Herpex

Leaflet attached to the packaging: patient information

HERPEX, 50 mg/g, cream

Aciclovir

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.
The medicine should always be used exactly as described in this patient leaflet or as advised by
the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 10 days or the patient feels worse, the doctor should be contacted.

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. Contents of the packaging 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 medicine. 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.
If there is no improvement after 10 days or the patient feels worse, the doctor should be consulted.

2. Important information before using Herpex

When not to use Herpex

If the patient is allergic to acyclovir, valacyclovir, propylene glycol, or any of the other ingredients of Herpex (listed in section 6).

Warnings and precautions

Before starting to use Herpex, the doctor or pharmacist should be consulted.
The medicine should not be used on mucous membranes (e.g., mouth, eyes, or vagina) due to the risk of irritation.
Contact with the eyes should be avoided.
Using Herpex on the genitals and around the anus may reduce the durability of latex condoms. Petrolatum and wax contained in Herpex may reduce the safety of using condoms.
Patient with severe immune system disorders (e.g., patients with HIV or after bone marrow transplantation) before starting to use Herpex cream should consult a doctor. The doctor may recommend taking acyclovir orally.
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The doctor should be consulted, even if the above warnings concern situations that have occurred in the past.

Herpex and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as about medicines that the patient plans to use.
No significant interactions with other medicines are known.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Herpex can be used during pregnancy only if, in the doctor's opinion, the benefit to 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 using machines

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

Herpex contains propylene glycol and cetyl alcohol

The medicine contains 150 mg of propylene glycol in 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 damaged or broken skin (e.g., burned skin) 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 medicine should be applied to the infected skin surface using a cosmetic stick. The medicine is used not only on visible lesions caused by herpes (blisters, swollen nodules, redness) but also on the surrounding skin area. If the medicine is applied directly with fingers, the hands should be washed thoroughly before and after applying the medicine 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 medicine 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 the symptoms of the disease have not disappeared after 10 days of treatment, the doctor should be consulted.
To be effective, the medicine 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 it is felt that the effect of the medicine is too strong or too weak, the doctor should be consulted.

Using a higher dose of Herpex than recommended

No symptoms of overdose of topically applied acyclovir have been reported.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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): erythema (redness of the skin) 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 not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Herpex

The medicine should be stored out of sight and reach of children.
There are no special requirements for storage conditions.
The medicine should not be used after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging 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 petrolatum, liquid paraffin, propylene glycol, purified water.

What Herpex looks like and contents of the packaging

An aluminum tube in a cardboard box contains 2 g or 5 g of cream.

Marketing authorization holder:

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer:

Salutas Pharma GmbH
Otto-von-Guericke Allee 1
39179 Barleben, Germany
Salutas Pharma GmbH
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Lange Göhren 3
39171 Osterweddingen
Germany

To obtain more detailed information about this medicine, the local representative of the marketing authorization holder should be contacted:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

Date of last revision of the leaflet:

{Sandoz logo}
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