Hascovir pro

Package leaflet: Information for the patient

HASCOVIR pro, 50 mg/g, cream
Aciclovirum
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 10 days, or if you feel worse, consult your doctor.

Table of contents

1. What Hascovir pro is and what it is used for
2. Important information before using Hascovir pro
3. How to use Hascovir pro
4. Possible side effects
5. How to store Hascovir pro
6. Contents of the pack and other information

1. What Hascovir pro is and what it is used for

Hascovir pro, cream contains the active substance aciclovir. When applied to the skin, aciclovir
exerts a strong antiviral effect against herpes simplex virus (Herpes simplex).
Indications
Hascovir pro is used in the local treatment of symptoms of cold sores (so-called "fever blisters")
and herpes lesions on the face caused by the herpes simplex virus (Herpes simplex).

2. Important information before using Hascovir pro

When not to use Hascovir pro

• if the patient is allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Hascovir pro, discuss this with your doctor or pharmacist.
This medicine must not be applied to the mucous membranes of the mouth or into the eyes, as it may cause irritation.
The medicine should be applied only to herpes lesions located on the lips and face.
It should not be used on mucous membranes or for the treatment of genital herpes.
Care must be taken to avoid contact of the medicine with the eyes.
If a particularly severe recurrent herpes labialis occurs, medical advice should be sought.
Patients with weakened immune systems should not use this medicine without consulting a doctor.
During treatment, do not scrape off blisters or scabs, or otherwise damage them, especially when washing and drying the skin.
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To reduce the risk of spreading infection, avoid allowing other people to touch the herpes lesions, and do not share towels, etc.

Hascovir pro and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
No interactions with other medicines or other types of interactions are known.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.

Driving and operating machinery
This medicine has no effect on the ability to drive or operate machinery.

Hascovir pro contains propylene glycol (E 1520)
The medicine contains 100 mg of propylene glycol in each gram of cream.

Hascovir pro contains cetostearyl alcohol
The medicine contains 67.5 mg of cetostearyl alcohol in each gram of cream.
The medicine may cause local skin reactions (e.g. contact dermatitis).

Hascovir pro contains sodium lauryl sulphate
The medicine contains 7.5 mg of sodium lauryl sulphate in each gram of cream. Sodium lauryl sulphate may cause local skin irritation (such as stinging or burning) or worsen skin reactions caused by other medicines applied to the same area of skin.

3. How to use Hascovir pro

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for topical application on the skin.
Herpes lesions and the surrounding area should be gently applied with a small amount of the medicine 5 times daily (every 4 hours).
It is best to start treatment at the first signs of infection (such as itching, burning, or tingling sensation). Immediate application of the medicine during a recurrence may completely prevent the development of the infection.
To prevent spreading the infection to other areas of the skin, hands should be washed before and after applying the medicine.
Treatment should last for 5 days. If symptoms have not resolved after this period, treatment may be extended for another 5 days. If symptoms persist after 10 days, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
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The medicine must be discontinued and immediate medical advice sought if any of the following symptoms occur (reported frequency: very rare):

• allergic reaction causing swelling, which may affect the hands and feet, face, lips, tongue, throat, and cause difficulty breathing or swallowing (so-called angioedema).

Common (affects 1 to 10 people in 100):

• mild skin dryness or peeling.

Uncommon (affects 1 to 10 people in 1,000):

• transient burning or tingling sensation;
• itching.

Rare (affects 1 to 10 people in 10,000):

• redness (erythema);
• contact dermatitis following application of the medicine.

Very rare (affects less than 1 person in 10,000):

• sudden hypersensitivity reactions, including severe reactions such as angioedema.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Hascovir pro

Store below 25 °C. Keep the tube tightly closed.
Do not store below 15 °C. Do not store in a refrigerator or freeze.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the package and other information

What Hascovir pro contains

• The active substance is aciclovir. 1 g of cream contains 50 mg of aciclovir.
• The other ingredients (excipients) are: propylene glycol (E 1520), poloxamer 407, cetearyl alcohol, sodium lauryl sulfate, light liquid paraffin, white soft paraffin, purified water.

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What Hascovir pro looks like and contents of the pack
Hascovir pro is a white cream.
One package contains 5 g of cream.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Drug Information
tel.: (22) 742 00 22
e-mail: [email protected]
Date of latest revision of the leaflet:
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