VAPORUB POMADA OINTMENT

Introduction

Leaflet: information for the user

VapoRub ointment

Read this leaflet carefully before starting to use this medicine, as it contains important information for you

Follow the administration instructions of the medicine contained in this leaflet or as indicated 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 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 it worsens or does not improve after 7 days.

Contents of the leaflet

1. What VapoRub is and what it is used for
2. What you need to know before starting to use VapoRub
3. How to use VapoRub
4. Possible side effects
5. 5 Storage of VapoRub
6. Package contents and additional information

1. What VapoRub is and what it is used for

VapoRub is an ointment used for the symptomatic relief of cough and nasal congestion present in colds and flu. It can be used directly on the skin (cutaneous use) or diluted in hot water for inhalation of the vapors.

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before starting to use VapoRub

Do not use VapoRub:

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6),
• in children under 6 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use VapoRub:

• if you are hypersensitive to perfumes or solvents,
• if you have or have had episodes of seizures or epilepsy,
• if you have or have had diseases such as bronchial asthma, or other respiratory diseases or hypersensitivities.

Children

It should be used with caution in children under 7 years of age, especially if they have had episodes of seizures or epilepsy.

Using VapoRub with other medicines

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

Pregnancy and breastfeeding

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

VapoRub is contraindicated during pregnancy and breastfeeding.

Driving and using machines

VapoRub does not interfere with the ability to drive vehicles or use machines.

3. How to use VapoRub

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 6 years of age:

Cutaneous use

• Apply a thin layer of ointment to the chest, neck, and back. Avoid contact with eyes and mucous membranes. Repeat application up to 3 times a day. Wear loose clothing to facilitate inhalation of the vapors.

Inhalation

• Add a spoonful of VapoRub to a container with hot water (not boiling). Inhale the vapors for 10-15 minutes.

Caution: neither VapoRub nor the mixture should be reheated in the microwave.

Children should always be under adult supervision during the use of this medicine.

VapoRub is for external use only. Do not exceed the recommended dose. Do not swallow or apply to the nasal passages or face. Do not apply to damaged or wounded skin.

Do not use for more than 7 consecutive days. If symptoms persist or worsen, consult your doctor or pharmacist.

Use in children

VapoRub is contraindicated in children under 6 years of age.

If you use more VapoRub than you should

No cases of overdose have been reported.

In case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

In case of accidental ingestion of VapoRub in children, consult a doctor immediately for necessary treatment. Do not attempt to induce vomiting.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

During the use of VapoRub, the following side effects have been reported, whose frequency could not be estimated from the available data:

• Ocular irritation (by inhalation)
• Redness, skin irritation, allergic dermatitis.
• Burn at the application site

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of VapoRub

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

No special storage conditions are required.

Keep away from fire or flames.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

VapoRub composition

• The active ingredients per 1 g of ointment are: 50 mg of camphor, 50 mg of turpentine oil, 27.5 mg of menthol, 15 mg of eucalyptus oil, and 2.5 mg of thymol.
• The other components are: cedar oil, petroleum jelly.

Appearance of the product and package contents

VapoRub is a greasy ointment, semi-solid in consistency and white in color. It is available in 35g (multidose packaging with cutaneous applicator), 50g, and 100g packages.

Marketing authorization holder and manufacturer

Laboratorios Vicks, S.L.U.

Avda. Bruselas, 24

28108 Alcobendas (MADRID)

Local representative

Procter & Gamble España S.A.U.

Avda. Bruselas, 24

28108 Alcobendas (MADRID)

Manufacturer

Procter & Gamble Manufacturing GmbH

Procter & Gamble Strasse, 1

D-64521 Gross Gerau

Germany

Date of the last revision of this leaflet: March 2025

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