people):
ciprofibrate Keep out of the sight and reach of children. Do not use ciprofibrate after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Further information What ciprofibrate contains
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Ciprofibrate 100mg Tablets comes as tablet containing 100mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Ciprofibrate 100mg Tablets is ciprofibrate.
This leaflet reproduces the patient information leaflet approved for Ciprofibrate 100mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Ciprofibrate tablets are indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:
- Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.
- Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.
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 of 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. Ciprofibrate should not be used in severe renal impairment.
Use in Children
Not recommended since safety and efficacy in children has not been established.
Ciprofibrate tablets are for oral administration only.
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.
Myalgia/myopathy:
- 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:
• Impaired renal function and any situation of hypoalbuminaemia such as nephrotic syndrome
• hypothyroidism
• alcohol abuse
• age > 70 years
• personal or family history of hereditary muscular disorders
• previous history of muscular toxicity with another fibrate
- 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.
Excipients:
Ciprofibrate 100mg tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactose deficiency or glucose-galactose malabsorption should not take this medicine
This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially 'sodium free'
• Contra-indicated combination
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 sections 4.3 and 4.4).
• Not recommended combinations
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). 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.
• Combination requiring caution
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).
• Combination to be taken into account
Oral hypoglycaemics: Although ciprofibrate may potentiate the effect of oral hypoglycaemics, available data do not suggest that such an interaction may be clinically significant..
Oestrogens: Oestrogens can raise lipid levels. Although a pharmacodynamic interaction may be suggested, no clinical data are currently available.
Pregnancy
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.
LactationCiprofibrate 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).
Common
Uncommon
Rare
Very rare
Not known
Blood and lymphatic system disorders
Thrombocytopenia
Nervous system disorders
Headache
Dizziness
Somnolence
Vertigo
Respiratory thoracic and mediastinal disorders
Pneumonitis
Pulmonary fibrosis
Gastrointestinal disorders
Nausea
Vomiting
Diarrhoea
Dyspepsia
Abdominal pain
Hepatobiliary disorders
Liver function test abnormal
Cholestasis
Cytolysis
Cholelithiasis
Skin and subcutaneous tissue disorders
Rash
Alopecia
Urticaria
Pruritis
Photosensitivity reaction
Eczema
Musculoskeletal and connective tissue disorders
Myalgia
Elevation of serum creatine phosphokinase
Myopathy
Myositis
Rhabdomyolysis
Reproductive system and breast disorders
Erectile dysfunction
General disorders and administration site conditions
Fatigue
Reporting of suspected adverse reactions
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
There are rare reports of overdosage with ciprofibrate but in these cases there are no adverse events that are specific to overdosage. There are 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.
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Ciprofibrate 100mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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