Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
TRAMADOL HYDROCHLORIDE
DEXCEL LTD, ISRAEL
N02AX02
TABLETS
TRAMADOL HYDROCHLORIDE 100 MG
PER OS
Required
DEXCEL LTD, ISRAEL
TRAMADOL
TRAMADOL
Short to medium term treatment of moderate to severe pain.
2021-02-28
PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine can be sold with a physician’s prescription only TRAMADEX ® TABLETS, 100 MG Each tablet contains tramadol hydrochloride 100 mg. Inactive ingredients and allergens in the medicine - see section 6 "Additional information" and in section 2 "Important information about some of the ingredients of the medicine". READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, ask the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if you think that their medical condition is the same as yours. THIS MEDICINE IS NOT INTENDED FOR CHILDREN UNDER THE AGE OF 14 YEARS. OPIOID MEDICINES CAN CAUSE ADDICTION (MAINLY WITH PROLONGED USE), AND POTENTIAL ABUSE AND OVERDOSE ARE POSSIBLE. THE REACTION TO OVERDOSE CAN BE SLOW BREATHING AND EVEN DEATH. MAKE SURE THAT YOU KNOW THE NAME OF THE MEDICINE, THE DOSAGE YOU ARE TAKING, HOW OFTEN YOU TAKE IT, THE DURATION OF TREATMENT, AND ITS SIDE EFFECTS AND POTENTIAL RISKS. ADDITIONAL INFORMATION ABOUT THE RISK OF DEPENDENCE AND ADDICTION CAN BE FOUND AT: _HTTPS://WWW.HEALTH.GOV.IL/UNITSOFFICE/HD/MTI/DRUGS/RISK/DOCLIB/OPIOIDS_EN.PDF_ 1. WHAT IS THE MEDICINE INTENDED FOR? TRAMADEX TABLETS is intended for the treatment of moderate to severe pain. THERAPEUTIC GROUP: opioids. Tramadol, the active ingredient in TRAMADEX TABLETS, is a painkiller belonging to the class of medicines called opioids and it acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE: if you are hypersensitive (allergic) to the active ingredient (tramadol hydrochloride) or to any of the other ingredients this medicine contains (see section 6). in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicin Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tramadex drops 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml (=40 drops) of Tramadex drops contains 100 mg of Tramadol hydrochloride. Excipient with known effect: Each 1ml of Tramadex drops contains 200 mg sucrose and 150 mg propylene glycol (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Drops, oral solution. Clear, transparent to light yellow solution, slightly viscous. WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see sections 4.4 and 4.5]. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short to medium term treatment of moderate to severe pain 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. Unless otherwise prescribed, Tramadex drops should be administered as follows: Adults and adolescents above the age of 14 years: 50 to 100 mg tramadol hydrochloride (20 to 40 drops), 4-6 hourly. The lowest analgesically effective dose should generally be selected. Daily doses of 400 mg active substance should not be exceeded, except in special clinical circumstances. Elderly patients: A dose adjustment is not usually necessary in elderly patients (up to 75 years) without clinically manifest hepatic or renal insufficiency. In elderly patients (over 75 years) the elimination may be prolonged. Therefore, if necessary, the dosage interval is to be extended according to Citiți documentul complet