Patient Information Leaflet

Relipic 1 mg/g gel

dimetindene maleate
Generic medicine
Please read all of this leaflet carefully before you start 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 to do.

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.
Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms after 3 days.

Contents of this leaflet:

What Relipic gel is and what it is used for
What you need to know before using Relipic gel
How to use Relipic gel
Possible side effects
How to store Relipic gel
Contents of the pack and other information

1. What Relipic gel is and what it is used for

Relipic gel contains the active substance dimethindene maleate, an active ingredient belonging to a group of medicines called antihistamines, used to relieve skin allergies and pruritus (itching sensation) of various origins.
Relipic reduces the sensation of itching by blocking the action of histamine in the body. Histamine is a substance released by the body during allergic reactions. When Relipic is absorbed through the skin, it relieves itching and skin irritations within a few minutes. Relipic also has local anaesthetic properties.
Relipic is indicated for adults, adolescents, and children aged 1 month and older for the short-term relief of skin pruritus associated with skin irritations such as minor rashes, urticaria, insect bites, mild sunburns, and minor superficial first-degree skin burns (skin redness).
Relipic should be used under medical supervision in children between 1 month and 2 years of age.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before using Relipic gel

Do not use Relipic gel:

if you are allergic to dimethindene maleate or to any of the other ingredients of this medicine (listed in section 6). If in doubt, consult your doctor or pharmacist
in cases of second- and third-degree skin burns
in children under 1 month of age, particularly premature infants
on large areas of skin
on damaged skin.

Warnings and precautions
Talk to your doctor or pharmacist before using Relipic gel:

avoid prolonged sun exposure of the treated skin areas;
inform your doctor if you experience intense itching or in case of extensive skin lesions;
use only on healthy, intact skin, without wounds.
If necessary, when covering wounds, dressings must not be occlusive.
Do not apply on large skin areas, especially in case of skin lesions and inflammation, particularly in infants, young children, and pregnant women.

Children
In infants and young children, do not use on large skin areas, especially in case of skin lesions and inflammation.
Do not use Relipic in children under 1 month of age, particularly in premature infants (see Do not use Relipic).

Other medicines and Relipic gel
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 may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy and breastfeeding, Relipic gel should not be applied to large areas of skin, especially if the skin is inflamed or damaged.
During breastfeeding, do not apply the product on the breast to prevent its absorption by the infant.

Driving and using machines
The application of Relipic gel on the skin does not affect the ability to drive or operate machinery.

Relipic gel contains benzalkonium chloride
This medicine contains 0.050 mg of benzalkonium chloride in each g of product.
Benzalkonium chloride may cause skin irritation.
If you are breastfeeding, do not apply this medicine on the breast because the baby could ingest it through your milk.

Relipic gel contains propylene glycol
This medicine contains 150 mg of propylene glycol in each g of gel.
Propylene glycol may cause skin irritation. Do not use this medicine in children under 4 weeks of age with open wounds or extensive areas of damaged skin (such as burns) without first talking to your doctor or pharmacist.

3. How to use Relipic gel

Use this medicinal product exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose is:
Relipic should be applied in adults, adolescents, and children as a thin layer to the affected, itchy area of skin up to 3 times daily.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.
The maximum duration of treatment without consulting a doctor is 7 days.

Use in children
In infants and young children, avoid use over large areas of skin, particularly in the presence of skin lesions and inflammation.
Do not use Relipic in children under 1 month of age, especially in premature infants (see Do not use Relipic).
Relipic should be used under medical supervision in children aged between 1 month and 2 years.

How to use Relipic gel
Relipic gel is a topical medicinal product. Apply only to healthy, intact skin, without wounds.
Apply a small amount of the gel to the affected area. Then gently massage with your hands to promote drug penetration into the skin. Do not cover the treated area with occlusive dressings. Do not apply to large skin areas or mucous membranes. If itching is severe or lesions are extensive, consult a doctor or pharmacist.

If you use more Relipic gel than you should
Contact your doctor immediately if you or your child have applied a large amount of Relipic gel over extensive skin areas or if Relipic gel has been accidentally ingested.

If you forget to use Relipic gel
If you forget to apply Relipic gel, apply it as soon as you remember, then continue treatment as usual. Do not apply a double amount to make up for the missed application.

If you have any doubts about the use of this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Uncommon (may affect less than 1 in 100 people):

Dry skin
Skin burning sensation

Very rare (may affect less than 1 in 10,000 people):

Allergic skin inflammation (allergic dermatitis)

Not known (frequency cannot be estimated from the available data):

Skin allergic reactions

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 Relipic gel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label or packaging.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store in the original packaging to protect the medicine from light.
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 Relipic gel contains

The active substance is dimethindene maleate. Each gram of gel contains 1 mg of dimethindene maleate.
The other ingredients are: benzalkonium chloride, disodium edetate, carbomer (type 974 P), sodium hydroxide, propylene glycol (E1520), and purified water.

Description of the appearance of Relipic gel and contents of the pack
Relipic is presented as a topical gel. It is a homogeneous, transparent and colourless gel.
Relipic is available in:
Pack size: 30 g and 50 g tubes.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
TOWA PHARMACEUTICAL S.p.A.
Via Enrico Tazzoli 6
20154 Milan
Italy

Manufacturer:
Zakłady Farmaceutyczne POLPHARMA SA
Oddział Medana w Sieradzu
Władysława Łokietka 10
98-200 Sieradz
Poland

This medicinal product is authorised in the European Economic Area member states under the following names:
Italy: Relipic
Portugal: Relipic
Spain: Relipic

Detailed and up-to-date information on this product is available by scanning the QR Code on the outer packaging with a smartphone. The same information is also available at the following URL: https://www.pensapharma.it/relipic