Leaflet: information for the user

Polaracrem 2 mg/g + 5 mg/g cream

Dexclorpheniramine maleate/alantoin

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated 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, including those not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

1. What is Polaracrem and what it is used for

2. What you need to know before using Polaracrem

3. How to use Polaracrem

4. Possible side effects

5. Storage of Polaracrem

6. Contents of the pack and additional information

Polaracrem provides temporary relief from discomforts due to minor skin irritation, itching, sunburn, and insect bites, in adults and children 2 years of age and older.

Do not use Polaracrem:

• if you are allergic to dexchlorpheniramine maleate, alantoin or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Polaracrem.

• Polaracrem is not suitable for ophthalmic use.
• Polaracrem should not be applied to skin with blisters, damaged or moist skin, or around the eyes, genitals or other mucous membranes.
• Avoid covering the treated area with bandages, diapers or plastic.
• Do not expose the treated skin areas to sunlight.
• If you experience a burning sensation, urticaria, persistent discomfort or irritation at the treated area, discontinue use of Polaracrem.
• If you plan to use it for a long period or on extensive skin areas, especially in children.
• If the product is absorbed through the skin, it may cause excitability, especially in children.
• Polaracrem should not be ingested. This medication is only for topical use.

Children

Polaracrem can be used in children from 2 years of age.

Avoid prolonged use or on extensive skin areas.

Using Polaracrem with other medications

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

Do not apply other antihistamines to the same skin area, or take them at the same time as non-topical antihistamines while using this medication, due to possible systemic absorption.

Pregnancy and breastfeeding

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

The safety of Polaracrem use in pregnant women or during breastfeeding has not been established.

Polaracrem should not be administered during the third trimester of pregnancy due to the risk of severe reactions in newborns and premature children.

During the first two trimesters of pregnancy, Polaracrem should only be used if your doctor considers it necessary.

The excretion of Polaracrem through breast milk is unknown, so if you are breastfeeding, consult your doctor before using this medication.

Driving and operating machinery

This medication does not affect the ability to drive or operate machinery.

Interaction with laboratory tests

Treatment with Polaracrem should be discontinued at least 48 hours before any skin allergy tests, as it may mask the results of these tests.

Polaracrem contains cetomacrogol and methylparaben (E-218)

This medication may cause local skin reactions (such as contact dermatitis) due to cetomacrogol.

It may cause allergic reactions (possibly delayed) due to methylparaben (E-218).

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

Apply a thin layer of Polaracrem, covering only the affected area completely, 2 to 4 times a day. Wash your hands after each application.

Use in children

Polaracrem is not indicated for children under 2 years.

If after 7 days of treatment there is no improvement or other symptoms appear, stop using the medication and consult with your doctor.

If you use more Polaracrem than you should

If you have used more Polaracrem than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20.

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

Topical antihistamines may cause dryness, itching, and skin rash. Less frequently, allergic reactions and photosensitivity may occur.

When using Polaracrem, consider the possibility of systemic adverse effects common to antihistamines, especially if applied to extensive areas of the skin.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for Human Use Medications: https://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.

Do not store at a temperature above 25°C.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Polaracrem

• The active principles are dexchlorpheniramine maleate and alantoin.
• Each gram of cream contains 2 mg of dexchlorpheniramine maleate and 5 mg of alantoin.
• The other components (excipients) are methylparahydroxybenzoate (E-218), glycerol (E-422), sorbitol (E-420), liquid paraffin, monoester of glycerol, cetyl palmitate, cetyl alcohol, lanolin alcoxylated alcohol, lavender essence (perfume, diethyl phthalate, dipropylene glycol) and purified water.

Appearance of the product and content of the packaging

White cream.

Aluminum tube with 20 g of cream.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid - Spain

Responsible for manufacturing:

SAG MANUFACTURING, S.L.U.

Crta. N-I, Km 36

28750 San Agustín de Guadalix

Madrid

Last review date of this leaflet: 02/2016

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