Acic Cold Sore 5% w/w Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Aciclovir

Available from:

Rowex Ltd

ATC code:

D06BB; D06BB03

INN (International Name):

Aciclovir

Dosage:

5 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antivirals; aciclovir

Authorization status:

Marketed

Authorization date:

2012-11-23

Patient Information leaflet

1
WHAT ACIC IS AND WHAT IT IS
USED FOR
The name of your medicine is Acic. This belongs to
a group of medicines that treat viral infections.
Acic is used to treat cold sores. These are caused
by the herpes simplex virus.
2
WHAT YOU NEED TO KNOW
BEFORE YOU USE ACIC
DO NOT USE ACIC:
−
if you are allergic to aciclovir, valaciclovir or any
of the other ingredients of this medicine (listed
in Section 6).
−
on sores inside your mouth, on the eyes or on
your genitals.
Do not use Acic if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist
before using Acic.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Acic
if you have any problems which might weaken your
immune system or if you have severe cold sores.
CHILDREN AND ADOLESCENTS
As for adults
OTHER MEDICINES AND ACIC
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
•
Acic should not affect any other medicines you
are taking by mouth.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
any medicine.
DRIVING AND USING MACHINES
This medicine is unlikely to affect you being able to
drive or use any tools or machines. However, you
should wait to see how Acic affects you before you
try these activities.
ACIC CONTAINS:
•
Cetyl alcohol: May cause skin reactions where
you apply the cream such as dermatitis.
•
300 mg of propylene glycol in each 2 g tube
which is equivalent to 150 mg/g of cream.
3
HOW TO USE ACIC
Always use this medicine exactly as described in
this leaflet or as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you
are not sure.
ADULTS AND CHILDREN:
•
Start using the cream when you get the first signs
of infection. You may see skin blisters or be able
to recognise the tingle sensation that means that
a blister will appear soon.
•
Spread a thin layer of cream onto the cold sore
about

Summary of Product characteristics

Health Products Regulatory Authority
25 November 2021
CRN00C6K4
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acic Cold Sore 5% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1g contains 50mg aciclovir
Excipients with known effect:
Contains Propylene Glycol 15% and Cetyl Alcohol 1.5%
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream
A white to off-white creamy mass
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ACIC Cold Sore 5% w/w Cream is indicated for the treatment of Herpes
simplex virus infections of the skin, lips and face
(recurrent herpes labialis).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION: Cutaneous
RECOMMENDED DOSAGE SCHEDULE:
Adults:
ACIC Cream should be applied five times daily at approximately
four-hourly intervals omitting the night time application.
Treatment should be continued for at least 4 days. If healing has not
occurred treatment may be continued for up to 10 days. If
lesions are still present after 10 days users should be advised to
consult a doctor.
ACIC Cream should be applied as soon as possible, preferably during
the earliest stages (prodrome or erythema). Treatment
can also be started during the later (papule or blister) stages.
Children:
Children should use the adult dose.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance, valaciclovir, propylene
glycol or to any of the excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Acic Cream should only be used on cold sores on the lips and face. It
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 contact with the
eye.
In severely immune-compromised patients (e.g. AIDS patients or bone
marrow transplant recipients) oral dosing should be
considered. Such patients should be encouraged to consult a physician
concerning the treatment of any infection.
Health Products Regulatory Authority
25 November 2021