FREST 1 mg /G Гель

Содержание инструкции

1. Frest 1 mg/g gel
   1. What is Frest and what is it used for
   2. What you need to know before using Frest
   3. How to use Frest
   4. Possible side effects
   5. How to store Frest
   6. Contents of the pack and other information

Frest 1 mg/g gel

dimetindene maleate

Equivalent medicine

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet:

• 1. What Frest is and what it is used for
• 2. What you need to know before using Frest
• 3. How to use Frest
• 4. Possible side effects
• 5. How to store Frest
• 6. Contents of the pack and other information

1. What is Frest and what is it used for

Frest contains an active ingredient that belongs to the group of medicines known as “antihistamines”
which are used to relieve skin allergies and itching of various origins.
Frest reduces itching by stopping the action of histamine in the body. Histamine is a substance released by the
body during allergic reactions. Because Frest is well absorbed by the skin, it relieves itching and irritation
of the skin in a few minutes. Frest also has local anesthetic properties.
Frest is used in adults, adolescents and children over one month of age for the short-term relief
of itching in skin conditions such as rashes and hives, as well as in case of insect bites, sunburns and superficial skin burns of 1st degree (skin redness).
Frest must 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 if you 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 any of the other ingredients of this medicine (listed in section 6)
• In case of second and third degree skin burns.
• Children under 1 month of age and especially premature babies.
• Application to large areas of skin.
• Application to 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 very severe itching or extensive skin lesions.
• Do not apply to large areas of skin or 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 and especially on areas with damaged and
inflamed skin.
Do not use Frest in children under 1 month of age and especially in premature babies (see Do not use Frest).

Other medicines and Frest
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Do not apply Frest to large areas of skin, especially if inflamed and wounded, and to the breasts during
breastfeeding.
Do not apply the gel to the nipples if you are breastfeeding.

Driving and operating machinery
Frest does not or negligibly alter the ability to drive vehicles and operate machinery.

Frest contains benzalkonium chloride and propylene glycol
This medicine contains 0.05 mg of benzalkonium chloride in every g of gel. Benzalkonium chloride can
irritate the skin. If you are breastfeeding, do not apply this medicine to the breasts as the baby could
ingest it with their milk.
This medicine contains 150 mg of propylene glycol in every g of gel. Propylene glycol can cause
skin irritation.
Do not use this medicine in children under 4 weeks of age with open wounds or large areas of skin
lesions or damage without consulting your doctor or pharmacist.

3. How to use Frest

Use this medicine following exactly what is reported in this leaflet or the instructions of the
doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.

The recommended dose is:
In adults, adolescents and children Frest must be applied in a thin layer on the affected and itchy area of the skin up to 3 times a day.
You should talk to 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 on 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 babies (see Do not use Frest)
Frest must be used under medical supervision in children between 1 month and 2 years of age.

How to use Frest
Frest is a medicine for external use. It is used on intact skin, without wounds.
Do not cover with occlusive bandages.
Do not apply to large areas of skin or on wounded skin or mucous membranes.
Apply a small amount to the area to be treated. Afterwards, perform a light massage with the
hand to facilitate the penetration of the gel in depth.

If you use more Frest than you should
Contact your doctor immediately if you or your child have used a large amount of Frest on
large areas of the skin or if you have accidentally ingested Frest.

If you forget to use Frest
If you forget to use Frest, use it as soon as you remember and then continue as usual.
Do not use a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, ask 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
• burning sensation on the skin.

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

• allergic dermatitis (skin inflammation of an allergic nature).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 at a temperature 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 Expiry. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Frest contains

• The active ingredient is dimetindene maleate. 1 g of gel contains 1 mg of dimetindene maleate
• The other ingredients are propylene glycol, carbomer 974P ,sodium hydroxide ,disodium edetate, benzalkonium chloride, purified water.

Description of the appearance of Frest and contents of the pack
Frest is a colorless to slightly opalescent gel, practically odorless.

Primary packaging
Aluminum tube (30 g or 50 g) with a nozzle sealed by a protective aluminum membrane placed on the orifice
of the nozzle and with a white HDPE or PP screw cap with a conical device for puncturing the membrane. The
aluminum tubes are coated internally with an epoxy phenolic lacquer J 3092 or TU25/N 48567

Secondary packaging
Not all pack sizes may be marketed.

Marketing authorization 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 Member States of the EEA with 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