ETORIAX Film-coated tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Etoriax 90 mg film-coated tablets. Etoriax 120 mg film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains 90 or 120 mg etoricoxib. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated tablet (tablet). Etoriax 90 mg film-coated tablets: Pink, round (diameter: 9 mm), biconvex, film coated tablets with beveled edges, engraved with mark 90 on one side of the tablet. ...

4.1. Therapeutic indications

Etoriax is indicated in adults and adolescents 16 years of age and older for the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of ...

4.2. Posology and method of administration

Posology As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patients need ...

4.3. Contraindications

Hypersensitivity to the active substance or to any pf the excipients listed in section 6.1. Active peptic ulceration or active gastro-intestinal (GI) bleeding. Patients who, after taking acetylsalicylic ...

4.4. Special warnings and precautions for use

Gastrointestinal effects Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with etoricoxib. Caution ...

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

Pharmacodynamic interactions Oral anticoagulants: In subjects stabilised on chronic warfarin therapy, the administration of etoricoxib 120 mg daily was associated with an approximate 13% increase ...

4.6. Pregnancy and lactation

Pregnancy No clinical data on exposed pregnancies are available for etoricoxib. Studies in animals have shown reproductive toxicity (see section 5.3). The potential for human risk in pregnancy is unknown. ...

4.7. Effects on ability to drive and use machines

Patients who experience dizziness, vertigo or somnolence while taking etoricoxib should refrain from driving or operating machinery.

4.8. Undesirable effects

Summary of the safety profile In clinical trials, etoricoxib was evaluated for safety in 7152 individuals, including 4614 patients with OA, RA, chronic low back pain or ankylosing spondylitis (approximately ...

4.9. Overdose

Symptoms In clinical studies, administration of single doses of etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. There have been reports of ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs ATC code: M01AH05 Mechanism of Action Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2) ...

5.2. Pharmacokinetic properties

Absorption Orally administered etoricoxib is well absorbed. The absolute bioavailability is approximately 100%. Following 120 mg once-daily dosing to steady state, the peak plasma concentration (geometric ...

5.3. Preclinical safety data

In preclinical studies, etoricoxib has been demonstrated not to be genotoxic. Etoricoxib was not carcinogenic in mice. Rats developed hepatocellular and thyroid follicular cell adenomas at >2-times the ...

6.1. List of excipients

Tablet core: Cellulose, microcrystalline Calcium hydrogen phosphate Croscarmellose sodium Sodium stearyl fumarate Silica, colloidal anhydrous Film coating: Poly(vinyl alcohol) Titanium dioxide ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Etoriax 30 mg film-coated tablets: Blister (OPA/Al/PVC, Alu foil): 28 film-coated tablets, in a box. Etoriax 60 mg and 90 mg film-coated tablets: Blister (OPA/Al/PVC, Alu foil): 20 and 28 ...

6.6. Special precautions for disposal and other handling

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

8. Marketing authorization number(s)

MA982/01401 Etoriax 90 mg film-coated tablets MA982/01402 Etoriax 120 mg film-coated tablets

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 3rd August 2018 Date of renewal: 1st November 2021

10. Date of revision of the text

28/10/2021

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