Package leaflet: Information for the patient

Polaramin 1% cream

Desloratadine maleate
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after a short period of treatment.

Contents of this leaflet:

What Polaramin 1% cream is and what it is used for
What you need to know before using Polaramin 1% cream
How to use Polaramin 1% cream
Possible side effects
How to store Polaramin 1% cream
Contents of the pack and other information

1. What Polaramin 1% cream is and what it is used for

Polaramin 1% cream contains the active substance deschlorpheniramine maleate, which belongs to a class of medicines called "antihistamines".
Polaramin 1% cream helps reduce allergic symptoms by blocking the effects of a substance called "histamine", which is produced by the human body in allergic individuals.
Polaramin 1% cream is a medicine that exerts its antihistamine action directly at the skin level, reducing redness, burning, and itching.
This medicine is used for the local treatment of symptoms of pruritic dermatitis (skin conditions causing itching), solar erythema (reddening characterized by itching, pain, burning sensation, and blistering following excessive sun exposure), and insect bites.
Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period of treatment.

2. What you need to know before using Polaramin 1% cream

Do not use Polaramin 1% cream

if you are allergic to desloratadine maleate, to other similar antihistamines, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Polaramin 1% cream.
Stop using Polaramin 1% cream approximately 48 hours before undergoing skin tests, as antihistamine medicines may prevent or reduce positive reactions.
Do not apply Polaramin 1% cream to the eyes.
Do not apply the medicine over large areas of abraded skin to avoid its absorption into the body. If absorbed, it may cause excitability, especially in children.
Do not apply on exuding surfaces (areas with fluid discharge due to inflammation), open sores, blistered skin, genital organs, or mucous membranes.
Do not cover the treated area with an occlusive dressing.
Exposure to sunlight of treated areas may cause photosensitization reactions (development of excessive skin sensitivity to sunlight).
If signs of sensitization (allergy) occur, discontinue treatment and consult your doctor.

Other medicines and Polaramin 1% cream
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicine.
No medicines are known to interact with Polaramin 1% cream.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before using this medicine.
If you are pregnant or breastfeeding, use Polaramin 1% cream only if strictly necessary and under direct medical supervision.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

Polaramin 1% cream contains cetyl alcohol and ethoxylated lanolin esters, which may cause local skin reactions (e.g. contact dermatitis).
Polaramin 1% cream contains methyl parahydroxybenzoate, which may cause local irritation.
Polaramin 1% cream contains a fragrance containing limonene and linalool. Limonene and linalool may cause allergic reactions.

3. How to use Polaramin 1% cream

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply Polaramin 1% cream to the affected area with gentle massage to promote deep penetration, 2–3 times daily, depending on the intensity of the inflammatory symptom.
Caution: Do not exceed the recommended doses without medical advice. Use this medicine only for short-term treatment.
Discontinue use of Polaramin 1% cream if a burning sensation or skin inflammation occurs, or if the original condition persists or irritation develops.
Consult your doctor if the condition recurs repeatedly or if you have noticed any recent changes in the characteristics of the condition.

If you use more Polaramin 1% cream than you should
There are no known cases of overdose due to the use of this medicine.
In case of accidental ingestion/intake of Polaramin 1% cream, inform your doctor immediately or go to the nearest hospital.

If you forget to use Polaramin 1% cream
Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Local application of Polaramin 1% cream may cause burning, inflammation, and skin photosensitization reactions (for example, redness, blisters).
After local application of antihistamines to extensive areas of skin, adverse effects due to the passage of the drug into the bloodstream have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Polaramin 1% cream

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Usable duration after first opening: 7 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Polaramin 1% cream contains

The active substance is desloratadine maleate. 100 g of cream contains 1 g of desloratadine maleate.
The other ingredients are: allantoin, glycerin, sorbitol 70%, glyceryl monostearate, spermaceti, cetyl alcohol, ethoxylated lanolin esters, methyl p-hydroxybenzoate, liquid paraffin, natural lavender fragrance, purified water.

Description of the appearance of Polaramin 1% cream and contents of the pack
Polaramin 1% cream – 25 g tube.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Marketing Authorization Holder: Bayer Spa, Viale Certosa 130, 20156 Milan, Italy
Manufacturer
Famar A.V.E. Avlona Industrial site
49 Km National Road Athens-Lamia
Avlona, 19011
Greece