ACICLOVIR 5% Cream

BEFORE USE
READ ALL INFORMATION CAREFULLY
This is a self-medication medicine that you can use to treat mild and
transient disorders easily recognizable and resolvable without resorting to the help of the doctor.
It can therefore be purchased without a prescription but must be used correctly to ensure its effectiveness
and reduce side effects.

• for more information and advice, consult your pharmacist
• - consult your doctor if the disorder does not resolve after a short period of treatment

ACICLOVIR ALMUS PHARMA 5% cream
Generic medicine
WHAT IT IS
ACICLOVIR ALMUS PHARMA is an antiviral drug specific and selective with activity against
herpes viruses including herpes simplex virus.

WHY IT IS USED
ACICLOVIR ALMUS PHARMA is used for the treatment of herpes simplex virus infections
of the lips (herpes labialisrecurrent) in adults and adolescents (over 12 years of age).

WHEN IT SHOULD NOT BE USED
If you are allergic (hypersensitive) to the active ingredient or any of the excipients.
If you are allergic to valaciclovir.
Children under 12 years of age.

PRECAUTIONS FOR USE
The cream should only be applied to herpes simplex lesions on the lips; application to the mucous membranes, such as those of the mouth, eyes and nose, is not recommended, as it may cause
irritation.
Do not use the medicine to treat genital herpes.
Particular care should be taken to avoid accidental application to the eyes.
The use, especially if prolonged, of the product may lead to sensitization reactions, if this happens
stop treatment and consult your doctor.
It is recommended that people with particularly severe recurrent herpes labialis consult
the doctor.
It is recommended that those who suffer from herpes labialis avoid transmitting the virus in particular
when active lesions are present.

WHICH MEDICINES OR FOODS CAN MODIFY THE EFFECT OF THE
MEDICINE
Do not apply other types of dermatological products (such as cosmetics, sunscreens, cocoa butter) or medicines that treat herpes while using ACICLOVIR ALMUS PHARMA.
Ask your doctor or pharmacist for advice if you are taking or have recently taken other
medicines, including those without a prescription.

IT IS IMPORTANT TO KNOW THAT
When it can be used only after consulting a doctor
The use of ACICLOVIR ALMUS PHARMA is not recommended in severely
immunocompromised patients (patients with AIDS or patients with bone marrow transplant). It is advisable
that such patients consult their doctor regarding the treatment of herpes labialis and any other
infection.

What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
During pregnancy and/or breastfeeding ACICLOVIR ALMUS PHARMA should only be used after
consulting your doctor and evaluating with him the risk/benefit ratio in your case.
Consult your doctor if you suspect you are pregnant or wish to plan a pregnancy.

Important information about some excipients of ACICLOVIR ALMUS PHARMA
Methyl-parahydroxybenzoate contained in the medicine may cause allergic reactions (even
delayed).

Health education notes

Herpes labialis is contagious, so do not allow others to touch your lesions or to

use your personal items that could transmit the infection (e.g.

the towel).

After applying the cream, do not touch other parts of your body with your fingers, especially your eyes,

before washing your hands. Always wash your hands before and after touching the lesions.

Avoid touching your eyes. Herpes eye infection can lead to corneal ulcers.

Avoid kissing - especially children - when you have lesions.

Avoid breaking blisters and scratching scabs. Not only could you infect the lesions with other

germs, but you could also infect your fingers with the virus.

Avoid sharing glasses, cutlery, etc. with others.

HOW TO USE THIS MEDICINE
Q(Adults and adolescents over 12 years of age)
ACICLOVIR ALMUS PHARMA should be applied 5 times a day at intervals of about 4 hours during
the day, omitting the nighttime application. Take a small amount of cream and apply it
to the infected area.
Caution: do not exceed the indicated doses.
Children: ACICLOVIR ALMUS PHARMA is not recommended for children under 12 years of age
(see paragraph When it should not be used).

Q
Apply the cream every 4 hours during the day for at least 5 consecutive days. If healing
does not occur, treatment may be continued for another 5 days (up to a maximum of 10
days).
The maximum effectiveness of ACICLOVIR ALMUS PHARMA is achieved when the cream is used
promptly, at the beginning of the herpes lesion. For optimal results, it is advisable to apply the
cream at the first signs of herpes (tingling, redness, swelling or itching).

Consult your doctor if the disorder recurs or if you have noticed any recent change
in its characteristics.
Consult your doctor if symptoms persist after 10 days of treatment or worsen at any
time.
Take a small amount of cream and apply it to the infected area to cover the lesion.
Always wash your hands before and after applying the cream.
Avoid rubbing the lesions unnecessarily or touching them with a towel to avoid
worsening or spreading the infection.

WHAT TO DO IF YOU HAVE TAKEN TOO MUCH MEDICINE
If accidentally ingested, as the medicine is poorly absorbed, no adverse effects should occur.
In case of accidental ingestion/intake of an excessive dose of ACICLOVIR ALMUS
PHARMA, immediately notify your doctor or go to the nearest hospital.

WHAT TO DO IF YOU FORGET TO TAKE A DOSE OR MORE
If you forget to use the cream, apply it as soon as possible, then continue to use it
normally.

S’ACICLOVIR ALMUS PHARMA,
.

SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following convention has been used for the classification of side effects in terms of
frequency: very common ≥1/10, common ≥1/100 and <1/10, uncommon ≥1/1000 and <1/100, rare
≥1/10,000 and <1/1000, very rare <1/10,000.

Skin and subcutaneous tissue disorders
Uncommon: transient burning or pain after application, moderate dryness,
skin flaking and itching
Rare: erythema, contact dermatitis following application. Where sensitivity tests have been conducted,
reactivity phenomena have been shown to be related to the components
of the cream rather than to acyclovir.

Immune system disorders
Very rare: immediate hypersensitivity reactions including angioedema and urticaria

if any of the side effects worsen, or if you notice any other effect

EXPIRY DATE AND STORAGE
Keep ACICLOVIR ALMUS PHARMA out of the reach and sight of children.
Do not use the medicine after the expiry date which is reported on the label. The expiry date refers to the last day of the month.
Store at a temperature not exceeding 25°C.
Do not refrigerate.
After first opening the tube, the medicine must be used within 3 months; after this period, the remaining medicine must be discarded.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, so keep both the

COMPOSITION
One gram of cream contains:
Active ingredient: Aciclovir 50 mg
Excipients: Tefose 1500, Glycerin, Stearic acid, Liquid paraffin, Methyl-parahydroxybenzoate,
Purified water.

PRESENTATION
ACICLOVIR ALMUS PHARMA is presented in the form of a white and homogeneous cream. The contents
of the pack is 1 tube of 3 g of cream.

MARKETING AUTHORISATION HOLDER
Almus S.r.l. – Via Cesarea 11/10 – 16121 Genoa

MANUFACTURER
Special Product’s Line S.p.A. – Via Campobello 15 – 00040 Pomezia (RM)

DRUG
August 2011