PACKAGE LEAFLET: INFORMATION FOR THE USER
Relipic gel contains the active ingredient dimetindene maleate, an active ingredient belonging to a group of medicines called antihistamines, which are used to relieve skin allergies and various types of itching.
Relipic reduces itching by blocking the action of histamine in the body. Histamine is a substance released by the body during allergic reactions. Because Relipic is absorbed through the skin, it relieves itching and irritation within minutes. Relipic also has a local anaesthetic effect.
Relipic is recommended for adults, adolescents, and children aged 1 month and older for the short-term relief of itching associated with skin reactions such as minor rashes, hives, insect bites, minor sunburn and minor first-degree superficial skin burns (skin redness).
Relipic should be used under medical supervision in children between 1 month and 2 years of age.
If you do not feel better or get worse after 3 days, you must seek medical attention.
Do not use Relipic gel:
Warnings and precautions
Talk to your doctor or pharmacist before using Relipic gel.
Children
For infants and young children, avoid using Relipic gel on large areas of skin, especially in cases of skin injury and inflammation.
Do not use Relipic gel in children younger than 1 month, particularly premature infants (see "Do not use Relipic gel").
Other medicines and Relipic gel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to get pregnant, 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 has lesions.
The gel should not be applied to the breast during breastfeeding to prevent absorption by the infant.
Driving and operating machinery
The application of Relipic gel to 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 per gram of gel.
Benzalkonium chloride may irritate the skin.
You should not apply this medicine to your breasts if you are breastfeeding because your baby may ingest it through your milk.
Relipic gel contains propylene glycol
This medicine contains 150 mg propylene glycol per gram of gel.
Propylene glycol may cause skin irritation. Do not use this medicine on babies younger than 4 weeks with open wounds or large areas of cracked skin or lesions (such as burns) without consulting your doctor or pharmacist.
Use the medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist.
If you are unsure, talk to your doctor or pharmacist.
How to use Relipic
Relipic is a medicine for topical use. It is used on intact skin without wounds.
Apply a small amount to the area to be treated. Then gently massage with your hand to help the medicine penetrate the skin. Do not cover with occlusive dressings. Do not apply to large areas of skin or mucous membranes. In case of very severe itching or extensive lesions, consult a doctor or pharmacist.
If you use more Relipic gel than you should
If you or your child use a considerable amount of Relipic on large areas of skin or accidentally ingest Relipic, contact your doctor immediately.
If you forget to use Relipic
If you forget to use Relipic, use it as soon as you remember and continue to use it as normal.
Do not take a double dose to make up for a missed dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause undesirable effects, although not everybody has them.
Uncommon (may affect less than 1 in 100 patients)
Very rare (may affect less than 1 in 10,000 patients)
Unknown frequency (the frequency cannot be calculated from the available data)
Reporting undesirable effects
If you have any undesirable effects, talk to your doctor or pharmacist. This includes any possible undesirable effects not listed in this leaflet. You can also report undesirable effects directly to INFARMED, I.P. using the contact information indicated below.
By reporting undesirable effects, you will help provide more information on the safety of this medicine.
Website: http://www.infarmed.pt/web/infarmed/submissaoram
(preferably)
or at the following addresses:
Direção de Gestão do Risco de Medicamentos
Parque da Saúde de Lisboa, Av. Brasil 53
1749-004 Lisbon
Tel: +351 21 798 73 73
Medicine Helpline: 800222444 (free)
email: farmacovigilancia@infarmed.pt
What Relipic gel contains
The active substance is dimetindene maleate. Each gram of gel contains 1 mg of dimetindene maleate.
The other ingredients are: benzalkonium chloride, disodium edetate, carbomer (type 974 P), sodium hydroxide, propylene glycol (E1520) and purified water.
What Relipic Gel looks like and contents of the packet
Relipic gel comes in the form of a gel for topical use. It is a homogeneous, clear and colourless gel.
Relipic gel is available in 30 g and 50 g tubes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Towa Pharmaceutical, S.A.
Av. do Forte, 3, Edif. Suécia IV, Piso 0
2794-093 Carnaxide
Portugal
Manufacturer:
Zakłady Farmaceutyczne POLPHARMA S.A.
Oddział Medana w Sieradzu
ul. Władysława Łokietka 10
98-200 Sieradz
Poland
This medicine is authorised in the Member States of the European Economic Area (EEA) under the following names:
Italy: Relipic
Portugal: Relipic
Spain: Relipic
Detailed and up-to-date information on this medicine is available by scanning the 2D code printed on the packet with a smartphone. The same information is also available at the following URL: https://www.tolifeotc.com/relipic.
This leaflet was last approved in July 2025.