NAPROREX Tablet (2018)
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Περιεχόμενα
1. Name of the medicinal product
Naprorex 250 mg Tablets.
Naprorex 500 mg Tablets.
2. Qualitative and quantitative composition
For Naprorex 250 mg tablets:
Each tablet contains 250 mg of naproxen.
For Naprorex 500 mg tablets:
Each tablet contains 500 mg of naproxen.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets.
For Naprorex 250 mg tablets:
White, concave, round tablets, 10 mm diameter in size, scored on one side.
For Naprorex 500 mg tablets:
White, concave, round tablets, 12 mm diameter in size...
4.1. Therapeutic indications
Adults:
Treatment of rheumatoid arthritis, osteoarthrosis (degenerative arthritis), ankylosing spondylitis, acute gout, acute musculoskeletal disorders and dysmenorrhoea.
Children:
Juvenile rheumat...
4.2. Posology and method of administration
Posology
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
Adults
Rheumatoid arthritis, osteoarthrit...
4.3. Contraindications
Active or history of peptic ulceration or active gastrointestinal bleeding (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, rel...
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 and GI and cardiovascular risks below). Patients tre...
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant administration of antacid or cholestyramine can delay the absorption of naproxen but does not affect its extent. Concomitant administration of food can delay the absorption of naproxen,...
4.6. Fertility, pregnancy and lactation
Pregnancy
Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. As wi...
4.7. Effects on ability to drive and use machines
Some patients may experience drowsiness, dizziness, vertigo, insomnia, fatigue, visual disturbances or depression with the use of Naprorex. If patients experience these or similar undesirable effec...
4.8. Undesirable effects
The following adverse events have been reported with NSAIDs and with naproxen.
Gastrointestinal disorders:
The most commonly observed adverse events are gastrointestinal in nature. Heartburn, naus...
4.9. Overdose
Symptoms
Symptoms include headache, heartburn, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, drowsiness, dizziness, tinnitus, fainting....
5.1. Pharmacodynamic properties
Pharmacotherapeutic group:
Anti-inflammatory and antirheumatic products, non-steroids
ATC:
M01AE02
Naproxen is a non-steroidal anti-inflammatory analgesic compound with antipyretic properties as...
5.2. Pharmacokinetic properties
Naproxen is completely absorbed from the gastro-intestinal tract, and peak plasma levels are reached in 2 to 4 hours. Naproxen is present in the blood mainly as unchanged drug, extensively bound to...
5.3. Preclinical safety data
Carcinogenicity
Naproxen was administered with food to Sprague-Dawley rats for 24 months at doses of 8, 16 and 24 mg/kg/day. Naproxen was not carcinogenic in rats.
Mutagenicity
Mutagenicity was not...
6.1. List of excipients
Magnesium stearate
Microcrystalline cellulose
Povidone
Sodium starch glycolate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Naprorex 250 mg: 3 years.
Naprorex 500 mg: 3 years.
6.4. Special precautions for storage
Store below 25°C.
Protect from light and humidity.
6.5. Nature and contents of container
Naprorex 250 and 500 mg tablets are packed in Aluminum/PVC blisters of 1x10 and 2x10 tablets.
Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union
8. Marketing authorization number(s)
Naprorex 250 tablets: 14662
Naprorex 500 tablets: 14664
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 4 April 1994
10. Date of revision of the text
07 August 2018
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