Package leaflet: Information for the patient

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Herpex
50 mg/g, cream
Aciclovirum
Please read this leaflet carefully 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
physician 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 your condition worsens, consult your doctor.

Table of contents of the leaflet:

What Herpex is and what it is used for
Important information before using Herpex
How to use Herpex
Possible side effects
How to store Herpex
Contents of the package and other information

1. What Herpex is and what it is used for

Herpex is a topical cream. It contains the active substance aciclovir, an antiviral agent. Aciclovir is highly active against Herpes simplex viruses (HSV) types 1 and 2, as well as against Varicella-Zoster viruses (VZV).
When applied topically over a small skin area, Herpex does not produce systemic effects.
Indications:
Herpex is used topically in the treatment of skin infections (cold sores and genital herpes) caused by Herpes simplex virus types 1 and 2.
If there is no improvement after 10 days, or if your condition worsens, consult your doctor.

2. Important information before using Herpex

When not to use Herpex

If the patient is allergic to aciclovir, valaciclovir, propylene glycol, or to any of the other ingredients of Herpex (listed in section 6). Warnings and precautions Before starting treatment with Herpex, discuss this with your doctor or pharmacist.
Do not apply the medicine to mucous membranes (e.g. mouth, eyes, or vagina) due to the risk of irritation.
Avoid contact of the medicine with the eyes.
Application of Herpex to genital areas and around the anus may reduce the strength of latex condoms and increase the risk of breakage. Paraffin and petroleum jelly contained in Herpex may reduce the effectiveness of condoms.
Patients with severe immune system disorders (e.g. patients infected with HIV or who have undergone bone marrow transplantation) should consult their doctor before starting treatment with Herpex cream. The doctor may recommend taking aciclovir orally.

Consult your doctor, even if the above warnings refer to conditions that occurred
in the past.
Herpex and other medicines
Inform your doctor or pharmacist about all medicines you are currently using,
have recently used, or plan to use.
No significant interactions with other medicines are known.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant,
she should consult her doctor or pharmacist before using this medicine.
Herpex 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.
Aciclovir may pass into breast milk, but the dose received by the infant from a mother using aciclovir cream is negligible.
Driving and operating machinery
Use of Herpex does not affect the ability to drive or operate machinery.
Herpex contains propylene glycol and cetyl alcohol
The medicine contains 150 mg of propylene glycol per 1 g of cream. Propylene glycol may cause skin irritation. This medicine 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 skin) without consulting a doctor or pharmacist.
Cetyl alcohol may cause local skin reactions (e.g. contact dermatitis).

3. How to use Herpex

Apply Herpex thinly in a thin layer to the affected skin surface 5 times daily every
4 hours (with a nighttime break).
Method of application and duration of treatment
Apply the medicine to the affected skin area using a cosmetic swab. The medicine should be applied not only to visible lesions caused by herpes (blisters, swollen nodules, redness) but also to the adjacent skin surface.
If the medicine is applied directly with fingers, hands must be thoroughly washed before and after application to avoid infecting the affected skin area (e.g. with bacteria) or spreading the herpes virus to unaffected mucous membranes or skin.
The medicine is usually used for 5 days.
If skin lesions have not healed, treatment should be continued until complete healing or until crusts have formed. However, treatment should not last longer than 10 days.
If symptoms persist after 10 days of treatment, consult a doctor.
For optimal effectiveness, the medicine should be applied immediately upon the first signs of herpes virus infection, such as burning, itching, tingling, and redness.
Herpex is not effective when applied at the stage when crusts have already formed.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Herpex
Symptoms of overdose with topically applied acyclovir have not been described.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Uncommon (more than 1 in 1,000 but less than 1 in 100 patients): transient sensation of
burning or pricking, slight drying or peeling of the skin, itching.
Rare (more than 1 in 10,000 but less than 1 in 1,000 patients): erythema (reddening of the skin) and contact dermatitis.
Very rare (less than 1 in 10,000 patients): immediate hypersensitivity reactions, including angioedema and urticaria.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in the leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Herpex medicine

Keep the medicine out of the sight and reach of children.
Do not store at temperatures below 8°C.
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. This will help protect the environment.

6. Contents of the packaging and other information

What Herpex contains
The active substance is aciclovir. 1 g of cream contains 50 mg of aciclovir.
The other ingredients are: cetyl alcohol, dimethicone 350, liquid paraffin, macrogol glycerides
stearates, propylene glycol, white soft paraffin, purified water.
What Herpex looks like and contents of the pack
An aluminium tube in a cardboard box contains 2 g of cream.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation 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:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
German Marketing Authorisation Number (country of export): 30775.00.01
Parallel Import Licence Number: 164/21