Minibet 10mg 10pcs

Indication

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 hypertriglyceridemia with or without low HDL cholesterol.- Mixed hyperlipidemia when a statin is contraindicated or not tolerated.

Dosge & Administration

PosologyAdultsThe recommended dosage is one tablet (100mg ciprofibrate) per day. This dose should not be exceeded (see Precautions). Elderly PatientsAs for adults, but see Precautions and Warnings. Use in Case of Impaired Renal FunctionIn 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 ChildrenNot recommended since safety and efficacy in children have not been established. Method of administration oral use.

• Before you start the treatment, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about ciprofibrate, and it will also provide you with a full list of the side effects which you could experience from taking it.
• Take ciprofibrate exactly as your doctor tells you to. The usual dose is one 100 mg tablet a day.
• You can generally take ciprofibrate at a time of day to suit you, but it is best to take your doses at the same time of day each day. This will help to remind you to take the tablets regularly.
• You can take ciprofibrate either with or without food. Some people find it helps to swallow the tablet with a drink of water.
• If you forget to take a dose, take it as soon as you remember. If you do not remember until the following day, leave out the forgotten dose from the previous day and take the dose that is due as normal. Do not take two doses at the same time to make up for a missed dose.

Interaction

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 combinationsHMG 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 cautionary anticoagulant therapy: Ciprofibrate is highly protein bound and therefore likely to displace other drugs from plasma protein binding sites. This may increase the effects of drugs like phenytoin, tolbutamide, and other sulphonylurea derivatives and coumarin-like anticoagulants. Ciprofibrate has been shown to potentiate the effect of warfarin, indicating that concomitant oral anticoagulant therapy should be given at a reduced dosage and adjusted according to INR. Combination to be taken into accountCholestyramine and colestipol may reduce the absorption of ciprofibrate. These drugs should not be taken together or close to each other.No clinically relevant interactions exist with cytochrome P450, beta-blocking agents, calcium antagonists, diuretics, other hypertensives digoxin, and nitroglycerinOral hypoglycaemics: Although ciprofibrate may potentiate the effect of oral hypoglycaemics, available data do not suggest that such an interaction may be clinically significant. Estrogens: Oestrogens can raise lipid levels. Although a pharmacodynamic interaction may be suggested, no clinical data are currently available.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed. 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.

Pregnancy & Lactation

Fertility There are no data on the effects of ciprofibrate on fertility in humans. Pregnancy There are insufficient data on the use of ciprofibrate in pregnant women. Animal studies have demonstrated neonatal thrombosis (see section 5.3). The potential risk for humans is unknown. Ciprofibrate is contraindicated during pregnancy (see section 4.3)Lactation Ciprofibrate is contraindicated during breastfeeding (see section 4.3). It is not known if ciprofibrate is excreted into breast milk.

Precautions & Warnings

Special warningsPatients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.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 hypoalbuminemia such as nephrotic syndrome• hypothyroidism or untreated hypothyroidism• alcohol abuse• age > 70 years• personal or family history of hereditary muscular disorders• previous history of muscular toxicity with another fibrate 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 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 dyslipidemia, such as hypothyroidism, should be excluded or corrected prior to commencing any lipid-lowering drug treatment. In patients with hypertriglyceridemia, ciprofibrate may cause an increase in the LDL level special precautions for use associated with oral anticoagulant therapy: concomitant oral anticoagulant therapy should be given at a reduced dosage and adjusted according to INR. 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.

Storage Conditions

Keep the temperature below 30°C and away from light and moisture. Keep out of children's reach.