RELEPOST 20 MG/G CUTANEOUS BAR

Introduction

Package Leaflet: Information for the User

Relepost 20 mg/g Cutaneous Bar

Tripelennamine Hydrochloride

Contents of the Package Leaflet

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

1. What is Relepost and what is it used for

It contains tripelennamine hydrochloride as the active ingredient, which is an antihistamine, a medication used on the skin to eliminate or reduce the effects of allergies, thereby reducing symptoms such as itching or pain caused by certain agents.

Relepost is used for the temporary relief of itching, pain, or stinging due to insect bites or contact with jellyfish or nettles, or itching due to mild skin irritations.

2. What you need to know before using Relepost

Do not use Relepost:

• If you are allergic to tripelennamine or related compounds or to any of the other components of this medication (listed in section 6).
• If you have a skin inflammation with fluid secretion and/or small blisters (exudative and/or vesicular dermatitis).
• In children under 2 years of age.
• On large areas of skin and in case of skin inflammation around the affected area.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Relepost.

Do not use on open wounds.

In case of allergy to the active ingredient of this medication or the related substance ethylenediamine, you may also have cross-sensitivity to antihistamine medications, such as aminophylline or hydroxyzine.

Children

This medication should not be used in children under 2 years of age.

In children over 2 years and under 6, the doctor or pharmacist should assess its use, as although absorption is minimal, sedative effects and others may occur.

Other medications and Relepost

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

No interactions with this medication are known.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your pharmacist before using this medication.

Relepost can be used during pregnancy under prescription and during breastfeeding.

No data are available on whether Relepost affects fertility.

Driving and using machines

Relepost has no influence on the ability to drive and use machines.

Relepost contains propylene glycol (E1520).

This medication contains 715 mg of propylene glycol per gram.

Propylene glycol may cause skin irritation.

3. How to use Relepost

Follow the administration instructions of the medication contained in this package leaflet exactly or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

• Adults and children over 6 years of age:

Relepost is applied to the affected skin area. Repeat if necessary, up to 3 or 4 times a day.

For cutaneous use.

Slide the bar with a gentle massage on the affected area.

Apply only to small-sized conditions (no larger than the size of the palm of the hand) for short-term treatments (maximum 7 days).

Do not use on damaged skin (or on wounds).

Use in children

This medication should not be used in children under 2 years of age.

In children over 2 years and under 6, the doctor or pharmacist should assess its use.

If you use more Relepost than you should

With a cutaneous bar, overdose is not relevant.

In case of systemic intoxication, symptoms may include lethargy, agitation, confusion, tinnitus, blurred vision, dilated pupils, dry mouth, flushing, fever, tremors, insomnia, and hallucinations. Toxic reactions have been reported in a child (agitation, convulsions, ...) in whom it was used on a large area of the body.

In case of overdose or accidental ingestion, go immediately to a medical center, consult your doctor or pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Relepost

Do not use a double dose to make up for forgotten doses.

Apply the dose as soon as you remember and the next dose at the usual time.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The most characteristic adverse reaction that may occur is irritation and mild allergic reactions on contact.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Relepost

Keep this medication out of the sight and reach of children.

Store in the original packaging, tightly closed. Do not store at a temperature above 25°C.

Do not refrigerate or freeze.

Do not use this medication after the expiration date shown on the box and on the base of the cutaneous bar applicator after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you notice a color different from white or a soft product consistency.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Relepost

The active ingredient is tripelennamine hydrochloride. Each gram contains 20 mg of tripelennamine hydrochloride (2%).

The other components (excipients) are: propylene glycol (E1520), sodium stearate, and water.

Appearance of the product and contents of the pack

White, oval-shaped, and consistent cutaneous bar.

Each applicator contains 5.7 grams.

Marketing authorization holder and manufacturer

Marketing authorization holder

Perrigo España S.A.

Pza. Xavier Cugat, 2 – Edif. D, Pl. 1ª

08174 Sant Cugat del Vallès (Barcelona), España

Manufacturer

Medgenix Benelux NV

Vliegveld 21

Wevelgem, 8560

Belgium

Date of the last revision of this package leaflet:March 2024

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).