Relepost 20 mg/g cutaneous patch

Spain
Brand name Relepost 20 mg/g cutaneous patch
Form barrier, cutaneous
Active substance / Dosage
Prescription type Over The Counter
Registration number 88786
Relepost 20 mg/g cutaneous patch barrier, cutaneous

Patient Information Leaflet

Introduction

Patient Information Leaflet

Relepost 20 mg/g cutaneous bar

Tripelennamine hydrochloride

Read the entire package leaflet carefully before you start using this medicine, as it contains important information for you.

Follow exactly the instructions for use provided in this leaflet

or those given by your doctor or pharmacist.

  • Keep this leaflet, as you may need to read it again.
  • If you need advice or further information, consult your pharmacist.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are

adverse effects not listed in this leaflet. See section 4.

  • You should consult a doctor if you worsen or do not improve after 4 days.

Package leaflet contents

  1. What Relepost is and what it is 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 other information

1. What Relepost is and what it is used for

It contains the active substance tripelenamine hydrochloride, which is an antihistamine, a medicine used on the skin to relieve or reduce the effects of allergies, thereby decreasing symptoms such as itching or pain caused by certain agents.

RelePost is used for the temporary relief of itching, pain, or stinging caused by insect bites, 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 ingredients of this medicine (listed in section 6).
  • If you have skin inflammation with fluid discharge and/or small blisters (exudative and/or vesicular dermatitis).
  • In children under 2 years of age.
  • Over large areas of skin and in cases of skin inflammation surrounding the affected area.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Relepost.

Do not use on open wounds.

If you are allergic to the active substance of this medicine or to ethylenediamine-related substances, you may also experience cross-sensitivity to antihistamine medicines, such as aminophylline or hydroxyzine.

Children

This medicine must not be used in children under 2 years of age.

In children over 2 years and under 6 years of age, the use of this medicine should be carefully considered, as although absorption is minimal, sedative effects and others may occur.

Other medicines and Relepost

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No interactions with this medicine are known.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your pharmacist before using this medicine.

Relepost may be used during pregnancy under medical prescription and during breastfeeding.

There are no available data indicating that Relepost affects fertility.

Driving and using machines

Relepost has no influence on the ability to drive or operate machinery.

Relepost contains propylene glycol (E1520).

This medicine contains 715 mg of propylene glycol per gram.

Propylene glycol may cause skin irritation.

3. How to use Relepost

Follow exactly the instructions for administration provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult 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 daily.

For topical use only.

Glide the stick gently with light massage over the affected area.

Apply only to small-sized lesions (no larger than the size of the palm of the hand) and for short-term treatment (maximum seven days).

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

Use in children

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

In children aged over 2 years and under 6 years, use should be evaluated by a doctor or pharmacist.

If you use more Relepost than you should

With a topical stick, overdose is not considered significant.

In cases of systemic intoxication, symptoms may include lethargy, agitation, confusion, tinnitus, blurred vision, dilated pupils, dry mouth, skin flushing, fever, tremors, insomnia, and hallucinations. Toxic reactions have been reported in a child (agitation, seizures, ...) following application over a large body surface area.

In case of overdose or accidental ingestion, seek immediate medical attention at a healthcare facility, or contact your doctor or pharmacist, or call the Toxicology Information Service at telephone number 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 missed doses.

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of RelePost

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

Store in the original tightly closed packaging. Do not store above 25 °C.

Do not refrigerate or freeze.

Do not use this medicine after the expiry date stated on the carton and on the base of the cutaneous bar applicator after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you observe a colour different from white or if the product has a soft consistency.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Relepost

The active substance 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 container

White, oval-shaped, 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), Spain

Manufacturer

Medgenix Benelux NV

Vliegveld 21

Wevelgem, 8560

Belgium

Date of the most recent revision of this leaflet: March 2024

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