Aciclovir 800mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ACICLOVIR

Available from:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC code:

J05AB01

INN (International Name):

ACICLOVIR 800 mg

Pharmaceutical form:

TABLET

Composition:

ACICLOVIR 800 mg

Prescription type:

POM

Therapeutic area:

ANTIVIRALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2006-08-18

Patient Information leaflet

1
PATIENT INFORMATION LEAFLET
ACICLOVIR 200MG, 400MG AND 800MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or your pharmacist.
-
This medicine has been prescribed only for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.If any of these side
effects gets serious, or if you
notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET
1.
What are Aciclovir Tablets and what are they used for
2.
Before you take Aciclovir Tablets
3.
How to take Aciclovir Tablets
4.
Possible side effects
5.
How to store Aciclovir Tablets
6.
Further information
1.
WHAT ARE ACICLOVIR TABLETS AND WHAT ARE THEY USED FOR
The name of your medicine is Aciclovir Tablets. This belongs to a
group pf medicines called
antivirals.
Aciclovir Tablets can be used:

to treat herpes and other viral infections caused by the herpes virus
(varicella zoster), such as
shingles

to prevent recurrent attacks of herpes simplex

to help prevent those who have low immune systems from getting herpes
infections.
Aciclovir Tablets should not be used to treat herpes simplex virus
(HSV) infections in newborns and
babies up to 3 months old or severe HSV infections in children with
low resistance to disease.
2.
BEFORE YOU TAKE ACICLOVIR TABLETS
DO NOT TAKE ACICLOVIR TABLETS AND TELL YOUR DOCTOR IF:

you are allergic (hypersensitive) to aciclovir, valaciclovir or any
other ingredients in this
medicine (see section 6: Further Information). An allergic reaction
can include a rash, itching or
shortness of breath.
Do not take this medicine if any of the above apply to you, talk to
your doctor or pharmacist before
taking Aciclovir Tablets.
TAKE SPECIAL CARE WITH ACICLOVIR TABLETS
Before you take Aciclovir Tablets tell your doctor if:

you are elderly

you have kidney problems

you are thirsty. You must make sure you drink

Summary of Product characteristics

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aciclovir 800mg_ _Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aciclovir PhEur 800mg
3
PHARMACEUTICAL FORM
Oral – tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of herpes simplex virus (HSV) infections of the skin and
mucous
membranes including initial and recurrent genital herpes (excluding
neonatal HSV and
severe HSV infections in immunocompromised children).
Suppression of recurrent herpes simplex virus infections.
Prevention of herpes simplex virus infections in immunocompromised
patients.
Treatment of herpes zoster infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_TREATMENT OF HERPES SIMPLEX INFECTIONS OF THE SKIN AND MUCOUS
MEMBRANES _
_INCLUDING INITIAL AND RECURRENT GENITAL HERPES _
_ _
_Adults: _200mg five times daily (usually every four hours while
awake), for five days.
In severe infections, duration of treatment may be extended. Aciclovir
is effective
only if started at the onset of symptoms.
_Renal impairment_: For patients with a creatinine clearance of less
than 10ml per
minute, reduce dosage to 200mg every 12 hours.
_Elderly: _dosage reduction may be required.
_ _
_Children aged two to fourteen years: _adult dose.
_ _
_Children under two years: _half the adult dose.
Page 2 of 8
_ _
_SUPPRESSION OF RECURRENT HERPES SIMPLEX INFECTIONS _
_ _
_Adults: _200mg four times daily or 400mg twice daily which can be
reduced to 200mg
two or three times daily. Therapy should be interrupted every six to
twelve months for
reassessment of the condition.
_Renal impairment:_ For patients with a creatinine clearance of less
than 10ml per
minute, reduce dosage to 200mg every 12 hours.
_Elderly: _dosage reduction may be required.
_Children aged two to fourteen years: _adult dose.
_Children under two years: _half the adult dose.
_PREVENTION OF HERPES SIMPLEX INFECTIONS IN IMMUNOCOMPROMISED PATIENTS
_
_Adults: _200mg four times daily for the duration of the period of
risk. In severely
immunocompromised patien