Source: Υπουργείο Υγείας (CY) Revision Year: 2015 Publisher: Medochemie Ltd, Constantinoupoleos 1-10, Limassol, Cyprus
Ipolipid is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:
Reduction of cardiovascular morbidity in males with increased non-HDL cholesterol and at high risk for a first cardiovascular event when a statin is contraindicated or not tolerated (see section 5.1).
Prior to initiating gemfibrozil, other medical problems such as hypothyroidism and diabetes mellitus must be controlled as best as possible and patients should be placed on a standard lipid-lowering diet, which should be continued during treatment.
Ipolipid should be taken orally.
The dose range is 900 mg to 1200 mg daily.
The only dose with documented effect on morbidity is 1200 mg daily.
The 1200 mg dose is taken as 600 mg twice daily, half an hour before breakfast and half an hour before the evening meal.
The 900 mg dose is taken as a single dose half an hour before the evening meal.
As for adults.
Gemfibrozil therapy has not been investigated in children. Due to the lack of data the use of Ipolipid in children is not recommended.
In patients with mild to moderate renal impairment, (Glomerular filtration rate 50-80 and 30-<50 ml/min/1.73 m², respectively), start treatment at 900 mg daily and assess renal function before increasing dose. Ipolipid should not be used in patients with severely impaired renal function (see section 4.3).
Gemfibrozil is contraindicated in hepatic impairment (see section 4.3).
Overdose has been reported. Symptoms reported with overdosage were abdominal cramps, abnormal LFT’s, diarrhea, increased CPK, joint and muscle pain, nausea and vomiting.
The patients fully recovered. Symptomatic supportive measures should be taken if overdose occurs.
5 years.
The product does not require any special storage conditions.
300mg capsules: PVC/aluminium foil blisters of 10 capsules, supplied in cartons of 50, 60, 100 and 500 capsules.
600mg tablets: PVC/aluminium foil blisters of 10 tablets, supplied in cartons of 20, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.
Any unused product or waste material should not be disposed to the drain or the household dustbin. Follow the instructions of your pharmacist. These measures will help to the environment protection.
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