البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
INDOMETHACIN
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
M01AB01
CAPSULES
INDOMETHACIN 25 MG
PER OS
Required
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
INDOMETACIN
INDOMETACIN
Non steroidal anti-inflammatory indicated for the active stages of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, degenerative joint disease of the hip, acute muscoloskeletal disorders, low back pain.
2015-02-28
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor's prescription only INDOVIS CAPSULES 25 MG Each capsule contains indomethacin 25 mg Inactive ingredients and allergens in the preparation – see the section “Important information about some ingredients of the medicine” and section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the doctor or the pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. The medicine is not intended for children. 1. WHAT IS THE MEDICINE INTENDED FOR? Non-steroidal anti-inflammatory drug for treatment of rheumatism, osteoarthritis, spondylitis, hip osteoarthritis, acute problems in the skeletal muscles system and lower back pain. THERAPEUTIC CLASS: Non-steroidal Anti-inflammatory Drugs (NSAIDs). 2. BEFORE USING THE MEDICINE: DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient (indomethacin) or any of the additional components the medicine contains (see section 6). • You are sensitive to aspirin, ibuprofen or other NSAIDs, or you have developed signs of asthma (wheezing), runny nose, swelling of the face, lips, tongue or throat, or a rash with pale or red irregular raised patches with severe itching when taking these medicines. • You are in the last three months of pregnancy or are breastfeeding. • You are taking other NSAIDs (e.g. naproxen), including COX-2 inhibitors (e.g. celecoxib). • You have angioneurotic edema (swelling of the face, lips, tongue or throat). • You have or have had two or more episodes of gastric or intestinal ulcer, or bleeding in your stomach or intestines. Symptoms may include coffee ground vomit, black tarry stool and blood in your stool. • You have severe liver, kidney or heart problems. • You have a n اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Indovis Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Indovis Capsules contain 25 mg of indomethacin Excipient with known effect: Also contains lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Indovis Capsules are white opaque capsules containing odorless white powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non-steroidal anti-inflammatory indicated for the active stages of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, degenerative joint disease of the hip, acute musculoskeletal disorders, low-back pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage of Indovis should be carefully adjusted to suit the needs of the individual patient. In order to reduce the possibility of gastro-intestinal disturbances, _Indovis Capsules_ _should _ _always be taken with food or an antacid._ In chronic conditions, starting therapy with a low dosage, increasing this gradually as necessary, and continuing a trial of therapy for an adequate period (in some cases, up to one month) will give the best results with a minimum of unwanted reactions. The recommended oral dosage range is 50 mg to 200 mg daily in divided doses. Paediatric dosage not established. _Use in the elderly_: Indovis should be used with particular care in older patients who are more prone to adverse reactions. 4.3 CONTRAINDICATIONS • NSAIDs are contra-indicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other non- steroidal anti-inflammatory drugs. • Hypersensitivity to indomethacin or any of the excipients listed in section 6.1. • Severe heart failure, hepatic failure and renal failure (See section 4.4). • Not to be used in patients who have nasal polyps. • During the last trimester of pregnancy or lactation (See section 4.6 ) • Safety in children has not been established. • Active or history of recurrent pepti اقرأ الوثيقة كاملة