Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
MELOXICAM
Ranbaxy Ireland Limited
MELOXICAM
7.5 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
550mm 200mm Meloxicam 7.5 mg PIL Size: 200 x 550mm 550mm 200mm Meloxicam 7.5mg PIL Size: 200 x 550mm PACKAGE LEAFLET: INFORMATION FOR THE USER MOBICAM 7.5 MG TABLETS Meloxicam 24LF 24LF IF YOU FORGET TO TAKE MOBICAM TABLETS If you forget to take a dose, do so as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. SERIOUS SIDE EFFECTS If any of the following happen, stop taking Mobicam Tablets and tell your doctor immediately or go to the casualty department at your nearest hospital immediately: - skin reactions, such as itching (pruritus), blistering or peeling of the skin, which can be severe (Steven-Johnson Syndrome and toxic epidermal necrolysis), lesions of soft tissues (mucosal lesions) or erythema multiforme. Erythema multiforme is a serious allergic skin reaction causing spots, red welts or purple or blistered areas. It can also affect the mouth, eyes and other moist body surfaces. - swelling of skin or mucosa, such as swelling around the eyes, face and lips, mouth or throat, possibly making breathing difficult, swollen ankles or legs (oedema of the lower limbs) - shortness of breath or asthma attack - inflammation of the liver (hepatitis). This can cause symptoms such as: o yellowing of the skin or the eyeballs (jaundice) o pain in the abdomen o loss of appetite Any side effects of the digestive tract, especially: - bleeding (causing tar-coloured stools) - ulceration of your digestive tract (causing abdominal pain) Bleeding of the digestive tract (gastrointestinal bleeding), formation of ulcers or formation of a hole in the digestive tract (perforation) may sometimes be severe and potentia Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mobicam 7.5 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Meloxicam 7.5 mg Excipient: Each tablet also includes 40.9 mg lactose (as lactose monohydrate) For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Pale yellow coloured round tablet with a score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term symptomatic treatment of exacerbations of osteoarthrosis. Mobicam is indicated in adults and adolescents above 16 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis. Exacerbations of osteoarthrosis: 7.5 mg/day (one tablet of 7.5mg) If necessary, in the absence of improvement, the dose may be increased to 15 mg/day (two tablets of 7.5mg) DO NOT EXCEED THE DOSE OF 15 MG/DAY. _SPECIAL POPULATIONS_ _Elderly patients and patients with increased risks for adverse reaction (see section 5.2):_ Patients with increased risks for adverse reactions should start treatment with 7.5 mg per day (see section 4.4). _Renal impairment (see section 5.2):_ In dialysis patients with severe renal failure, the dose should not exceed 7.5 mg per day. No dose reduction is required in patients with mild to moderate renal impairment (i.e. patients with a creatinine clearance of greater than 25 ml/min). (For patients with non-dialysed severe renal failure, see Прочитайте повний документ