Verpyllo dimetiskin

Patient Information Leaflet

Verpyllo Dimetiskin, 1 mg/g, gel
Dimetindene maleate
Please read this leaflet carefully before using the medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor 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 possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 7 days of treatment, consult your doctor.

Table of contents:

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

Verpyllo Dimetiskin contains the active substance dimetindene maleate. It is an antiallergic medicine used topically to treat or relieve itching caused by skin disorders, insect bites, minor burns, and sunburn in adults, adolescents, and children from 1 month of age.

Indications
For short-term relief of itching due to minor insect bites on intact skin.
Itching caused by skin diseases (dermatoses), such as chronic eczema, urticaria, and other allergic skin conditions; first-degree burns, sunburn.

Before using Verpyllo Dimetiskin, consult your doctor for diagnosis and treatment of chronic skin conditions (e.g. chronic eczema).
If there is no improvement or if symptoms worsen after 7 days of use, contact your doctor.

2. Important information before using Verpyllo Dimetiskin

When NOT to use Verpyllo Dimetiskin

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• when applying to large skin areas,
• on damaged skin.

Warnings and precautions
Before starting to use Verpyllo Dimetiskin, discuss this with your doctor or pharmacist.

• Do not expose treated skin areas to direct sunlight for prolonged periods.
• Inform your doctor about severe itching or extensive skin disorders.
• Verpyllo Dimetiskin should not be used on large areas of skin, particularly areas that are damaged or affected by inflammatory conditions; this especially applies to infants and young children.
• Systemic formulations (administered intravenously) are available for the treatment of diagnosed insect venom allergy.

Children
Verpyllo Dimetiskin should not be used in children under 1 month of age.
Do not use on large skin surfaces in infants aged 1 month and older, or in young children.

Verpyllo Dimetiskin and other medicines
Tell your doctor or pharmacist if the patient is taking, has recently taken, or might take any other medicines.

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.

Pregnancy
During pregnancy, Verpyllo Dimetiskin should not be used on large skin areas, especially on damaged skin or skin affected by inflammatory conditions.

Breastfeeding
Breastfeeding women should not use this medicine on large skin areas, especially on damaged or inflamed skin, or on the nipple area.

Driving and operating machinery
Verpyllo Dimetiskin has no effect or has a negligible effect on the ability to drive and operate machinery.

Verpyllo Dimetiskin contains benzalkonium chloride and propylene glycol

Verpyllo Dimetiskin contains 0.05 mg of benzalkonium chloride in each gram of gel.
Benzalkonium chloride may cause skin irritation. Breastfeeding women should not apply this medicine to the skin of the breast, as it may be ingested by the child with breast milk. This medicine is not intended for use on mucous membranes.

Verpyllo Dimetiskin contains 150 mg of propylene glycol in each gram of gel.
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. This 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 patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Dosage
Apply a thin layer of gel to the affected areas of skin up to 3 times daily.
If you feel that the effect of Verpyllo Dimetiskin is too strong or too weak, consult your doctor or pharmacist.
Method of administration
For external use only. Gently rub in the gel.
Do not use bandages.
Duration of treatment
Do not use Verpyllo Dimetiskin for longer than 7 days without consulting a doctor.
Use in children
Avoid application over large areas of skin in infants aged 1 month and older and in young children.
Verpyllo Dimetiskin should not be used in children under 1 month of age.
Use of more than the recommended dose of Verpyllo Dimetiskin
If too much gel has been applied, wipe off the excess from the skin with a cloth.
If Verpyllo Dimetiskin is accidentally swallowed by the patient or their child, contact a doctor immediately.
In case of intentional or accidental overdose, contact a doctor or pharmacist immediately so they can assess the degree of overdose and determine any necessary actions.
Missed dose of Verpyllo Dimetiskin
Do not use a double dose to make up for a missed dose.
Stopping treatment with Verpyllo Dimetiskin
If treatment is interrupted or the gel is discontinued prematurely, the desired effect may not be achieved or the patient's condition may worsen again.
If the patient wishes to stop treatment, they should consult their doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Frequency unknown (cannot be determined from available data)

• dry skin
• skin burning sensation
• skin allergic reactions

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of 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.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Verpyllo Dimetiskin

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

6. Contents of the pack and other information

What Verpyllo Dimetiskin contains

• The active substance is dimethindene maleate. Each gram of gel contains 1 mg of dimethindene maleate.
• The other ingredients are: carbomer (type 974 P), disodium edetate, sodium hydroxide (E 524, for pH adjustment), propylene glycol (E 1520), benzalkonium chloride (in the form of a 50% solution), and purified water.

What Verpyllo Dimetiskin looks like and contents of the pack
Verpyllo Dimetiskin is a colourless, transparent to slightly opalescent, homogeneous gel.
Aluminium tube with an internal epoxy-phenolic layer, polyurethane enamel as the outer coating,
and an aqueous polymer dispersion as the sealing compound.
Each tube is fitted with a polypropylene cap with a piercing tip designed to pierce the aluminium membrane inside the tube.
Pack sizes: 30 g or 50 g of gel.
Not all pack sizes may be marketed.
Marketing Authorisation 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
For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Tel. +48 22 737 79 20
This medicinal product is authorised in the European Economic Area under the following names:
Germany: Dimetinden STADA 1 mg/g Gel
Poland: Verpyllo Dimetiskin