Daklinza

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

daclatasvir dihydrochloride

Available from:

Bristol-Myers Squibb Pharma EEIG

ATC code:

J05AP07

INN (International Name):

daclatasvir

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

Hepatitis C, Chronic

Therapeutic indications:

Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1). For HCV genotype specific activity, see sections 4.4 and 5.1.,

Product summary:

Revision: 15

Authorization status:

Withdrawn

Authorization date:

2014-08-22

Patient Information leaflet

45
B. PACKAGE LEAFLET
Medicinal product no longer authorised
46
Package leaflet: Information for the patient
Daklinza 30 mg film-coated tablets
Daklinza 60 mg film-coated tablets
daclatasvir
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Daklinza is and what it is used for
2.
What you need to know before you take Daklinza
3.
How to take Daklinza
4.
Possible side effects
5.
How to store Daklinza
6.
Contents of the pack and other information
1.
What Daklinza is and what it is used for
Daklinza contains the active ingredient daclatasvir. It is used to
treat adults with hepatitis C, an
infectious disease that affects the liver, caused by the hepatitis C
virus.
This medicine works by stopping the hepatitis C virus from multiplying
and infecting new cells. This
lowers the amount of hepatitis C virus in your body and removes the
virus from your blood over a
period of time.
Daklinza must always be used together with other medicines against
hepatitis C infection and must
never be used by itself.
It is very important that you also read the package leaflets for the
other medicines that you will be
taking with Daklinza. If you have any questions about your medicines,
please ask your doctor or
pharmacist.
2.
What you need to know before you take Daklinza
Do not take Daklinza

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Daklinza 30 mg film-coated tablets
Daklinza 60 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Daklinza 30 mg film-coated tablets
Each film-coated tablet contains daclatasvir dihydrochloride
equivalent to 30 mg daclatasvir.
Daklinza 60 mg film-coated tablets
Each film-coated tablet contains daclatasvir dihydrochloride
equivalent to 60 mg daclatasvir.
Excipient(s) with known effect
Each 30-mg film-coated tablet contains 58 mg of lactose (as
anhydrous).
Each 60-mg film-coated tablet contains 116 mg of lactose (as
anhydrous).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Daklinza 30 mg film-coated tablets
Green biconvex pentagonal of dimensions 7.2 mm x 7.0 mm, debossed
tablet with "BMS" on one side
and "213" on the other side.
Daklinza 60 mg film-coated tablets
Light green biconvex pentagonal of dimensions 9.1 mm x 8.9 mm,
debossed tablet with "BMS" on one
side and "215" on the other side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Daklinza is indicated in combination with other medicinal products for
the treatment of chronic
hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and
5.1).
For HCV genotype specific activity, see sections 4.4 and 5.1.
4.2
Posology and method of administration
Treatment with Daklinza should be initiated and monitored by a
physician experienced in the
management of chronic hepatitis C.
Medicinal product no longer authorised
3
Posology
The recommended dose of Daklinza is 60 mg once daily, to be taken
orally with or without meals.
Daklinza must be administered in combination with other medicinal
products. The Summary of
Produ