Daklinza 30 mg film-coated tablets

Country: European Union

Language: English

Source: myHealthbox

Active ingredient:

Daclatasvir Dihydrochloride

Available from:

Bristol-Myers Squibb Pharma EEIG

ATC code:

J05AX14

INN (International Name):

Daclatasvir

Dosage:

30 mg

Pharmaceutical form:

Film-coated tablet (tablet)

Administration route:

Oral use

Units in package:

28 (calendar pack), 28 x 1 tablet

Prescription type:

Subject to medical prescription

Manufactured by:

Bristol-Myers Squibb

Therapeutic group:

Direct-acting antiviral

Therapeutic area:

Hepatitis C, Chronic

Therapeutic indications:

Indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults

Authorization status:

A

Authorization date:

2014-08-22

Patient Information leaflet

65 
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

DAKLINZA 30 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 
pharma

Summary of Product characteristics

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 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains daclatasvir dihydrochloride
equivalent to 30 mg daclatasvir. 

Excipient(s) with known effect: 
Each 30-mg film-coated tablet contains 58 mg of lactose (as
anhydrous). 

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Film-coated tablet (tablet). 

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. 

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. 

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 
Product Characteristics for the other medicinal products in the
regimen should also be consulted 
before initiation of therapy with Daklinza. 

Recommended regimens and treatment duration are provided in Table 1
below (see sections 4.4 and 
5.1): 

3 
TABLE 1: RECOMMENDED REGIMENS AND TREATMENT DURATION FOR
DAKLINZA COMBINATION THERAPY 
HCV GENOTYPE AND PATIENT 
POPULATION* 
TREATMENT  
DURATION 
Genotype 1 or 4 with