Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
PSEUDOEPHEDRINE AS HYDROCHLORIDE
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
R01BA02
DROPS
PSEUDOEPHEDRINE AS HYDROCHLORIDE 15 MG/ML
PER OS
Not required
CTS CHEMICAL INDUSTRIES LTD
PSEUDOEPHEDRINE
PSEUDOEPHEDRINE
Symptomatic treatment of nasal congestion, to relief eustachian tube congestion.
2021-01-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed without a doctor's prescription ORAL DROPS The active ingredient and its concentration Pseudoephedrine (as hydrochloride) 15 mg/ml Each drop contains 1 mg of pseudoephedrine. Inactive ingredients and allergens in the preparation - see section 6 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. The medicine is not intended for babies under 1 year of age. For children 1 to 6 years old, the medicine is dispensed with a doctor’s prescription only. Take the product according to the instructions in the dosage section of this leaflet. Consult the pharmacist if you have further questions. Refer to the doctor if signs of the ailment (symptoms) worsen or do not improve, or if fever develops after 7 days. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for relief of nasal congestion and middle ear congestion. Therapeutic class: the active ingredient belongs to the class of sympathomimetic agents. The active ingredient pseudoephedrine is a decongestant which acts to constrict blood vessels and to reduce swelling and mucous production, and thus relieves congestion. 2. BEFORE USING THE MEDICINE: DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or any of the additional components the medicine contains. • You are currently treated with medicines of the monoamine oxidase inhibitors group (for depression) or you have stopped using such medicines less than 14 days ago. • You are suffering from a severe problem in your kidneys, heart disease, circulation problems, hypertension, diabetes, overactive thyroid gland, glaucoma, pheochromocytoma (a tumor in the adrenal gland). • You are pregnant or breastfeeding. • You are taking medicin Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TIPTIPOT AFALPI 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredients: PSEUDOEPHEDRINE (AS HYDROCHLORIDE) 15 MG/ML For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Drops. A clear, yellowish liquid with strawberry smell. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of nasal congestion, to relief eustachian tube congestion.. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. The generally accepted dosage is: For children 6-12 years old: one drop per kg body weight per dose, up to 4 doses per 24 hours (a maximum of 30 drops per dose). For children 1 to 6 years old, the medicine should be dispensed with a doctor’s prescription only. 4.3 CONTRAINDICATIONS • Hypersensitivity to pseudoephedrine or to any of the excipients listed in section 6.1. • Patients receiving monoamine oxidase inhibitors or who have received these agents in the last two weeks. Patients using other sympathomimetic decongestants or beta-blockers. (See Section 4.5). • Patients with cardiovascular disease including ischaemic heart disease, occlusive vascular disease and hypertension. • Children under 1 year of age. • Patients with: o Severe renal impairment o Phaeochromocytoma o Diabetes o Hyperthyroidism o Closed angle glaucoma. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Caution should be used in prescribing Tiptipot Afalpi for patients with prostatic enlargement or bladder dysfunction. Also use with caution in patients with severe hepatic impairment, or with mild to moderate renal impairment. If any of the following occur, Tiptipot Afalpi should be stopped o Hallucinations o Restlessness o Sleep disturbances. Excipients with known effect: Tiptipot Afalpi contains Sorbitol. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Severe Skin reactions Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrin Прочитайте повний документ