Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
DIPYRONE
TEVA ISRAEL LTD
N02BB02
CAPLETS
DIPYRONE 500 MG
PER OS
Not required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
METAMIZOLE SODIUM
Relief of moderate to severe pain as in headache, toothache, dysmenorrhea andfor high fever that does not respond to other measures.
2015-01-31
DOR-Opt-Tab-Cap-PIL-0622-11 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed without a doctor’s prescription OPTALGIN ® 500 MG CAPLETS OPTALGIN ® 500 MG TABLETS COMPOSITION Each caplet/tablet contains: dipyrone 500 mg For information about inactive ingredients, see section 6, ‘Additional information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. Take this medicine according to the instructions in the section about dose in this leaflet. Consult your pharmacist if you need further information. BABIES AND CHILDREN CAN BE GIVEN THIS MEDICINE IN DROPS. CONSULT YOUR DOCTOR IF YOUR FEVER LASTS MORE THAN 3 DAYS OR PAIN PERSISTS FOR MORE THAN 7 DAYS, EVEN THOUGH YOU ARE USING THE MEDICINE. THERE IS A GREATER RISK OF AGRANULOCYTOSIS IF TREATMENT CONTINUES FOR LONGER THAN 7 DAYS (SEE SECTION 4, ‘SIDE EFFECTS’). 1. WHAT IS THIS MEDICINE INTENDED FOR? This medicine is intended for relieving moderate to severe pain, such as headache, toothache, and menstrual pain, and for reducing high fever that does not respond to other treatment measures. THERAPEUTIC GROUP: pyrazolone group. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: · You are sensitive (allergic) to the active ingredient dipyrone (metamizole) or other pyrazolones (such as propyphenazone, phenazone) or pyrazolidines )such as phenylbutazone, oxyphenbutazone(; this also includes patients who have, for example, developed a significant reduction in counts of certain white blood cells (agranulocytosis) after using these medicines. · You are sensitive (allergic) to any of the other ingredients in this medicine (see section 6, ‘Additional information’). · You have a known sensitivity to pain relievers (analgesics asthma syndrome or sensitivity to pain relievers experienced as rash/ angioedema). This applies to patients who r Pročitajte cijeli dokument
Optalgin Caplets/Tablets SPC, SZ, 6/2022 Notification SUMMARY OF PRODUCT CHARACTERISTICS OPTALGIN ® CAPLETS OPTALGIN ® TABLETS 1. NAME OF THE MEDICINAL PRODUCT Optalgin ® Caplets Optalgin ® Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Optalgin Caplets _ Each caplet contains 500 mg _ _ Dipyrone (Metamizole sodium). _ _ _ _ _Optalgin Tablets _ Each tablet contains 500 mg _ _ Dipyrone (Metamizole sodium). _ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Caplets Optalgin caplets are white to creamy, oblong film coated caplets, scored on one side. The caplet can be divided into equal halves. Tablets Optalgin tablets are white to off-white, round flat beveled tablets with a score line on one side and engraved "TEVA" on the other side. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Relief of moderate to severe pain as in headache, toothache, dysmenorrhea, and for high fever that does not respond to other measures. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology Dosage is determined by the intensity of the pain or fever and individual sensitivity of response to Optalgin. It is essential to choose the lowest dose that controls pain and fever. _ _ _Adults _ 1-2 caplets or 1-2 tablets up to 4 times daily. Do not exceed 8 caplets or 8 tablets daily. Depending on the maximum daily dose, the single dose can be taken in intervals of 6 to 8 hours. Adults and adolescents aged 15 years and over (> 53 kg) can take up to 1000 mg per single dose. Where the effect is inadequate, the respective single dose can be administered up to 4 times daily, depending on the maximum daily dose. 2 Optalgin Caplets/Tablets SPC, SZ, 6/2022 NOTIFICATION _Children and infants _ Other pharmaceutical forms are available that allow for adequate dosing in young children and infants such as Optalgin drops. _Elderly patients _ The dose should be reduced in the elderly, since elimination of the metabolites of Optalgin may be prolonged. _Debilitated patients and pati Pročitajte cijeli dokument