Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
BENZOIC ACID AS SODIUM; GUAIACOLSULFONATE AS POTASSIUM; OXOMEMAZINE
TARO PHARMACEUTICAL INDUSTRIES LTD
R06AD08
SYRUP
OXOMEMAZINE 1.65 MG / 5 ML; BENZOIC ACID AS SODIUM 33.3 MG / 5 ML; GUAIACOLSULFONATE AS POTASSIUM 33.3 MG / 5 ML
PER OS
Required
TARO PHARMACEUTICAL INDUSTRIES LTD
OXOMEMAZINE
OXOMEMAZINE
Antitussive expectorant.
2022-12-31
Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986_ _ This medicine is dispensed with a doctor’s prescription only_ _ Oxacatin _®_ Syrup Active ingredients_ _ Each 5 ml contain: oxomemazine 1.65 mg potassium guaiacol sulphonate 33.30 mg Inactive ingredients and allergens in this medicine: see section 2 "Important information about some of this medicine’s ingredients" and section 6 "Additional information". Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or 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 medical condition is similar to yours._ _ 1. What is this medicine intended for? Antitussive syrup, expectorant. Therapeutic group: Oxomemazine - cough suppressant antihistamine of the phenothiazine group. Potassium guaiacol sulphonate – expectorant. 2. Before using this medicine:_ _ Do not use this medicine: • If you are sensitive (allergic) to the active ingredients (oxomemazine_ _or potassium guaiacol sulphonate) or to any of the other ingredients in this medicine (see section 6)._ _ • If you are allergic to an antihistaminic medicine used to treat allergies. • In children under 2 years of age. • If you have ever had a significant decrease in the level of certain white blood cells (granulocytes) in the blood (agranulocytosis). • If you experience difficulty urinating (prostate problem or other problems). • If you are at risk of angle-closure glaucoma (high intraocular pressure that may impair eyesight). • If you are taking a medicine containing cabergoline or quinagolide (used to inhibit excessive prolactin production) (see section "Drug interactions"). _ _ Special warnings about using this medicine: _ _ • If the cough persists despite using Oxacatin syrup, do not increase the dosages. Consult your doctor. Cough is actually Prečítajte si celý dokument
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT OXACATIN 2. QUALITATIVE AND QUANTITATIVE COMPOSITION oxomemazine ................ ..………..1.65 mg/5 ml potassium guaiacol sulphonate…..33.3 mg/5 ml Excipients with known effect: sugar, sorbitol, propylene glycol, sodium benzoate and sodium. For the complete list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup 4. CLINICAL DATA 4.1. Therapeutic indications Antitussive expectorant 4.2. Dosage and method of administration Dosage RESERVED FOR ADULTS AND CHILDREN OVER 2 YEARS OLD. In adults: 10 ml per dose, 4 times a day. _Paediatric population _ In children: the daily dosage depends on the weight of the child (1 ml of syrup per kg of body weight per day), or as a general guide : • Children from 13 to 20 kg (2 to 6 years): 5 ml per dose, 2 to 3 times a day, • Children from 20 to 30 kg (6 to 10 years): 10 ml per dose, 2 to 3 times a day, • Children from 30 to 40 kg (10 to 12 years): 10 ml per dose, 3 to 4 times a day • Children over 40 kg (12 years): 10 ml per dose, 4 times a day. The sockets are to be renewed if necessary and spaced at least 4 hours apart. Method of administration Oral. Use the measuring cup. Vesperal intake should be preferred because of the sedative effect of oxomemazine, especially at the beginning of treatment. 4.3. Contraindications This medication is CONTRAINDICATED in the following cases: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, • Hypersensitivity to antihistamines, • Due to the presence of oxomemazine o infant (less than 2 years of age) (see section 4.4), o history of agranulocytosis, o risk of urinary retention related to urethro-prostate disorders, o risk of narrow angle glaucoma, • In combination with cabergoline or quinagolide (see section 4.5). Page 2 of 7 4.4. Special warnings and precautions for use Special warnings: Productive coughs, which are a fundamental element of bronchopulmonary defense, should be allowed to occu Prečítajte si celý dokument