


Ask a doctor about a prescription for POLARACREM 2 mg/g + 5 mg/g CREAM
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.
Contents of the Package Leaflet
Polaracrem provides temporary relief from minor skin irritation, itching, sunburn, and insect bites in adults and children from 2 years of age.
Do not use Polaracrem:
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Polaracrem.
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).
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.
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.
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.
Composition of Polaracrem
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/)
Discuss dosage, side effects, interactions, contraindications, and prescription renewal for POLARACREM 2 mg/g + 5 mg/g CREAM – subject to medical assessment and local rules.