Aleric gel

Package leaflet: Information for the patient

Aleric Gel, 1 mg/g, gel
Dimetinden maleate
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement within 2 days of use in infants and children, or 7 days in adults, or if you feel worse, consult your doctor.

Table of contents of the leaflet:

1. What Aleric Gel is and what it is used for
2. Important information before using Aleric Gel
3. How to use Aleric Gel
4. Possible side effects
5. How to store Aleric Gel
6. Contents of the pack and other information

1. What Aleric Gel is and what it is used for

Aleric Gel is a topical gel for application to the skin. Aleric Gel contains the active substance dimetinden maleate, which inhibits the action of histamine—a compound responsible for allergic reactions.
When applied to the skin, the medicine acts locally as an antiallergic agent, strongly relieving itching (except cholestatic itching), reducing swelling, and soothing skin irritation.
It has local anesthetic properties. It also has a cooling effect, which additionally soothes irritated skin.
Indications
Itching associated with skin disorders, urticaria, insect bites, sunburn, and superficial skin burns (first degree).
The medicine may be used in infants over one month of age, children, and adults.

2. Important information before using Aleric Gel

When not to use Aleric Gel

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• in cases of second- and third-degree burns (skin lesions with accompanying swelling, blisters or necrosis affecting superficial and deeper layers of the skin),
• in infants under 1 month of age,
• over large areas of skin,
• on damaged or wounded skin.

1 of 4
Warnings and precautions

• Avoid prolonged exposure of treated areas to direct sunlight.
• Inform your doctor if there is severe itching or extensive skin lesions. This medicine is not intended for use on large, particularly damaged or inflamed areas of skin, especially in infants and young children.
• If there is no improvement after 7 days of use in adults, or if the patient feels worse, consult a doctor.

Systemic dosage forms are available for the treatment of diagnosed insect venom allergy.
In case of doubt regarding the use of Aleric Gel, consult your doctor or pharmacist before use.
Children
Aleric Gel must not be used in children under 1 month of age.
Use of Aleric Gel in infants aged over 1 month up to 1 year of age should be under medical advice.
If there is no improvement within 2 days of starting treatment in infants and children, or if the patient feels worse, consult a doctor.
Do not use the medicine in infants and young children over large areas of skin, especially in cases of wounds, second- and third-degree burns, and inflammatory skin conditions.
Aleric Gel and other medicines
Tell your doctor or pharmacist if the patient is currently taking, has recently taken, or plans to take any other medicines.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Aleric Gel should not be used during pregnancy and breastfeeding unless otherwise advised by a doctor.
During pregnancy and breastfeeding, Aleric Gel must not be applied over extensive areas of skin, especially if the skin is damaged or inflamed.
During breastfeeding, do not apply the gel to the nipples.
Breastfeeding women should not use this medicine on the skin of the breasts, as it may be ingested by the infant with breast milk.
Driving and operating machinery
Aleric Gel applied to the skin has no effect on the ability to drive or operate machinery.
Aleric Gel contains benzalkonium chloride and propylene glycol
This medicine contains 0.05 mg of benzalkonium chloride per gram of gel. Benzalkonium chloride may irritate the skin. Breastfeeding women should not use this medicine on the skin of the breasts, as it may be ingested by the infant with breast milk (see "Pregnancy and breastfeeding").
This medicine is not intended for use on mucous membranes.
The medicine contains 150 mg of propylene glycol per gram of gel. Propylene glycol may cause skin irritation.
2 of 4

3. How to use Aleric Gel

This medicine should always be used exactly as described in this patient information leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Apply the gel 2 to 4 times daily, covering the affected and itchy skin area with a thin layer. The medicine should be applied to intact skin only and must not be applied to open wounds.
Method of administration
Topical application to the skin.
Do not use occlusive dressings (e.g. airtight bandages) with this product.
Use in children
Use of Aleric Gel in infants aged over 1 month up to 1 year of age should be under medical supervision.
Aleric Gel must not be used in children under 1 month of age.
Do not use this medicine in infants and young children over large areas of skin, especially in cases of injuries, second- and third-degree burns, or inflammatory skin conditions.
If there is no improvement after 2 days of treatment in infants and children, or after 7 days in adults, or if symptoms worsen, consult a doctor.
Overdose of Aleric Gel
There have been no reported cases of overdose with Aleric Gel when applied topically to the skin.
In case of accidental ingestion, seek immediate medical advice from a doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Missed dose of Aleric Gel
Do not apply a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Frequency unknown (cannot be estimated from the available data)

• Dry skin.
• Skin burning sensation.
• Allergic skin reactions including rash and itching.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: + 48 22 49 21 301; fax: + 48 22 49 21 309;
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
3 of 4
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Aleric Gel

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the tube and carton after "EXP". The expiry date refers to the last day of the stated month.
Period of use after first opening the immediate packaging: 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What Aleric Gel contains

• The active substance is dimetindene maleate. One gram of gel contains 1 mg of dimetindene maleate.
• Other ingredients are: benzalkonium chloride, solution; disodium edetate; carbomer (type 974 P); sodium hydroxide; propylene glycol (E 1520); purified water.

What Aleric Gel looks like and contents of the pack
Aleric Gel is a colourless, clear to slightly opalescent, homogeneous gel.
Aluminium tube with a membrane, internally coated with epoxy-phenolic varnish, with a PP cap with a piercing nozzle, in a cardboard box.
Pack sizes: aluminium tube containing 30 g or 50 g of gel.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.,
ul. Ziębicka 40, 50-507 Wrocław
Manufacturer:
Laboratórios Basi - Industria Farmaceutica, S.A.
Parque Industrial Manuel Lourernҫo Ferreira, Lotes 8, 15 e 16, 3450-232 Mortagua, Portugal
For further information about this medicinal product, please contact:
USP Zdrowie Sp. z o.o.,
ul. Poleczki 35, 02-822 Warsaw, tel. +48 (22) 543 60 00.
4 of 4