codipront

 

CODIPRONT SYRUP ABRIDGED PRESCRIBING INFORMATION: Please refer to full Summary of Product Characteristics (SPC) before prescribing. TRADE NAME: Codipront. ACTIVE INGREDIENTS: Composition per 100 g (= 90 ml) of prolonged release suspension: 935 ‐1 205mg codeine‐poly (styrene, divinylbenzene)‐sulfonate, equivalent to codeine 200 mg and 148.5‐194 mg Phenyltoloxamine‐poly(styrene, divinylbenzene)‐sulfonate, equivalent to phenyltoloxamine 66 mg. PHARMACEUTICAL FORM: Prolonged release suspension for oral administration. INDICATIONS: Symptomatic treatment of acute disturbing cough (nonproductive cough) in acute and chronic bronchitis, and in flu, as well as in airway inflammation due to allergic or respiratory causes. DOSAGE: Unless otherwise prescribed by a doctor, adults and children take the following dosages in the morning, and in the evening: children between 2‐4 years: ½ teaspoon; children between 4 ‐ 6 years: 1 teaspoon; children between 6 ‐ 14 years: 2 teaspoons; children over 14 years and adults: 1 tablespoon. Codeine is contraindicated for children under one year. There are no posological recommendations available for 2‐year‐olds. CONTRAINDICATIONS:  Hypersensitivity to the active substance or to any of the excipients as well as to parabens; Prostate hypertrophy with the formation of residual urine; Angle‐closure glaucoma; Respiratory insufficiency; Acute asthma crisis; Coma. PRECAUTIONS: Opiate dependency; Disturbances of consciousness; Disturbances of respiratory centre and respiratory function; Situations that run parallel to intracranial hypertension; Chronic constipation. INTERACTIONS: central nervous system depressants, alcohol. ADVERSE EVENTS: Mild headache and slight drowsiness, States of excitement can occur in infants (with overdosage). Respiratory depression and an exaggerated feeling of well‐being (euphoria) can also occur. Sleep disturbances or tinnitus were rarely observed. Nausea, vomiting, and constipation. Induction of glaucoma (angle‐closure glaucoma) may occur. Eye‐motor coordination and visual capacity may be compromised, depending on the dosage. PRESENTATION: Bottles with 90 ml (= 100 g) of syrup. Marketing Authorisation Holder: Ferraz, Lynce, S.A. Portugal. Marketing Authorisation Number: 9275701 Date of presentation: May 2016In order to ensure that this product information reflects the most up-to date clinical and post marketing surveillance data, please always refer to the latest Summary of Product Characteristics which is available from E.J.Busuttil Ltd (Tel +356 21447184). For Medical information contact: busuttilc@ejbusuttil.com and for ADR reporting contact: rp@ejbusuttil.com Healthcare professionals are asked to report any suspected adverse reactions via ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal.

 

In order to ensure that this product information reflects the most up-to date clinical and post marketing surveillance data, please always refer

to the latest Summary of Product Characteristics which is available from E.J.Busuttil Ltd (Tel +356 21447184). For Medical information contact: busuttilc@ejbusuttil.com and for ADR reporting contact: rp@ejbusuttil.com

Healthcare professionals are asked to report any suspected adverse reactions via ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal.