MELOX Tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Melox 7.5mg tablets. Melox 15mg tablets.
2. Qualitative and quantitative composition
Each Melox 7.5mg Tablet contains 7.5mg meloxicam. Each Melox 15mg Tablet contains 15mg meloxicam. <u>Excipient with known effect:</u> lactose monohydrate. One 7.5 mg tablet contains 18.75 mg lactose monohydrate. ...
3. Pharmaceutical form
Tablet. For oral administration. <u>Melox 7.5mg tablets:</u> Light yellow, round, flat, scored on one side, 7mm diameter tablets. The score line is only to facilitate breaking for ease of swallowing and ...
4.1. Therapeutic indications
Short term symptomatic therapy of exacerbations of osteoarthrosis. Long term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis.
4.2. Posology and method of administration
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The patients need for symptomatic relief and response ...
4.3. Contraindications
This medicinal product is contra-indicated in the following situations: third trimester of pregnancy (see section 4.6). children and adolescents aged under 16 years. hypersensitivity to the active substance ...
4.4. Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below). The recommended ...
4.5. Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Risks related to hyperkalaemia Certain medicinal products or therapeutic groups may promote hyperkalaemia: potassium salts, potassium-sparing diuretics, ...
4.6. Fertility, pregnancy and lactation
Fertility The use of meloxicam, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair female fertility and is not recommended in women attempting to conceive. In women who ...
4.7. Effects on ability to drive and use machines
No specific studies on the ability to drive and use machinery have been performed. However, on the basis of the pharmacodynamic profile and reported adverse drug reactions, meloxicam is likely to have ...
4.8. Undesirable effects
a) General Description Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial ...
4.9. Overdose
Symptoms Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with supportive care. Gastrointestinal ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Non steroidal anti-inflammatory agent, Oxicams <b>ATC Code:</b> M01AC06 Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam family, with anti- inflammatory, ...
5.2. Pharmacokinetic properties
Absorption Meloxicam is well absorbed from the gastrointestinal tract, which is reflected by a high absolute bioavailability of about 90% following oral administration (capsule). Tablets, oral suspension ...
5.3. Preclinical safety data
The toxicological profile of meloxicam has been found in preclinical studies to be identical to that of other NSAIDs: gastrointestinal ulcers and erosions; renal papillary necrosis at high doses during ...
6.1. List of excipients
Melox 7.5 mg tablets also contain sodium citrate dehydrate, lactose monohydrate, microcrystaline cellulose, anhydrous silica, povidone K-25, crospovidone and magnesium stearate. Melox 15 mg tablets also ...
6.2. Incompatibilities
None known.
6.3. Shelf life
24 months.
6.4. Special precautions for storage
Store below 25°C in the original package, in order to protect from light and moisture.
6.5. Nature and contents of container
Tablets are packaged in Polyvinyl chloride/Poyvinynylidene chloride film-aluminium foil blisters with a patient in packs of 10, 20 and 30 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
Melox 7.5mg Tablets – 17762 Melox 15mg Tablets – 17763
9. Date of first authorization / renewal of the authorization
Date of first authorisation: Melox 7.5mg Tablets – 27.05.1998 Melox 15mg Tablets – 27.05.1998 Date of latest renewal: Melox 7.5mg Tablets – 12.10.2009 Melox 15mg Tablets – 12.10.2009
10. Date of revision of the text
29/06/2020
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