VASELINE REIG JOFRE OINTMENT

Patient Information Leaflet

Introduction

Patient Information Leaflet

Vaselina pura Reig Jofre ointment

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Always follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 6 days.

Contents of the leaflet

1. What Vaselina pura Reig Jofre is and what it is used for
2. What you need to know before using Vaselina pura Reig Jofre
3. How to use Vaselina pura Reig Jofre
4. Possible side effects
5. How to store Vaselina pura Reig Jofre
6. Contents of the pack and other information

1. What Vaselina pura Reig Jofre is and what it is used for

It is an emollient ointment.

Vaselina pura Reig Jofre is indicated for: Symptomatic relief of dry, cracked, and irritated skin. As a protective and soothing agent for the skin due to its emollient properties (softening action).

Use by qualified healthcare personnel: as a general lubricant for gynecological and rectal examinations, insertion of catheters, and application of dressings.

2. What you need to know before starting to use Vaselina pura Reig Jofre

Do not use Vaselina pura Reig Jofre:

• If you are allergic to petroleum jelly.
• On infected areas or wounds.

Warnings and precautions

Consult your doctor or pharmacist before using Vaselina pura Reig Jofre.

• This is a medicine for external use only. Do not ingest.
• Avoid contact with the eyes.

Children and adolescents

This medicine may be used on children's skin.

Regarding use in explorations, data in children are not available.

Use of Vaselina pura Reig Jofre with other medicines

The use of this medicine does not interact with the use of other medicines.

Pregnancy and breastfeeding

This medicine may be used during pregnancy on the skin.

Do not apply the medicine to the breasts if you are breastfeeding.

Driving and use of machines

Not applicable.

3. How to use Vaselina pura Reig Jofre

Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

• On the skin: Apply a thin layer of vaseline to the affected area one to three times a day.
• During gynecological and rectal examinations (by qualified healthcare personnel): Apply a thin layer of the product to the area of friction before the examination.

If you use more Vaselina pura Reig Jofre than you should

No adverse effects have been reported when using a thin layer of vaseline on the skin.

With excessive dosing on mucous membranes (for example, in the nasal passages), leakage or aspiration may occur, leading to adverse effects.

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

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.

Rarely, hypersensitivity reactions have occurred in susceptible individuals.

Acne and inflammatory reactions following absorption due to unindicated use have also been reported.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Reig Jofre White Petroleum Jelly

Store below 30°C.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vaselina pura Reig Jofre

• The active substance is vaseline.
• It does not contain excipients.

Nature of the product and pack contents

The product is presented as an ointment; this is white or almost white and greasy to the touch.

It is available in a printed aluminium tube containing 18 g, 25 g or 32 g of ointment.

Marketing Authorization Holder

Laboratorio Reig Jofré, S.A.

C/ Gran Capitán, 10

08970 – Sant Joan Despí (Barcelona)

Spain

Manufacturer

BIOGLAN AB

Box 503 10

SE-202 13 Malmö

Sweden

Date of the most recent review of this leaflet: March 2025.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS):

http://www.aemps.gob.es/.