Dimetindene Alkaloid-Int
Italy
Package leaflet: Information for the patient
Dimetindene Alkaloid-INT 1 mg/g gel
dimethindene maleate
Please read all of 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, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.
Contents of this leaflet
- What Dimetindene Alkaloid-INT is and what it is used for
- What you need to know before using Dimetindene Alkaloid-INT
- How to use Dimetindene Alkaloid-INT
- Possible side effects
- How to store Dimetindene Alkaloid-INT
- Contents of the pack and other information
1. What Dimetindene Alkaloid-INT is and what it is used for
Dimetindene Alkaloid-INT contains the active substance dimetindene maleate, which belongs to a group
of medicines known as antihistamines (antiallergic medicines).
Dimetindene Alkaloid-INT is used for the short-term relief of itching associated with
skin reactions such as skin rashes, urticaria, insect bites, sunburns, and superficial burns (first-degree).
How Dimetindene Alkaloid-INT works
Dimetindene Alkaloid-INT stops itching by blocking the action of histamine released by the body during
an allergic reaction. As the gel penetrates the skin, itching and irritation are rapidly relieved,
within a few minutes. It also has a local anesthetic effect.
Dimetindene Alkaloid-INT is indicated for use in adults, adolescents, and children from 1 month of age.
Consult your doctor if you do not notice improvement or if 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 unsure, consult your doctor or pharmacist.
- on damaged or broken skin.
If any of the conditions listed above 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 sunlight of skin areas treated with Dimetindene Alkaloid-INT.
- Inform your doctor if you experience severe itching or significant skin lesions.
- Avoid contact of the medicine with eyes or mucous membranes.
- The gel must not be applied to large skin areas in newborns or young children, and must not be used if the skin is damaged or inflamed (swollen).
Children
Dimetindene Alkaloid-INT must not be used in newborns under 1 month of age.
Avoid use on extensive skin areas in infants aged 1 month and older and in young children.
Other medicines and Dimetindene Alkaloid-INT:
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Do not apply Dimetindene Alkaloid-INT to large skin areas during pregnancy and breastfeeding, especially if the skin is damaged or swollen. If you are breastfeeding, do not apply the gel to the nipples. Since this medicine contains benzalkonium chloride, do not apply it to the breast while breastfeeding, as it may be ingested by the infant with breast milk.
Driving and using machines
The application of Dimetindene Alkaloid-INT to the skin does not affect or affects negligibly the ability to drive or operate machinery.
Dimetindene Alkaloid-INT contains benzalkonium chloride.
This medicine contains 0.05 mg of benzalkonium chloride per gram.
Benzalkonium chloride may cause skin irritation. Do not apply this medicine to the breast while breastfeeding, as the infant may ingest it through breast milk.
Dimetindene Alkaloid-INT contains propylene glycol.
This medicine contains 150 mg of propylene glycol per gram. Propylene glycol may cause skin irritation.
3. How to use Dimetindene Alkaloid-INT
Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply Dimetindene Alkaloid-INT in a thin layer to the affected, itchy skin area, up to 3 times daily.
This medicine should only be applied to undamaged and healthy skin. Apply this medicine to intact skin only and do not apply it to inflamed skin or open wounds (such as cuts and open sores).
Use in children
Avoid use on large skin areas in infants aged 1 month and older and in young children.
Dimetindene Alkaloid-INT must not be used in infants under 1 month of age.
After applying the gel, wash your hands (unless the gel has been applied to the hands).
Do not cover with occlusive dressings.
Contact your doctor if you do not notice any improvement or if 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, contact your doctor immediately.
The following symptoms may occur: drowsiness (especially in adults), excitement, movement coordination disorder (ataxia), hallucinations, involuntary muscle contractions (tonic-clonic spasms), dilated pupils (mydriasis), dry mouth, facial flushing with sensation of warmth, urinary retention, and fever. Low blood pressure (hypotension) may also occur.
If you have any questions about 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 will experience them.
The following side effects occur with unknown frequency (frequency cannot be determined from the available data):
- dry skin;
- skin burning sensation;
- allergic rash accompanied by itching.
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 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 stated on the packaging, provided it is stored below 25°C.
Do not use this medicine after the expiry date shown on the carton and tube 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 no longer required. This will help protect the environment.
6. Package contents and other information
What Dimetindene Alkaloid-INT contains
The active substance is dimetindene maleate. 1 g of gel contains 1 mg of dimetindene maleate.
The other components are: disodium edetate, carbomer, sodium hydroxide, benzalkonium chloride, propylene
glycol and purified water.
Description of the appearance of Dimetindene Alkaloid-INT and package contents
Dimetindene Alkaloid-INT is a homogeneous, odourless, colourless gel, from transparent to slightly
opalescent, packed in an aluminium tube with a white polyethylene closure.
It is available in a cardboard box containing one tube with 30 g of gel and the patient leaflet.
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 under the
following names:
Croatia FLENTY 1 mg/g gel
FLENTY 1 mg/g gel/
Bulgaria
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