FENOFIBRATE Hard capsule (2023)
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Περιεχόμενα
Name of the medicinal product
Fenofibrate 200 mg capsules.
Qualitative and quantitative composition
Each capsule contains 200 mg micronised fenofibrate. Excipient with known effect: Each capsule contains 46.34 mg lactose monohydrate. This capsule also contains sunset yellow FCF (E110). For the full list ...
Pharmaceutical form
Hard capsule. Orange cap/orange body, self locked hard gelatin capsules of size 0 imprinted with FB200 on cap and body containing white to off white granular powder.
Therapeutic indications
Fenofibrate 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
Dietary measures initiated before therapy should be continued. Response to therapy should be monitored by determination of serum lipid values. If an adequate response has not been achieved after several ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality). Known ...
Special warnings and precautions for use
Secondary causes of hyperlipidaemia Secondary causes of hyperlipidemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological ...
Interaction with other medicinal products and other forms of interaction
Oral anti-coagulants Fenofibrate enhances oral anti-coagulant effect and may increase risk of bleeding. In patients receiving oral anti-coagulant therapy, the dose of anti-coagulant should be reduced by ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of fenofibrate in pregnant women. Animal studies have not demonstrated any teratogenic effects. Embryotoxic effects have been shown at doses in the range ...
Effects on ability to drive and use machines
Fenofibrate 200 mg Capsules have no or negligible influence on the ability to drive and use machines.
Undesirable effects
The most commonly reported ADRs during Fenofibrate therapy are digestive, gastric or intestinal disorders. The following undesirable effects have been observed during placebo-controlled clinical trials ...
Overdose
Only anecdotal cases of fenofibrate overdosage have been received. In the majority of cases no overdose symptoms were reported. No specific antidote is known. If overdose is suspected, treat symptomatically ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Serum Lipid Reducing Agents/Cholesterol and Triglyceride Reducers/Fibrates. <b>ATC code:</b> C10AB05 Fenofibrate 200 mg Capsules are a formulation containing 200 mg of ...
Pharmacokinetic properties
Absorption Maximum plasma concentrations (C<sub>max</sub>) occur within 4 to 5 hours after oral administration. Plasma concentrations are stable during continuous treatment in any given individual. <b> ...
Preclinical safety data
In a three-month oral nonclinical study in the rat species with fenofibric acid, the active metabolite of fenofibrate, toxicity for the skeletal muscles (particularly those rich in type I slow oxidative ...
List of excipients
<>Intragranular:</u> Sodium lauryl sulphate Lactose Pregelatinised starch Crospovidone <u>Extragranular:</u> Crospovidone Pregelatinised starch Talc Colloidal anhydrous silica Magnesium stearate <u>Capsule: ...
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Store in the original package. Do not store above 25°C.
Nature and contents of container
Blister strip of clear transparent PVC film coated with PVdC on the inner side with a backing of aluminium foil. Pack size of 10, 14, 20, 28, 30, 56, 60 or 90 capsules. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
SUN PHARMA UK LIMITED, 6-9 The Square, Stockley Park, Uxbridge, UB11 1FW, United Kingdom
Marketing authorization number(s)
PL 14894/0368
Date of first authorization / renewal of the authorization
01/01/2012
Date of revision of the text
18/08/2023
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