MELCAM Tablet (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Melcam 7.5 mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 7.5 mg of meloxicam. <u>Excipient with known effect:</u> Each tablet contains 40.9 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. Pale yellow coloured round, flat bevelled uncoated tablets with central break-line on one side and plain on the other side. The score line is only to facilitate breaking for ease of swallowing ...
4.1. Therapeutic indications
Short-term symptomatic treatment of exacerbations of osteoarthrosis. Long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis. Melcam is indicated in adults and children aged ...
4.2. Posology and method of administration
Posology The total daily amount should be taken as a single dose. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section ...
4.3. Contraindications
This medicinal product is contra-indicated in the following situations: hypersensitivity to the active substance or to any of the excipients listed in section 6.1 third trimester of pregnancy (see section ...
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 gastrointestinal and cardiovascular risks below). ...
4.5. Interaction with other medicinal products and other forms of interaction
Risksrelatedtohyperkalaemia Certain medicinal products or therapeutic groups may promote hyperkalaemia: potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin ...
4.6. Fertility, pregnancy and lactation
Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of ...
4.7. Effects on ability to drive and use machines
No specific studies with respect to the effects on the ability to drive and use machinery have been performed. However, on the basis of the pharmacodynamic profile and reported adverse drug reactions, ...
4.8. Undesirable effects
a) 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 ...
4.9. Overdose
Symptoms Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with supportive care. Gastrointestinal ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Anti-inflammatory and antirheumatic products, non-steroids; oxicams <b>ATC code:</b> M01AC06 Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam ...
5.2. Pharmacokinetic properties
Absorption Meloxicam is well absorbed from the gastrointestinal tract, which is reflected by a high absolute bioavailability of about 90% following oral administration (capsule). Tablets, oral suspension ...
5.3. Preclinical safety data
The toxicological profile of meloxicam has been found in preclinical studies to be identical to that of NSAIDs: gastrointestinal ulcers and erosions, renal papillary necrosis at high doses during chronic ...
6.1. List of excipients
Maize starch Pregelatinized maize starch Colloidal anhydrous silica Sodium citrate Lactose monohydrate Microcrystalline cellulose Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
30 months.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
PVC/PVDC aluminium blisters. Packs of 10, 20, 30, 50, 60 or 100 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Rowex Ltd, Newtown, Bantry, Co. Cork, Ireland
8. Marketing authorization number(s)
PA0711/060/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 19 November 2004 Date of last renewal: 31 October 2008
10. Date of revision of the text
September 2020
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
