MASTIOL OINTMENT

Introduction

Package Leaflet: Information for the Patient

Mastiol Ointment

Vitamin A / Chlorhexidine Acetate / Benzocaine

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

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Mastiol and what is it used for
2. What you need to know before using Mastiol
3. How to use Mastiol
4. Possible side effects
5. Storage of Mastiol
6. Package Contents and Additional Information

1. What is Mastiol and what is it used for

Mastiol is a topical ointment (for use on the skin) that contains as active ingredients vitamin A, chlorhexidine, which is an antiseptic (antimicrobial), and benzocaine, a local anesthetic that reduces itching on the skin. This medication belongs to the group of antiseptics and disinfectants.

It is indicated for:

Treatment of nipple cracks and prevention of mastitis (inflammation of the mammary glands) due to lactation.

Small skin fissures or irritations and superficial burns.

2. What you need to know before using Mastiol

Do not use Mastiol

• if you are allergic to vitamin A, chlorhexidine, or benzocaine, or to any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Mastiol.

• This medication is for external use only, do not ingest.
• Its use with other preparations that inactivate chlorhexidine should be avoided (see "Other Medications and Mastiol" section).
• Do not apply the medication to the face or head.
• Do not use the medication on open wounds, as the components may be absorbed into the body.
• Do not apply to the eyes, ears, or mouth.

Children

Mastiol ointment should not be used in children under 2 years of age for safety reasons.

Other Medications and Mastiol

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

Do not use this medication at the same time as other products such as anionic soaps or detergents (most are of this type), iodine, silver salts, etc. In general, do not use this medication with other antiseptics.

Pregnancy, Breastfeeding, and Fertility

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.

The use of Mastiol is not recommended during pregnancy.

During the breastfeeding period, the remains of the ointment should be removed before breastfeeding by washing the breasts with water and mild soap and using a cotton swab.

Driving and Using Machines

The influence of this medication on the ability to drive vehicles and use machines is nil or insignificant.

Mastiol contains Lanolin

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

3. How to use Mastiol

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Topical use.

The recommended dose is:

• In nipple cracks and prevention of mastitis, apply a small amount of Mastiol to the nipple and areola and spread it with a gentle massage, covering the area with a sterile gauze, after each feeding and having previously dried the breast with a cotton swab. Before the next feeding, wash the area with water and mild soap and remove the remains of the ointment with a cotton swab.

• In other indications, apply a thin layer of Mastiol to the affected area and, depending on the location, cover it with a suitable gauze; if necessary, the operation can be repeated two or three times a day.

Use in Children

Mastiol should not be used in children under 2 years of age (see Childrenin section 2).

If you use more Mastiol than you should

Due to the characteristics of this preparation, intoxication phenomena are not expected with its use on the skin.

In case of accidental ingestion, proceed with gastric lavage and protection of the digestive mucosa.

Cases of hemolysis (breakdown of red blood cells) have been described after ingestion of chlorhexidine.

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

If you forget to use Mastiol

Do not use a double dose to make up for forgotten doses. Wait to apply the forgotten dose after the next feeding.

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

4. Possible Side Effects

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

The assessment of side effects is based on the following frequencies: Very common: may affect more than 1 in 10 people.

Common: may affect up to 1 in 10 people.

Uncommon: may affect up to 1 in 100 people.

Rare: may affect up to 1 in 1,000 people.

Very rare: may affect up to 1 in 10,000 people.

Frequency not known: cannot be estimated from the available data.

This medication may cause local skin reactions, uncommonly (such as contact dermatitis), in part because it contains lanolin, among other components.

Urticaria (hives with itching) has been reported with an unknown frequency.

Erupción, redness, swelling due to fluid accumulation (edema), and severe allergic reaction (anaphylaxis) have also been reported, although rarely.

Metahemoglobinemia, a blood disorder with a very high amount of a form of hemoglobin, may occur rarely due to the presence of benzocaine, although it usually occurs at much higher concentrations than those contained in this medication.

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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Mastiol

Keep this medication out of the sight and reach of children. It does not require special storage conditions.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be thrown down the drain or into the 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 will help protect the environment.

6. Package Contents and Additional Information

Mastiol Composition

The active ingredients are Vitamin A Palmitate, Chlorhexidine Acetate, and Benzocaine.

Each gram of ointment contains 300 IU of vitamin A (0.176 mg of vitamin A palmitate), 10 mg of chlorhexidine acetate (1%), and 10 mg of benzocaine (1%).

The other components (excipients) are: Petrolatum, Anhydrous Lanolin, Dimethylpolysiloxane, Liquid Petrolatum, Rose Essence.

Product Appearance and Package Contents

Mastiol ointment is a ointment; yellowish-white in color. It is presented in 20g tubes.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

NUTRA ESSENTIAL OTC, S.L.

C/ La Granja 1

28108 - Alcobendas - Madrid

Spain

Manufacturer

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

Laguna, 66-68-70.

Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Or

FARMALIDER, S.A. C/ Aragoneses 2

28108 Alcobendas, Madrid

Spain

Date of the Last Revision of this Package Leaflet:October 2018

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/.