Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Ciprofibrate 100mg Tablets

⚠ This medicine appears to have been discontinued

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.

Active substance: Ciprofibrate
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

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:

  • You are allergic (hypersensitive) to ciprofibrate or any of the other ingredients of ciprofibrate (see Section 6: Further information) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
  • You are pregnant, might become pregnant or think you may be pregnant (see "Pregnancy and breast-feeding" section below)
  • You are breast-feeding (see "Pregnancy and breast-feeding" section below)
  • You have severe liver or kidney problems
  • You are taking 'fibrates' (such as clofibrate, bezafibrate, fenofibrate or gemfibrozil)- used to treat high blood fat levels Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking ciprofibrate.

Take special care with ciprofibrate. Check with your doctor or pharmacist before taking ciprofibrate if you:

  • have unexpected muscle pains, tenderness or weakness
  • have liver or kidney problems
  • have an under-active thyroid gland
  • are over 70 years of age
  • or a member of your family have had muscle problems in the past. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking ciprofibrate. Blood Tests
  • Taking ciprofibrate may affect the results of some blood tests. During treatment your doctor may do blood tests to check how your liver is working
  • If you are going to have any other blood tests, it is important to tell the person taking the test that you are taking ciprofibrate. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken, any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because ciprofibrate can affect the way some other medicines work. Also some medicines can affect the way ciprofibrate works. Tell your doctor if you are taking any of the following medicines:
  • Statins (such as simvastatin, atorvastatin,pravastatin, fluvastatin and rosuvastatin)- used to treat high blood fat levels
  • Warfarin – used for thinning the blood
  • Insulin or Metformin – used for diabetes
  • Contraceptive medicines (such as 'The Pill') or hormone replacement therapy (HRT) Taking ciprofibrate with alcohol One of the side effects of this medicine is muscle problems. Drinking a lot of alcohol may increase the chance of muscle problems. This means that you must limit the amount of alcohol you drink while you are taking ciprofibrate. Ask your doctor for more advice. Pregnancy and breast-feeding Do not take ciprofibrate if you are:
  • Pregnant, might become pregnant, or think you may be pregnant
  • Breast-feeding or planning to breast-feed. This is because small amounts of ciprofibrate may pass into the mother's milk. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. Driving and using machines If you get dizzy, drowsy and tired while taking ciprofibrate, then you should not drive or use any tools or machinery.

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'.

How to take it

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

  • Take this medicine by mouth
  • Do not give to children under 12 years
  • It is important while you are taking ciprofibrate to keep to any special diet you have been given
  • If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor. How much to take
  • The usual dose for adults is 1 tablet every day
  • Do not take any more than 1 tablet each day
  • If you have kidney problems, only take 1 tablet every other day. If you take more ciprofibrate than you should If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. If you forget to take ciprofibrate
  • If you forget a dose, take it as soon as you remember it.
  • However, if it is time for the next dose, skip the missed dose.
  • Do not take a double dose to make up for a forgotten dose. If you stop taking ciprofibrate Keep taking your medicine until your doctor tells you to stop. Do not stop taking ciprofibrate just because you feel better. If you stop, your illness may get worse. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

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.

  • Muscle problems, such as cramps, pain or tenderness. This can lead to kidney failure. Tell your doctor as soon as possible if you have any of the following side effects:
  • An allergic reaction. The signs may include: a rash (which may be itchy and lumpy), itching and being more sensitive to the sun than usual.
  • Inflammation of the lungs which causes breathlessness, cough and raised temperature.
  • Scarring of the lungs which causes shortness of breath.
  • Liver problems. This may cause the eyes or skin to go yellow (jaundice).
  • Severe pain in the upper right corner of your stomach, which could reach through to your back.

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):

  • Hair loss, balding.
  • Headache, balance problems.
  • Feeling dizzy, drowsy or tired.
  • Feeling sick (nausea) or being sick (vomiting).
  • Diarrhoea, indigestion or stomach pains.
  • Pain in your muscles. Not Known (frequency cannot be estimated from the available data):
  • Impotence
  • You may bruise more easily than usual. This could be because of a blood disorder (thrombocytopenia).
  • Muscle weakness, cramps, stiffness and spasm.
  • Inflammation of your muscles. Reporting of side effects 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.

How to store it

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

  • The active substance is ciprofibrate
  • The other ingredients are maize starch, lactose monohydrate, microcrystalline cellulose, hypromellose, powdered vegetable stearine, sodium laurilsulfate What ciprofibrate looks like and contents of the pack Ciprofibrate tablets are round and white with a breakline on one side and S170 stamped on the other. They are supplied in cartons of 28 tablets. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom Manufacturer Opella Healthcare Poland Sp. z o.o. Oddział w Rzeszowie ul. Lubelska 52 35-233 Rzeszów Poland This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in June 2022 ©2022 Zentiva

833314 1065029419

Frequently asked questions about Ciprofibrate 100mg Tablets

How do I take Ciprofibrate 100mg Tablets?

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.

What is the active substance in Ciprofibrate 100mg Tablets?

The active substance in Ciprofibrate 100mg Tablets is ciprofibrate.

Where does this information come from?

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.

Can I get Ciprofibrate 100mg Tablets without a prescription?

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.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Ciprofibrate (1 medicine)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

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.

4.2. 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 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.

4.3. Contraindications

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.

4.4. Special warnings and precautions for use

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'

4.5. Interaction with other medicinal products and other forms of interaction

• 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.

4.6. Pregnancy and lactation

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.

4.7. Effects on ability to drive and use machines

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.

4.8. Undesirable effects

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.

4.9. Overdose

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.

🇵🇱 Known in Poland as

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.

  • LipanorCiprofibratum

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 about this leaflet

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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