MELOXICAM Orodispersible tablet (2017)
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Περιεχόμενα
Name of the medicinal product
Meloxicam 7.5 mg Orodispersible Tablets.
Qualitative and quantitative composition
Meloxicam 7.5 mg. Excipients: E421: Mannitol 126.3 mg E420: Sorbitol 20 mg E951: Aspartame 4 mg For other Excipients See 6.1.
Pharmaceutical form
Orodispersible Tablet. Round light yellow, flat tablet embossed with AX6 on one side.
Therapeutic indications
Short-Term Symptomatic Treatment of Exacerbations of Osteoarthrosis. Long-Term Symptomatic Treatment of Rheumatoid Arthritis or Ankylosing Spondylitis.
Posology and method of administration
Oral Use. Exacerbations of Osteoarthrosis: 7.5 mg/day (one 7.5 mg tablet); if necessary, in the absence of improvement, the dose may be increased to 15 mg/day (two 7.5 mg tablets). Rheumatoid arthritis, ...
Contraindications
This medicinal product is contra-indicated in the following situations: Third trimester of pregnancy (see section 4.6 Pregnancy and lactation); Children and adolescents aged under 16 years; Hypersensitivity ...
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 ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Meloxicam is metabolised in liver, mostly by CYP 2C9 and CYP 3A4. Possibility of pharmacokinetic interactions between meloxicam and drugs inhibiting ...
Pregnancy and lactation
Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of ...
Effects on ability to drive and use machines
There are no specific studies on the ability to drive and use machinery. However, on the basis of the pharmacodynamic profile and reported adverse drug reactions, meloxicam is likely to have no or negligible ...
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 ...
Overdose
Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding ...
Pharmacodynamic properties
Pharmacotherapeutic group: Non steroidal anti-inflammatory agents, oxicams ATC code: M01AC06 Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam family, with anti-inflammatory, analgesic ...
Pharmacokinetic properties
Absorption Meloxicam is well absorbed from the gastrointestinal tract, which is reflected by a high absolute bioavailability of 89% following oral administration (capsule). Tablets, oral suspension and ...
Preclinical safety data
The toxicological profile of meloxicam has been found in preclinical studies to be identical to that of NSAID: Gastrointestinal ulcers and erosions, renal papillary necrosis at high doses during chronic ...
List of excipients
E421: Mannitol E421: Mannitol pregranulated E420: Sorbitol E1201: Povidone Cl E330: Citric acid anhydrous E951: Aspartame E553: Talc E572: Magnesium stearate E1202: Povidone K30 E572: Sodium lauryl sulphate ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
The medicinal product does not require any special storage conditions.
Nature and contents of container
Boxes containing 2 Alu/PA-Alu-PVC blister packs of 10 tablet each. Boxes containing 3 Alu/PA-Alu-PVC blister packs of 10 tablet each. Boxes with one polyethylene bottle with polypropylene child-resistant ...
Special precautions for disposal and other handling
No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Alpex Pharma (UK) Limited, Warren Plantation Church End, Haynes, Bedford, MK45 3RJ, UK Contact address: PO BOX 849, Bedford, MK45 9EG
Marketing authorization number(s)
PL 31388/0003
Date of first authorization / renewal of the authorization
07/08/2009
Date of revision of the text
27/07/2017
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