NIMM Tablet (2019)
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Περιεχόμενα
1. Name of the medicinal product
Nimm 100mg tablets.
2. Qualitative and quantitative composition
Each tablet contains 100 mg nimesulide. <u>Excipient with known effect:</u> lactose monohydrate. Each tablet contains 153.7mg of lactose monohydrate. For the full list of excipients, see section 6.1. ...
3. Pharmaceutical form
Tablet. Nimm tablets are light yellow, round flat, scored, with a diameter of 10.5 mm.
4.1. Therapeutic indications
Nimesulide is indicated for the treatment of: Treatment of acute pain (see section 4.2) Primary dysmenorrhoea Nimesulide should only be prescribed as second line treatment. The decision to prescribe nimesulide ...
4.2. Posology and method of administration
Nimesulide tablets should be used for the shortest possible duration, as required by the clinical situation of the patients. In addition, the side effects may be minimized by using the lowest effective ...
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 (like rhinitis, bronchospasm, ...
4.4. Special warnings and precautions for use
Concomitant use of NSAIDs, including selective inhibitors of cyclooxygenase-2 should be avoided. During treatment with Nimm patients should be advised to refrain from other analgesics. Side effects may ...
4.5. Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Other nonsteroidal anti-inflammatory drugs (NSAIDs) Simultaneous use of nimesulide (see section 4.4) with other non-steroidal anti-inflammatory drugs, including acetylsalicylic ...
4.6. Fertility, pregnancy and lactation
Pregnancy The use of nimesulide is contraindicated during the last trimester of pregnancy. As with other NSAIDs the use of nimesulide is not recommended in women trying to conceive (see section 4.4). ...
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 Nimm should refrain ...
4.8. Undesirable effects
Overview Clinical studies and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a modest increase in the risk of arterial ...
4.9. Overdose
Symptoms After overdosage of nimesulide symptoms are usually limited to somnolence, nausea, vomiting, epigastric pain. These symptoms are reversible after supportive treatment. Gastrointestinal bleeding ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other antiinflammatory and antirheumatic agents, non-steroids, Antiinflammatory and antirheumatic products <b>ATC code:</b> M01AX17 Nimesulide is a non-steroidal anti-inflammatory ...
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. No signs of teratogenic or embryotoxic ...
6.1. List of excipients
Nimm also contains: lactose monohydrate, cellulose microcrystalline, docusate sodium, sodium starch glycollate, hydroxy-propyl cellulose, hydrogenated vegetable oil, magnesium stearate.
6.2. Incompatibilities
None known.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Stored below 25°C in the original packaging.
6.5. Nature and contents of container
PVC-Aluminium blisters of 10 tablets in packs of 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
CODAL-SYNTO Ltd, 21 Constantinoupoleos Street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
17715
9. Date of first authorization / renewal of the authorization
30/04/1998 / 23/05/2013
10. Date of revision of the text
03/07/2019
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