DIMETINDENE 1 mg /G Гель

Содержание инструкции

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

Dimetindene Alkaloid-INT 1 mg/g gel

dimetindene maleate

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 effect occurs, 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 Dimetindene Alkaloid-INT is and what it is used for
• 2. What you need to know before using Dimetindene Alkaloid-INT
• 3. How to use Dimetindene Alkaloid-INT
• 4. Possible side effects
• 5. How to store Dimetindene Alkaloid-INT
• 6. Contents of the pack and other information

1. What is Dimetindene Alkaloid-INT and what is it used for

Dimetindene Alkaloid-INT contains the active ingredient dimetindene maleate which belongs to the group
of medicines known as antihistamines (anti-allergic medicines).
Dimetindene Alkaloid-INT is used for the short-term relief of itching accompanying
skin reactions such as rashes, urticaria, insect bites, sunburns and superficial (1st degree) burns.
How does Dimetindene Alkaloid-INT work
Dimetindene Alkaloid-INT stops itching by blocking the action of histamine released by the body during
an allergic reaction. When the gel penetrates the skin, itching and irritation are relieved
quickly, within a few minutes. It also has a local anesthetic effect.
Dimetindene Alkaloid-INT is indicated in adults, adolescents and children from 1 month of age.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

2. What you need to know before using Dimetindene Alkaloid-INT

Do not use Dimetindene Alkaloid-INT

• if you are allergic to dimetindene maleate or to any of the other ingredients of this medicine (listed in section 6). If you are not sure, ask your doctor or pharmacist.
• on damaged or broken skin.

If any of the above conditions apply to you, do not use Dimetindene Alkaloid-INT.

Warnings and precautions
Talk to your doctor or pharmacist before using Dimetindene Alkaloid-INT

• Avoid prolonged exposure to the sun of the skin areas treated with Dimetindene Alkaloid-INT.
• Inform your doctor in case of very severe itching or significant skin lesions.
• Avoid contact of the medicine with the eyes or mucous membranes.
• The gel should not be applied to extensive areas of skin in newborns or small children and should not be applied if the skin is damaged or inflamed (swollen).

Children
Dimetindene Alkaloid-INT should not be used in newborns less than 1 month of age.
Avoid use on extensive skin areas in newborns aged 1 month or more and in small children.

Other medicines and Dimetindene Alkaloid-INT:
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

Pregnancy and breastfeeding
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 Dimetindene Alkaloid-INT to extensive areas of skin during pregnancy and breastfeeding,
especially if the skin is damaged or swollen. If you are breastfeeding, do not apply the gel to the
nipples. Because this medicine contains benzalkonium chloride, do not apply it to the breast if you are
breastfeeding as it may be ingested by the infant with the milk.

Driving and using machines
Applying Dimetindene Alkaloid-INT to the skin does not alter or negligibly alters the
ability to drive vehicles or use machines.

Dimetindene Alkaloid-INT contains benzalkonium chloride.
This medicine contains 0.05 mg of benzalkonium chloride per gram.
Benzalkonium chloride can irritate the skin. Do not apply this medicine to the breast if you are breastfeeding
as the baby may ingest it with your milk.

Dimetindene Alkaloid-INT contains propylene glycol.
This medicine contains 150 mg of propylene glycol per gram. Propylene glycol can
cause skin irritation.

3. How to use Dimetindene Alkaloid-INT

Use this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dimetindene Alkaloid-INT is applied in a thin layer to the affected and itchy skin area, up to 3 times a day.
This medicine should only be applied to undamaged and healthy skin. Apply this medicine to intact skin and do not apply it to inflamed skin or open wounds (such as cuts and open sores).

Use in children
Avoid use on extensive skin areas in neonates aged 1 month and over and in young children.
Dimetindene Alkaloid-INT should not be used in neonates under 1 month of age.
After applying the gel, wash your hands (unless you are applying the gel to your hands).
Do not cover with occlusive dressings.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days of using Dimetindene Alkaloid-INT.

If you use more Dimetindene Alkaloid-INT than you should
If you or your child accidentally ingest Dimetindene Alkaloid-INT, seek immediate medical attention.
The following symptoms may occur: drowsiness (especially in adults), excitement, disturbance of movement coordination (ataxia), hallucinations, involuntary muscle contractions (tonic-clonic spasms), dilated pupils (mydriasis), dry mouth, facial flushing with a feeling of warmth, urinary retention, and fever. Low blood pressure (hypotension) may also occur.
If you have any questions regarding the use of this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects occur with an unknown frequency(the frequency cannot be
defined based on available data):

• dry skin;
• burning skin sensation;
• allergic rash accompanied by itching.

Reporting of side effects
If you get any side effects, talk to 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 .
Reporting side effects helps to provide more information on the safety of
this medicine.

5. How to store Dimetindene Alkaloid-INT

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light. Do not freeze.
After first opening, the medicine can be used until the expiry date indicated on the
pack if stored at a temperature below 25 C.
Do not use this medicine after the expiry date which is stated on the carton and tube after Exp.
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 Dimetindene Alkaloid-INT contains
The active ingredient is dimetindene maleate. 1 g of gel contains 1 mg of dimetindene maleate.
The other ingredients are: disodium edetate, carbomer, sodium hydroxide, benzalkonium chloride, propylene
glycol and purified water.

Description of the appearance of Dimetindene Alkaloid-INT and contents of the pack
Dimetindene Alkaloid-INT is a homogeneous, odorless, colorless gel, from transparent to slightly
opalescent, packaged in an aluminum tube with a white polyethylene cap.
patient.

Marketing authorisation holder and manufacturer
Alkaloid-INT d.o.o.
Šlandrova ulica 4
Ljubljana-Črnuče, 1231, Slovenia
email: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Croatia FLENTY 1 mg/g gel
Bulgaria
FLENTY 1 mg/g gel/
Фленти 1 mg/g гел
Slovenia FLENTY 1 mg/g gel
Romania FLENTY 1 mg/g gel
Germany Dimetinden Alkaloid-INT 1 mg/g Gel
Italy Dimetindene Alkaloid-INT