Source: Υπουργείο Υγείας (CY) Revision Year: 2018 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Lipofor 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 or 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. Lipofor should be taken orally.
The dose range is 900 mg and 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 Lipofor 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. Lipofor 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).
Oral administration.
Overdose has been reported. Symptoms reported with overdosages were abdominal cramps, abdominal 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.
Store below 25°C. Protect from light and moisture.
PVC/Aluminium blisters. Pack-sizes of 30 and 100 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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