Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
PARACETAMOL
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
N02BE01
SUSPENSION
PARACETAMOL 100 MG/ML
PER OS
Not required
CTS CHEMICAL INDUSTRIES LTD
PARACETAMOL
PARACETAMOL
Analgesic and antipyretic.
2021-05-31
LFL 006 03/22 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed without a doctor's prescription Suspension Each 1 ml contains 100 mg paracetamol Inactive ingredients and allergens in the preparation - see section 6 - “Additional information” and the “Important information about some ingredients of the medicine” section. 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. Use the preparation according to the instructions in the dosage section of this leaflet. Consult the pharmacist if you have further questions. Refer to the doctor if the fever persists for more than 3 days or if the symptoms do not resolve within 5 days despite use of the medicine. 1. What is the medicine intended for? The medicine is intended to relieve pain and reduce fever. Therapeutic class: analgesic and antipyretic. 2. Before using the medicine: Do not use this medicine if: • There is a known sensitivity to paracetamol or to any of the other ingredients the medicine contains (see section 6). Special warnings regarding the use of the medicine: • If you developed skin side effects in the past as a result of taking preparations containing paracetamol, do not take preparations containing paracetamol, so that severe skin side effects will not recur. • The preparation contains paracetamol, which may cause liver damage when: ○ Given at a higher dosage than recommended or for a prolonged period of time. ○ Alcoholic beverages are consumed during the course of treatment. ○ Additional medicines which affect liver function are taken. • In patients with glutathione deficiency, use of paracetamol may increase the risk for metabolic acidosis. • Do not use this medicine frequently without consulting the doctor. • Do not take additional antipyretics and analgesics or cold medicines without consulting a doctor or a pharmacist, Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINE TIPTIPOT NOVIMOL 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PARACETAMOL 100 MG/ML SUSPENSION For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Pink to red suspension with white particles and a strawberry odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Analgesic and antipyretic. 4.2 DOSE AND METHOD OF ADMINISTRATION The generally accepted dosage is: The dosage according to the child’s weight is calculated as 15 mg/kg of the child’s weight, per dose. In other words, 0.15 ml for every kg of the child’s body weight. Only if the child’s weight is not known - the dosage will be determined according to age, as shown in the age table indicating dosage according to the child’s age only. Maximum number of doses per 24 hours Dose in ml Child’s age Up to 5 times 0.40 0-3 months Up to 5 times 0.80 4-11 months Up to 5 times 1.20 1-2 years Up to 5 times 1.60 2-3 years Up to 5 times 2.40 4-5 years Doses should be taken/administered in intervals of at least 4 hours, as necessary, up to 5 doses in 24 hours. Method of use: Shake well before use 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or any of its excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE IDENTIFIED PRECAUTIONS Contains paracetamol. Do not use with any other paracetamol- containing products. The concomitant use with other products containing paracetamol may lead to an overdose. In patients with glutathione depleted states, the use of paracetamol may increase the risk of metabolic acidosis. If symptoms persist, medical advice must be sought. Keep out of sight and reach of children. TIPTIPOT NOVIMOL contains sorbitol. Patients with hereditary fructose intolerance (HFI) should not take/ be given this medicine. USE IN HEPATIC IMPAIRMENT Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Paracetamol should be used with caution in patients with: Impaired liver function: Underlyin Citiți documentul complet