Valaciclovir Bluefish 500 mg film-coated tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Valaciclovir

Saatavilla:

Bluefish Pharmaceuticals AB

ATC-koodi:

J05AB; J05AB11

INN (Kansainvälinen yleisnimi):

Valaciclovir

Annos:

500 milligram(s)

Lääkemuoto:

Film-coated tablet

Prescription tyyppi:

Product subject to prescription which may not be renewed (A)

Terapeuttinen alue:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; valaciclovir

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2009-08-28

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
VALACICLOVIR BLUEFISH 500 MG FILM-COATED TABLETS
valaciclovir
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Valaciclovir Bluefish is and what it is used for
_ _
2.
What you need to know before you take Valaciclovir Bluefish
_ _
3.
How to take Valaciclovir Bluefish
_ _
4.
Possible side effects
_ _
5.
How to store Valaciclovir Bluefish
_ _
6.
Contents of the pack and other information
_ _
1. WHAT VALACICLOVIR BLUEFISH IS AND WHAT IT IS USED FOR
Valaciclovir Bluefish belongs to a group of medicines called
antivirals. It works by killing or stopping
the growth of viruses called herpes simplex (HSV), varicella zoster
(VZV) and cytomegalovirus
(CMV).
Valaciclovir Bluefish can be used to:
•
treat shingles (in adults)
•
treat HSV infections of the skin and genital herpes (in adults and
adolescents over 12 years
old). It is also used to help prevent these infections from returning.
•
treat cold sores (in adults and adolescents over 12 years old)
•
prevent infection with CMV after organ transplants (in adults and
adolescents over 12 years
old)
•
treat and prevent HSV infections of the eye
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALACICLOVIR BLUEFISH
DON’T TAKE VALACICLOVIR BLUEFISH
•
If you are allergic (hypersensitive) to valaciclovir or aciclovir or
any of the other ingredients of
this medicine (listed in Section 6).
•
If you have ever developed an extended rash associated with fever,
enlarged lymph node,
increased levels of liver enzy

Valmisteyhteenveto

Health Products Regulatory Authority
26 January 2023
CRN00DCP5
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valaciclovir Bluefish 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains valaciclovir hydrochloride
monohydrate equivalent to 500 mg valaciclovir.
Excipients with known effect:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, capsule-shaped, biconvex, film-coated tablets. The tablets are
embossed 'V' on one side and '500' on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Varicella zoster virus (VZV) infections – herpes zoster_
Valaciclovir Bluefish is indicated
for the treatment of herpes zoster (shingles) and ophthalmic zoster in
immunocompetent adults (see sections 4.4).
Valaciclovir Bluefish is indicated for the treatment of herpes zoster
in adult patients with mild or moderate immunosuppression
(see section 4.4).
_Herpes simplex virus (HSV) infections_
Valaciclovir Bluefish is indicated
● for the treatment and suppression of HSV infections of the skin
and mucous membranes including
- treatment of first-episode of genital herpes in immunocompetent
adults and adolescents and in
immunocompromised adults
- treatment of recurrences of genital herpes in immunocompetent adults
and adolescents, and in
immunocompromised adults
- suppression of recurrent genital herpes in immunocompetent adults
and adolescents and in
immunocompromised adults
● Treatment and suppression of recurrent ocular HSV infections (see
section 4.4)
Clinical studies have not been conducted in HSV-infected patients
immunocompromised for other causes than HIV-infection
(see section 5.1).
_Cytomegalovirus (CMV) infections_:
Valaciclovir Bluefish is indicated for the prophylaxis of CMV
infection and disease following solid organ transplantation in
adults and adolescents (see section 4.4)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Health Products Regulatory Authority
26 January 2023
CRN00