Votubia 5mg dispersible tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Everolimus

Disponível em:

Novartis Pharmaceuticals UK Ltd

Código ATC:

L01XE10

DCI (Denominação Comum Internacional):

Everolimus

Dosagem:

5mg

Forma farmacêutica:

Dispersible tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 08010500; GTIN: 5010678922530

Folheto informativo - Bula

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

Características técnicas

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