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Variderm

Variderm

About the medicine

How to use Variderm

APPENDIX III

B. PATIENT LEAFLET

Patient Leaflet

Read the entire leaflet carefully, as it contains important information for

the patient

  • - This medicine is available without a prescription to treat certain conditions without the helpof a doctor. However, to achieve good treatment results, the medicine VARIDERM should beused carefully and in accordance with the information on the leaflet.
  • - Keep this leaflet, so you can read it again if needed.
  • - Consult a doctor or pharmacist if advice or additional information is needed.
  • - 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
96% Ethanol
50 mg/g
86% Glycerin

Medicine content in the packaging:

60 g

Name and address of the responsible entity:

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 is VARIDERM and what is it used for

2. Before using VARIDERM

3. How to use VARIDERM

4. Possible side effects

5. Storage of the medicine VARIDERM

6. Other information

1. What is VARIDERM and what is it used for:

VARIDERM is a preparation in the form of a thick paste containing benzocaine and menthol,
ingredients with local anesthetic action, zinc oxide with anti-inflammatory and astringent action,
and talc, a drying agent.
The preparation is used as an adjunct in the treatment of vesicular rash in chickenpox,
in the treatment of skin symptoms of shingles, in skin diseases characterized by
rash, it alleviates the effects of sunburn, and relieves skin pain and itching symptoms.

2. Before using VARIDERM:

A contraindication to use is a tendency to allergies to the ingredients, it should not be
applied to injured skin, avoid contact of the paste with the mucous membranes of the eyes, mouth, and nose.
In case of need, wash the preparation with warm water.

Pregnancy

Before using the medicine, consult a doctor.
Due to the lack of data on safety, it is recommended to use the preparation with caution during pregnancy.

Breastfeeding

Before using (any) medicine, consult a doctor.
Due to the lack of data on safety, it is recommended to use the preparation with caution during breastfeeding.

Driving vehicles and operating machinery

The medicine does not affect the ability to drive vehicles and operate machinery

3. How to use VARIDERM:

A small amount of paste should be applied locally several times a day to the rash or smeared on the skin
in the area of the rash. Sunburns should be smeared with a thin layer of the preparation.
If necessary, mix before use, in case of separation of a liquid phase on the surface of the paste.
After application, wash your hands to avoid contact of the paste with the mucous membrane of the mouth,
nose, and eye conjunctiva.

4. Possible side effects:

Like any medicine, VARIDERM can cause side effects.
In people prone to allergies, skin irritation and allergic reactions may occur.
In some people, during the use of the medicine VARIDERM, other side effects may occur.
If other adverse symptoms occur, not mentioned in this leaflet, inform your doctor.
Reporting side effects:
If any side effects occur, including all adverse symptoms not listed in this leaflet, tell your doctor or pharmacist, or nurse.
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,
e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the responsible entity.
Thanks to the reporting of side effects, more information can be collected on the safety of the medicine.

5. Storage of the medicine VARIDERM:

The medicine should be stored in a place inaccessible and invisible to children.
Do not use the medicine VARIDERM after the expiry date stated on the packaging.
After the first opening, store the medicine for 1 year, but no longer than the end of the shelf life.
Store the medicine at a temperature below 25°C.

6. Other information:

Responsible entity:

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

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