POLARACREM 2 mg/g + 5 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Polaracrem 2 mg/g + 5 mg/g cream

Dexclorfeniramine maleate/allantoin

Read the package leaflet carefully before starting to use this medicine because it contains important information for you.

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

• Keep this package leaflet, 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 not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days of treatment.

Contents of the Package Leaflet

1. What is Polaracrem and what is it 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 further information

1. What is Polaracrem and what is it used for

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

2. What you need to know before using Polaracrem

Do not use Polaracrem:

• if you are allergic to dexclorfeniramine maleate, allantoin, or any of the other components of this medicine (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 broken, damaged, or wet 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, hives, persistent discomfort, or irritation develops in the treated area, you should discontinue the use of Polaracrem.
• If you are going 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 medicine is for cutaneous use only.

Children

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

Avoid prolonged use or application to extensive skin areas.

Using Polaracrem with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Do not apply other antihistamines to the same skin area, and do not take other non-cutaneous antihistamines at the same time as this medicine, due to possible systemic absorption.

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 medicine.

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

Polaracrem should not be administered during the third trimester of pregnancy because newborns and premature infants may have severe reactions to antihistamines.

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

It is unknown whether Polaracrem is excreted in breast milk; therefore, if you are breastfeeding, you should consult your doctor before using this medicine.

Driving and using machines

This medicine does not affect the ability to drive or use machines.

Interaction with laboratory tests

Treatment with Polaracrem should be suspended at least 48 hours before performing any skin allergy test, as it may mask the result of these tests.

Polaracrem contains cetyl alcohol and methylparahydroxybenzoate (E-218)

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.

It may cause allergic reactions (possibly delayed) because it contains methylparahydroxybenzoate (E-218).

3. How to use Polaracrem

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

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

Use in children

Polaracrem is not indicated in children under 2 years of age.

If after 7 days of treatment, it does not improve or other symptoms appear, stop using the medicine and consult 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 Toxicology Information Service, telephone 91 562 04 20.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

With the use of Polaracrem, the possibility of systemic side effects common to antihistamines should be considered, especially if applied to extensive skin areas.

Reporting of side effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Polaracrem

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Polaracrem

• The active ingredients are dexclorfeniramine maleate and allantoin.
• Each gram of cream contains 2 mg of dexclorfeniramine maleate and 5 mg of allantoin.
• The other ingredients (excipients) are methylparahydroxybenzoate (E-218), glycerol (E-422), sorbitol (E-420), liquid paraffin, glycerol monostearate, cetyl palmitate, cetyl alcohol, ethoxylated lanolin alcohol, lavender essence (perfume, diethyl phthalate, dipropylene glycol), and purified water.

Appearance and packaging of the product

White cream.

Aluminum tube with 20 g of cream.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid - Spain

Manufacturer:

SAG MANUFACTURING, S.L.U.

Crta. N-I, Km 36

28750 San Agustín de Guadalix

Madrid

Date of last revision of this package leaflet: 02/2016

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