Eltrombopag Synthon 25 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Synthon BV Microweg 22, 6545 CM Nijmegen, Netherlands

ATC code:

B02BX05

INN (International Name):

ELTROMBOPAG 25 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ELTROMBOPAG 25 mg

Prescription type:

POM

Therapeutic area:

ANTIHEMORRHAGICS

Authorization status:

Authorised

Authorization date:

2023-10-10

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ELTROMBOPAG SYNTHON 12.5 MG FILM-COATED TABLETS
ELTROMBOPAG SYNTHON 25 MG FILM-COATED TABLETS
ELTROMBOPAG SYNTHON 50 MG FILM-COATED TABLETS
ELTROMBOPAG SYNTHON 75 MG FILM-COATED TABLETS
eltrombopag
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 Eltrombopag Synthon is and what it is used for
2.
What you need to know before you take Eltrombopag Synthon
3.
How to take Eltrombopag Synthon
4.
Possible side effects
5.
How to store Eltrombopag Synthon
6.
Contents of the pack and other information
1
WHAT ELTROMBOPAG SYNTHON IS AND WHAT IT IS USED FOR
Eltrombopag Synthon contains eltrombopag, which belongs to a group of
medicines called
thrombopoietin-receptor agonists
_. _
It is used to help increase the number of platelets in your blood.
Platelets are blood cells that help to reduce or prevent bleeding.
Eltrombopag Synthon is used to treat a bleeding disorder called immune
(primary) thrombocytopenia
(ITP) in patients aged 1 year and above who have already taken other
medicines (corticosteroids or
immunoglobulins), which have not worked.
ITP is caused by a low blood platelet count (thrombocytopenia). People
with ITP have an increased
risk of bleeding. Symptoms patients with ITP may notice include
petechiae (pinpoint- sized flat round
red spots under the skin), bruising, nosebleeds, bleeding gums and not
being able to control bleeding
if they are cut or injured.
Eltrombopag Synthon can also be used to treat low platelet count
(thrombocytopen

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Eltrombopag Synthon 12.5 mg film-coated tablets
Eltrombopag Synthon 25 mg film-coated tablets
Eltrombopag Synthon 50 mg film-coated tablets
Eltrombopag Synthon 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Eltrombopag Synthon 12.5 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to
12.5 mg eltrombopag.
Eltrombopag Synthon 25 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 25
mg eltrombopag.
Eltrombopag Synthon 50 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 50
mg eltrombopag.
Eltrombopag Synthon 75 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 75
mg eltrombopag.
Excipient with known effect
Eltrombopag Synthon 12.5 mg film-coated tablets
Each film-coated tablet contains 29 mg of isomalt.
Eltrombopag Synthon 25 mg film-coated tablets
Each film-coated tablet contains 58 mg of isomalt.
Eltrombopag Synthon 50 mg film-coated tablets
Each film-coated tablet contains 117 mg of isomalt.
Eltrombopag Synthon 75 mg film-coated tablets
Each film-coated tablet contains 175 mg of isomalt.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Eltrombopag Synthon 12.5 mg film-coated tablets
Orange to brown, round, biconvex film-coated tablets with “I”
debossed on one side and with a diameter
of approximately 5.5 mm.
Eltrombopag Synthon 25 mg film-coated tablets
Dark pink, round, biconvex film-coated tablet with “II” debossed
on one side and with a diameter of
approximately 8 mm.
Eltrombopag Synthon 50 mg film-coated tablets
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Pink, round, biconvex film-coated tablet with “III” debossed on
one side and with a diameter of
approximately 10 mm.
Eltrombopag Synthon 75 mg film-coated tablets
Red to brown, round, biconvex film-coated tablet with “IV”
debossed on one side and with a diameter
of approxima