Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Piroxicam
Pfizer Ltd
M01AC01
Piroxicam
20mg
Orodispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5013457012552 5013457010190
Take special care with Feldene as like all NSAIDs, Feldene can cause serious reactions in the stomach and intestines, such as pain, bleeding, ulceration and perforation. You should STOP TAKING FELDENE IMMEDIATELY and TELL YOUR DOCTOR if you have stomach pain or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements or vomiting blood. Your doctor may prescribe Feldene Melt together with another medicine to protect your stomach and intestines from side effects, particularly if you are over 70 years old, or you are taking other medicines like corticosteroids (medicines given to treat a variety of conditions such as allergies and hormone imbalances), certain medicines for depression called selective serotonin reuptake inhibitors (SSRIs) or low dose acetylsalicylic acid (aspirin) to help prevent heart attack or stroke. Feldene Melt may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant. PATIENTS OVER 70 YEARS OF AGE If you are over 70 years old, your doctor may wish to minimise the length of your treatment and to see you more often while you are taking Feldene Melt. You should not take this medicine if you are over 80 years of age. TAKING OTHER MEDICINES Tell your doctor about any other medicines you are taking or took recently (in the last week) - even medicines you bought yourself without a prescription. Medicines can sometimes interfere with each other. Your doctor may limit your use of Feldene or other medicines, or you may need to take a different medicine. The following medicines MUST NOT BE TAKEN WITH FELDENE: • aspirin or other non-steroidal anti-inflammatory drugs for pain relief • anticoagulants such as warfarin to prevent blood clots Tell your doctor BEFORE you take Feldene Melt if you are taking any of the following medicines: • corticosteroids, which are medicines given to treat a variety of conditions such as allergies and hormone imbalances • lo Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Feldene Melt 20mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Piroxicam 20mg. Excipient with known effect Each Feldene Melt 20 mg tablet contains 0.25 mg aspartame. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Fast Dissolving Dosage Form (Tablet) 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Feldene is indicated for symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis. Due to its safety profile (see sections 4.2, 4.3 and 4.4), Feldene is not a first line option should an NSAID be indicated. The decision to prescribe Feldene should be based on an assessment of the individual patient’s overall risks (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The prescription of Feldene should be initiated by physicians with experience in the diagnostic evaluation and treatment of patients with inflammatory or degenerative rheumatic diseases. The maximum recommended daily dose is 20mg. Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms. The benefit and tolerability of treatment should be reviewed within 14 days. If continued treatment is considered necessary, this should be accompanied by frequent review. Given that piroxicam has been shown to be associated with an increased risk of gastrointestinal complications, the possible need for combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered, in particular for elderly patients. USE IN THE ELDERLY Elderly, frail or debilitated patients may tolerate side-effects less well and such patients should be carefully supervised. As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function. For oral administration. To be taken preferably with or after food. The fast dissolving dosage form may Baca dokumen lengkap