PRAVAFEN Hard capsule (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Pravafen 40 mg/160 mg hard capsules.

2. Qualitative and quantitative composition

Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate. Excipient(s) with known effect: Each hard capsule contains 19 mg of lactose monohydrate. For a full list of excipients, ...

3. Pharmaceutical form

Hard capsule. Pravafen is a hard capsule, with light green body and olive cap, containing a waxy white beige mass and a tablet.

4.1. Therapeutic indications

Pravafen is indicated as an adjunct to diet to reduce triglyceride (TG) and increase HDL-C in high coronary heart disease (CHD)-risk adult patients with mixed dyslipidemia whose LDL-C levels are adequately ...

4.2. Posology and method of administration

Prior to initiating Pravafen, secondary causes of combined dyslipidaemia should be excluded and patients should be placed on a standard cholesterol and triglycerides-lowering diet which should be continued ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients. Severe hepatic impairment including biliary cirrhosis or active liver disease including unexplained persistent elevations in liver ...

4.4. Special warnings and precautions for use

The pharmacokinetics properties of Pravafen are not completely identical to the co-administration of the existing monotherapies when taken with fat-meal or in fasting state. Patients should not be switched ...

4.5. Interaction with other medicinal products and other forms of interaction

There have been no formal interaction studies for Pravafen. The following statements reflect the information available on the individual active substances (fenofibrate and pravastatin). Interactions relevant ...

4.6. Fertility, pregnancy and lactation

Pregnancy Pravafen There are no data from the combined use of pravastatin and fenofibrate in pregnant women. The combination has not been tested in reproductive toxicity studies. The potential risk for ...

4.7. Effects on ability to drive and use machines

Pravafen has no or negligible influence on the ability to drive and use machines. However, when driving vehicles or using machines, it should be taken into account that dizziness and visual disturbances ...

4.8. Undesirable effects

In clinical trials, over 1,566 patients received Pravafen. Adverse reactions have usually been mild and transient. Overall adverse reactions with Pravafen Clinical adverse reactions reported by the investigators ...

4.9. Overdose

In the event of an overdose, symptomatic and supportive measures should be employed. Pravastatin Reported cases of overdose were asymptomatic and did not give rise to abnormal laboratory tests. No specific ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Lipid modifying agents, HMG CoA reductase inhibitors in combination with other lipid modifying agents ATC code: C10BA03 Pharmacodynamic effects Pravafen contains ...

5.2. Pharmacokinetic properties

No clinically significant pharmacokinetic interaction was seen when fenofibrate was coadministered with pravastatin. Absorption Pravafen is bioequivalent to coadministered fenofibrate and pravastatin in ...

5.3. Preclinical safety data

The safety of concomitant administration of pravastatin and fenofibrate was assessed in rats. Toxicological findings in these co-administration studies were consistent with those seen with pravastatin ...

6.1. List of excipients

Capsule content: Lactose monohydrate Cellulose microcrystalline Ascorbyl palmitate Povidone K29-32 Sodium starch glycolate Magnesium stearate Talc Triacetin Sodium hydrogen carbonate Lauroyl macrogolglycerides ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 30°C.

6.5. Nature and contents of container

Opaque white HDPE bottles containing 30 hard capsules.

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

SMB Technology S.A., Rue du Parc Industriel 39, B-6900 Marche en Famenne, Belgium

10. Date of revision of the text

03/05/2021

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