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SPC, Israel: MESULID Tablets (2012)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Mesulid 100 mg caplets.

Qualitative and quantitative composition

Each caplet contains 100mg nimesulide. For excipients, see section 6.1.

Pharmaceutical form

Off-white to light yellow capsule-shaped tablet.

Therapeutic indications

Treatment of acute pain. Primary dysmenorrhoea. Nimesulide should only be prescribed as second line treatment. The decision to prescribe nimesulide should be based on assessment of the individual patient ...

Posology and method of administration

Mesulid should be used for the shortest possible duration, as required by the clinical situation. Moreover, undesirable effects may be minimized by using the minimum effective dose for the shortest duration ...

Contraindications

Hypersensitivity to nimesulide or to any of the excipients. History of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria, nasal polyps)) in response to acetylsalicylic acid or other non-steroidal ...

Special warnings and precautions for use

The use of Mesulid with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided. In addition, patients should be advised to refrain from other concomitant analgesics. Undesirable ...

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions Other non steroidal anti-inflammatory drugs (NSAIDs): The combined use of Mesulid (see section 4.4) with other non steroidal anti-inflammatory drugs, including acetylsalicylic ...

Pregnancy and lactation

The use of Mesulid is contraindicated in the third trimester of pregnancy (see section 4.3). Like other NSAIDs, Mesulid is not recommended in women attempting to conceive (see section 4.4). Inhibition ...

Effects on ability to drive and use machines

No studies on the effect of Mesulid on the ability to drive or use machines have been performed. However, patients who experience dizziness, vertigo or somnolence after receiving Mesulid should refrain ...

Undesirable effects

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 overdoses are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding ...

Pharmacodynamic properties

ATC code: M01AX17 Nimesulide is a non-steroidal anti-inflammatory drug with analgesic and antipyretic properties which acts as an inhibitor of prostaglandin synthesis enzyme cyclo-oxygenase.

Pharmacokinetic properties

Nimesulide is well absorbed when given per os. After a single dose of 100mg nimesulide a peak plasma level of 3-4 mg/L is reached in adults after 2-3 hours. AUC = 20-35 mg h/L. No statistically significant ...

Preclinical safety data

Preclinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. In repeated dose toxicity studies, ...

List of excipients

Cellulose microcrystalline Docusate sodium Hydrogenated castor oil Hydroxypropyl cellulose Lactose Magnesium stearate Sodium starch glycolate

Incompatibilities

Not applicable.

Special precautions for storage

Store below 25°C.

Nature and contents of container

Blister packs (10, 20, 30 caplets).

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

RAFA LABORATORIES LTD., P. O. Box 450, Jerusalem 91003 Registration number: 0132727286 Manufactured under license from Helsinn Healthcare SA, Switzerland

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