FELDENE Capsule, FELDENE D Tablet (2023)
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Περιεχόμενα
1. Name of the medicinal product
FELDENE, FELDENE-D (Piroxicam).
2. Qualitative and quantitative composition
FELDENE (piroxicam) 10 mg capsules. FELDENE-D (piroxicam) 20 mg tablets. <u>Excipient(s) with known effect:</u> Sugars (as lactose). For the full list of excipients, see Section 6.1 List of excipients. ...
3. Pharmaceutical form
FELDENE 10 mg capsules are blue and red in colour, marked FEL10 on one side and Pfizer on the other. FELDENE-D 20 mg dispersible tablets are white, oblong, scored, capsule-shaped and marked FEL/20 on one ...
4.1. Therapeutic indications
Piroxicam is indicated for symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.
4.2. Posology and method of administration
<u>Pregnancy:</u> for patients in their third trimester of pregnancy or are breastfeeding, see Section 4.3 Contraindications and Section 4.6 Fertility, pregnancy and lactation. Rheumatoid Arthritis, Osteoarthritis ...
4.3. Contraindications
Piroxicam should not be administered to patients with active peptic ulcerations, active gastrointestinal ulceration, bleeding or perforation, active inflammatory disease of the gastrointestinal tract or ...
4.4. Special warnings and precautions for use
Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms. The clinical benefit and tolerability should be re-evaluated periodically ...
4.5. Interaction with other medicinal products and other forms of interaction
Anticoagulants The concurrent use of NSAIDs and coumarin anticoagulants (including warfarin) has been associated with severe, sometimes fatal, haemorrhage. Patients should be monitored closely if piroxicam ...
4.6. Fertility, pregnancy and lactation
Effects on Fertility Based on the mechanism of action, the use of NSAIDs, including piroxicam, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in ...
4.7. Effects on ability to drive and use machines
The effects of this medicine on a person’s ability to drive and use machines were not assessed as part of its registration.
4.8. Undesirable effects
Results from clinical trials involving approximately 2300 patients (of whom about 400 were treated for more than one year and 170 for more than two years) indicate that about 30% of patients reported side ...
4.9. Overdose
Insufficient human data are available to fully assess the toxicity following acute overdosage. Signs and Symptoms Mild symptoms of lethargy, drowsiness and gastrointestinal upset have been reported. Rarely ...
5.1. Pharmacodynamic properties
Mechanism of Action Piroxicam is a NSAID which also possesses analgesic and antipyretic properties. While its mode of action is not fully understood, independent studies in vitro as well as in vivo have ...
5.2. Pharmacokinetic properties
Absorption Piroxicam is well absorbed following oral administration. The extent and rate of absorption are not influenced by administration in the fasting state. The plasma half-life is approximately 36-45 ...
5.3. Preclinical safety data
Genotoxicity No data available. Carcinogenicity No data available.
6.1. List of excipients
FELDENE capsules contain the following inert ingredients: Lactose monohydrate, Maize starch, Magnesium stearate/sodium lauryl sulfate 9:1 blend, Gelatin, Erythrosine, Titanium dioxide, Brilliant blue FCF. ...
6.2. Incompatibilities
Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
6.3. Shelf life
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
6.4. Special precautions for storage
Store below 30°C.
6.5. Nature and contents of container
FELDENE 10 mg capsules are available in PVC/Al blister packs of 50 capsules. FELDENE-D 20 mg dispersible tablets are available in PVC/Al blister packs of 25 tablets. Not all pack sizes may be marketed. ...
6.6. Special precautions for disposal and other handling
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.
7. Marketing authorization holder
Pfizer Australia Pty Ltd, Level 17, 151 Clarence Street, Sydney NSW 2000, Toll Free Number: 1800 675 229, www.pfizermedinfo.com.au
9. Date of first authorization / renewal of the authorization
FELDENE Capsules 10 mg: 24 January 1994 FELDENE-D Tablets 20 mg: 24 November 1992
10. Date of revision of the text
19 December 2022
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