Ciprofibrate is indicated as an adjunct to diet, physical activity, and weight reduction for the following conditions:

• Management of severe hypertriglyceridemia, with or without low HDL cholesterol levels.
• Treatment of mixed hyperlipidemia in patients who cannot tolerate statins or when statins are contraindicated.

Ciprofibrate lowers levels of LDL and VLDL, thereby reducing triglyceride and cholesterol concentrations associated with these lipoproteins. It also increases HDL cholesterol levels. Ciprofibrate is effective in treating hyperlipidemia associated with elevated plasma LDL and VLDL levels. Evidence suggests that fibrate therapy may help reduce the risk of coronary heart disease events.

Adults: The recommended daily dose is Ciprofibrate 100 mg. This dose should not be exceeded.

Patients with renal insufficiency: In cases of moderate renal impairment (creatinine clearance 30–80 ml/min/1.73 m²), the dose should be reduced to one tablet every alternate day. Patients must be closely monitored. Ciprofibrate is contraindicated in severe renal impairment (creatinine clearance <30 ml/min/1.73 m²).

Patients with hepatic insufficiency: Use with caution in patients with impaired liver function. Treatment should be discontinued if AST or ALT levels rise to more than three times the upper limit of normal or if signs of cholestatic liver injury appear.

Elderly: Same dosage as adults, but extra caution is advised in patients over 70 years of age.

Paediatric population: Not recommended, as safety and efficacy in children have not been established.

Other fibrates & HMG-CoA reductase inhibitors: The risk of myopathy, rhabdomyolysis, and myoglobinuria may increase when Ciprofibrate is used together with other fibrates or HMG-CoA reductase inhibitors.

Oral anticoagulant therapy: Caution is required when Ciprofibrate is used with oral anticoagulants. The dose of anticoagulants should be reduced and adjusted based on INR monitoring.

• Hypersensitivity to the active ingredient or any of the excipients
• Severe hepatic impairment
• Severe renal impairment (creatinine clearance <30 ml/min/1.73 m²)
• Pregnancy and lactation or suspected pregnancy
• Concomitant use with another fibrate

Headache, dizziness, drowsiness, vertigo, nausea, vomiting, diarrhea, dyspepsia, abdominal pain, rash, alopecia, muscle pain (myalgia), and fatigue.

There is no evidence that Ciprofibrate is teratogenic; however, signs of toxicity at high doses have been observed in animal studies. Due to the lack of data in human pregnancy, Ciprofibrate is contraindicated during pregnancy. Similarly, as there is no information regarding its use during lactation, it is contraindicated in breastfeeding mothers.

Special warnings: Patients with rare hereditary disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should avoid taking this medication.

Myalgia/myopathy: Patients should be advised to immediately report any unexplained muscle pain, tenderness, or weakness.

Patients with impaired hepatic function: Regular liver function tests are recommended (every 3 months during the first year of treatment). Ciprofibrate should be discontinued if AST or ALT levels rise to more than three times the upper limit of normal or if there is evidence of cholestatic liver injury.

Antihypertensive agents; other anti-anginal and anti-ischemic drugs.

Store below 30°C. Protect from light and moisture. Keep out of reach of children.