Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Piroxicam
DE Pharmaceuticals
M02AA07
Piroxicam
5mg/1gram
Cutaneous gel
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 10030200
14:57 14 MAR 2020 Package leaflet: Information for the patient UNITED KINGDOM Feldene ® 0.5% w/w Gel piroxicam Read all of this leaflet carefully before you start using this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Feldene Gel is and what it is used for 2. What you need to know before you use Feldene Gel 3. How to use Feldene Gel 4. Possible side effects 5. How to store Feldene Gel 6. Contents of the pack and other information 1. What Feldene Gel is and what it is used for Feldene Gel is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). This means it will help to relieve pain and reduce swelling affecting joints and muscles when rubbed into the skin over the affected area. Feldene Gel is for the treatment of rheumatism, sprains, strains and mild osteoarthritis of joints (knees, wrists, ankles etc). 2. What you need to know before you use Feldene Gel Do not use Feldene Gel • If you are allergic to piroxicam or any of the other ingredients of this medicine (listed in section 6), any other form of piroxicam, aspirin or any other medicines used to treat painful joints and muscles. This may have been itching, reddening of the skin or difficulty in breathing. Warnings and precautions Talk to your doctor or pharmacist before taking Feldene Gel. Medicines are not always suitable for everyone. Your doctor needs to know before you use Feldene Gel if you suffer from or have suffered in the past from any of the following conditions: • liver disease. • kidney disease. Potentially life-threatening skin rashes (Stevens Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Feldene 0.5% w/w Gel. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains 5 mg piroxicam (0.5% w/w). Excipient with known effect: Propylene glycol 200 mg/g Benzyl alcohol 10 mg/g For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel for topical application. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Feldene Gel is a non-steroidal anti-inflammatory agent indicated for a variety of conditions characterised by pain and inflammation, or stiffness. It is effective in the treatment of osteoarthritis of superficial joints such as the knee, acute musculoskeletal injuries, periarthritis, epicondylitis, tendinitis and tenosynovitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults No occlusive dressings should be employed. Apply 1 g of Gel, corresponding to 3cm, and rub into the affected site three to four times daily leaving no residual material on the skin. Therapy should be reviewed after 4 weeks. Paediatric population Dosage recommendations and indications for the use of Feldene Gel in children have not been established. Elderly No special precautions are required. Method of administration Feldene Gel is for external use only. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The potential exists for cross sensitivity to aspirin and other non-steroidal anti-inflammatory agents (NSAIDs). Feldene Gel should not be given to patients in whom aspirin and other non- steroidal anti-inflammatory agents induce the symptoms of asthma, nasal polyps, angioneurotic oedema or urticaria. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Life-threatening cutaneous reactions (Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) have been reported with the systemic administration of piroxicam. These reactions have not been associated with topical piroxicam, but the possibility of occurring with topical piroxicam cannot be excluded. Patients should Belgenin tamamını okuyun