Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
Lopid 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. Lopid 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.
See Method of administration.
As for adults.
Gemfibrozil therapy has not been investigated in children. Due to the lack of data the use of Lopid 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. Lopid 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).
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.
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.
3 years.
Store below 25°C.
Film-coated tablets: PVC/Aluminium blisters with 14, 20, 28, 30, 50, 56, 60, 98, 100, 196, 500 and 600 tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
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