Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
CAFFEINE; CHLORPHENIRAMINE MALEATE; PARACETAMOL; PHENYLEPHRINE HYDROCHLORIDE
TEVA ISRAEL LTD
R01BA53
CAPLETS
PARACETAMOL 300 MG; CHLORPHENIRAMINE MALEATE 2 MG; PHENYLEPHRINE HYDROCHLORIDE 10 MG; CAFFEINE 30 MG
PER OS
Not required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
PHENYLEPHRINE, COMBINATIONS
PHENYLEPHRINE, COMBINATIONS
Symptomatic relief of common cold, congestion associated with sinusitis, allergic rhinitis accompanied by fever and pain.
2023-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed without a doctor’s prescription TEVA-COLD TABLETS TEVA-COLD CAPLETS The active ingredients and their quantities in each tablet/caplet: Paracetamol 300 mg Caffeine anhydrous 30 mg Phenylephrine hydrochloride 10 mg Chlorpheniramine maleate 2 mg For information on the inactive and allergenic ingredients in the preparation, see section 2 – “Important information regarding some of the ingredients of the medicine” and section 6 – “Further Information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. Take the medicine according to the instructions given in this leaflet )section 3( in the section on dosage. Consult the pharmacist if you need further information. Refer to the doctor if the symptoms of the illness worsen or if there is no improvement after 3-5 days. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended to relieve cold symptoms, sinus congestion and allergic rhinitis accompanied by fever and pain. THERAPEUTIC GROUP: • Paracetamol – analgesic and antipyretic. • Caffeine anhydrous – xanthine alkaloid, central nervous system stimulant. • Phenylephrine hydrochloride – sympathomimetic, decongestant for the nose and ears. • Chlorpheniramine maleate – antihistamine. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive )allergic( to paracetamol, caffeine, phenylephrine, chlorpheniramine or to any of the additional ingredients contained in the medicine. • In the past you developed an allergic reaction after using antihistamines. • You suffer from problems of the kidneys, liver, from hyperthyroidism, from diabetes, from high blood pressure or from heart disease. • You suffer from pheochromocytoma or from glaucoma. • You are taking tricyclic antidepressants )for example, imipram Izlasiet visu dokumentu
Teva‐Cold Tablets/Caplets New SPC SZ 8.2022 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Teva-Cold Tablets Teva-Cold Caplets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet/caplet contains: Paracetamol 300 mg Caffeine anhydrous 30 mg Phenylephrine Hydrochloride 10 mg Chlorpheniramine maleate 2 mg Excipients with known effect: Lactose. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets and Caplets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The product is recommended for symptomatic relief of common cold, congestion associated with sinusitis, allergic rhinitis accompanied by fever and pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: One tablet/caplet every 4 hours as required. Children of 6-12 years old: One tablet/caplet, up to 3 times a day. Do not exceed the stated dose. Use the lowest amount needed to achieve benefit for the shortest duration of treatment. If the disease symptoms worsen or do not improve after 3-5 days, patients should consult a doctor. Teva‐Cold Tablets/Caplets New SPC SZ 8.2022 4.3 CONTRAINDICATIONS Known hypersensitivity to paracetamol, caffeine, phenylephrine, chlorpheniramine or any of the other constituents of the medicine. Concomitant use of other sympathomimetic decongestants or paracetamol medicine Phaeochromocytoma Closed angle glaucoma Hepatic or severe renal impairment, Hypertension and heart disease. hyperthyroidism, diabetes. Patients taking tricyclic antidepressants, or beta-blocking drugs Patients taking or who have taken within the last two weeks monoamine oxidase inhibitors (MAOIs) (see section 4.5). Hypersensitivity to antihistamines 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Contains paracetamol. Patients should be advised not to take other paracetamol- containing products concurrently. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which may require liver transplant o Izlasiet visu dokumentu