APONIL Tablet (2015)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Aponil 100 mg tablets.
2. Qualitative and quantitative composition
Each tablet contains 100 mg nimesulide. <u>Excipient with known effect:</u> lactose monohydrate. Each 100 mg tablet contains 153.7 mg lactose. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. Light yellow, round flat, scored, with diameter of 10.5 mm. The tablet can be divided into equal doses.
4.1. Therapeutic indications
Treatment of acute pain (see section 4.2) Primary dysmenorrhoea Nimesulide should only be prescribed as second line treatment. The decision to prescribe nimesulide should be based on assessment of the ...
4.2. Posology and method of administration
Aponil should be used for the shortest possible duration, as required by the clinical situation of the patients. The side effects can be minimized by using the lowest effective dose for the shortest duration ...
4.3. Contraindications
Nimesulide is contraindicated in patients with: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. History of hypersensitivity reactions (e.g.bronchospasm, urticaria, ...
4.4. Special warnings and precautions for use
Simultaneous use of NSAIDs including cyclooxygenase-2 selective inhibitors is not recommended. Patients should be advised to refrain from other analgesics. The risk of adverse reactions may be reduced ...
4.5. Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Other NSAIDs Coadministration of Aponil (see section. 4.4) with other NSAIDs, including aspirin at doses with anti-inflammatory effect (≥ 1 g as a single dose or as total daily ...
4.6. Pregnancy and lactation
Pregnancy The use of nimesulide is contraindicated during the last trimester of pregnancy (see section 4.3). As with other NSAIDs, the use of nimesulide is not recommended in women trying to conceive(see ...
4.7. Effects on ability to drive and use machines
No studies on the effect of nimesulide on the ability to drive or use machines have been performed. However patients who experience dizziness, vertigo or somnolence after receiving Aponil should refrain ...
4.8. Undesirable effects
a) Summary of the safety profile Clinical and epidemiological data suggest that the use of certain NSAIDs (particularly at high doses and long-term treatment) may be associated with a small increase in ...
4.9. Overdose
Symptoms Symptoms that occur following acute overdosage with NSAIDs are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. These symptoms are generally reversible after supportive ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other anti-inflammatory and antirheumatic agents, non-steroids, Antiinflammatory and antirheumatic products <b>ATC code:</b> M01AX17 Nimesulide is a NSAID with analgesic ...
5.2. Pharmacokinetic properties
Nimesulide is well absorbed after oral administration. After a single dose of 100 mg peak plasma levels of 3-4 mg/ml are reached within 2 to 3 hours. AUC = 20 to 35 mgxh/lt. No statistically significant ...
5.3. Preclinical safety data
Preclinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential. Repeated dose toxicity studies ...
6.1. List of excipients
Aponil also contains lactose monohydrate, cellulose microcrystalline, docusate sodium, sodium starch glycolate, hydroxypropyl cellulose, hydrogenated vegetable oil, magnesium stearate.
6.2. Incompatibilities
None known.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store below 25°C, in the original packaging.
6.5. Nature and contents of container
PVC-Aluminum blisters 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 for disposal.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
17417
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 11/11/1997 Date of latest renewal: 20/09/2010
10. Date of revision of the text
March 2015
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