Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL
Bezafibrate is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:
The recommended dosage is one tablet (200 mg Bezafibrate) taken three times daily equivalent to 600 mg bezafibrate. Occasionally gastrointestinal symptoms may occur. In susceptible patients, slowly increasing dosage over 5 to 7 days may help to avoid such symptoms.
In elderly people there is a physiological reduction of the renal function with age. Bezafibrate dosage should be adjusted based on serum creatinine clearance values (see Patients with renal impairment below).
In dialysis patients the use of bezafibrate is contraindicated.
In patients with renal insufficiency the dose should be adjusted according to serum creatinine levels or creatinine clearance as shown in the following table.
| Serum creatinine (micro mol/l) | Creatinine clearance (ml/min) | Dosage (tablets/day) |
|---|---|---|
| Up to 135 | Over 60 | 3 |
| 136-225 | 60-40 | 2 |
| 226-530 | 40-15 | 1 every 1 or 2 days |
| Over 530 | Less than 15 | Contraindicated |
The response to therapy is normally rapid, although a progressive improvement may occur over a number of weeks. Treatment should be withdrawn if an adequate response has not been achieved within 3 to 4 months.
At present there is inadequate information regarding an appropriate dosage in children and adolescents.
Bezafibrate Film-coated Tablets are for oral use.
Tablets should be swallowed whole with a sufficient amount of fluid after each meal.
No specific effects of acute overdose are known. Rhabdomyolysis has occurred. There is no specific antidote. Thus appropriate symptomatic therapy is recommended in cases of overdose. In cases of rhabdomyolysis, bezafibrate must be stopped immediately and renal function carefully monitored.
2 years.
This medicinal product does not require any special storage conditions.
Bezafibrate 200 mg Film-coated Tablets are available in either: -
Not all pack sizes may be marketed.
No special requirements for disposal.
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