Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
GUAIFENESIN; IPECACUANHA; PROMETHAZINE HYDROCHLORIDE
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
R05CA10
SYRUP
PROMETHAZINE HYDROCHLORIDE 5 MG / 5 ML; GUAIFENESIN 45 MG / 5 ML; IPECACUANHA 10 MG / 5 ML
PER OS
Required
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
COMBINATIONS
COMBINATIONS
For temporary relief of cough due to colds, allergies.
2015-01-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only PROTHIAZINE EXPECTORANT SYRUP Each 5 ml contains: Promethazine hydrochloride 5 mg Guaiphenesin 45 mg Ipecacuanha 10 mg For inactive ingredients and allergens in the preparation - see section 2 “Important information about some of the ingredients of the medicine” and section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have additional questions, refer to the doctor or the pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their illness is similar. The medicine is not intended for children under the age of 6 years. Refer to the doctor if signs of the ailment (symptoms) worsen or do not improve after 7 days. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for relieving cough and certain allergic conditions. THERAPEUTIC CLASS: Promethazine is an antihistamine Guaiphenesin and ipecacuanha are expectorants 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • The patient is under 6 years of age. • You are breastfeeding or two weeks before the estimated delivery date. • You are sensitive (allergic) to the active ingredients or to any of the other ingredients this medicine contains (see section 6 “Additional information”). Signs of an allergic reaction include: rash, problems swallowing or breathing, swelling of the lips, face, throat or tongue. • You are taking monoamine oxidase inhibitors (to treat depression) or you have completed treatment with monoamine oxidase inhibitors in the past two weeks. • The patient is unconscious (or in a coma) or suffering from severe effects of dizziness, drowsiness or headache. • You are taking this medicine concomitantly with another medicine for relieving cough and cold. • You are in a state of shock, at a risk of developing seizu Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Prothiazine 25 mg Tablets Prothiazine Syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25mg of the active substance Promethazine hydrochloride. Each 5ml syrup contains 5mg of the active substance Promethazine hydrochloride. For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Prothiazine tablets are purple, round, and biconvex. Prothiazine syrup is a clear orange-colored liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antihistaminic, Antiemetic, Sedative. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral. Not for use in children under the age of 2 years (see section 4.3). FOR TREATMENT OF ALLERGIES: Children aged 2-5 years: 5-15 ml of syrup in one dose, to be taken at night or 5 ml two to three times a day. Do not administer more than 15 ml per day. Children aged 6-12 years: 10-25 ml of syrup in one dose to be taken at night, or 10 ml twice a day. Do not administer more than 25 ml per day. Children above the age of 12 and adults: Begin treatment by taking one tablet at night. The dosage can be increased to a maximum of one tablet twice a day, as required. FOR TREATMENT AND PREVENTION OF NAUSEA AND VOMITING: Children aged 2-5 years: 5 ml of syrup every 4-6 hours up to a maximum of 15 ml per day. Children aged 6-12 years: A dose of 10 ml of syrup; wait 4-6 hours before administering another dose. Up to two doses per day can be administered (a total of 20 ml per day). Children above the age of 12 and adults: One tablet every 4-6 hours, up to a maximum of 4 tablets per day. FOR SHORT-TERM USE AS A SEDATIVE, WITH THE DOCTOR’S INSTRUCTION ONLY: Children aged 2-5 years: 5-15 ml of syrup as a single dose to be taken at night, at bedtime. Children aged 6-12 years: 10-20 ml of syrup as a single dose to be taken at night, at bedtime. Children above the age of 12 and adults: One to three tablets as a single dose, to be taken at night, at bedtime. 4.3 CONTRAINDICATIONS Prothiazine should Izlasiet visu dokumentu