DERMAPIC 1 mg/g GEL

Introduction

Package Leaflet: Information for the Patient

Dermapic 1 mg/g Gel

Dimetindene, maleate

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What Dermapic is and what it is used for
2. What you need to know before using Dermapic
3. How to use Dermapic
4. Possible side effects
5. Storage of Dermapic
6. Package Contents and Additional Information

1. What Dermapic is and what it is used for

This medication contains dimetindene maleate, an active ingredient belonging to the group of medications called antihistamines.

Dermapic is used for the relief of itching of the skin associated with skin reactions such as small skin eruptions, urticaria, insect bites and marine stings, small sunburns, and small superficial burns, in adults and children from 1 month of age.

You should consult a doctor if it worsens or does not improve after 7 days of treatment.

2. What you need to know before using Dermapic

Do not use Dermapic

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• In newborn and premature infants.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Dermapic.

• Avoid prolonged exposure to the sun of the treated skin areas.
• Inform your doctor if you experience very intense itching or in case of extensive lesions.
• Use only on intact skin, without wounds.

Children

In children from 1 month to 2 years, do not use on extensive areas of the skin and only under medical supervision.

Other Medications and Dermapic

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

During pregnancy and breastfeeding, Dermapic should not be applied to extensive areas of the skin. During breastfeeding, do not apply the medication to the nipples.

Driving and Using Machines

The application of this medication to the skin does not affect the ability to drive or use machines.

Dermapic contains benzalkonium chloride and propylene glycol (E-1520)

This medication contains 0.05 mg of benzalkonium chloride per gram of gel. Benzalkonium chloride may cause skin irritation. Do not apply to mucous membranes.

Do not apply this medication to the chest during breastfeeding, as it may pass to the baby.

This medication contains 150 mg of propylene glycol per gram of gel.

3. How to use Dermapic

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children from 1 month of age

Apply a small amount of the medication to the affected area. The operation can be repeated 2 to 4 times a day, if necessary.

Do not use on extensive areas of the skin.

If it worsens or does not improve after 7 days of treatment, consult your doctor.

The use of the medication in children from 1 month to 2 years of age will be done exclusively under medical advice.

Method of use

This is a topical medication. For use on intact skin, without wounds.

After applying a small amount of the medication to the area to be treated, gently massage with your hand to facilitate the penetration of the medication into the skin.

If you use more Dermapic than you should

The symptoms of overdose are:

Drowsiness (mainly in adults), excitability, difficulty coordinating movements (ataxia), hallucinations, involuntary muscle contractions (tonic-clonic spasms), pupil dilation (mydriasis), dry mouth, facial flushing, urinary retention, and fever (especially in children).

In case of overdose or accidental ingestion, consult your doctor or go to a medical center or call the Toxicology Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

During the marketing period of this medication, the following side effects have occurred, whose frequency could not be established with precision:

• Dry skin
• Burning sensation on the skin
• Rash and itching

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dermapic

Keep this medication out of the sight and reach of children.

Store in the original package to protect it from light.

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Use the medication within 36 months after the first opening of the tube.

Medications should not be thrown away through the sewage system or in the trash. Deposit the packages and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Dermapic

• The active ingredient is dimetindene maleate. Each gram of gel contains 1 mg of dimetindene maleate.
• The other components (excipients) are: benzalkonium chloride, disodium edetate (E-385), carbomer, sodium hydroxide (E-524), propylene glycol (E-1520), and purified water.

Appearance of the Product and Package Contents

Transparent, colorless, homogeneous gel without perfume.

It is presented in aluminum tubes with a polyethylene cap containing 5 g, 30 g, and 50 g of gel.

Only some package sizes may be marketed.

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Manufacturer

Pharmaceutical Works POLPHARMA S.A.

Medana Branch in Sieradz

10 W. Lokietka St, 98-200 Sieradz,

(Poland)

Date of the Last Revision of this Package Leaflet: October 2018

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/