SUMMARY OF PRODUCT CHARACTERISTICS

Transcription

1 SUMMARY OF PRODUCT CHARACTERISTICS 1

2 1. NAME OF THE MEDICINAL PRODUCT WICK Chesty Cough Syrup 200 mg/15 ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 15 ml syrup contains 200 mg guaifenesin. Each ml syrup contains mg guaifenesin. Excipients with known effect: Sucrose 370 mg/ml Ethanol (alcohol) 42 mg/ml Invert Sugar (honey) 9 mg/ml Sodium compounds 2 mg sodium/ml (0.09 mmol) Levomenthol 0.2 mg/ml For the full list of excipients, see section PHARMACEUTICAL FORM Syrup Yellow/yellow brown viscous liquid with honey-ginger menthol aromas and flavour, free from visible contamination. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications To loosen mucus and to facilitate expectoration in cough due to: - colds and flu like illness, - acute bronchitis WICK Chesty Cough Syrup is indicated in adults and adolescents aged over 14 years. 4.2 Posology and method of administration Posology Adults and adolescents aged over 14 years: Should take 200 mg guaifenesin i.e. 15 ml (one cup measure, up to the level of the 15 ml line) every 4 hours. Maximum 6 doses per day. Although in principle the recommendation is a maximum of 6 doses per day, Guaifenesin should not be taken before bedtime. Paediatric population No dosage recommendations or study results are available for children under 14 years. Method of administration Oral use. Shake before use. 2

3 WICK Chesty Cough Syrup can be used independently by patients for no longer than 3-5 days. If no significant improvement has occurred after this period, and if mucus continues to be coughed up or coughing remains persistent seek medical advice as this could indicate a more serious disease. WICK Chesty Cough Syrup should not be used for longer than two weeks. 4.3 Contraindications Hypersensitivity to the active substance, levomenthol or to any of the excipients listed in section Special warnings and precautions for use In the following cases, WICK Chesty Cough Syrup should only be used after careful consideration of the benefits and risks: - Impaired kidney function - Myasthenia gravis - Chronic or persistent cough associated with asthma, chronic bronchitis, emphysema or due to smoking - Severe gastrointestinal disease - In combination with cough suppressants. This medicinal product contains sucrose and invert sugar (honey). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine. This medicinal product contains 5.55 g sucrose per dose. This should be taken into account in patients with diabetes mellitus. This medicinal product contains 5 % vol. ethanol (alcohol). When the dosage instructions are followed, one dose (15 ml) contains 0.63 g alcohol, equivalent to 15 ml beer, 6 ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy. The effects of other medicines may be impaired or potentiated. This medicinal product contains 1.3 mmol (or 30 mg) sodium per dose. To be taken into consideration by patients on a controlled sodium diet (restricted salt content). Paediatric population No dosage recommendations or study results are available for children under 14 years and therefore, use of the product by these patients is not recommended. 4.5 Interaction with other medicinal products and other forms of interaction WICK Chesty Cough Syrup can potentiate the action of sedatives and muscle relaxants. 4.6 Fertility, pregnancy and lactation Pregnancy The safety of Guaifenesin in pregnancy has not been fully established. A moderate amount of data on pregnant women (1000) indicate no malformative or feto/ neonatal toxicity of Guaifenesin. 3

4 Breastfeeding Guaifenesin is excreted in human milk. There is insufficient information on the effects of Guaifenesin in newborns/infants. As a precautionary measure, it is recommended to avoid the use of this product during pregnancy and lactation. 4.7 Effects on ability to drive and use machines Due to alcohol content, WICK Chesty Cough Syrup has minor influence on the ability to drive and use machines. 4.8 Undesirable effects Undesirable effects are classified into the following frequency categories: Very common ( 1/10) Common ( 1/100 to <1/10) Uncommon ( 1/1 000 to <1/100) Rare ( 1/ to <1/1 000) Very rare ( 1/10 000) Not known (cannot be estimated from the available data). Gastrointestinal disorders - Rare: Gastrointestinal disorders, including nausea, vomiting or diarrhoea. Immune system disorders - Very rare: Hypersensitivity reactions such as difficulties swallowing, oedema of the face, lips, tongue or throat, strong itching with rash or swelling of the skin, coma, confusion, bradycardia, bronchospasm, dyspnoea, granulocytopenia and anaphylactic shock. These types of reactions may be preceded by fever, dizziness, nausea, vomiting, stomach cramps, heartburn or pain. Patients who are sensitised to levomenthol may experience hypersensitivity reactions, including dyspnoea. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 4.9 Overdose Symptoms Mild or moderate overdosing can give rise to dizziness, gastrointestinal disorders, nausea, vomiting or decreased muscle tone. Very high doses may produce symptoms such as excitation, confusion and respiratory depression. There have been rare reports of urinary or renal calculi in those patients who have consumed large quantities of guaifenesin for long periods of time. Treatment 4

5 Symptomatic. Gastric lavage and supportive treatment to be used if required. 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Cough and cold preparations; Expectorants, excl. combinations with cough suppressants; Expectorants ATC code: R05CA03 Pharmacodynamic effects Guaifenesin is an ether of guaiacol and glycerol and belongs to the expectorant therapeutic group. A study in patients with chronic bronchitis showed that it increases secretion (effect on volume and nature of secretion) and also facilitates the expectoration of secretions and significantly decreases the frequency of coughing. A study in patients with colds showed a clear improvement with respect to discomfort caused by a feeling of constriction in the respiratory tract. 5.2 Pharmacokinetic properties Following oral administration of 600 mg guaifenesin to 3 individuals, gas chromatographic testing was performed. The maximum level in the blood was 1.4 µg/ml and the terminal elimination half-life was 1 hour. Elimination of guaifenesin is slower in patients with impaired renal function. The metabolic transformation of guaifenesin involves hydrolysis and oxidation. The main metabolites in humans are: O-desmethyl-guaifenesin and hydroxy-guaifenesin. 5.3 Preclinical safety data Acute toxicity The LD50 following a single oral dose of guaifenesin is 6810 mg/kg body weight in mice, mg/kg body weight in rats (average from two studies), mg/kg in rabbits (average from two studies) and over 10,000 mg/kg in dogs. Chronic and subchronic toxicity In subacute toxicity studies, rats aged over 90 days survived following oral doses of up to 2,000 mg/kg body weight. Development of calculi was observed in all organs of the urinary tract. Mutagenic and carcinogenic potential In view of the lack of mutagenicity and carcinogenicity studies in animals, the risk of this type of activity cannot currently be determined. Reproductive toxicity Insufficient reproductive toxicity studies have been conducted with WICK Chesty Cough Syrup. Animal studies have not shown the active substance (guaifenesin) to have teratogenic activity. Experience in humans does not indicate a risk to embryo-fetal development. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Sucrose Propylene glycol (E1520) Ethanol 96 % Sodium citrate (E331) Carmellose sodium 5

6 Citric acid anhydrous (E330) Macrogol stearate Honey-ginger flavour (contains honey) Verveine flavour Sodium benzoate (E211) Polyethylene oxide Saccharin sodium (E954) Levomenthol Purified water. 6.2 Incompatibilities Not applicable. 6.3 Shelf life 3 years. Shelf life after opening: 3 months. 6.4 Special precautions for storage Store below 25 C (Opened or Unopened). 6.5 Nature and contents of container Amber glass bottle with a polypropylene child resistant closure and polypropylene dosing cup with CE mark and marked volumes at 5 ml, 10 ml, 15 ml, 22.5 ml. Pack sizes: 120 ml, 180 ml syrup. Not all pack sizes may be marketed. 6.6 Special precautions for disposal Any unused product or waste material should be disposed of in accordance with local requirements. 7. MARKETING AUTHORISATION HOLDER 8. MARKETING AUTHORISATION NUMBER(S) 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <Date of first authorisation: {DD month YYYY}> <Date of latest renewal: {DD month YYYY}> 6

7 10. DATE OF REVISION OF THE TEXT <MM/YYYY> 7