Viralief 50 mg/g Cream

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

ACICLOVIR

Доступна з:

Clonmel Healthcare Ltd

Код атс:

D06BB; D06BB03

ІПН (Міжнародна Ім'я):

ACICLOVIR

Дозування:

50 milligram(s)/gram

Фармацевтична форма:

Cream

Тип рецепту:

Product not subject to medical prescription

Терапевтична области:

Antivirals; aciclovir

Статус Авторизація:

Marketed

Дата Авторизація:

1998-11-27

інформаційний буклет

Page 1 of 3
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIRALIEF 50MG/G CREAM
aciclovir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effect
not listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel
worse after 14 days.
WHAT IS IN THIS LEAFLET
1. What Viralief 50 mg/g cream is and what it is used for
2. What you need to know before you use Viralief 50 mg/g cream
3. How to use Viralief 50 mg/g cream
4. Possible side effects
5. How to store Viralief 50 mg/g cream
6. Contents of the pack and other information
1. WHAT VIRALIEF 50 MG/G CREAM IS AND WHAT IT IS USED FOR
Viralief 50 mg/g cream is a medicine against viral infections
(antiviral agents).
VIRALIEF 50 MG/G CREAM IS USED FOR

the treatment of cold sores caused by _Herpes simplex _virus.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VIRALIEF 50 MG/G CREAM
DO NOT USE VIRALIEF 50 MG/G CREAM

if you are allergic to aciclovir, valaciclovir or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Viralief 50 mg/g cream
if you have or in the past have
had any medical conditions or illnesses, especially

severe deficiency of the immune system, e.g.
-
AIDS patients
-
people who have received a bone marrow transplant.
In this case, your doctor may decide to prescribe you tablets instead.

You should not use Viralief 50 mg/g cream on mucous membranes (e.g. in
the mouth, eye or vagina)
to avoid local irritation. Accidental eye contact must also be
prevented

If your immune system is seriously weakened talk to your doctor about
the

Характеристики продукта

Health Products Regulatory Authority
06 February 2020
CRN0098T8
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Viralief 50 mg/g Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 50 mg aciclovir.
Excipient(s) with known effect
Each gram of cream contains 150 mg propylene glycol (E1520) and 15 mg
cetyl alcohol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
White to off-white cream
4 CLINICAL PARTICULARS
Treatment of cold sores caused by herpes simplex virus.
4.1 THERAPEUTIC INDICATIONS
Treatment of cold sores caused by herpes simplex virus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Viralief 50 mg/g cream should be applied to infected lips 5 times
daily at approximately 4 hourly intervals, omitting the night
time application.
Viralief 50 mg/g cream should be applied to the lesions or impending
lesions as early as possible after the start of an infection.
Treatment should be continued for 5 days. If, after 5 days, healing is
not complete then treatment can be continued for up to
an additional 5 days.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance, to valaciclovir or to any of
the excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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.
In severely immune-compromised patients (e.g. 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.
Excipients
The excipient cetyl alcohol may cause local skin reactions (e.g.
contact dermatitis).
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
No clinically significant interactions have been identified.
Health Products Regulatory Authority
06 February 2020
CRN0098T8
Page 2 of 4
4.