AMNIOLINA POMADA OINTMENT

Introduction

Leaflet: information for the user

AMNIOLINA ointment

Zinc oxide/ Talc

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist.

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

Contents of the leaflet

1. What AMNIOLINA ointment is and what it is used for
2. What you need to know before starting to use AMNIOLINA ointment
3. How to use AMNIOLINA ointment
4. Possible side effects
5. Storage of AMNIOLINA ointment
6. Package contents and additional information

1. What is Amniolina ointment and what it is used for

It contains zinc oxide and talc as active ingredients. Zinc oxide is a skin protector that acts as a barrier between the skin and irritants, and talc relieves skin irritations; they facilitate healing.

Amniolina is indicated for the prevention and treatment of diaper area dermatitis (inflammation and irritation of the skin in contact with the diaper) and for the prevention of chafing and irritations in other areas of friction with clothing or other areas of the skin.

Amniolina ointment is indicated for children and incontinent adults.

2. What you need to know before starting to use Amniolina ointment

Do not use Amniolina

• If you are allergic to zinc oxide, talc, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Amniolina ointment.

• This medication is for external use (cutaneous).
• Avoid contact with the eyes, nose, mouth, ears, or other mucous membranes.
• Do not use if the skin area to be treated has wounds that secrete fluid.

Children

This medication is indicated for children. The usual precautions are required in babies and children.

Using Amniolina ointment with other medications

Tell your doctor or pharmacist if you are using, have recently used, 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.

In necessary cases, you can use this medication if necessary, with due precautions.

Driving and using machines:

This medication does not affect the ability to drive and use machines.

Amniolina ointment contains lanolin

This medication may cause local skin reactions (such as contact dermatitis) because it contains lanolin.

3. How to use Amniolina ointment

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

For external use (on the skin).

Apply the ointment regularly to the area to be treated, usually after a diaper change.

Method of use

Clean and dry the area to be protected or treated well. Apply Amniolina to the area, spreading the ointment with your fingertips in a smooth but insistent manner, until you cover the entire surface of the skin to be protected or treated with a thin layer, without forgetting the folds and creases of the affected area.

The application of Amniolina should always be done after bathing and as many other times as necessary, usually coinciding with diaper changes: insisting particularly on those parts most prone to injury (diaper friction, prolonged contact with feces, etc.).

If you use more Amniolina than you should

No possibility of intoxication is expected if the product is used as recommended.

Prolonged use of this medication may cause irritation.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Amniolina

Do not use a double dose to make up for forgotten doses.

Apply Amniolina when it is due.

If you stop treatment with Amniolina

If you have any other doubts about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

In rare cases, hypersensitivity to one of its components may occur (local or general allergic manifestations in sensitive individuals (rash, irritation, etc.).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet.

You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Amniolina ointment

No special storage conditions are required.

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

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.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of AMNIOLINA ointment

• The active ingredients are zinc oxide and talc. Each gram of ointment contains 170 mg of zinc oxide (17%) and 75 mg of talc (7.5%).
• The other components (excipients) are: petroleum jelly, liquid petroleum jelly, lanolin, dimethicone, glycerol, cornstarch, and rose essence.

Appearance of the product and package contents

This medication is presented in the form of an ointment, which is white, greasy to the touch, and has a rose scent.

Each box contains a tube with 50 g of ointment.

Marketing authorization holder

LABORATORIO REIG JOFRE, S.A.

Avda. Gran Capitan, 10

08970 Sant Joan Despí (Barcelona)

Manufacturer

BIOGLAN AB

Borrgatan 31,

211 24, Malmö

Sweden

Date of the last revision of this leaflet:04/2021.

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