Gemfibrozil 600mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gemfibrozil

Available from:

Teva UK Ltd

ATC code:

C10AB04

INN (International Name):

Gemfibrozil

Dosage:

600mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 5017007300922

Patient Information leaflet

Space for
pharmacode
PATIENT INFORMATION LEAFLET
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1
WHAT THIS MEDICINE IS AND WHAT IT IS
USED FOR
2
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE GEMFIBROZIL
3
HOW TO TAKE GEMFIBROZIL
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GEMFIBROZIL 600MG FILM-COATED TABLETS
Gemfibrozil belongs to a group of medicines called
lipid-lowering medicines or fibrates. These work by helping
to reduce cholesterol and triglycerides (fats) in the blood.
Gemfibrozil is used to treat the following:
·
To prevent heart disease in men between 40-55 years
of age suffering from hyperlipidaemias (where the
concentration of fats in the blood is too high) and
diet/other appropriate measures have been insufficient
to correct the condition
·
To prevent heart disease in men with increased
cholesterol levels and at high risk for first-time heart
problems and statin medicines (HMG-CoA reductase
inhibitors) are contraindicated or not well tolerated
·
It is also used to treat patients who have high blood
cholesterol and triglyceride levels (hyperlipidaemia of
types IIa, IIb, III, IV and V), which cannot be controlled
by diet or exercise or weight loss o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gemfibrozil 600mg film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contain 600mg gemfibrozil
For the
full list of
excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet.
White oblong, film-coated tablet of 9 x 19mm dimension with three
break
marks on both sides.
The score line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses
4.1
THERAPEUTIC INDICATIONS
Gemfibrozil tablets are indicated for the primary prevention of
coronary heart
disease in men between 40-55 years of age and with hyperlipidaemias
who
have not responded to diet and other appropriate measures.
Gemfibrozil tablets are also indicated for the treatment of patients
with
hyperlipidaemias of Fredrickson Type IIa (Primary
hypercholesterolaemia)
when a statin is contraindicated or not tolerated, Fredrickson Type
IIb (mixed
hyperlipidaemia), Fredrickson Type III (familial
dysbetalipoproteinaemia),
Fredrickson Type IV (hypertriglyceridaemia) and Type V (severe
hypertriglyceridaemia) with or without low HDL cholesterol.
Gemfibrozil Tablets should be prescribed only for patients with lipid
or
lipoprotein abnormalities demonstrated by laboratory tests and where
diet
alone is insufficient to correct the condition.
Primary prevention
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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY 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.
ADULTS
The dose range is 900 mg to 1200 mg daily, in divided doses usually
twice
daily, half an hour before breakfast and half an hour before the
evening meal.
The only dose with docume