ALFOXAN Hard capsule (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Alfoxan 250 mg hard capsules.
2. Qualitative and quantitative composition
Each hard capsule contains 250 mg mefenamic acid. <u>Excipient(s) with known effect:</u> This product contains 64.9 mg lactose. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsules. Light blue/ivory capsules.
4.1. Therapeutic indications
As an anti-inflammatory analgesic for symptomatic relief of mild to moderate pain associated with rheumatic, muscular or arthritic disorders (including rheumatoid arthritis, Stills Disease and osteoarthritis), ...
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, Special warnings and precautions for use). Posology Adults ...
4.3. Contraindications
Use in patients with intestinal ulceration or inflammation and in patients with# lammatory bowel disease. Use in patients with a history of gastrointestinal bleeding or perforation, related to previous ...
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, Posology and method of administration, and G.I and cardiovascular ...
4.5. Interaction with other medicinal products and other forms of interaction
Concurrent administration with other protein bound drugs may require adjustment in their dosage. Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4, Special ...
4.6. Pregnancy and lactation
Pregnancy Safety in pregnancy has not been established, and because of the effects of drugs in this class on the foetal cardiovascular system, the use of mefenamic acid in pregnant women is not recommended ...
4.7. Effects on ability to drive and use machines
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.
4.8. Undesirable effects
a) General description The most frequently reported side effects associated with mefenamic acid involve the gastrointestinal tract. Diarrhoea appears to be the most common side effect and is usually dose-related. ...
4.9. Overdose
Gastric lavage in the conscious patient and intensive supportive therapy where necessary. Vital functions should be monitored and supported. Activated charcoal has been shown to be a powerful absorbent ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antiinflammatory and antirheumatic products, Non-steroids <b>ATC code:</b> M01AG01 ANIMAL MODELS Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) and anti-inflammatory, ...
5.2. Pharmacokinetic properties
Absorption and distribution Mefenamic acid is absorbed from the gastrointestinal tract. Peak levels of 10 mg/l occur two hours after the administration of a 1 g oral dose to adults. Metabolism Mefenamic ...
5.3. Preclinical safety data
Preclinical safety data does not add anything of further significance to the prescriber.
6.1. List of excipients
<u>Capsule content:</u> Povidone Polysorbate 80 Lactose monohydrate Maize starch Sodium starch glycolate (Type A) Silica, colloidal anhydrous Magnesium stearate Talc Sodium laurilsulfate <u>Capsule shell: ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C, protected from light and moisture.
6.5. Nature and contents of container
PVC/Aluminium blisters. Pack sizes of 20, 100 and 1000 hard capsules. PP containers with PE closure. Pack sizes of 100, 500 and 1000 hard capsules. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
19924
9. Date of first authorization / renewal of the authorization
Date of first authorization: 29 December 2005 Date of latest renewal: 11 June 2012
10. Date of revision of the text
23/04/2018
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