Votrient 200mg tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

pazopanib

Available from:

Glaxo Wellcome S.A.

ATC code:

L01XE11

INN (International Name):

pazopanib

Dosage:

200mg

Pharmaceutical form:

tablets film-coated

Units in package:

(30) plastic container

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-03-10

Patient Information leaflet

VOTRIENT
® 200 MG FILM-COATED TABLETS
VOTRIENT
® 400 MG FILM-COATED TABLETS
PAZOPANIB
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 VOTRIENT IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VOTRIENT
3
HOW TO TAKE VOTRIENT
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE VOTRIENT
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
What Votrient is and what it is used for
Votrient is a type of medicine called a _protein kinase inhibitor. _It
works by
preventing the activity of proteins that are involved in the growth
and spread
of cancer cells.
Votrient is used in adults to treat:
• kidney cancer that is advanced or has spread to other organs
• certain forms of soft tissue sarcoma a type of cancer that affects
the
supportive tissues of the body. It can occur in muscles, blood
vessels, fat
tissue or in other tissues that support, surround and protect the
organs.
2
What you need to know before you take
Votrient
Do not take Votrient
• IF YOU ARE ALLERGIC to pazopanib or any of the other ingredients of
this
medicine (listed in Section 6).
• CHECK WITH YOUR DOCTOR if you think this applies to you. Don’t take
Votrient.
Warnings and precautions
BEFORE YOU TAKE VOTRIENT your doctor needs to know:
• if you have HEART DISEASE
• if you have LIVER DISEASE
• if you have had HEART FAILURE OR A HEART ATTACK
• if you have had prior COLLAPSE OF A LUNG
• if you have had problems with BLEEDING, BLOOD CLOTS OR NARROWING OF
THE ARTERIES
• if you have had STOMACH OR BOWEL PROBLEMS su

Summary of Product characteristics

VOTRIENT 200 MG AND 400 MG FILM COATED TABLETS
Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Votrient® 200 mg and 400 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg or 400 mg pazopanib (as
hydrochloride).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
200 mg: capsule-shaped, pink, film-coated tablet with GS JT debossed
on one side.
400 mg: Capsule-shaped, white, film-coated tablet with GS UHL debossed
on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Renal cell carcinoma (RCC)_
Votrient is indicated in adults for the first line treatment of
advanced Renal Cell
Carcinoma (RCC) and for patients who have received prior cytokine
therapy for
advanced disease.
_Soft tissue sarcoma (STS)_
Votrient is indicated for the treatment of adult patients with
selective subtypes of
advanced Soft Tissue Sarcoma (STS) who have received prior
chemotherapy for
metastatic disease or who have progressed within 12 months after (neo)
adjuvant
therapy.
Efficacy and safety has only been established in certain STS
histological tumour
subtypes (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Votrient treatment should only be initiated by a physician experienced
in the
administration of anti-cancer agents.
Posology
_Adults_
The recommended dose of pazopanib for the treatment of RCC or STS is
800 mg once
daily.
_Dose modifications_
Dose modification should be in 200 mg increments in a stepwise fashion
based on
individual tolerability in order to manage adverse reactions. The dose
of pazopanib
should not exceed 800 mg.
_Paediatric population_
Pazopanib should not be used in children younger than 2 years of age
because of
safety concerns on organ growth and maturation (see section 4.4 and
5.3).
The safety and efficacy of pazopanib in children aged 2 to 18 years of
age have not yet
been established (see section 5.1).
_Elderly_
There are limited data of the use of pazopanib in patients aged 65