CORICIB Film-coated tablet (2022)

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

1. Name of the medicinal product

CORICIB 30 mg Film coated tablets. CORICIB 60 mg Film coated tablets. CORICIB 90 mg Film coated tablets. CORICIB 120 mg Film coated tablets.

2. Qualitative and quantitative composition

CORICIB 30 mg: Each film coated tablet contains etoricoxib 30 mg. Contains sugar: lactose monohydrate 1,05 mg/coated tablet. CORICIB 60 mg: Each film coated tablet contains etoricoxib 60 ...

3. Pharmaceutical form

CORICIB 30 mg: Blue green, film coated, round biconvex tablets, E30 debossed on one side and plain on other side. CORICIB 60 mg: Green to dark green, film coated, round biconvex tablets, ...

4.1. Therapeutic indications

CORICIB is indicated for: symptomatic relief of osteoarthritis (OA) and rheumatoid arthritis (RA). treatment of ankylosing spondylitis (AS). treatment of acute gouty arthritis. short term relief of acute ...

4.2. Posology and method of administration

Posology CORICIB is administered orally. CORICIB may be taken with or without food. CORICIB should be administered for the shortest duration possible and the lowest effective daily dose should be used. ...

4.3. Contraindications

CORICIB is contraindicated in: patients with known hypersensitivity to any of the excipients of CORICIB (see section 6.1) patients with active peptic ulceration or gastrointestinal (GI) bleeding patients ...

4.4. Special warnings and precautions for use

CORICIB may predispose to cardiovascular events, gastrointestinal events or cutaneous reactions which may be fatal. Clinical trials suggest that the selective COX-2 inhibitor class of medicines, ...

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

Ciclosporin and tacrolimus: Co-administration of ciclosporin or tacrolimus with any NSAID, including CORICIB, may increase the nephrotoxic effect of ciclosporin or tacrolimus. Renal function should ...

4.6. Fertility, pregnancy and lactation

CORICIB is contraindicated in pregnancy and lactation (see section 4.3). Pregnancy CORICIB, as in other medicines inhibiting prostaglandin synthesis may cause uterine inertia and premature ductus arteriosis ...

4.7. Effects on ability to drive and use machines

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

4.8. Undesirable effects

a) Summary of the safety profile The following serious undesirable effects have been reported in association with the use of NSAIDs and cannot be ruled out for etoricoxib: nephrotoxicity including interstitial ...

4.9. Overdose

The most frequently observed adverse experiences were gastrointestinal events, renovascular events. In the event of overdose, it is reasonable to employ the usual supportive measures e.g. remove unabsorbed ...

5.1. Pharmacodynamic properties

Pharmacological classification: A.3.1 Anti-Rheumatics (Anti-inflammatory Agents) ATC code: M01AH05 Etoricoxib is a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, ...

5.2. Pharmacokinetic properties

Absorption Orally administered etoricoxib is absorbed with a mean oral bioavailability of approximately 100%. Following 120 mg once-daily dosing to steady state, the peak plasma concentration (geometric ...

6.1. List of excipients

Cellulose microcrystalline Calcium hydrogen phosphate anhydrous Croscarmellose sodium Magnesium stearate Coating: 30 mg: Opadry II green 32K510020 (lactose monohydrate, hypromellose, titanium dioxide, ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store at or below 25°C. Protect from moisture. Keep blister in carton until required for use.

6.5. Nature and contents of container

The tablets are packed in cold form blisters. Each blister strip contains 7 tablets. Carton contains 7 or 28 tablets. Cold form blister pack: Cold form blister pack comprises of cold form blister laminate ...

7. Marketing authorization holder

Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext.1, Roodepoort, 1724, South Africa

8. Marketing authorization number(s)

CORICIB 30 mg: 51/3.1/1148.1144 CORICIB 60 mg: 51/3.1/1149.1145 CORICIB 90 mg: 51/3.1/1150.1146 CORICIB 120 mg: 51/3.1/1151.1147

9. Date of first authorization / renewal of the authorization

Date of registration: February 2020

10. Date of revision of the text

21 January 2022

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

application/pdf