Patient Information Leaflet

Frest 1 mg/g gel

Maleate de dimetindene
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

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, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

What Frest is and what it is used for
What you need to know before using Frest
How to use Frest
Possible side effects
How to store Frest
Package contents and other information

1. What Frest is and what it is used for

Frest contains an active substance that belongs to a group of medicines known as "antihistamines",
which are used to relieve skin allergies and itching of various origins.
Frest reduces itching by blocking the action of histamine in the body. Histamine is a substance released by
the body during allergic reactions. Since Frest is well absorbed through the skin, it relieves itching and skin irritation
within a few minutes. Frest also has local anaesthetic properties.
Frest is used in adults, adolescents, and children over 1 month of age for short-term relief of itching associated with
skin conditions such as skin rashes and urticaria, as well as insect bites, sunburn, and superficial first-degree skin burns (skin redness).
Frest should be used under medical supervision in children between 1 month and 2 years of age.
Consult a doctor if you do not feel better or feel worse after 3 days.

2. What you need to know before using Frest

Do not use Frest

if you are allergic to dimetindene maleate or to any of the other ingredients of this medicine (listed in section 6)
in case of second- and third-degree skin burns
in children under 1 month of age, particularly premature infants
on large areas of skin
on wounded skin

Warnings and precautions

If the skin area is treated intensively with Frest, prolonged exposure to sunlight should be avoided.
Inform your doctor if you experience severe itching or extensive skin lesions.
Do not apply on large areas of skin or on mucous membranes. Consult your doctor or pharmacist before using Frest.

Children
In infants and young children, do not use Frest on large areas of skin, particularly on areas with damaged and inflamed skin.
Do not use Frest in children under 1 month of age, particularly in premature infants (see Do not use Frest).

Other medicines and Frest
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not apply Frest over large areas of skin, especially if inflamed or damaged, or on the breast during breastfeeding.
Do not apply the gel on the nipples if you are breastfeeding.

Driving vehicles and using machinery
Frest does not affect, or affects negligibly, the ability to drive vehicles and use machinery.

Frest contains benzalkonium chloride and propylene glycol
This medicine contains 0.05 mg of benzalkonium chloride per gram of gel. Benzalkonium chloride may cause skin irritation. If you are breastfeeding, do not apply this medicine to the breast area, as the baby could ingest it through breast milk.
This medicine contains 150 mg of propylene glycol per gram of gel. Propylene glycol may cause skin irritation.
Do not use this medicine in children under 4 weeks of age with open wounds or large areas of damaged or injured skin (such as burns) without consulting your doctor or pharmacist.

3. How to use Frest

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.
Recommended dose:
In adults, adolescents, and children, Frest should be applied in a thin layer to the affected,
itchy area of skin up to 3 times daily.
You should speak with a doctor if you do not feel better or if you feel worse after 3 days.
The maximum duration of treatment without consulting a doctor is 7 days.
Use in children
In newborns and young children, avoid use over large areas of skin, especially in case of skin lesions and
inflammation.
Do not use Frest in children under 1 month of age, and particularly in premature infants (see Do not use Frest).
Frest should be used under medical supervision in children between 1 month and 2 years of age.
How to use Frest
Frest is a topical medicine. It is applied to intact, unbroken skin.
Do not cover with occlusive dressings.
Do not apply to large areas of skin or to broken or damaged skin or mucous membranes.
Apply a small amount to the area to be treated. Then gently massage with your hand to help the gel penetrate deeply.
If you use more Frest than you should
Contact your doctor immediately if you or your child have applied a large amount of Frest over
large areas of skin or if Frest has been accidentally ingested.
If you forget to use Frest
If you forget to use Frest, apply it as soon as you remember, then continue as usual.
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 gets them.

Uncommon side effects (may affect up to 1 in 100 people)

Dry skin
Skin burning sensation

Very rare side effects (may affect up to 1 in 10,000 people)

Allergic inflammation of the skin (allergic dermatitis)

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 Frest

Store below 25°C. Do not freeze.
Opened tube: 3 months.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Frest contains

The active substance is dimethindene maleate. 1 g of gel contains 1 mg of dimethindene maleate.
The other components are propylene glycol, carbomer 974P, sodium hydroxide, disodium edetate, benzalkonium chloride, purified water.

Description of the appearance of Frest and package contents
Frest is a colourless, clear to slightly opalescent gel, practically odourless.
Primary packaging
Aluminium tube (30 g or 50 g) with nozzle sealed by an aluminium protective membrane placed on the nozzle orifice, and with white HDPE or PP screw cap equipped with a conical device for piercing the membrane.
The aluminium tubes are internally coated with an epoxiphenolic lacquer J 3092 or TU25/N 48567.
Secondary packaging
Carton box containing the aluminium tube and the Package Leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel: +371 67083205
Fax: +371 67083505
E-mail: [email protected]

This medicinal product is authorised in the EEA Member States under the following names:
Portugal Dimestil
Latvia Dimestil 1 mg/g gel
Lithuania Frest 1 mg/g gelis
Estonia Dimestil
Czech Republic Frest
Slovakia Frest 1 mg/g gél
Hungary Dimestil 1 mg/g gel
Poland Frest
Romania Frest 1 mg/g gel
Slovenia Frest 1 mg/g gel
Austria Dimestil 1 mg/g gel
Germany Dimestil 1 mg/g Gel
Bulgaria Dimestil 1 mg/g гел
Croatia Dimetindenmaleat Grindeks 1 mg/g gel
Greece Dimestil 1 mg/g gel
Italy Frest
Spain Dimestil 1 mg/g gel