Valganciclovir 450mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Valganciclovir hydrochloride

Available from:

Zentiva Pharma UK Ltd

ATC code:

J05AB14

INN (International Name):

Valganciclovir hydrochloride

Dosage:

450mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05030202; GTIN: 5000283658429

Patient Information leaflet

Package leaflet: Information for the user
Valganciclovir 450 mg film-coated tablets
valganciclovir
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 valganciclovir is and what it is used for
2. What you need to know before you take valganciclovir
3. How to take valganciclovir
4. Possible side effects
5. How to store valganciclovir
6. Contents of the pack and other information
1. What valganciclovir is and what it is used for
The name of your medicine is Valganciclovir 450 mg film-coated tablets
(referred to as valganciclovir throughout this leaflet).
Valganciclovir belongs to a group of medicines, which work directly to
prevent
the growth of viruses. In the body the active ingredient in the
tablets,
valganciclovir, is changed into ganciclovir. Ganciclovir prevents a
virus called
cytomegalovirus (CMV) from multiplying and invading healthy cells. In
patients
with a weakened immune system, CMV can cause an infection in the
body's
organs. This can be life threatening.
Valganciclovir is used:
•
for the treatment of CMV-infections of the retina of the eye in adult
patients
with acquired immunodeficiency syndrome (AIDS). CMV-infection of the
retina of the eye can cause vision problems and even blindness.
•
to prevent CMV-infections in adults and children who are not infected
with
CMV and who have received an organ transplant from somebody who was
infected by CMV.
2. What you need to know before you take valganciclovir
Do not take valganciclovir
- If you are allergic to valganciclovir, ganciclovir or

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Valganciclovir 450 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 496.3 mg of valganciclovir
hydrochloride equivalent to
450 mg of valganciclovir (as free base).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Oval, biconvex, pink colored film-coated tablets approx16.83 x 7.95
mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Valganciclovir is indicated for the induction and maintenance
treatment of cytomegalovirus
(CMV) retinitis in adult patients with acquired immunodeficiency
syndrome (AIDS).
Valganciclovir is indicated for the prevention of CMV disease in
CMV-negative adults and
children (aged from birth to 18 years) who have received a solid organ
transplant from a
CMV-positive donor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CAUTION – STRICT ADHERENCE TO DOSAGE RECOMMENDATIONS IS ESSENTIAL TO
AVOID OVERDOSE
(SEE SECTIONS 4.4 AND 4.9).
Valganciclovir is rapidly and extensively metabolised to ganciclovir
after oral dosing. Oral
valganciclovir 900 mg b.i.d. is therapeutically equivalent to
intravenous ganciclovir 5 mg/kg
b.i.d.
TREATMENT OF CYTOMEGALOVIRUS (CMV) RETINITIS
_ _
_Adult patients _
_Induction treatment of CMV retinitis: _
For patients with active CMV retinitis, the recommended dose is 900 mg
valganciclovir (two
Valganciclovir 450 mg tablets) twice a day for 21 days and, whenever
possible, taken with
food. Prolonged induction treatment may increase the risk of bone
marrow toxicity (see
section 4.4).
_Maintenance treatment of CMV retinitis: _
Following induction treatment, or in patients with inactive CMV
retinitis, the recommended
dose is 900 mg valganciclovir (two Valganciclovir 450 mg tablets) once
daily
and, whenever possible, taken with food. Patients whose retinitis
worsens may repeat
induction treatment; however, consideration should be given to the
possibility of viral drug
resistance.
The duration of maintenance treatment should be determined on a