Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ciprofibrate
CST Pharma Ltd
C10AB08
Ciprofibrate
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000; GTIN: 5055946807331
PACKAGE LEAFLET: INFORMATION FOR THE USER CIPROFIBRATE 100MG TABLETS • READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Ciprofibrate is and what it is used for 2. What you need to know before you take Ciprofibrate 3. How to take Ciprofibrate 4. Possible side effects 5. How to store Ciprofibrate 6. Contents of the pack and other information 1. WHAT CIPROFIBRATE IS AND WHAT IT IS USED FOR The name of your medicine is Ciprofibrate 100mg Tablets (called ciprofibrate throughout this leaflet). It contains a medicine called ciprofibrate. This belongs to a group of medicines called ‘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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CIPROFIBRATE DO NOT TAKE CIPROFIBRATE: - if you are allergic to ciprofibrate or any of the other ingredients of this medicine (listed in section 6) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue - if you have previously taken ciprofibrate (or related substances) and your skin reacted badly to sunlight - if you are pregnant, might become pregnant or think you may be pregnant (see “Pregnancy and breast-feeding” section below) - if you are breast-feeding (see “Pregnancy and breast-feeding” section below) - if you have severe liver Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ciprofibrate 100mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100mg ciprofibrate as the active ingredient. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to Off White capsule shaped tablet plain on one side and break line on other side. The break line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 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 Posology 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 (creatinine clearance 30-80 ml/min/1.73m2) 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 (creatinine clearance <30 ml/min/1.73m2). Use in Children Not recommended since safety and efficacy in children has not been established. Method of administration For oral use. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section6.1. Severe hepatic impairment. Severe renal impairment (creatinine clearance <30 ml/min/1.73m2). Pregnancy and lactation, or when pregnancy is suspected. Concurrent use with another fibrate. Previous phototoxicity caused by fibrates 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Special warnings Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-gala Read the complete document