Land: Malta
Sprache: Englisch
Quelle: Medicines Authority
THYMUS VULGARIS, AMMONIA EXTRACTION, SOLVENT, GLYCEROL, ETHANOL
Laboratoria Qualiphar N.V/S.A Rijksweg 9 2880 Bornem, Belgium
R05X
THYMUS VULGARIS AMMONIA EXTRACTION SOLVENT 10 % GLYCEROL 85 % ETHANOL 90 %
SYRUP
THYMUS VULGARIS AMMONIA EXTRACTION SOLVENT 10 % GLYCEROL 85 % ETHANOL 90 %
OTC
COUGH AND COLD PREPARATIONS
Authorised
2018-11-07
1/3 TOULARYNX THYM, SYRUP THYMUS VULGARIS L. LIQUID EXTRACT [1:2-3], EXTRACTION SOLVENT AMMONIA 10% (M/M) : GLYCEROL 85% (M/M) : ETHANOL 90% (V/V) : WATER (1:20:70:109) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. WHAT IS IN THIS LEAFLET 1. What Toularynx thym is and what it is used for. 2. What you need to know before you take Toularynx thym. 3. How to take Toularynx thym. 4. Possible side effects. 5. How to store Toularynx thym. 6. Contents of the pack and other information. 1. WHAT TOULARYNX THYM IS AND WHAT IT IS USED FOR. Toularynx thym is a traditional herbal medicinal product used as an aid to facilitate coughing up phlegm (expectorant) in productive cough associated with cold. It is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. The indication should be rephrased as shown above 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOULARYNX THYM. DO NOT TAKE TOULARYNX THYM - If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6). - If you are allergic to plants belonging to the mint or deadnettle family (Lamiaceae family). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Toularynx thym. - The use in children younger than 2 years old is not recommended because medical advice should be sought. - Consult your doctor when shortness of breath (dyspnoea), fever or phlegm containing pus (purulent sputum) occurs. - Consult your doctor if the symptoms worsen during the use of this medicine. - Toularynx thym contains alcohol and maltitol. Please also read the section “Toularynx thym contains alcohol and maltitol”. - If you are using other medicines. Please also read the section “Other medicines and Toularynx thym”. Consult your doctor if one of the above warnings applies to you, or i Lesen Sie das vollständige Dokument
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Toularynx Thym 6.5 g/100 ml, syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Thymus vulgaris L. liquid extract [1:2-3], extraction solvent ammonia 10% (m/m): glycerol 85% (m/m): ethanol 90% (v/v): water (1:20:70:109) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Traditional herbal medicinal product used for the relief of a productive cough associated with a cold. It is a traditional herbal medicinal product for use in the specified indication exclusively based upon long- standing use. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION This syrup is sugar-free and can therefore be used without any problems by diabetics. The packaging contains a cup that can measure up to 30 ml. The bottle is sealed with a child-resistant closure that should be opened as followed: push the closure system down while turning counter- clockwise. Posology Children from 2 to 4 years old: 4 x 5 ml per day. Children from 4 to 12 years old: 4 x 10 ml per day. Children over 12 years of age and adults: 4 x 15 ml per day. The interval between two intakes should be at least 4 hours. The use in children under 2 years of age is not recommended (see 4.4: Special warnings and precautions for use). Consult your doctor if your symptoms do not improve after 7 days. Method of administration Oral use. Page 2 of 4 4.3. CONTRAINDICATIONS Hypersensitivity to the active substance 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_ _ When dyspnoea, fever or purulent sputum occurs, a doctor should be consulted. If the symptoms worsen during the use of this medicine, a doctor should be consulted. This medicinal product contains 2.2 vol % ethanol (alcohol) in the syrup, i.e. up to 260 mg per dose (15 ml), equivalent to 6.6 ml beer or 2.8 ml wine per dose. This may be harmful to people suffering f Lesen Sie das vollständige Dokument