ECOXAR Flm-coated tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
ECOXAR 30 mg Film coated tablets. ECOXAR 60 mg Film coated tablets. ECOXAR 90 mg Film coated tablets. ECOXAR 120 mg Film coated tablets.
2. Qualitative and quantitative composition
<u>ECOXAR 30 mg:</u> Each film coated tablet contains etoricoxib 30 mg. Contains sugar: lactose monohydrate 1,05 mg/coated tablet. <u>ECOXAR 60 mg:</u> Each film coated tablet contains etoricoxib 60 mg. ...
3. Pharmaceutical form
<u>ECOXAR 30 mg:</u> Blue green, film coated, round biconvex tablets, E30 debossed on one side and plain on other side. <u>ECOXAR 60 mg:</u> Green to dark green, film coated, round biconvex tablets, E60 ...
4.1. Therapeutic indications
ECOXAR 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 ECOXAR is administered orally. ECOXAR may be taken with or without food. ECOXAR should be administered for the shortest duration possible and the lowest effective daily dose should be used. <b> ...
4.3. Contraindications
ECOXAR is contraindicated in: patients with known hypersensitivity to any of the excipients of ECOXAR (see section 6.1) patients with active peptic ulceration or gastrointestinal (GI) bleeding patients ...
4.4. Special warnings and precautions for use
<b>ECOXAR may predispose to cardiovascular events, gastrointestinal events or cutaneous reactions which may be fatal.</b> 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 ECOXAR, may increase the nephrotoxic effect of ciclosporin or tacrolimus. Renal function should be monitored ...
4.6. Fertility, pregnancy and lactation
ECOXAR is contraindicated in pregnancy and lactation (see section 4.3). Pregnancy ECOXAR, 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 ECOXAR 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
<b>Pharmacological classification:</b> A.3.1 Anti-Rheumatics (Anti-inflammatory Agents) <b>ATC code:</b> 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 <u>Coating:</u> 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)
ECOXAR 30 mg: 51/3.1/1144 ECOXAR 60 mg: 51/3.1/1145 ECOXAR 90 mg: 51/3.1/1146 ECOXAR 120 mg: 51/3.1/1147
9. Date of first authorization / renewal of the authorization
Date of registration: February 2020
10. Date of revision of the text
21 January 2022
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