Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mebendazole
Janssen-Cilag Ltd
P02CA01
Mebendazole
100mg
Chewable tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05050100; GTIN: 5012674076224
PACKAGE LEAFLET: INFORMATION FOR THE USER VERMOX ® 100 MG TABLETS Mebendazole Vermox is a registered trademark READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again • If you have any further questions, ask your doctor or pharmacist • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours • If you get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist IN THIS LEAFLET 1. What Vermox tablets are and what they are used for 2. Before you use Vermox tablets 3. How to use Vermox tablets 4. Possible side effects 5. How to store Vermox tablets 6. Further information 7. Further advice regarding worms 1. WHAT VERMOX TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Vermox 100 mg tablets (referred to as Vermox tablets in this leaflet). Vermox tablets contain a medicine called mebendazole. It is one of a group of medicines called ‘anthelmintics’. Vermox tablets are used to treat worm infections of the gut such as: • threadworms (pinworms) • other common worm infections (such as whipworm, roundworm, hookworm) You or your child has been advised to take Vermox tablets because you have a worm infection. Worms can infect anyone. It does not necessarily mean that your hygiene is poor. 2. BEFORE YOU USE VERMOX TABLETS DO NOT USE VERMOX TABLETS IF: • You are allergic to anything in Vermox tablets (listed in section 6 below) • Your child is under 2 years old Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Vermox tablets. TAKING OTHER MEDICINES Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription, herbal medicines, dietary supplements or vitamins. In particular tell your doctor or Прочитать полный документ
OBJECT 1 VERMOX 100 MG TABLETS Summary of Product Characteristics Updated 21-Nov-2014 | Janssen-Cilag Ltd 1. Name of the medicinal product Vermox 100 mg tablets 2. Qualitative and quantitative composition Each tablet contains 100 mg of mebendazole. Excipients: Each tablet also contains 0.06 mg of sunset yellow (E110). For a full list of excipients, see section 6.1 3. Pharmaceutical form Tablet. Flat, circular, pale orange tablets with Me/100 on one side and JANSSEN on the other. 4. Clinical particulars 4.1 Therapeutic indications For the treatment of _Trichuris trichuria_ (whipworm), _Enterobius vermicularis_ (pinworm or threadworm), _Ascaris lumbricoides_ (roundworm), _Ancylostoma duodenale_ (common hookworm), _Necator americanus_ (American hookworm) in single or mixed gastrointestinal infestations. There is no evidence that Vermox Tablets are effective in the treatment of cysticercosis. 4.2 Posology and method of administration Adults and children over 2 years: For the control of trichuriasis, ascariasis and hookworm infections, one tablet twice a day for three consecutive days. For the control of enterobiasis a single tablet is administered. It is highly recommended that a second tablet is taken after two weeks, if re-infection is suspected. Tablets may be chewed or swallowed whole. Crush the tablet before giving it to a young child. Always supervise a child while they are taking this medicine. Method of Administration Oral use. 4.3 Contraindications Vermox is contraindicated in pregnancy and in patients who have shown hypersensitivity to the product or any components. 4.4 Special warnings and precautions for use Not recommended in the treatment of children under 2 years. A case-control study of a single outbreak of Stevens-Johnson syndrome /toxic epidermal necrolysis (SJS/TEN) suggested a possible association with the concomitant use of metronidazole with mebendazole. Although there are no additional data on this potential interaction, concomitant use of mebendazole and metronidazole should be avoided Прочитать полный документ