Aciclovir 5% cream

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Aciclovir

Beszerezhető a:

A A H Pharmaceuticals Ltd

ATC-kód:

D06BB03

INN (nemzetközi neve):

Aciclovir

Adagolás:

50mg/1gram

Gyógyszerészeti forma:

Cutaneous cream

Az alkalmazás módja:

Cutaneous

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 13100300; GTIN: 5037563005468 5037563003204

Betegtájékoztató

ACICLOVIR CREAM 5%
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
Ask your doctor or pharmacist if you need more information or advice.
•
You must contact a doctor if your symptoms worsen or do not improve.
•
If you have any unusual effects after using this product, tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
WHAT IS ACICLOVIR CREAM IS AND WHAT IS IT USED FOR?
2.
BEFORE YOU USE ACICLOVIR CREAM
3.
HOW TO USE ACICLOVIR CREAM
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ACICLOVIR CREAM
6.
FURTHER INFORMATION
1.
WHAT IS ACICLOVIR CREAM AND WHAT IS IT USED FOR?
Aciclovir cream is used in the treatment of genital herpes and cold
sores. Once genital herpes or a cold sore has appeared,
treatment with Aciclovir cream can accelerate the healing process.
The active substance in Aciclovir cream is aciclovir. Aciclovir is an
antiviral agent that has been shown to be effective in
treating infections caused by the herpes simplex virus, such as
genital herpes and cold sores.
2.
BEFORE YOU USE ACICLOVIR CREAM
DO NOT USE ACICLOVIR CREAM AND TELL YOUR DOCTOR:
•
If you are
ALLERGIC
(hypersensitive)
TO ACICLOVIR, VALACICLOVIR
or
ANY OF THE OTHER INGREDIENTS
OF ACICLOVIR CREAM
(listed in section 6, Further Information). Cetyl alcohol, propylene
glycol or sorbic acid may cause local skin
reactions or irritation (e.g. contact dermatitis).
•
In the eyes,
INSIDE
the mouth or genitals.
CHECK WITH YOUR DOCTOR OR PHARMACIST BEFORE USING ACICLOVIR CREAM IF:
•
Your
IMMUNE SYSTEM
is not working properly (for instance you have had a bone marrow
transplant or you have
AIDS).
TAKING OTHER MEDICINES:
Please
TELL YOUR DOCTOR OR PHARMACIST
if you are taking or have recently taken any other medicines,
including medicines obtained
without a prescription. This is especially important if you are
taking:
•
Probenecid (used for gout).
PREGNANCY AND BREAST-FEEDING:
As with all medicines, Aciclovir cream should not be used during
pregnancy or brea

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ACICLOVIR CREAM 5%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains 5% w/w Aciclovir PhEur.
3.
PHARMACEUTICAL FORM
White to off-white cream.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
1) Treatment of herpes simplex virus infections of the skin including
initial
and recurrent genital herpes and herpes labialis.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Aciclovir Cream should be applied to the lesion or impending lesion as
early
as possible after the start of an infection. It is particularly
important to start
treatment of recurrent episodes during the prodromal period or when
lesions
first appear.
_Adults_ (_including elderly_): Aciclovir Cream should be applied five
times daily
at approximately four hourly intervals, omitting the night time
application.
Treatment should be continued for five days. If, after five days,
healing is not
complete then treatment can be continued for up to an additional five
days.
4.3
CONTRA-INDICATIONS
Aciclovir cream is contraindicated in patients known to be
hypersensitive to aciclovir,
valaciclovir, propylene glycol or any of the excipients of aciclovir
cream.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In severely immunocompromised patients (_eg _AIDS patients or bone
marrow
transplant recipients) oral Aciclovir dosing should be considered.
Such patients
should be encouraged to consult a physician concerning the treatment
of any
infection. Aciclovir Cream is
not recommended for application to mucous membranes such as in the
mouth, eye or
vagina, as it may be irritant.
Particular care should be taken to avoid accidental introduction into
the eye. Largely
reversible adverse effects on spermatogenesis in association with
overall toxicity in
rats and dogs have been reported only at doses of Aciclovir greatly in
excess of those
employed therapeutically. There has been no experience of the effect
of Aciclovir
Cream on human fertility. Two generation studies in mice did not
reveal any effect of
(orally admi