GENERIC NOW AVAILABLE
Carbocisteine 250mg/5ml Syrup
For the adjunctive therapy of respiratory tract disorders
PIP: 122-0078 Alliance: 6330971 AAH: CAR1646U
Abridged Prescribing Information Carbocisteine 250mg/5ml Syrup
Presentation: Amber Syrup containing 250 mg carbocisteine per 5 ml.
Uses: Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease.
Dosage and Administration: Adults: Dosage is based upon an initial daily dosage of 2250 mg carbocisteine in divided doses, reducing to 1500 mg daily in divided doses e.g. 15 ml three times a day reducing to 10 ml three times a day. Paediatric population: 2 – 5 years: 1.25 – 2.5 ml, four times a day. 6 – 12 years: 5 ml, three times a day.
Use the measuring device to measure the appropriate amount.
Contraindications: Use in children less than 2 years of age. Use in patients with active peptic ulceration. Hypersensitivity to the active substance or to any of the excipients.
Special Warnings and Precautions for Use: Asthmatic patients with a history of bronchospasm; severe respiratory failure; debilitated patients, by decreasing the cough reflex there is a risk of obstruction of the airways. No recommended with antitussive medication. Caution is advised in the administration of carbocisteine in patients susceptible to gastroduodenal ulcers. Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine. This medicine contains methyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Pregnancy and Lactation: Not recommended during the first trimester of pregnancy. Effects on Ability to Drive and Use Machines: No expected effects.
Undesirable Effects: Cardiac disorders: Palpitations (rare). Endocrine disorders: Hypothyroidism (frequency not known). Gastrointestinal disorders: Nausea, vomiting and diarrhoea (uncommon), gastrointestinal bleeding (very rare), gastric discomfort (frequency not known). Immune disorders: Urticaria and bronchospasm (rare), rash (very rare). Musculoskeletal and connective tissue disorders: Muscle pain (rare). Nervous system disorders: Headache, dizziness, urinary incontinence, palpitations (rare). Respiratory, thoracic and mediastinal disorders: Shortness of breath (rare), bronchorrhea (frequency not known).
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, erythema multiforme (frequency not known).
Pack Size and Price: 300 ml, £7.55 Legal Category: POM
Marketing Authorisation Number: PL 19255/0014 Marketing Authorisation Holder: Amdeepcha Ltd. Date of Preparation: January 2018
See Carbocisteine 250mg/5ml Syrup Summary of Product Characteristics for full prescribing information.
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Typharm Limited on 02037 694160.
For further information, please contact: Typharm Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, Norfolk, NR13 6LH, UK, Tel: 01603 722480
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