Vaseline pure Cuve ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vaselina Pura CUVE ointment

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

Follow exactly the instructions for use provided in this leaflet or those given 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 reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions 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 CUVE is and what it is used for
2. What you need to know before using Vaselina Pura CUVE
3. How to use Vaselina Pura CUVE
4. Possible adverse effects
5. How to store Vaselina Pura CUVE
6. Contents of the pack and other information

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

Vaselina Pura CUVE is an ointment containing petroleum jelly as the active ingredient, which has softening and skin-protecting properties due to its emollient (softening) effects.

It is indicated for use on the skin to provide symptomatic relief of dryness, mild irritation, and excoriations (chafing).

As a general lubricant.

For use by qualified healthcare personnel: as a lubricant for digital rectal examinations or application of dressings.

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

Do not use Vaselina Pura CUVE

• If you are allergic to petroleum jelly (it contains no excipients).

• On areas of skin that are infected, inflamed, or injured, and in case of inflammatory skin diseases.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Vaselina Pura CUVE.

• This medicine is for external use only; do not ingest.
• Avoid contact of the medicine with the eyes.

In any case, if discomfort increases during treatment or after 6 days of treatment, or persists after discontinuation, you must consult your doctor.

Children

There are no available data on use in children.

Other medicines and Vaselina Pura CUVE

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to use any other medicines.

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

Pregnancy and breastfeeding

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

Given the type of medicine and route of administration, this medicine may be used during pregnancy.

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

Driving and using machines

Not applicable.

3. How to use Vaselina Pura CUVE

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

The recommended dose is:

On the skin: apply a thin layer of the product to the affected area 1 to 3 times daily.

For examinations: apply a thin layer of the product to the friction area prior to the examination.

For topical use.

By qualified healthcare personnel: other routes of administration.

If you use more Vaselina Pura CUVE than you should

Due to the type of medicine and the route of administration, there have been no reported cases of poisoning associated with overdose related to the topical use of vaseline.

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

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 cause adverse effects, although not everyone will experience them.

Although adverse effects have not been observed, some could still occur.

Hypersensitivity reactions have been reported rarely (may affect up to 1 in 1,000 people).

Acne may occur, although the frequency is unknown.

Inflammatory reactions have also been reported following absorption due to unindicated use.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of CUVE Pure Vaseline

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the container following EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, please ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of VASELINA PURA CUVE ointment

• The active substance is: Vaseline. 1 g of ointment contains 1 g of vaseline.
• It contains no excipients.

Appearance of the product and contents of the container

The ointment appears as a soft, translucent, white or almost white, greasy mass.

It is supplied in an aluminum tube containing 30 g of ointment.

Marketing Authorization Holder and Manufacturer

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431, Km. 19

Almodóvar del Río -14720

(Córdoba) - Spain

Date of the most recent review of this leaflet: September 2021.

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