SUMMARY OF PRODUCT CHARACTERISTICS. for. Felden, gel

Transcription

1 Translation of approved SmPC for Felden gel SmPC dated 30 May Translated by Andreas Lyngbye Danish Medicines Agency 30 May 17 SUMMARY OF PRODUCT CHARACTERISTICS for Felden, gel 0. D.SP.NR NAME OF THE MEDICINAL PRODUCT Felden 2. QUALITATIVE AND QUANTITATIVE COMPOSITIONS Piroxicam 0.5% Excipients with known effect: Propylenglycol For the full list of excipients, see section PHARMACEUTICAL FORM Gel Clear to pale yellow gel. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Local inflammatory diseases. 4.2 Posology and method of administration Adults: 1 gram 0.5 % gel (2-5 cm) corresponding to 5 mg piroxicam is applied locally on the affected area 3-4 times daily. Rub in the gel leaving no residual material on the skin. No occlusive dressing should be employed. Children: Should only be used in children below the age of 15 years according to doctor s recommendation. U:\Products\Felden\Local Product Documents\Product Information\Translation\FELD 0.5G 019 SmPC V5.0 11Nov2008 ENG-c DNM.doc

2 4.3 Contraindications Hypersensitivity to piroxicam or any of the excipients. Third trimester of the pregnancy. The potential exists for cross sensitivity to acetylsalicylic acid and other NSAIDs. Piroxicam should not be given to patients in whom acetylsalicylic acid and other NSAID products induce the symptoms of asthma, rhinitis, angiooedema or urticaria. 4.4 Special warnings and special precautions for use If local irritation develops, Felden gel should be discontinued and alternative therapy instituted as necessary. Do not apply to the eyes, mucosa or to open skin lesions or skin conditions affecting the site of application. NSAIDs, including piroxicam, may cause interstitial nephritis, nephrotic syndrome and renal failure. There have also been reports of interstitial nephritis, nephrotic syndrome and renal failure with topical piroxicam, although the causal relationship to treatment with topical piroxicam has not been established. As a result, the possibility that these events may be related to the use of topical piroxicam cannot be ruled out. Isolated cases of systemic reactions such as renal effects have been reported when using other topically administered antiphlogistics. Mild but transient skin discoloration and staining of clothing have been noted when the gel is not rubbed in completely. Felden gel contains propylenglycole which may cause skin irritation. Since the medicinal product contains ethanol, there is a theoretical possibility of an interaction occurring in patients treated with disulfiram or metronidazole. The amount of absorbed alcohol is probably small, but it may be large enough to cause a reaction in particularly sensitive patients. 4.5 Interactions with other medicinal products and other forms of interaction Felden gel contains ethanol, see section Pregnancy and lactation Fertility Cyclooxygenase/prostaglandin synthesis inhibitors may cause impairment on fertility by an effect on ovulation. This effect is reversible. Pregnancy The use of Felden gel is not recommended in pregnant women. Contraindicated in pregnant woment during the last three months prior to expected delivery. The safety of piroxicam use during pregnancy has not been established. No teratogenic effects were seen when piroxicam was orally administered in animal

3 testing. Piroxicam inhibits prostaglandin synthesis and release through a reversible inhibition of the cyclooxygenase enzyme. This effect, as with other NSAIDs has been associated with an increased incidence of dystocia and delayed parturition in pregnant animals when drug administration was continued into late pregnancy. NSAIDs are also known to induce closure of the ductus anteriosus in infants. Lactation Felden gel should not be used in breast-feeding women. The safety of piroxicam use during lactation has not been established. Following oral administration piroxicam exists in maternal milk in a concentration of approximately 1% of that reached in plasma after oral administration. 4.7 Effects on ability to drive and use machines No labelling. Felden may have no or negligible influence on the ability to drive or use machines. 4.8 Undesirable effects The most common undesirable effects are local skin reactions, which may extend to untreated area. Respiratory, thoracic and mediastinal disorders Very Rare (<1/10.000) Gastrointestinal disorders Uncommon ( 1/1000 and <1/100) Rare ( 1/ and 1/1000) Skin and subcutaneous tissue disorders Frequency unknown (cannot be estimated based on available data) Renal and urinary disorders Frequency unknown (cannot be estimated based on available data) Bronchospasm, dyspnea. Gastrointestinal discomfort such as nausea, dyspepsia. Abdominal pain, gastritis. Mild to moderate local irritation, erythema, rash, pruritus, contact dermatitis, eczema, pityroid desquamation, photosensitivity, transient skin discoloration, reactions on the application site. Renal effects. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Lægemiddelstyrelsen, Axel Heides Gade 1, DK-2300 København S. Websted: dkma@dkma.dk. 4.9 Overdose Not relevant. Overdosage is unlikely with local treatment.

4 4.10 Dispensing from pharmacy HF (= over-the-counter medicines) 5. PHARMACOLOGICAL INFORMATION 5.0 Therapeutic classification ATC code: M 02 AA 07, Non-steroidal anti-inflammatory agents for external use. 5.1 Pharmacodynamic properties Felden (piroxicam) gel is a nonsteroidal anti-inflammatory agent, which also possesses analgesic properties. The mechanism of action for Felden is not known with certainty, but in vitro as well as in vivo studies have shown that Felden affects several steps in the immunological and inflammatory processes by inhibiting the prostaglandin synthesis through a reversible inhibition of cyclooxygenase, inhibition of neutrophil granulocyte aggregation, inhibition of the migration of polymorphnucleus leukocytes and monocytes to inflammation focus, inhibition of lysosomal enzyme release from stimulated leukocytes, inhibition of superoxide anion generation by the neutrophil granulocytes, and a reduction in the amount of rheumatoid factor, both systemically and in the synovial fluid in patients with seropositive rheumatoid arthritis. Felden does not act by pituitary-adrenal axis stimulation. In vitro studies have not revealed any negative effect on cartilage metabolism. 5.2 Pharmacokinetic properties On the basis of pharmacokinetic and tissue distribution studies in rats and dogs, Felden gel 0.5% is gradually and continuously released from the skin to the underlying muscle or the synovial fluid. Equilibrium between the skin, and muscle and synovial fluid appears within a few hours after application. A multiple-dose study of twice daily application of Felden gel (total daily dose equivalent to 20 mg per day, piroxicam) for 14 days found that plasma levels rose slowly over the course of the treatment period and reached a value of over 200 ng/ml on the fourth day. On an average, steady state plasma levels were between 300 ng/ml and 400 ng/ml, and mean values remained below 400 ng/ml even on the fourteenth day of treatment. These piroxicam levels observed at equilibrium were 5% of those observed in subjects receiving similar oral dosing (20 mg daily). Elimination half-life in this study was calculated to be approximately 79 hours. In humans, the gel was well tolerated by skin sensitive volunteers. The serum half-life of piroxicam is approximately 50 hours. 5.3 Preclinical Safety Data In reproductive toxicity studies, piroxicam increases the incidence of dystocia and delayed parturition in animals, when drug administration is continued during pregnancy. Administration of prostaglandin synthesis inhibitors has also been shown to result in increased pre- and post-implantation loss. These observations were made using oral dosing, and as noted in section 5.2, equilibrium plasma levels of piroxicam

5 obtained in patients using the topical gel are only approximately 5% of those achieved using an equivalent dose of oral product. In animal studies of Felden gel no treatment related adverse reactions were reported following application of 1 g gel daily for up till 30 days. No signs of photoallergy or skin sensitization. 6.0 PHARMACEUTICAL INFORMATION 6.1 List of excipients Carbomer 980, propylene glycol, ethanol 96%, benzyl alcohol, diisopropanolamine, hydroxyethylcellulose, purified water. 6.2 Incompatibilities Not relevant. 6.3 Shelf life 3 years. 6.4 Special precautions for storage None special storage conditions. 6.5 Nature and contents of container Aluminium tube of 25 g, 50 g, 100 g and 112 g. Not all pack sizes are necessarily marketed. 6.6 Instructions for use/handling No special precautions. Any unused product or waste material should be disposed of in accordance with local requirement. 7. MARKETING AUTHORIZATION HOLDER Pfizer ApS Lautrupvang Ballerup 8. MARKETING AUTHORIZATION NUMBER(S) DATE OF FIRST AUTHORISATION 26 March DATE OF REVISION OF THE TEXT 19 May 2016