BEZAFIBRATE Film-coated tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Bezafibrate 200 mg Film-coated Tablets.
Qualitative and quantitative composition
Each tablet contains: 200 mg of bezafibrate. Excipient with known effect: Each tablet contains 1.56 mg lactose. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. Bezafibrate 200 mg Film-coated Tablets are 10mm, round normal convex white film-coated tablets, debossed BZ/200 on one side and G on the other.
Therapeutic indications
Bezafibrate is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following: Treatment of severe hypertriglyceridaemia with or without low ...
Posology and method of administration
Posology Adults 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, ...
Contraindications
Bezafibrate is contraindicated in patients with: hypersensitivity to the active substance or to any of the excipients listed in section 6.1 hypersensitivity to other fibrates significant hepatic disease ...
Special warnings and precautions for use
Bezafibrate should be used as an adjunct to diet and measures such as physical activity, weight loss and adequate treatment of other metabolic disorders (e.g. diabetes, gout). Secondary causes of dyslipidaemia, ...
Interaction with other medicinal products and other forms of interaction
Care is required in administering bezafibrate to patients taking coumarin-type anticoagulants, the action of which may be potentiated. The dosage of anticoagulant should be reduced by up to 50 per cent ...
Pregnancy and lactation
Pregnancy There are limited data from the use of bezafibrate in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. The potential risk for humans is unknown. Bezafibrate ...
Effects on ability to drive and use machines
Bezafibrate has been shown to cause dizziness and can have a minor to moderate effect on the ability to drive or use machines. Patients should not drive or use machines if they are affected.
Undesirable effects
The overall safety profile of bezafibrate is based on a combination of clinical study data and post-marketing experience. The frequency of adverse drug reactions (ADRs) according to MedDRA System Organ ...
Overdose
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, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Lipid modifying agents, plain Fibrates ATC Code: C10AB02 Mechanism of action Bezafibrate lowers elevated blood lipids (triglycerides and cholesterol). Elevated VLDL and LDL are ...
Pharmacokinetic properties
Absorption Bezafibrate is rapidly and almost completely absorbed from the standard film-coated tablet formulation. A peak plasma concentration of about 8mg/l is reached after 1-2 hours following a single ...
Preclinical safety data
The chronic administration of a high dose of bezafibrate to rats was associated with hepatic tumour formation in females. This dosage was in the order of 30 to 40 times the human dosage. No such effect ...
List of excipients
Bezafibrate 200 mg Film-coated Tablets contain the following excipients: <u>Tablet core excipients:</u> Silica, colloidal anhydrous Magnesium stearate Maize starch Cellulose, microcrystalline Povidone ...
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Bezafibrate 200 mg Film-coated Tablets are available in either: - cartoned PVC/PVdC/Aluminium foil blister packs along with patient leaflets as packs of 84 or 100 or HDPP containers with tamper evident ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL
Marketing authorization number(s)
PL 04569/0390
Date of first authorization / renewal of the authorization
26 October 1999 / 8 April 2005
Date of revision of the text
December 2018
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