País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Chamomilla recutita
Pharmaceutical Business Consultants Limited
Chamomilla recutita
Granules
Marketed
2017-12-15
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE GIVING THIS MEDICINE, IT CONTAINS IMPORTANT INFORMATION. PLEASE KEEP THIS LEAFLET; YOU MIGHT NEED TO READ IT AGAIN. 1. WHAT IS THIS MEDICINE FOR Teetha ® Teething Granules are a homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of teething pain and the symptoms associated with teething which are sore & tender gums, flushed cheeks and dribbling. 2. BEFORE GIVING THIS MEDICINE • This medicine may not be suitable for some babies. Ask your doctor or pharmacist before giving it to the baby if you are not sure. • Do not give this medicine to the baby if he/she is allergic to any of the ingredients, see section 6. • This product contains lactose. If you have been told by your doctor that your baby has an intolerance to some sugars, consult your doctor before using this medicine. • If the baby is being given any other medicines including medicines prescribed by your doctor, or any medicines you have bought for them, talk to your doctor or pharmacist before giving them this medicine. 3004410 P3 P2 FRONT BACK A HOMEOPATHIC MEDICINAL PRODUCT TEETHA ® TEETHING GRANULES CHAMOMILLA 6C 5. HOW TO STORE THIS MEDICINE • Keep all medicines out of reach and sight of children. • Do not store above 25ºC. Store in the original packaging. • Do not use after expiry date shown on carton and sachet. • Return any unused medicine to your pharmacist for safe disposal. 6. FURTHER INFORMATION WHAT IS IN THIS MEDICINE ACTIVE INGREDIENT Each 300mg granules in a sachet contain: Chamomilla recutita (Chamomilla) 6c ALSO CONTAINS Lactose monohydrate, Xylitol (E967), Starch, Pregelatinised maize starch WHAT DOES THE MEDICINE LOOK LIKE Teetha ® Teething Granules are fine white to off-white granules in a sachet. There are 24 or 40 sachets in a box. NATIONAL RULES AUTHORISATION HOLDER: PBC Biomed Unit 4D Western Business Park, Shannon, Co. Clare, Ireland HOA23352/001/001 THIS LEAFLET IS AVAILABLE ON REQUEST IN FORMATS SUITABLE FOR THE BLIND A Llegiu el document complet
Health Products Regulatory Authority 28 October 2022 CRN00CT2Z Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Teetha Teething Granules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 300mg granules in a sachet contain: Chamomilla recutita (Chamomilla) 6C Excipient(s) with known effects: Lactose 60% w/w For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral Granules Fine white to off white granules 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of teething pain and the symptoms associated with teething which are sore & tender gums, flushed cheeks and dribbling. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use For babies aged 3 months and over Detach one sachet from strip of 4. Babies 3-6 months With the baby upright or in a sitting position. Use a spoon. Slowly give the baby half a sachet at a time. The granules should be given slowly into the front of the baby’s mouth a little at a time. Check all the granules have been fully dissolved before giving the remaining half. Babies over 6 months With the baby upright or in a sitting position slowly pour the contents of the sachet into the front of the baby’s mouth a little at a time. Alternatively use a spoon. Ensure the granules fully dissolve in the baby’s mouth. Use one sachet every 2 hours for a maximum of 6 doses during any 24 hour period. If symptoms worsen or persist after 7 days of using this product, a doctor or qualified healthcare practitioner should be consulted. 4.3 CONTRAINDICATIONS Hypersensitivity to Chamomilla recutita or any of the excipients. Health Products Regulatory Authority 28 October 2022 CRN00CT2Z Page 2 of 3 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not exceed the stated dose. If symptoms worsen or persist after 7 days of using this product, a doctor or qualified healthcare practitioner should be consulted. This product is not recommended for use in babies under 3 months of Llegiu el document complet