Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Everolimus
Novartis Pharmaceuticals UK Ltd
L01XE10
Everolimus
5mg
Dispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500; GTIN: 5010678922530
1 PACKAGE LEAFLET: INFORMATION FOR THE USER VOTUBIA ® 1 MG DISPERSIBLE TABLETS VOTUBIA ® 2 MG DISPERSIBLE TABLETS VOTUBIA ® 3 MG DISPERSIBLE TABLETS VOTUBIA ® 5 MG DISPERSIBLE TABLETS everolimus READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Votubia is and what it is used for 2. What you need to know before you take Votubia 3. How to take Votubia 4. Possible side effects 5. How to store Votubia 6. Contents of the pack and other information 1. WHAT VOTUBIA IS AND WHAT IT IS USED FOR Votubia dispersible tablets contain an active substance called everolimus. It is used to treat children aged 2 years and above and adults with partial seizures with or without secondary generalisation (epilepsy) associated with a genetic disorder called tuberous sclerosis complex (TSC) and which are not controlled by other antiepileptic medicines. Partial seizures start by only affecting one side of the brain but can spread and extend to larger areas on both sides of the brain (called a “secondary generalisation”). Votubia dispersible tablets are given together with other medicines for epilepsy. Votubia is also an anti-tumour medicine which can block certain cells in the body from growing. It may reduce the size of brain tumours called subependymal giant cell astrocytomas (SEGA) which are also caused by TSC. Votubia dispersible tablets are used to treat SEGA associated with TSC in adults and children for whom surgery is not appropriate. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VOTUBIA Votubia will only be pre Citiți documentul complet
OBJECT 1 VOTUBIA 5MG DISPERSIBLE TABLETS Summary of Product Characteristics Updated 10-Sep-2018 | Novartis Pharmaceuticals UK Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Votubia ® 1 mg dispersible tablets Votubia ® 2 mg dispersible tablets Votubia ® 3 mg dispersible tablets Votubia ® 5 mg dispersible tablets 2. Qualitative and quantitative composition Votubia 1 mg dispersible tablets Each dispersible tablet contains 1 mg everolimus. _Excipient with known effect _ Each dispersible tablet contains 0.98 mg lactose. Votubia 2 mg dispersible tablets Each dispersible tablet contains 2 mg everolimus. _Excipient with known effect _ Each dispersible tablet contains 1.96 mg lactose. Votubia 3 mg dispersible tablets Each dispersible tablet contains 3 mg everolimus. _Excipient with known effect _ Each dispersible tablet contains 2.94 mg lactose. Votubia 5 mg dispersible tablets Each dispersible tablet contains 5 mg everolimus. _Excipient with known effect _ Each dispersi Citiți documentul complet