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ARAVA Film-coated tablet (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Arava 10 mg film-coated tablets.

Qualitative and quantitative composition

Each tablet contains 10 mg of leflunomide. Excipients with known effect: Each tablet contains 78 mg of lactose monohydrate. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. White to almost white, round film-coated tablet, imprinted with ZBN on one side.

Therapeutic indications

Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a disease-modifying antirheumatic drug (DMARD), active psoriatic arthritis. Recent or concurrent treatment ...

Posology and method of administration

The treatment should be initiated and supervised by specialists experienced in the treatment of rheumatoid arthritis and psoriatic arthritis. Alanine aminotransferase (ALT) or serum glutamopyruvate transferase ...

Contraindications

Hypersensitivity (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to the active substance, to the principal active metabolite teriflunomide or to any of the ...

Special warnings and precautions for use

Concomitant administration of hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) is not advisable. The active metabolite of leflunomide, A771726, has a long half-life, usually 1 to 4 weeks. Serious ...

Interaction with other medicinal products and other forms of interaction

Interactions studies have only been performed in adults. Increased side effects may occur in case of recent or concomitant use of hepatotoxic or haematotoxic medicinal products or when leflunomide treatment ...

Fertility, pregnancy and lactation

Pregnancy The active metabolite of leflunomide, A771726 is suspected to cause serious birth defects when administered during pregnancy. Arava is contraindicated in pregnancy (see section 4.3). Women of ...

Effects on ability to drive and use machines

In the case of side effects such as dizziness the patients ability to concentrate and to react properly may be impaired. In such cases patients should refrain from driving cars and using machines.

Undesirable effects

Summary of the safety profile The most frequently reported adverse effects with leflunomide are: mild increase in blood pressure, leucopenia, paraesthesia, headache, dizziness, diarrhoea, nausea, vomiting, ...

Overdose

Symptoms There have been reports of chronic overdose in patients taking Arava at daily doses up to five times the recommended daily dose, and reports of acute overdose in adults and children. There were ...

Pharmacodynamic properties

Pharmacotherapeutic group: selective immunosuppressants ATC code: L04AA13 Human pharmacology Leflunomide is a disease-modifying anti-rheumatic agent with antiproliferative properties. Animal pharmacology ...

Pharmacokinetic properties

Leflunomide is rapidly converted to the active metabolite, A771726, by first-pass metabolism (ring opening) in gut wall and liver. In a study with radiolabelled <sup>14</sup>C-leflunomide in three healthy ...

Preclinical safety data

Leflunomide, administered orally and intraperitoneally, has been studied in acute toxicity studies in mice and rats. Repeated oral administration of leflunomide to mice for up to 3 months, to rats and ...

List of excipients

<u>Tablet core:</u> Maize starch Povidone (E1201) Crospovidone (E1202) Silica colloidal anhydrous Magnesium stearate (E470b) Lactose monohydrate <u>Film-coating:</u> Talc (E553b) Hypromellose (E464) Titanium ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

Blister: Store in the original package. Bottle: Keep the bottle tightly closed.

Nature and contents of container

Blister: Aluminium/Aluminium blister. Pack sizes: 30 and 100 film-coated tablets. Bottle: 100 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container, containing either 30 or 100 ...

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

Sanofi-Aventis Deutschland GmbH, D-65926, Frankfurt am Main, Germany

Marketing authorization number(s)

EU/1/99/118/001-004

Date of first authorization / renewal of the authorization

Date of first authorisation: 02 September 1999 Date of latest renewal: 02 September 2009

Πηγαίο έγγραφο

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