Velpanat tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

sofosbuvir, velpatasvir

Available from:

Natco Pharma Limited-Pharma Division

ATC code:

J05AP55

INN (International Name):

sofosbuvir, velpatasvir

Dosage:

400mg+ 100mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28) plastic bottle

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-11-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SOFOSBUVIR AND VELPATASVIR TABLETS, 400 MG/100 MG
VELPANAT
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 Velpanat is and what it is used for
2.
What you need to know before you take Velpanat
3.
How to take Velpanat
4.
Possible side effects
5.
How to store Velpanat
6.
Contents of the pack and other information
1.
WHAT VELPANAT IS AND WHAT IT IS USED FOR
Velpanat is a medicine that contains the active substances sofosbuvir
and velpatasvir in a
single tablet. It is given to treat a chronic (long-term) viral
infection of the liver called
hepatitis C in adults of 18 years and older.
The active substances in this medicine work together by blocking two
different proteins that
the virus needs to grow and reproduce itself, allowing the infection
to be permanently
eliminated from the body.
Velpanat is sometimes taken with another medicine, ribavirin.
It is very important that you also read the leaflets for the other
medicines that you will be
taking with Velpanat. If you have any questions about your medicines,
please ask your doctor
or pharmacist.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VELPANAT
DO NOT TAKE VELPANAT

IF YOU ARE ALLERGIC to sofosbuvir, velpatasvir or any of the other
ingredients of this
medicine (listed in section 6 of

Summary of Product characteristics

NATCO PHARMA LIMITED – PHARMA DIVISION
VELPANAT 400 MG/100 MG
SUMMARY OF PRODUCT CHARACTERISTICS
VELPANAT 400 MG/100 MG
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
VELPANAT (Sofosbuvir and Velpatasvir Tablets, 400 mg/100 mg).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg sofosbuvir and 100 mg
velpatasvir.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Blue coloured, oval shaped, film coated tablets debossed with ‘S’
on one side and ‘V’ on other
side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Velpanat tablets are indicated for the treatment of chronic hepatitis
C virus (HCV) infection in
adults (see sections 4.2, 4.4 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Velpanat
treatment
should
be
initiated
and
monitored
by
a
physician
experienced
in
the
management of patients with HCV infection.
Posology
The recommended dose of Velpanat is one tablet, taken orally, once
daily with or without food
(see section 5.2).
TABLE 1: RECOMMENDED TREATMENT AND DURATION FOR ALL HCV GENOTYPES
PATIENT POPULATION
A
TREATMENT AND DURATION
Patients without cirrhosis and patients
with compensated cirrhosis
Velpanat
for 12 weeks
Addition of ribavirin may be considered for genotype 3 infected
patients with compensated cirrhosis (see section 5.1.)
Patients with decompensated cirrhosis
Velpanat
+ ribavirin for 12 weeks
a.
Includes patients co-infected with human immunodeficiency virus (HIV)
and patients with recurrent HCV post-
liver transplant (see section 4.4.)._ _
NATCO PHARMA LIMITED – PHARMA DIVISION
VELPANAT 400 MG/100 MG
When used in combination with ribavirin, refer also to the Summary of
Product Characteristics
of the medicinal product containing ribavirin.
The following dosing is re