LIPANTIL Capsule (2020)
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Περιεχόμενα
1. Name of the medicinal product
Lipantil Micro 67 mg, capsules.
2. Qualitative and quantitative composition
Each capsule contains 67 mg fenofibrate. <u>Excipients with known effect:</u> each capsule contains 33.8 mg of lactose monohydrate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Yellow, hard gelatin capsule.
4.1. Therapeutic indications
Lipantil Micro 67mg 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 ...
4.2. 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 ...
4.3. Contraindications
Hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality), Known gallbladder disease, Severe renal insufficiency (estimated glomerular filtration rate <30 ...
4.4. Special warnings and precautions for use
Secondary causes of hyperlipidemia Secondary causes of hyperlipidemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological ...
4.5. 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 ...
4.6. 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 ...
4.7. Effects on ability to drive and use machines
Lipantil Micro 67mg has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
The most commonly reported ADRs during Lipantil therapy are digestive, gastric or intestinal disorders. The following undesirable effects have been observed during placebo-controlled clinical trials (n=2344) ...
4.9. 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 ...
5.1. Pharmacodynamic properties
Serum Lipid Reducing Agents/Cholesterol and Triglyceride Reducers/Fibrates. <b>ATC code:</b> C10AB05 Lipantil Micro 67 is a formulation containing 67mg of micronised fenofibrate. Fenofibrate is a fibric ...
5.2. 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. The ...
5.3. 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 ...
6.1. List of excipients
<u>Excipients:</u> Lactose monohydrate Magnesium stearate Pregelatinised starch Sodium laurilsulfate Crospovidone <u>Composition of the capsule shell:</u> Gelatin Titanium dioxide (E171) Quinoline yellow ...
6.2. Incompatibilities
No effect noted to date.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store in the original package. Do not store above 30°C.
6.5. Nature and contents of container
Pack of 28, 56, 84, 90 capsules in blisters (PVC/Aluminium). * Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom
8. Marketing authorization number(s)
PL 46302/0044
9. Date of first authorization / renewal of the authorization
11 September 1997 / 10 September 2002
10. Date of revision of the text
September 2020
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