Herpex

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Herpex(Acic Creme), 50 mg/g, cream
Aciclovirum
Herpex and Acic Creme are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains

important information for the patient.
This drug should always be used in accordance with the description in the patient leaflet or as directed by a doctor
or pharmacist. You should keep this leaflet so that you can read it again if necessary.

• You should consult a pharmacist if you need advice or additional information.
• If any side effects occur, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. If after 10 days there is no improvement or the patient feels worse, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Herpex and what is it used for
• 2. Important information before using Herpex
• 3. How to use Herpex
• 4. Possible side effects
• 5. How to store Herpex
• 6. Package contents and other information

1. What is Herpex and what is it used for

Herpex is a cream for topical use. It contains the active substance acyclovir - an antiviral drug.
Acyclovir acts strongly against herpes viruses Herpes simplex(HSV) type 1 and 2 and against chickenpox and shingles viruses Varicella-Zoster(VZV).
Herpex used topically on a small area of skin does not have a systemic effect.

Indications:

Herpex is used topically to treat skin infections (cold sores and genital herpes) caused by the herpes simplex virus type 1 and 2.

2. Important information before using Herpex

When not to use Herpex

• If the patient is allergic (hypersensitive) to acyclovir, valacyclovir, propylene glycol, or any of the other ingredients of Herpex.

Warnings and precautions

• The drug should not be applied to mucous membranes (e.g., mouth, eyes, or vagina) due to the risk of irritation.
• Eye contact with the drug should be avoided.
• Using Herpex on the genitals and around the anus may reduce the durability of latex condoms. Petrolatum and white wax contained in Herpex may reduce the safety of using condoms.
• Patients with severe immune system disorders (e.g., patients infected with HIV or after bone marrow transplantation) should consult a doctor before starting Herpex. The doctor may recommend taking acyclovir orally.

You should consult a doctor, even if the above warnings refer to situations that have occurred in the past.

Other drugs and Herpex

In case of doubt, you should inform your doctor or pharmacist about all drugs currently being taken or recently taken, as well as drugs planned to be used, even those available without a prescription.
Important interactions with other drugs are not known.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if there is a suspicion that the woman is pregnant, or if she plans to become pregnant, before using this drug, you should consult a doctor or pharmacist.
Herpex can be used during pregnancy only if, in the doctor's opinion, the benefit of using the drug by the mother outweighs the potential risk to the child.
Acyclovir may pass into breast milk, but the dose received by the infant from breast milk of a mother using acyclovir cream is negligible.

Driving and operating machines

Using Herpex does not affect the ability to drive vehicles and operate machines.

Herpex contains propylene glycol and cetyl alcohol

The drug contains 150 mg of propylene glycol in 1 g of cream. Propylene glycol may cause skin irritation. This drug should not be used in children under 4 weeks of age on open wounds or large areas of injured or damaged skin (e.g., burned) without consulting a doctor or pharmacist.
Cetyl alcohol may cause a local skin reaction (e.g., contact dermatitis).

3. How to use Herpex

Herpex should be applied in a thin layer to the infected skin surface 5 times a day, every 4 hours (with a night break).
Method of application and duration of treatment
The drug should be applied to the infected skin surface using a cosmetic stick. The drug is applied not only to visible lesions caused by herpes (blisters, swollen nodules, redness) but also to the surrounding skin area. If the drug is applied directly with fingers, before and after applying the drug, hands should be washed thoroughly to prevent infection (e.g., with bacteria) of the diseased skin area or transmission of the herpes virus to unaffected mucous membranes and skin.
The drug is usually used for 5 days.
If the skin lesions have not healed, treatment should be continued until healing or crusting occurs. However, treatment should not last longer than 10 days.
If after 10 days of treatment the symptoms of the disease have not disappeared, you should consult a doctor.
To be effective, the drug should be applied immediately after the first symptoms of herpes infection appear: i.e., burning, itching, feeling of tension, and redness.
Herpex is not effective when applied at the stage of crust formation.
If you feel that the effect of the drug is too strong or too weak, you should consult a doctor.

Using a higher dose of Herpex than recommended

There have been no reports of symptoms of overdose of topically applied acyclovir.

4. Possible side effects

Like all drugs, this drug can cause side effects, although not everyone will experience them.
Uncommon (more than 1 in 1000, but less than 1 in 100 patients): transient burning or stinging sensation, mild drying or flaking of the skin, itching.
Rare (more than 1 in 10,000, but less than 1 in 1000 patients): redness (skin redness) and contact dermatitis.
Very rare (less than 1 in 10,000 patients): immediate hypersensitivity reactions, including angioedema and urticaria.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be gathered on the safety of the drug.

5. How to store Herpex

• The drug should be stored out of sight and reach of children.
• Do not store below 8°C.
• The drug should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.

Translation of some information on the immediate packaging:
Ch.-B.:/verwendbar bis – Batch number:/Expiry date

• Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Herpex contains

The active substance is acyclovir. 1 g of cream contains 50 mg of acyclovir.
The other ingredients are: macrogol stearate, dimethicone 350, cetyl alcohol, white wax, liquid paraffin, propylene glycol, purified water.

What Herpex looks like and what the package contains

A tube in a cardboard box contains 2 g or 5 g of cream.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Hexal AG
Industriestraße 25
83607 Holzkirchen, Germany

Manufacturer:

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export:30775.00.01
Parallel import authorization number:211/18
Date of leaflet approval: 25.04.2023
[Information about the trademark]