Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Thyme
Omega Pharma Ltd
Thyme
59.5mg
Pastille
Oromucosal
No Controlled Drug Status
Valid as a prescribable product
BNF: 12030300; GTIN: 5012616262227 5012616262234 5012616262241
PACKAGE LEAFLET: INFORMATION FOR THE USER Buttercup Bronchostop Cough Pastilles Thyme herb extract Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or qualified healthcare practitioner has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist or qualified healthcare practitioner if you need more information or advice. - If you get any side effects, talk to your pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor or qualified healthcare practitioner if you do not feel better or if you feel worse after 7 days. What is in this leaflet: 1. What Buttercup Bronchostop Cough Pastilles are and what they are used for 2. What you need to know before you take Buttercup Bronchostop Cough Pastilles 3. How to take Buttercup Bronchostop Cough Pastilles 4. Possible side effects 5. How to store Buttercup Bronchostop Cough Pastilles 6. Contents of the pack and other information 1. WHAT BUTTERCUP BRONCHOSTOP COUGH PASTILLES ARE AND WHAT THEY ARE USED FOR Buttercup Bronchostop Cough Pastilles are 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUTTERCUP BRONCHOSTOP COUGH PASTILLES Do not take Buttercup Bronchostop Cough Pastilles • If you are allergic to Thyme or other members of the Lamiaceae family (e.g. Basil, Rosemary, Sage), or to any of the other ingredients of this medicine (listed in section 6). • If you are pregnant or breast-feeding. Warnings and precautions Consult your doctor before taking Buttercup Bronchostop Cough Pastilles if you: • are prone to develop allergic reactions. There is a possible risk that this medicine may trigger severe and life-threatening allergic reactions in patients wh Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Buttercup Bronchostop Cough Pastilles 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pastille contains 59.5 mg of extract (as dry extract) from Thyme herb (Thymus vulgaris L. and Thymus zygis L., herb ) (DER 7-13:1) extraction solvent: water Excipient(s) with known effect: Each pastille contains: 523 mg sorbitol (E420), 300 mg fructose, 5.53 mg propylene-glycol (E1520) and 0.0018 mg benzyl-alcohol (E1519) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hexagonal, brown pastilles with a fruity taste. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 _ _ Adults, the elderly and children over 12 years: 1 – 2 pastilles to be taken every 4 hours, 4 times a day. If required, up to a maximum of 12 pastilles can be taken per day. _ _ _Method of administration:_ For oral use (allow to dissolve in the mouth through sucking). This product is not recommended for use in children under 12 years of age (See ‘Section 4.4 Special warnings and precautions for use.’) _Duration of use: _ _ _ If symptoms worsen, or persist after 7 days, a doctor or a qualified healthcare practitioner should be consulted. 4.3 CONTRAINDICATIONS Hypersensitivity to Thyme or to other members of the Lamiaceae family, or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not exceed the stated dose. The use in children under 12 years of age is not recommended due to lack of data and because medical advice should be sought. If symptoms worsen, or persist after 7 days, a doctor or qualified healthcare practitioner should be consulted. If dyspnoea, fever or purulent sputum occurs, a doctor or qualified healthcare practitioner should be consulted. Patients with asthma should consult their doctor before using Butt Läs hela dokumentet