Label: information for the user

Orravan 20 mg/g Mentholated Vaseline ointment

Menthol

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 5 days.

It contains menthol as the active ingredient, which, when applied to the skin, causes a sensation of cold followed by an analgesic effect (pain relief) and also has decongestant properties.

Mentholated Vaseline Orravan is indicated for:

- Symptomatic relief of superficial skin pain such as itching and urticaria (skin rashes with itching in general), and neuropathic pain (pain originating from a nerve).

- When applied to the chest, relief of symptoms of nasal congestion.

Do not use Orravan Mentholated Vaseline:

- If you are allergic to menthol or to any other component of this medication, the vaseline.

- In children under 3 years old.

- In areas of skin that are infected, inflamed, or injured, or in inflammatory skin diseases.

Warnings and precautions

Consult your doctor or pharmacist before using Orravan Mentholated Vaseline.

- It is a medication exclusively for external use.

- Avoid contact with the eyes.

- Do not ingest.

- If symptoms persist during treatment, consult your doctor.

Children and adolescents

Do not use this medication in children under 3 years old for safety reasons.

Use of Orravan Mentholated Vaseline with other medications

The use of this medication does not interact with the use of other medications.

Pregnancy, breastfeeding, and fertility

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

This medication can be used on the skin during pregnancy, but only in cases where there are no other safer alternatives.

Do not apply the medication to the breasts if breastfeeding a baby.

Driving and operating machines

No information available.

Follow exactly the administration instructions of the medication 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 3 years old:

- As an analgesic, apply a thin layer of the product to the affected area twice a day.

- As a decongestant, apply a thin layer of the ointment to the chest at bedtime.

Skin use.

Apply the ointment with a gentle massage.

Wash your hands after each application.

If symptoms worsen or persist after 5 days of treatment, consult your doctor.

Use in children

Do not use this medication in children under 3 years old.

If you use more Vaselina Mentolada Orravan than you should

Given the type of medication and the administration route, overdose is not expected.

Accidental ingestion of large amounts of menthol may cause digestive disturbances such as nausea, vomiting, or drowsiness, or other effects. Inhaling large amounts of menthol may also cause adverse effects.

Symptomatic treatment will be required.

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

If you forgot to use Vaselina Mentolada Orravan

Do not apply a double dose to compensate for the missed doses.

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

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

During the period of use of Vaselina Mentolada Orravan, no adverse effects have been reported.

However, some adverse effects may occur:

Reactions of hypersensitivity to menthol, such as contact dermatitis, may occur. Reactions of sensitivity to petroleum jelly may occur in rare cases.

Acne has also been reported.

Reporting Adverse Effects

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

Store below 30°C.

Keep this medication out of sight and reach of children.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Mentholated Vaseline Orravan 20 mg/g ointment

• The active ingredient is menthol. Each gram of ointment contains 20 mg of menthol (2%).
• The other component (excipient) is vaseline.

Appearance of the product and contents of the packaging

The medication is presented in the form of an ointment; it is white and greasy to the touch.

It is presented in an aluminum tube containing 13 g of ointment.

Holder of the marketing authorization and responsible for manufacturing

Laboratorio Reig Jofré, S.A.

C/ Gran Capitán, 10

08970 – Sant Joan Despí (Barcelona), Spain

Date of the last review of this leaflet: 06/2015.

Detailed and updated information on this medication is available on the

website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

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