Leaflet: information for the user

AMNIOLINA ointment

Oxide of zinc/ Talc

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 4 days.

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 alleviates skin irritations; it facilitates healing.

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

Amniolina ointment is indicated for incontinent children and adults.

Do not use Amniolina

• If you are allergic to zinc oxide, talcum powder, 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 only.
• Avoid contact with the eyes, nose, mouth, ears, or other mucous membranes.
• Do not use if the skin area to be treated has open wounds that secrete fluid.

Children

This medication is indicated for children. The usual precautions should be taken in babies and children.

Use of Amniolina ointment with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

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

In necessary cases, this medication may be used if necessary, with due precautions.

Driving and operating machines:

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

Amniolina ointment contains lanolin

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

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.

Skin use (on the skin).

Apply the ointment regularly to the affected area generally after a diaper change.

Form of use

Clean and dry the area to be protected or treated well. Apply Amniolina to the same, spreading the ointment with the fingertips in a soft but insistent manner, until a thin layer covers the entire surface of the skin to be protected or treated, not forgetting the folds and creases of the affected area.

Amniolina application should be made always after bathing and as often as necessary, generally coinciding with diaper changes: insisting particularly on those parts more prone to injury (diaper friction, prolonged contact with feces, etc.).

If you use more Amniolina than you should

No possibility of poisoning 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Amniolina

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

Apply Amniolina as needed.

If you interrupt treatment with Amniolina

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

pharmacist.

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this prospectus.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es

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

No requires special conditions for conservation.

Keep this medication out of the 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 thrown down the drain or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of AMNIOLINA ointment

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

Appearance of the product and contents of the packaging

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.

Holder of the marketing authorization

LABORATORIO REIG JOFRE, S.A.

Avda. Gran Capitan, 10

08970 Sant Joan Despí (Barcelona)

Responsible for manufacturing

BIOGLAN AB

Borrgatan 31,

211 24, Malmö

Sweden

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

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.