Aciclovir 200mg dispersible tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-10-2017
Summary of Product characteristics
(SPC)
13-11-2017
Active ingredient:
Aciclovir
Available from:
Waymade Healthcare Plc
ATC code:
J05AB01
INN (International Name):
Aciclovir
Dosage:
200mg
Pharmaceutical form:
Dispersible tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 05030201
Patient Information leaflet
Aciclovir 200mg and 400mg Dispersible Tablets (referred to
as Aciclovir throughout this leaflet) belongs to a group of
medicines called anti-virals.
Aciclovir can be used:
§
to treat herpes simplex infections of the skin and
mucous membranes e.g. cold sores and genital herpes
(EXCLUDING newborn babies and children with low
immune systems and severe herpes simplex infections)
§
to prevent recurrent attacks of herpes simplex
§
to help prevent those who have low immune systems
from getting herpes infections
§
to treat chicken pox (varicella infection) and shingles
(herpes zoster infection)
DO NOT TAKE ACICLOVIR:
If you are allergic (hypersensitive) to aciclovir, valaciclovir
or any of the other ingredients in these tablets (see Section
6 "Contents of the pack and other information")
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE TAKING ACICLOVIR:
§
If you are taking other nephrotoxic medicines
(medicines that may cause kidney failure) such as
cyclosporin and tacrolimus (See "Other medicines and
Aciclovir" section)
§
If you suffer from kidney problems [including if you have
dialysis therapy] (as you may need a lower dose of
aciclovir - see Section 3 "How to take aciclovir")
§
if you are elderly (as you may need a lower dose of
aciclovir - see Section 3 "How to take aciclovir")
§
if you have a severely low immune system and need to
have this medicine over a long period of time or in
repeated doses .
OTHER MEDICINES AND ACICLOVIR
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines, including
medicines obtained without a prescription. This includes
herbal medicines.
Medicines which MAY INTERACT with Aciclovir:
§
Probenecid (used to treat gout)
§
Cimetidine (used to reduce stomach acid)
§
Mycophenolate mofetil (used to prevent transplant
rejection)
§
Medicines which may affect the kidneys e.g.
cyclosporin, tacrolimus (nephrotoxic medicines)
§
Theophylline (used to treat breathing problems, such as
asthma)
ACICLOVIR WITH FOOD AND DRINK
It is important t
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aciclovir 200mg Dispersible Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Aciclovir 200 mg
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Dispersible tablet
A white or almost white, round, convex tablet of 9.5mm diameter,
coded:
HF
200
on one side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of herpes simplex 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 infections. Prevention of herpes simplex
infections in
immunocompromised
patients.
Treatment
of
herpes
zoster
infections.
Treatment of varicella (chickenpox) infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Aciclovir Dispersible Tablets may be dispersed in a minimum of 50 ml
of
water or swallowed whole with a little water. Ensure that patients on
high
doses of aciclovir are adequately hydrated.
Dosage in adults
_Treatment of herpes simplex infections: _
200 mg should be taken five times daily at approximately four hourly
intervals
omitting the night time dose. Treatment should continue for 5 days,
but in
severe initial infections this may have to be extended.
In severely immunocompromised patients (e.g. after marrow transplant)
or in
patients with impaired absorption from the gut the dose can be doubled
to 400
mg or alternatively intravenous dosing could be considered.
Dosing should begin as early as possible after the start of an
infection; for
recurrent episodes this should preferably be during the prodromal
period or
when lesions first appear.
_Suppression of herpes simplex infections in immunocompetent patients:
_
200 mg should be taken four times daily at approximately six-hourly
intervals.
Many patients may be conveniently managed on a regimen of 400 mg twice
daily at approximately twelve-hourly intervals.
Dosage titration down to 200 mg taken thrice daily at ap
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