国家: 以色列
语言: 英文
来源: Ministry of Health
TRAMADOL HYDROCHLORIDE
TEC-O-PHARM-LIBRA LTD
N02AX02
TABLETS EXTENDED RELEASE
TRAMADOL HYDROCHLORIDE 100 MG
PER OS
Required
GRUNENTHAL GMBH, GERMANY
TRAMADOL
TRAMADOL
Moderate to severe pain.
2022-08-31
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS’ Regulations (Preparations) – 1986 The medicine is dispensed with a physician’s prescription only Tramal Retard 100 Tramal Retard 50 The active ingredient and its quantity: Tramadol hydrochloride 100 or 50 mg Inactive ingredients and allergens: See under ‘Important information about some of this medicine’s ingredients, and section 6 ‘Additional information’. 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 physician or the pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. This medicine is not intended for children under the age of 14 years. 1. What is the medicine intended for? Tramadol - the active ingredient in Tramal Retard - is a painkiller belonging to the class of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain. Tramal Retard is intended for the treatment of moderate to severe pain. Therapeutic group: opioids. 2. Before using the medicine Do not take the medicine: if you are sensitive (allergic) to the active ingredient or any of the other ingredients of this medicine (listed in section 6). in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions). if you are taking MAO inhibitors (certain medicines to treat depression) or have taken them in the last 14 days before treatment with Tramal Retard (see section "Other medicines and Tramal Retard"). if you are an epileptic and your fits are not adequately controlled by your treatment. as a substitute in drug withdrawal. Opioid medicines can cause addiction (mainly with prolonged use), and potential abuse and overdose are possible. The reaction to overdose can be slow bre 阅读完整的文件
TRAMAL RETARD 100 TRAMAL RETARD 50 1. NAME OF THE MEDICINAL PRODUCT TRAMAL RETARD 100, TRAMAL RETARD 50MG extended-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each extended-release tablet contains 100 or 50 mg tramadol hydrochloride. Excipient with known effect: Each prolonged-release tablet contains 2.5 mg lactose monohydrate (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Extended-release tablet Tramal Retard 100: Round, biconvex, white coloured film-coated tablets, marked with the manufacturer‘s logo on one side, marked T1 on the other side. Tramal Retard 50: Pale yellow coloured, round, biconvex, film-coated tablets, marked with the manufacturer's logo on one side and T0 on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Moderate to severe pain 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with tramadol in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4). Posology 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. The total daily dose of 400 mg active substance should not be exceeded, except in special circumstances. Unless otherwise prescribed, Tramal Retard should be administered as follows: _Adults and adolescents above the age of 14 years: _ The usual initial dose is 50-100 mg tramadol hydrochloride twice daily, morning and evening. If pain relief is insufficient, the dose may be titrated upwards to 150 mg or 200 mg tramadol hydrochloride twice daily (see section 5.1). _Children: _ Tramal Retard is not suitable for children below the age of 14 years. _Geriatric patients_ : A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimina 阅读完整的文件