Polaracrem 2 mg/g + 5 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Polaracrem 2 mg/g + 5 mg/g cream
Dexchlorpheniramine maleate / allantoin
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use of this medicine as described in this leaflet or as 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 adverse effects, consult your doctor, pharmacist, or nurse, even if these are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days of treatment.
Contents of the leaflet
- What Polaracrem is and what it is used for
- What you need to know before using Polaracrem
- How to use Polaracrem
- Possible adverse effects
- How to store Polaracrem
- Contents of the pack and other information
1. What Polaracrem is and what it is used for
Polaracrem provides temporary relief from discomfort due to minor skin irritation, itching, sunburn, and insect bites in adults and children aged 2 years and older.
2. What you need to know before using Polaracrem
Do not use Polaracrem:
- if you are allergic to dexchlorpheniramine maleate, allantoin, or any of the other ingredients 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 blistered, damaged skin, or wet areas, nor around the eyes, genitals, or other mucous membranes.
- Avoid covering the treated area with bandages, diapers, or plastic.
- Do not expose skin areas treated with Polaracrem to sunlight.
- If you experience a burning sensation, hives, if discomfort persists, or if irritation develops in the treated area, you should discontinue use of Polaracrem.
- If you intend to use it for a prolonged period or over large areas of skin, especially in children.
- If the product is absorbed through the skin, it may cause excitability, particularly in children.
- Polaracrem must not be ingested. This medicine is for topical use only.
Children
Polaracrem can be used in children from 2 years of age.
Prolonged use or application over large skin areas should be avoided.
Use of Polaracrem with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not apply other antihistamines to the same area of skin, nor take systemic (non-topical) antihistamines concurrently during treatment with this medicine, due to the possibility of systemic absorption.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
The safety of Polaracrem in pregnant or breastfeeding women has not been established.
Polaracrem must not be administered during the third trimester of pregnancy, as newborns and premature infants may have severe reactions to antihistamines.
During the first two trimesters of pregnancy, Polaracrem should only be used if considered necessary by your doctor.
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 operate machinery.
Interaction with laboratory tests
Treatment with Polaracrem should be discontinued at least 48 hours before undergoing any skin allergy testing, as it may mask the results of such tests.
Polaracrem contains cetyl alcohol and methyl parahydroxybenzoate (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 methyl parahydroxybenzoate (E-218).
3. How to use Polaracrem
Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.
Apply a thin layer of Polaracrem, completely covering only the affected area, 2 to 4 times daily. Wash your hands after each application.
Use in children
Polaracrem is not indicated for children under 2 years of age.
If there is no improvement after 7 days of treatment, or if 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, contact the Toxicology Information Service, telephone 91 562 04 20.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Topically applied antihistamines may cause dryness, stinging, and skin rash. Less frequently, allergic reactions and photosensitivity may occur.
When using Polaracrem, the possibility of systemic adverse effects common to antihistamines should be considered, especially if applied to large areas of skin.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Polaracrem
Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and containers should be taken to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and containers. This helps protect the environment.
6. Contents of the pack and other information
Composition of Polaracrem
- The active substances are dexchlorpheniramine maleate and allantoin.
- Each gram of cream contains 2 mg of dexchlorpheniramine maleate and 5 mg of allantoin.
- The other components (excipients) are methylparahydroxybenzoate (E-218), glycerol (E-422), sorbitol (E-420), liquid paraffin, glyceryl monostearate, cetyl palmitate, cetyl alcohol, ethoxylated lanolin alcohol, lavender essence (perfume, diethyl phthalate, dipropylene glycol), and purified water.
Appearance of the product and contents of the pack
White-colored cream.
Aluminum tube containing 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 the most recent revision of this leaflet: 02/2016
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)