Aciclovir Almus Pharma

PACKAGE LEAFLET

BEFORE USE
READ CAREFULLY ALL THE INFORMATION CONTAINED IN THIS LEAFLET
This is a self-medication product that you can use to treat mild and transient disorders which are easily recognizable and resolvable without medical assistance.
It can therefore be purchased without a prescription, but must be used correctly to ensure its effectiveness and reduce unwanted effects.

• For further information and advice, consult your pharmacist
• Consult a doctor if the condition does not resolve after a short period of treatment

ACICLOVIR ALMUS PHARMA 5% cream
Generic medicine

WHAT IS IT?
ACICLOVIR ALMUS PHARMA is a specific and selective antiviral agent active against herpesviruses, including the herpes simplex virus.

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

WHEN IT MUST NOT BE USED
Do not use if you are allergic (hypersensitive) to the active substance or to any of the excipients.
Do not use if you are allergic to valaciclovir.
Not recommended for children under 12 years of age.

PRECAUTIONS FOR USE
The cream should be applied only to herpes simplex lesions present on the lips; application on mucous membranes such as those of the mouth, eyes, and nose is not recommended, as it may cause irritation.
Do not use this medicine for the treatment of genital herpes.
Particular care should be taken to avoid accidental application into the eyes.
Prolonged use of the product may lead to sensitization phenomena; if this occurs, discontinue treatment and consult your doctor.
Patients with particularly severe forms of recurrent herpes labialis are advised to consult a doctor.
Patients affected by herpes labialis should avoid transmitting the virus, especially when active lesions are present.

WHICH MEDICINES OR FOODS CAN AFFECT THE MEDICINE’S EFFECT?
Do not apply other types of dermatological products (such as cosmetics, sun-protective creams, lip balms) or antiviral treatments for herpes while using ACICLOVIR ALMUS PHARMA.
Ask your doctor or pharmacist for advice if you are currently using or have recently used any other medicines, including those without a prescription.

IMPORTANT INFORMATION

When use is only allowed after consulting a doctor
Use of ACICLOVIR ALMUS PHARMA is not recommended in severely immunocompromised patients (e.g. patients with AIDS or bone marrow transplant recipients). Such patients should consult their doctor regarding treatment of herpes labialis and any other infections.

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 be used only after consulting a doctor and evaluating the risk/benefit ratio in your individual case.
Consult your doctor if you suspect you are pregnant or if you plan to become pregnant.

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

Health education notes
Herpes labialis is contagious, so do not allow others to touch your lesions or use your personal items that could transmit the infection (e.g. towel).
After applying the cream, do not touch other parts of your body, especially your eyes, before washing your hands. Always wash your hands before and after touching the lesions.
Avoid touching your eyes. Herpes infection of the eyes may 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 other people.

HOW TO USE THIS MEDICINE
(Adults and adolescents over 12 years of age)
Apply ACICLOVIR ALMUS PHARMA five times daily at approximately 4-hour intervals during the day, omitting the nighttime application. Take a small amount of cream and apply it to the affected area.
Caution: Do not exceed the recommended doses.
Children: ACICLOVIR ALMUS PHARMA is not recommended for children under 12 years of age (see section When it must not be used).

HOW TO USE
Apply the cream every 4 hours during the day for at least 5 consecutive days. If healing has not occurred, treatment may continue for an additional 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 onset of the herpes lesion. For optimal results, apply the cream at the first signs of herpes (tingling, redness, swelling, or itching).
Consult your doctor if the condition recurs frequently or if you have noticed any recent changes 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 affected area to cover the lesion.
Always wash your hands before and after applying the cream.
Avoid unnecessarily rubbing the lesions or touching them with a towel, to prevent worsening or spreading of the infection.

WHAT TO DO IF YOU HAVE USED TOO MUCH MEDICINE
If accidentally ingested, since the medicine is poorly absorbed, no adverse effects are expected.
In case of accidental ingestion or overdose of ACICLOVIR ALMUS PHARMA, contact your doctor immediately or go to the nearest hospital.

WHAT TO DO IF YOU FORGET TO APPLY ONE OR MORE DOSES
If you forget to apply the cream, apply it as soon as possible, then continue using it as directed.

SIDE EFFECTS
Like all medicines, this product may cause side effects, although not everybody experiences them.
The following classification is used to describe the frequency of side effects:
Very common ≥1/10, common ≥1/100 and <1/10, uncommon ≥1/1,000 and <1/100, rare ≥1/10,000 and <1/1,000, very rare <1/10,000.

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

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

Following the instructions in this leaflet reduces the risk of side effects. If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

EXPIRY DATE AND STORAGE
Keep ACICLOVIR ALMUS PHARMA out of the reach and sight of children.
Do not use after the expiry date stated on the label. The expiry date refers to the last day of the month.
Store below 25°C.
Do not refrigerate.
After first opening, the medicine should be used within 3 months; after this period, any remaining medicine should be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.
It is important to always keep the packaging and the leaflet for future reference.

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

PRESENTATION
ACICLOVIR ALMUS PHARMA is presented as a white, homogeneous cream. The pack contains one 3 g tube.

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)
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY
August 2011