Label: Information for the User

VapoRub Ointment

Read this label carefully before starting to use this medication, as it contains important information for you

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

VapoRub is a topical ointment used for symptomatic relief of cough and nasal congestion associated with the common cold and flu. It can be applied directly to the skin (topical use) or diluted in hot water for inhalation of vapors.

Consult a doctor if symptoms worsen or do not improve after 7 days

Do not use VapoRub:

• if you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6),
• in children under 6 years old

Warnings and precautions

Consult your doctor or pharmacist before starting to use VapoRub:

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

Children

Use with caution in children under 7 years old, especially if they have had episodes of seizures or epilepsy.

Use of VapoRub with other medications

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

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 medication.

VapoRub is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery

VapoRub does not interfere with the ability to drive vehicles or operate machinery.

Follow exactly the medication administration instructions contained in this leaflet or those 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 old:

Cutaneous use

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

Inhalation

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

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

Children must always be supervised by an adult during the use of this medication.

VapoRub is only for external use. Do not exceed the recommended dose. Do not swallow or apply to the nostrils or face. Do not apply to damaged or injured 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 old.

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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

During the use of VapoRub, the following adverse effects have been reported, whose frequency has not been estimated from the available data:

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store below 25°C.

Keep away from fire or flames.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of VapoRub

• The active principles per 1 g of ointment are: 50 mg of camphor, 50 mg of eucalyptus 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 content of the packaging

VapoRub is a greasy, thick semi-solid paste of a whitish color. It is presented in 50 g and 100 g containers.

Holder of the marketing authorization and responsible for manufacturing

Vicks Laboratories, S.L.

Brussels Avenue, 24

28108 Alcobendas (MADRID)

Local representative

Procter & Gamble España S.A.

Brussels Avenue, 24

28108 Alcobendas (MADRID)

Responsible for manufacturing

Procter & Gamble Manufacturing GmbH

Procter & Gamble Street, 1

D-64521 Gross Gerau

Germany

Last review date of this prospectus: October 2018

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)