Pazopanib Lotus 200 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PAZOPANIB

Available from:

Lotus Support Services S.R.L. 47 Theodor Pallady Blvd. 2nd Office, Entrance B, 1st Floor 3rd District Bucharest, Romania

ATC code:

L01EX03

INN (International Name):

PAZOPANIB 200 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

PAZOPANIB 200 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Withdrawn

Authorization date:

2021-03-22

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PAZOPANIB LOTUS 200 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 Pazopanib Lotus is and what it is used for
2.
What you need to know before you take Pazopanib Lotus
3.
How to take Pazopanib Lotus
4.
Possible side effects
5.
How to store Pazopanib Lotus
6.
Contents of the pack and other information
1.
WHAT PAZOPANIB LOTUS IS AND WHAT IT IS USED FOR
Pazopanib Lotus 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.
Pazopanib Lotus is used in adults to treat:
-
kidney cancer that is advanced or has spread to other organs.
-
certain forms of soft-tissue sarcoma, which is a type of cancer that
affects the supportive tissues
of the body. It can occur in muscles, blood vessels, fat tissue or
other tissues that support,
surround and protect the organs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PAZOPANIB LOTUS
DO NOT TAKE PAZOPANIB LOTUS
-
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.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Pazopanib Lotus:
-
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 ar

Summary of Product characteristics

Page 1 of 30
1.
NAME OF THE MEDICINAL PRODUCT
Pazopanib Lotus 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg pazopanib (as hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Capsule-shaped, pink, film-coated tablet (14.5 mm length and 5.6 mm
width) with “173” debossed on
one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Renal cell carcinoma (RCC)
Pazopanib Lotus 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)
Pazopanib Lotus 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
Pazopanib Lotus treatment should only be initiated by a physician
experienced in the administration
of anti-cancer medicinal products.
Posology
_Adults _
The recommended dose of pazopanib for the treatment of RCC or STS is
800 mg once daily.
_Dose modifications _
Dose modification (decrease or increase) should be in 200 mg
decrements or 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 with
regard to organ growth and maturation (see sections 4.4 and 5.3).
Page 2 of 30
The safety and efficacy of pazopanib in children aged 2 to 18 years of
age have not yet been
established. No data are available (see section 5.1).
_Elderly _
There are limited data on the use of pazopanib in patients