Vaseline pure Pege ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vaselina Pura Pege ointment

(Purified liquid paraffin)

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 indicated by your doctor, pharmacist or nurse.

• 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 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 if you do not improve after 6 days.

Contents of the leaflet

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

1. What Vaselina Pura Pege is and what it is used for

Vaselina Pura Pege is an emollient ointment.

It is indicated for the symptomatic relief of dry, cracked, irritated skin and chafing.

As a lip moisturizer. Skin protectant.

For use by qualified healthcare personnel: As a general lubricant in gynecological and rectal examinations, insertion of catheters, and application of dressings.

2. What you need to know before starting to use Vaselina Pura Pege

Do not use Vaselina Pura Pege

• If you are allergic to petroleum jelly.

Warnings and precautions

• Consult your doctor or pharmacist before using Vaselina Pura Pege.
• This is a medicine for external use only.
• Avoid contact with the eyes.
• Do not ingest.

Children and adolescents

Vaselina Pura Pege may be used in children as an emollient.

Use during examinations must be supervised by qualified healthcare personnel.

Use of Vaselina Pura Pege with other medicines

Inform your doctor or pharmacist if you are using or have recently used any 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 or pharmacist before using this medicine.

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

Driving and using machines

The use of this medicine does not affect the ability to drive or operate machinery.

3. How to use Vaselina Pura Pege

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

The recommended dose is:

• On skin and lips:

Cutaneous use.

Apply a thin layer of the product to the affected area 2 or 3 times daily, as needed.

• During gynecological and rectal examinations (by qualified healthcare personnel):

Apply a thin layer of the product to the area of friction before each examination.

Use in children and adolescents

Apply as indicated above.

If you use more Vaselina Pura Pege than you should

No cases of poisoning have been reported if you use more petroleum jelly than indicated.

Excessive rectal doses could cause anal leakage and irritation.

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

If you forget to use Vaselina Pura Pege

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

If you stop using Vaselina Pura Pege

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

4. Possible adverse effects

Like all medicines, Pure Petroleum Jelly Pege may produce adverse effects, although not everyone experiences them.

Isolated cases of allergy (sensitivity reaction) have occurred in susceptible individuals; acne may also occur. Cases of inflammatory reactions after absorption have 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 System of Pharmacovigilance of Human Medicines. Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pure Petroleum Jelly Pege

No special storage conditions are required.

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 is the last day of the month indicated.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Vaselina Pura Pege

• The active substance is filant pure petroleum jelly.
• It does not contain excipients.

Appearance of the product and contents of the container

The product is presented as an ointment; a white, translucent, greasy mass to the touch.

It is available in aluminum tubes containing 5 g and 33 g of ointment.

Marketing Authorization Holder and Manufacturer

LABORATORIOS BOHM, S.A.
C/ Molinaseca 23. Polígono Industrial Cobo Calleja.
28947 Fuenlabrada (Madrid)
Spain

Date of the most recent revision of this leaflet: April 2013.

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