№ files_lp_3_process_7_046798
Regulatory pharmaceutical product information outlining composition, indications, dosage, contraindications, warnings, and interactions for an oral carbocisteine and promethazine syrup.
Name of medicinal product: ISOCET-P syrup
Dosage form: Oral syrup
Appearance: Orange colored syrup, free from visible impurities
Active substances: Carbocisteine 100 mg per 5 ml; Promethazine hydrochloride 2.5 mg per 5 ml
Excipients: See section 6.1
Therapeutic indications: Symptomatic treatment of troublesome, non-productive cough, particularly occurring at night
Target population: Adults and children over 2 years of age
Contraindications: Hypersensitivity to active substances or excipients; history of agranulocytosis; risk of urinary retention; angle-closure glaucoma; children under 2 years; pregnancy
Warnings and precautions: Risk of respiratory depression in young children; caution in elderly patients and in hepatic or renal impairment; risk of sedation; avoid alcohol; caution with CNS depressants
Drug interactions: Atropine-like medicinal products; CNS depressants; alcohol; sodium oxybate; lithium; antacids; opioids; antihypertensives; orlistat and others
Special populations: Elderly patients; patients with epilepsy; patients with cardiovascular disease; patients with liver or kidney impairment; diabetic patients
Sugar content: 3 g sucrose per measuring spoon; 9 g per tablespoon
Route of administration: Oral
Document type: Summary of Product Characteristics
Subject area: Pharmaceutical product information and clinical guidance
Price: 8 / 10 USD
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