País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Delphinium staphisagria; Anamirta cocculus; Petroleum rectificatum; Nicotiana tabacum; Strychnos nux-vomica
A. Nelson & Company Limited
Delphinium staphisagria; Anamirta cocculus; Petroleum rectificatum; Nicotiana tabacum; Strychnos nux-vomica
6C
Tablet
Marketed
2020-12-18
_ _ 1.3.1 Packaging leaflet Created date: 09/11/20 _Confidential _ HOA 1149/004/001 Travella Page 1 of 3 1.3 PRODUCT INFORMATION 1.3.1 PACKAGE LEAFLET PARTICULARS TO APPEAR ON THE PACKAGE LEAFLET PACKAGE LEAFLET A Homeopathic Medicinal Product Travella 6C tablets Anamirta cocculus 6C Delphinium staphisagria 6C Nicotiana tabacum 6C Petroleum rectificatum 6C Strychnos nux-vomica 6C PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE TAKING THIS MEDICINE, IT CONTAINS IMPORTANT INFORMATION. KEEP THIS LEAFLET; YOU MIGHT NEED TO READ IT AGAIN. 1. WHAT IS THIS MEDICINE FOR Travella is a homeopathic medicinal product used within the homeopathic tradition for the relief of symptoms of travel sickness, such as nausea, vomiting, dizziness and headache. 2. BEFORE TAKING THIS MEDICINE • Do not take this medicine if you are under 12 years old. • Do not take this medicine if you are allergic to any of the ingredients, see section 6. • This product contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine. • Talk to your doctor or pharmacist before taking this medicine if you are: - taking any other medicines, including those bought without a prescription. - pregnant or breastfeeding. 3. HOW TO USE THIS MEDICINE FOR ORAL USE ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS DIRECTIONS Take 2 tablets every hour for 2 hours before the journey. Take 2 tablets hourly during the journey if necessary. Tablets to be sucked or chewed. If symptoms worsen, or persist after 5 days, consult your doctor or qualified healthcare practitioner. _ _ 1.3.1 Packaging leaflet Created date: 09/11/20 _Confidential _ HOA 1149/004/001 Travella Page 2 of 3 DO NOT exceed the stated dose. IF YOU FORGET TO TAKE THIS MEDICINE, continue with the usual dose at the usual time. It does not matter if you have missed a dose. Do not take a double dose to make up for a missed dose. IF YOU TAKE TOO MUCH OF THIS MEDICINE speak to a doctor or pharmacist and take this Llegiu el document complet
Health Products Regulatory Authority 18 December 2020 CRN008K7X Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Travella 6C tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Anamirta cocculus 6C Delphinium staphisagria 6C Nicotiana tabacum 6C Petroleum rectificatum 6C Strychnos nux-vomica 6C Excipient(s) with known effect: Lactose 174.26 mg Sucrose 42.39 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Biconvex circular white to off-white tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A Homeopathic Medicinal product used within the homeopathic tradition for the relief of symptoms of travel sickness, such as nausea, vomiting, dizziness and headache. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use Adults, the elderly and children over 12 years: Take 2 tablets every hour for 2 hours before the journey. Take 2 tablets hourly during the journey if necessary. Tablets to be sucked or chewed. This product is not recommended for use in children under 12 years of age. If the symptoms worsen, or persist after 5 days, a doctor or qualified healthcare practitioner should be consulted. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the active ingredients or any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not exceed the stated dose. This product is not recommended for use in children under 12 years of age and medical advice should be sought. If symptoms worsen, or persist after 5 days, a doctor or qualified healthcare practitioner should be consulted. Health Products Regulatory Authority 18 December 2020 CRN008K7X Page 2 of 3 Contains lactose and sucrose - Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrose-insomaltese insufficiency should not take this medicine. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None known 4.6 FERTILITY, PREGNANCY AND LACTATION Pregn Llegiu el document complet