Patient Information Leaflet

Dermapic 1 mg/g Gel

Dimetindeno, maleate

Read this leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given by your doctor, pharmacist, or nurse.

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

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. Contents of the pack and additional information

This medication contains dimetindene maleate, an active ingredient that belongs to a group of medications called antihistamines.

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

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

Do not use Dermapic

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dermapic.

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

Children

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

Other medications and Dermapic

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

Pregnancy and breastfeeding

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

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

Driving and operating 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 on 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.

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

The recommended dose is:

Adults and children over 1 month

Apply a small amount of the medication to the affected area. The procedure 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 will be done exclusively under the doctor's advice.

Method of use

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

After applying a small amount of the medication to the area to be treated, give a gentle 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), dilated pupils (mydriasis), dry mouth, flushing on the face, urinary retention, and fever (especially in children).

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

During the marketing period of this medication, the following adverse effects have occurred, whose frequency has not been established with precision:

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging 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 disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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 content of the container

Transparent, colorless, homogeneous and odorless gel.

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

Only some sizes of containers may be commercially available.

Holder of the marketing authorization

Laboratorios Normon, S.A.

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

Responsible for manufacturing

Pharmaceutical Works POLPHARMA S.A.

Medana Branch in Sieradz

10 W. Lokietka St, 98-200 Sieradz,

(Poland)

Last review date of this leaflet: October 2018

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