ZOVIRAX TABLETS 200 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ACICLOVIR

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

D06BB03

Pharmaceutical form:

TABLETS

Composition:

ACICLOVIR 200 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

GLAXO SMITHKLINE TRADING SERVICES LIMITED, IRELAND

Therapeutic group:

ACICLOVIR

Therapeutic area:

ACICLOVIR

Therapeutic indications:

•Zovirax Tablets are indicated for the treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding neonatal HSV and severe HSV infections in immunocompromised children).•Zovirax Tablets are indicated for the suppression (prevention of recurrences) of recurrent herpes simplex infections in immunocompetent patients.•Zovirax Tablets are indicated for the prophylaxis of herpes simplex infections in immunocompromised patients.•Zovirax Tablets are indicated for the treatment of varicella (chickenpox) and herpes zoster (shingles) infections

Authorization date:

2022-08-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician’s prescription
only
Zovirax Tablets 200 mg
Zovirax Tablets 400 mg
Zovirax Tablets Dispersible 800 mg
Zovirax Tablets 200 mg – each tablet contains aciclovir 200 mg
Zovirax Tablets 400 mg – each tablet contains aciclovir 400 mg
Zovirax Tablets Dispersible 800 mg – each tablet contains aciclovir
800 mg
For the list of inactive and allergenic ingredients in the medicine,
see section 2 –
"Important information about some of the ingredients in the medicine"
and section 6 –
"Additional information".
Read the leaflet carefully in its entirety before using the medicine.
This leaflet contains
concise information about the medicine. If you have further questions,
refer to the
physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them even if it seems to you that their medical condition is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Zovirax Tablets (called 'Zovirax' in this leaflet) contains a medicine
called aciclovir. It
works by killing or stopping the growth of viruses.
Zovirax can be used to:
200 mg, 400 mg and 800 mg tablets:
•
treat chickenpox and shingles
200 mg and 400 mg tablets:
•
treat cold sores, genital herpes and other herpes simplex infections
•
prevent recurrence of herpes simplex infections in patients with a
normal immune
system
•
prevent herpes simplex infections in people whose immune system is not
functioning
so well, which means their bodies are less capable of fighting
infections
Therapeutic group:
Antiviral.
2.
BEFORE USING THE MEDICINE
Do not use the medicine if:
•
you are sensitive (allergic) to aciclovir or valaciclovir or to any of
the additional
ingredients contained in this medicine (listed in section 6).
Do not take Zovirax if the above applies to you. If you are not sure,
refer to your
physician or pharmacist before taking Zovirax.
Special warnings regarding use of the me

Summary of Product characteristics

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ZOVIRAX TABLETS 200 MG
ZOVIRAX TABLETS 400 MG
ZOVIRAX TABLETS DISPERSIBLE 800 MG
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Zovirax Tablets 200 mg.
Zovirax Tablets 400 mg.
Zovirax Tablets Dispersible 800 mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zovirax Tablets 200 mg - Aciclovir 200 mg
Zovirax Tablets 400 mg - Aciclovir 400 mg
Zovirax Tablets Dispersible 800 mg - Aciclovir 800 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Zovirax Tablets 200 mg –
are white, round, biconvex tablets which are branded “GXCL3” on
one side and plain on the other.
Zovirax Tablets 400 mg –
are white, shield shaped tablets which are branded “GXCM1” on one
side and plain on the other.
Zovirax Tablets Dispersible 800 mg -
are white film-coated oval biconvex tablets, branded
“GXCG1” on one side and plain on the other.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
ZOVIRAX TABLETS 200MG,
ZOVIRAX TABLETS 400MG:
Zovirax Tablets are indicated for the treatment of herpes simplex
virus infections of the skin
and mucous membranes including initial and recurrent genital herpes
(excluding
neonatal
HSV and severe HSV infections in immunocompromised children)
.
Zovirax Tablets are indicated for the suppression (prevention of
recurrences) of recurrent
herpes simplex infections in immunocompetent patients.
Zovirax Tablets are indicated for the prophylaxis of herpes simplex
infections in
immunocompromised patients.
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2
of
11
Zovirax Tablets are indicated for the treatment of varicella
(chickenpox) and herpes zoster
(shingles) infections.
ZOVIRAX TABLETS DISPERSIBLE 800 MG:
Zovirax tablets 800 mg are indicated for the treatment of varicella
(chickenpox) and herpes
zoster (shingles) infections
(excluding neonatal HSV and severe HSV infections in
immunocompromised children)
.
Zovirax 800mg tablets is recommended in children over the age of 6.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
Zovirax 800mg tablets may be dispersed in a minimum of 50 ml of water
or swa