Country: Israel
Language: English
Source: Ministry of Health
DEXTROMETHORPHAN HYDROBROMIDE; PARACETAMOL; PSEUDOEPHEDRINE HYDROCHLORIDE
TEVA ISRAEL LTD
N02BE01
CAPLETS
PARACETAMOL 500 MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG; DEXTROMETHORPHAN HYDROBROMIDE 15 MG
PER OS
Not required
TEVA ISRAEL LTD, ISRAEL
PARACETAMOL
For the relief of cold, cough and nasal congestion associated with fever and pain, for day care.
2022-02-28
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed without a doctor’s prescription Acamol ® Tsinun & Shapa’at Day Caplets Composition Each caplet contains: Paracetamol 500 mg Pseudoephedrine hydrochloride 30 mg Dextromethorphan hydrobromide 15 mg For information regarding inactive ingredients and allergens, see section 2 – “Important information about some of the ingredients of the medicine” and section 6 – “Additional information”. 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 is dispensed without need for a doctor’s prescription and is intended for adults and children from the age of 12 years and above. Take the medicine properly. Consult the pharmacist if you need any further information. Refer to the doctor if the fever persists for more than 3 days or if the signs of ailment worsen or do not improve after 5 days despite the use of the medicine or in any case in which new symptoms appear. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for the relief of cold, cough and nasal congestion accompanied by fever and pain – for day care. Therapeutic class: Paracetamol – analgesic and antipyretic. Pseudoephedrine – relieves nasal congestion. Dextromethorphan – cough suppressant. 2. BEFORE USING THE MEDICINE Do not use this medicine: • If you are sensitive (allergic) to paracetamol, or to pseudoephedrine, or to dextromethorphan, or to other decongestants, or to any of the other ingredients the medicine contains (see section 6). • If you are being concomitantly treated with medicines from the monoamine oxidase inhibitors group (MAOI) (for depression) or with reversible inhibitors of monoamine oxidase (RIMAs) or within 14 days of discontinuing treatment with them. • If you are taking selective serotonin reuptake inhibitors [SSRIs] (against depress Read the complete document
Acamol Tsinun and Shapaat Day SK 09.2023 Acamol Tsinun and Shapaat Day Summary of Product Characteristics 1. Name of the medicinal product Acamol Tsinun and Shapaat Day 2. Qualitative and quantitative composition Acamol Tsinun and Shapaat Day caplets contain Paracetamol 500 mg, Pseudoephedrine hydrochloride 30 mg and Dextromethorphan hydrobromide 15 mg . Excipients with known effect: Each caplet contains Sodium 0.588-0.882 mg Each caplet contains Lactose monohydrate 6.5 mg Each caplet contains FD&C YELLOW #6/SUNSET YELLOW FCF For the full list of excipients, see section 6.1 3. Pharmaceutical form Green, capsule shaped biconvex film coated tablet, plain on one side and scored on the other side 4. Clinical particulars 4.1 Therapeutic indications Acamol Tsinun and Shapaat Day is indicated for a relief of cold, cough and nasal congestion associated with fever and pain, for day care. 4.2 Posology and method of administration Posology Adults and children aged 12 years and over: 1-2 caplets every four to six hours, up to four times a day. Maximum daily dose: 8 caplets (i.e. 4 g paracetamol, 240 mg pseudoephedrine hydrochloride, 120 mg Dextromethorphan hydrobromide). Children under 12 years: Acamol Tsinun and Shapaat Day is contraindicated in children under the age of 12 years (see section 4.3). In the elderly the rate and extent of paracetamol absorption is normal but plasma half life is longer and paracetamol clearance is lower than in young adults. Consult with your doctor before using this product. When taking with Acamol Tsinun and Shapaat Night, do not take more than a total of 8 caplets a day. You have to take one dose of Acamol Tsinun and Shapaat Night instead of one dose of Acamol Tsinun and Shapaat Day. Do not add to the maximum recommended dosage. Hepatic dysfunction Caution should be exercised when administering Acamol Tsinun and Shapaat Day to patients with severe hepatic impairment. Renal dysfunction: Caution should be exercised when administering Acamol Tsinun and Shapaat Day to patients with moderate to s Read the complete document