Source: Υπουργείο Υγείας (CY) Revision Year: 2018 Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus
Lacromid is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:
Dosage and duration of therapy should be individualized. The lowest effective dose should be prescribed for the shortest time possible. The risk of withdrawal and rebound phenomena is greater after abrupt discontinuation; therefore, the drug should be discontinued gradually for all patients (see section 4.4). Generally, the duration of treatment varies from a few days to 4 weeks including the tapering off process. Extension of the treatment period should not take place without re-evaluation of the need for continued therapy. Increases in the dosage of bezafibrate should be made gradually to help avoid adverse effects. The evening dose should be increased before the daytime doses.
The recommended dosage for Lacromid film-coated tablets is three tablets daily, equivalent to 600mg bezafibrate. Each tablet should be swallowed whole with sufficient fluid after a meal. Occasionally gastro-intestinal symptoms may occur. In susceptible patients a 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. Lacromid dosage should be adjusted based on serum creatinine clearance values (see Patients with renal impairments below).
At present there is inadequate information regarding an appropriate dosage in children.
In dialysis patients the use of Lacromid 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 (μmol/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 | Contra-indicated |
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 Treatment should be withdrawn if an adequate response has not been achieved within 3 to 4 months.
Oral administration.
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 case of rhabdomyplysis, bezafibrate must be stopped immediately and function carefully monitored.
5 years.
Lacromid Tablets should be stored below 25°C, protected from light and moisture.
PVC/Aluminium Blisters. Pack-size of 50 and 1000 film-coated tablets.
PP containers with PE closure. Pack-size 50 and 1000 film-coated tablets.
Not all pack-sizes may be marketed.
No special requirements.
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