País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Norway spruce extract
A.Vogel UK Ltd
Norway spruce extract
289mg/1ml
Oral solution
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 03090200; GTIN: 7610313808212
® Bronchosan ® Pine Cough syrup Patient Information Leaflet i Information _Please turn over..._ Important things you need to know This product is used for the relief of coughs. This product is suitable for adults and children over 12 years. Don't take this product if you are allergic to any of the ingredients: see section 6. Before you take this product: read section 2. Dosage instructions: see section 3. Talk to your doctor if your symptoms worsen or do not improve within 7 days. Side effects are minor and very rare: see section 4. Now read the rest of this leaflet carefully. Keep this leaflet. You may need to read it again. 1. What this product is for Bronchosan is a traditional herbal medicinal product used for the relief of coughs. This is based on traditional use only. Used to relieve: Dry coughs Tickly coughs Irritating coughs Do's & Don'ts 2. Before you use this product Do not give this product to children under 12. Do not take this product: If you are allergic to: Spruce (_Picea abies_). This product contains spruce. Pine species. Colophony. Any of the other ingredients in this product (See section 6 Further Information). If you are pregnant or breast-feeding. See your doctor before taking this product: If you have been told by your doctor that you have an intolerance to some sugars. This product contains sugars. Information for people who suffer from diabetes: This product contains 5.25 g of carbohydrate per 5 ml dose. 644 80821IN3 9542401/AV20191105 pharma code 296x160/111114 644 80821IN3 9542401/AV20191105 4. Possible side effects Like all medicines, this product can cause side effects, although not everybody gets them. Minor side effects The following minor side effects can occur when using this product. These are very rare and likely to affect less than 1 in 10,000 people. Skin reactions Itching (pruritis) Rash Stop taking the product if any of these occur. If you are concerned about any side effect or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bronchosan Pine Cough syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 5 ml [6.95 g] of oral liquid contains 1,445 mg of extract (as soft extract) from fresh _Picea abies _(L.) Karsten (spruce) shoots (0.9 – 1.2:1). Extraction solvent: Water 5 ml of syrup contains 5.25 g of carbohydrate mainly present as sucrose, glucose and fructose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Syrup It is brown syrup. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A traditional herbal medicinal product used for the relief of coughs, such as chesty coughs and dry, tickly, irritating coughs, and catarrh based on traditional use only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use only. Adults and children over 12 years: 5-10 ml 2-4 times daily The use is not recommended in children under 12 years of age (see 4.4 Special warnings and precautions for use). Duration of use: If symptoms persist after 7 days a doctor or qualified healthcare practitioner should be consulted. 4.3 CONTRAINDICATIONS Hypersensitivity to the active ingredient, Pine species, colophony or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not exceed stated dose. If symptoms worsen or persist for more than one week, a doctor or qualified health care practitioner should be consulted. If dyspnoea, fever or purulent sputum occurs, a doctor or qualified health care practitioner should be consulted. Contains sucrose as well as sources of glucose and fructose (honey and concentrated pear juice). Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Contains 5.25 g of carbohydrate per 5 ml dose. This should be taken into account in patients with diabetes mellitus. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interaction studies have been performed. 4.6 PREGNANCY AND LACTATION The safety of this pro Leia o documento completo