Country: Իսրայել
language: անգլերեն
source: Ministry of Health
PARACETAMOL; TRAMADOL HYDROCHLORIDE
TEC-O-PHARM-LIBRA LTD
N02BE01
FILM COATED TABLETS
PARACETAMOL 325 MG; TRAMADOL HYDROCHLORIDE 37.5 MG
PER OS
Required
GRUNENTHAL GMBH, GERMANY
PARACETAMOL
PARACETAMOL
Symptomatic treatment of moderate to severe pain.The use of Zaldiar should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol.
2022-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (Preparations) – 1986 The medicine is dispensed according to a physician's prescription only Name of preparation and form: ZALDIAR ® film-coated tablets Active ingredients and quantity: Tramadol Hydrochloride 37.5 mg Paracetamol 325 mg Inactive and allergic ingredients in the medicinal product – see section 6 and also "Important information about some ingredients of the medicine" in section 2. ! Read the entire leaflet carefully before using the medicine. This leaflet contains concise information about the medicine. If you have any further questions, refer to the physician or the pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems like their disease is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? Zaldiar is a combination of two analgesics, tramadol and paracetamol, which work together to relieve pain. Zaldiar is intended for use only by adults and children over the age of 14. Therapeutic group: The preparation contains a combination of tramadol – a pain reliever from the opioids group and paracetamol – a pain reliever and fever reducer from the anilide group and is intended to treat moderate to severe pain. 2. BEFORE USING THE MEDICINE: Do not use the medicine if: You are sensitive (allergic) to the active ingredients or to any of the additional ingredients contained in the medicine (listed in section 6). In cases of acute alcohol poisoning. You are taking sleeping pills, pain relievers or medicines that affect mood and emotions. You are also taking medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the last 14 days before treatment with Zaldiar. MAOIs are used in the treatment of depression or Parkinson’s disease. You have a severe liver disorder. You have epilepsy that is not adequately controlled by your current medicine. In children under the age of 14. Opioids may cause addiction, e read_full_document
1 Zaldiar SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zaldiar 37.5 mg/325 mg, film coated-tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol. Excipients: One film coated tablet contains 1.878 mg lactose monohydrate (= 1.784 mg lactose). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Pale yellow film-coated tablet, marked with the manufacturer‘s logo on one side and ‘T5’ on the other side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Zaldiar tablets are indicated for the symptomatic treatment of moderate to severe pain. The use of Zaldiar should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol (see also Section 5.1). 4.2 Posology and method of administration _Posology_ The use of Zaldiar should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol. The dose should be individually adjusted according to intensity of pain and response of the patient. The lowest effective dose for analgesia should generally be selected. The total dose of 8 tablets (equivalent to 300 mg tramadol hydrochloride and 2600 mg paracetamol) per day should not be exceeded. The dosing interval should not be less than six hours. Adults and Adolescents (14 years and older). An initial dose of two tablets of Zaldiar is recommended Additional doses can be taken as needed, not exceeding 8 tablets (equivalent to 300 mg tramadol and 2600 mg paracetamol) per day. The dosing interval should not be less than six hours. Zaldiar should under no circumstances be administered for longer than is strictly necessary (see also section 4.4 - Special warnings and precautions for use). If repeated use or long term treatment 2 with Zaldiar is required as a result of the nature and severity of the illness, then careful, regular monitoring should take pl read_full_document