Variderm

ANNEX III
Please read this entire leaflet carefully, as it contains important information for the
patient

• This medicine is available without a prescription so that certain conditions can be treated without a doctor's assistance. However, to achieve effective treatment, VARIDERM must be used carefully and in accordance with the information provided in this leaflet.
• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you need advice or further information.
• If symptoms worsen or do not improve, consult a doctor.

VARIDERM
(Benzocaine + Menthol + Zinc Oxide)
(10 mg + 10 mg + 300 mg)/g
skin paste
List of active substances:
Benzocaine 10 mg/g
Menthol 10 mg/g
Zinc oxide 300 mg/g
List of excipients:
Talc
Ethanol 96% 50 mg/g
Glycerol 86%
Medicine content in the package:
60 g
Name and address of the marketing authorization holder:
PPFK „Profarm” sp. z o.o., ul. Słupska 18, 84 - 300 Lębork, tel. (59)8633303, fax. (59)8627240.
Table of contents of the leaflet:
1. What VARIDERM is and what it is used for
2. Before using VARIDERM
3. How to use VARIDERM
4. Possible side effects
5. How to store VARIDERM
6. Other information
1. What VARIDERM is and what it is used for:
VARIDERM is a thick paste formulation containing benzocaine and menthol, which have local anesthetic properties, zinc oxide, which has anti-inflammatory and astringent effects, and talc, a drying agent.
The product is used as an adjunct in the treatment of vesicular rash in chickenpox, in the symptomatic treatment of shingles, in skin diseases characterized by rashes, and to relieve symptoms of sunburn. It also alleviates pain and itching of the skin.

2. Before using VARIDERM:

Contraindicated in individuals with hypersensitivity to any of the components. Do not apply to damaged skin. Avoid contact of the paste with mucous membranes of the eyes, mouth, and nose.
If necessary, wash off the preparation with warm water.
Pregnancy
Consult a doctor before using this medicine.
Due to lack of safety data, cautious use of the product during pregnancy is recommended.
Breastfeeding
Consult a doctor before using any medicine.
Due to lack of safety data, cautious use of the product during breastfeeding is recommended.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.

3. How to use VARIDERM:

Apply a small amount of the paste locally several times a day to the pimples or spread over the skin area affected by the rash. For sunburns, apply a thin layer of the product.
If necessary, mix before use in case a liquid phase separates on the surface of the paste.
After application, wash hands to avoid contact of the paste with the mucous membranes of the mouth, nose, and eye conjunctivae.

4. Possible adverse effects:

Like any medicine, VARIDERM may cause adverse effects.
Skin irritation and allergic reactions may occur in individuals prone to allergies.
Other adverse effects may also occur in some people during treatment with VARIDERM.
If any other adverse symptoms not listed in this leaflet occur, inform your doctor.

Reporting of adverse effects:
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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, phone: +48 22 49-21-301, fax: +48 22 49-21-309,
e-mail: [email protected] .
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to gather further information on the safety of using the medicine.

5. Storage of the VARIDERM medicinal product:

Keep the medicine out of the reach and sight of children.
Do not use the VARIDERM medicinal product after the expiry date stated on the
packaging.
After first opening, store the medicine for 1 year, but no longer than until the end of the expiry period.
Store the medicine below 25 °C.

6. Other information:

Marketing Authorization Holder:
PPFK „Profarm” sp. z o.o., ul. Słupska 18, 84 - 300 Lębork, tel. (59) 8633303,
fax. (59) 8627240.
Date of preparation of the leaflet:
29.10.2008