Verpillo Dimetiskin

Package Leaflet: Information for the Patient

Verpyllo Dimetiskin, 1 mg/g, Gel

Dimetindene Maleate

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days of using the medicine, there is no improvement or you feel worse, you should contact a doctor.

Table of Contents of the Leaflet:

• 1. What is Verpyllo Dimetiskin and what is it used for
• 2. Important information before using Verpyllo Dimetiskin
• 3. How to use Verpyllo Dimetiskin
• 4. Possible side effects
• 5. How to store Verpyllo Dimetiskin
• 6. Contents of the pack and other information

1. What is Verpyllo Dimetiskin and what is it used for

Verpyllo Dimetiskin contains the active substance dimetindene maleate. It is an anti-allergic medicine for local treatment/relief of itching caused by skin diseases, insect bites, minor burns, and sunburns in adults, adolescents, and children from 1 month of age.
Indications for use
For short-term relief of itching in case of minor insect bites on intact skin.
Itching caused by skin diseases (dermatoses), such as chronic eczema, urticaria, and other skin diseases related to allergies; first-degree burns, sunburns.
Before using Verpyllo Dimetiskin, consult a doctor to diagnose and treat chronic diseases (e.g., chronic eczema).
If there is no improvement or worsening of symptoms after 7 days, consult a doctor.

2. Important information before using Verpyllo Dimetiskin

When NOT to use Verpyllo Dimetiskin

• in case of application to a large surface area
• on damaged skin

Warnings and precautions

Before starting to use Verpyllo Dimetiskin, discuss it with a doctor or pharmacist.

• Do not expose treated skin areas to direct sunlight for a long time.
• Tell your doctor about very strong itching or extensive skin diseases.
• Verpyllo Dimetiskin is not intended for use on large areas of skin, especially those that are damaged or inflamed; this applies especially to infants and small children.
• Systemic forms of administration (given intravenously) are available for the treatment of confirmed insect venom allergy.

Children

Verpyllo Dimetiskin should not be used in children under 1 month of age.
Do not apply to large areas of skin in infants over 1 month of age and small children.

Verpyllo Dimetiskin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use Verpyllo Dimetiskin on large areas of skin, especially on damaged or inflamed skin, during pregnancy.
Breastfeeding
Women who are breastfeeding should not use the medicine on large areas of skin, especially on damaged or inflamed skin, or on the nipples.

Driving and using machines

Verpyllo Dimetiskin has no or negligible influence on the ability to drive and use machines.

Verpyllo Dimetiskin contains benzalkonium chloride and propylene glycol

Verpyllo Dimetiskin contains 0.05 mg of benzalkonium chloride per gram of gel.
Benzalkonium chloride may irritate the skin. Breastfeeding women should not use this medicine on the breast skin, as it may be ingested by the child with breast milk. This medicine is not intended for use on the mucous membrane.
Verpyllo Dimetiskin contains 150 mg of propylene glycol per gram of gel.
Propylene glycol may cause skin irritation. Do not use this medicine 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. However, the medicine should not be used at all in infants under 4 weeks of age.

3. How to use Verpyllo Dimetiskin

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.

Dosage

Apply a thin layer of gel to the affected skin areas up to 3 times a day.
If you feel that the effect of Verpyllo Dimetiskin is too strong or too weak, consult a doctor or pharmacist.

Method of administration

For use on the skin. Gently rub in the gel.
Do not use bandages.

Duration of use

Do not use Verpyllo Dimetiskin for more than 7 days without consulting a doctor.

Use in children

Avoid using on large areas of skin in infants over 1 month of age and small children.
Verpyllo Dimetiskin should not be used in children under 1 month of age.

Using more than the recommended dose of Verpyllo Dimetiskin

If you apply more gel than you should, wipe off the excess from the skin with a cloth.
If you or your child accidentally swallow Verpyllo Dimetiskin, immediately inform a doctor.
In case of intentional or accidental overdose, immediately inform a doctor or pharmacist so that they can decide on the degree of overdose and any further actions that may be necessary.

Missing a dose of Verpyllo Dimetiskin

Do not use a double dose to make up for a missed dose.

Stopping use of Verpyllo Dimetiskin

If you stop the treatment or stop using the gel too early, you may not achieve the desired effect or the patient's condition may worsen again.
If you want to stop the treatment, consult a doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Verpyllo Dimetiskin can cause side effects, although not everybody gets them.
Frequency not known(cannot be estimated from the available data)

• dry skin
• burning sensation of the skin
• skin allergic reactions

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Verpyllo Dimetiskin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging and tube after: "EXP". The expiry date refers to the last day of that month.
Store below 25°C.
Shelf life after first opening: 3 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Verpyllo Dimetiskin contains

• The active substance is dimetindene maleate. Each gram of gel contains 1 mg of dimetindene maleate.
• The other ingredients are: carbomer (type 974 P), disodium edetate, sodium hydroxide (E 524, to adjust pH), propylene glycol (E 1520), benzalkonium chloride (as 50% solution), and purified water.

What Verpyllo Dimetiskin looks like and contents of the pack

Verpyllo Dimetiskin is a colorless, transparent to slightly opalescent, homogeneous gel.
Aluminum tube with an inner epoxy-phenolic coating, polyurethane enamel as the outer coating, and water-based polymer dispersion as the sealing mass.
Each tube is equipped with a polypropylene screw cap with a piercing tip for piercing the aluminum membrane in the tube.
Pack sizes: 30 g or 50 g of gel.
Not all pack sizes may be marketed.

Marketing Authorization Holder:

STADA Arzneimittel AG,
Stadastrasse 2-18,
61118 Bad Vilbel,
Germany

Manufacturer:

STADA Arzneimittel AG,
Stadastrasse 2-18,
61118 Bad Vilbel,
Germany
Laboratórios Basi - Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, lote 15
3450-232 Mortágua
Portugal
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany:
Dimetinden STADA 1 mg/g Gel
Poland:
Verpyllo Dimetiskin

Date of last revision of the leaflet: