MENTHOLATED VASELINE ORROVAN 20 MG/G OINTMENT

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Orravan Mentholated Vaseline 20 mg/g ointment

Menthol

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

Follow exactly the instructions for use of the medicine contained in this

leaflet or those provided 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 your condition worsens or does not improve after 5 days.

Contents of the leaflet

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

1. What Vaselina Mentolada Orravan is and what it is used for

It contains menthol as the active ingredient, which when applied to the skin produces a cooling sensation followed by an analgesic (pain-relieving) effect, and also has decongestant properties.

Vaselina Mentolada Orravan is indicated for:

• Symptomatic relief of superficial skin pains such as itching and urticaria (itchy skin rashes), and neuropathic-type pains (originating from a nerve).
• Relief of nasal congestion symptoms when applied to the chest.

2. What you need to know before starting to use Vaselina Mentolada Orravan

Do not use Vaselina Mentolada Orravan:

• If you are allergic to menthol or to the other component of this medicine, vaseline.
• In children under 3 years of age.
• On areas of skin that are infected, inflamed, or wounded, or in inflammatory skin diseases.

Warnings and precautions

Consult your doctor or pharmacist before using Vaselina Mentolada Orravan.

• This medicine is for external use only.
• Avoid contact with the eyes.
• Do not ingest.
• If discomfort persists during treatment, consult your doctor.

Children and adolescents

Do not use this medicine in children under 3 years of age for safety reasons.

Use of Vaselina Mentolada Orravan with other medicines

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

Pregnancy, breastfeeding and fertility

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

This medicine may be used on the skin during pregnancy, but is only recommended when no safer alternatives are available.

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

Driving and operating machinery

Not applicable.

3. How to use Vaselina Mentolada Orravan

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and children over 3 years of age:

• As an analgesic, apply a thin layer of the product to the affected area twice daily.
• As a decongestant, apply a thin layer of the ointment to the chest at night before going to bed.

For cutaneous use.

Apply the ointment with gentle massage.

Wash your hands after each application.

If symptoms worsen or persist for more than 5 days of treatment, consult your doctor.

Use in children

Do not use this medicine in children under 3 years of age.

If you use more Vaselina Mentolada Orravan than you should

Due to the type of medicine and its route of administration, overdose poisoning is not expected.

Accidental ingestion of large amounts of menthol may cause gastrointestinal disturbances such as nausea and vomiting, as well as drowsiness or other effects. Inhalation of high amounts of menthol may also cause adverse effects.

Symptomatic treatment will be required.

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

If you forget to use Vaselina Mentolada Orravan

Do not apply a double dose to make up for missed doses.

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.

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

However, some adverse effects could occur:

Hypersensitivity reactions to menthol, such as contact dermatitis, may occur. Sensitivity reactions to petroleum jelly may occur rarely.

Acne has 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Orravan Mentholated Vaseline

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 drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, 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 Orravan Mentholated Vaseline 20 mg/g ointment

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

Appearance of the medicine and contents of the pack

The medicine is presented as an ointment; it is whiteish and greasy to the touch.

It is supplied in an aluminium tube containing 13 g of ointment.

Marketing Authorization Holder and Manufacturer

Laboratorio Reig Jofré, S.A.

C/ Gran Capitán, 10

08970 – Sant Joan Despí (Barcelona), Spain

Date of the most recent review of this leaflet: 06/2015.

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