Votubia 10mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Everolimus

Saatavilla:

Novartis Pharmaceuticals UK Ltd

ATC-koodi:

L04AA18

INN (Kansainvälinen yleisnimi):

Everolimus

Annos:

10mg

Lääkemuoto:

Tablet

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 08010500; GTIN: 5010678922455

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VOTUBIA
® 2.5 MG TABLETS
VOTUBIA
® 5 MG TABLETS
VOTUBIA
® 10 MG 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 is an anti-tumour medicine which can block certain cells in
the body from growing. It
contains an active substance called everolimus which may reduce the
size of kidney tumours called
renal angiomyolipomas and brain tumours called subependymal giant cell
astrocytomas (SEGA).
These tumours are caused by a genetic disorder called tuberous
sclerosis complex (TSC).
Votubia tablets are used to treat:

TSC with angiomyolipoma of the kidney in adults who do not require
immediate surgery.

SEGA associated with TSC in adults and children for whom surgery is
not appropriate.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VOTUBIA
If you are being treated for TSC with angiomyolipoma of the kidney,
Votubia will only be prescribed
for you by a doctor with experience in treating patients with TSC.
If you are being treated for SEGA associated with TSC, Votubia will
only be prescribed by a doctor
with experience in treating patients with SEGA and with access to
blood tests which will measure how
much Votubia is in your blood.
Follow all the doctor’s instructions carefully. They may diffe

Valmisteyhteenveto

OBJECT 1
VOTUBIA 10MG TABLETS
Summary of Product Characteristics Updated 11-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
®
2.5 mg tablets
Votubia
®
5 mg tablets
Votubia
®
10 mg tablets
2. Qualitative and quantitative composition
Votubia 2.5 mg tablets
Each tablet contains 2.5 mg everolimus.
_Excipient with known effect _
Each tablet contains 74 mg lactose.
Votubia 5 mg tablets
Each tablet contains 5 mg everolimus.
_Excipient with known effect _
Each tablet contains 149 mg lactose.
Votubia 10 mg tablets
Each tablet contains 10 mg everolimus.
_Excipient with known effect _
Each tablet contains 297 mg lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
Votubia 2.5 mg tablets
White to slightly yellow, elongated tablets of approximately 10.1 x
4.1 mm, with a bevelled edge and no
score, engraved with “LCL” on one side and “NVR” on the other.
Votubia 5 mg tablets
White to slig