Aftajuventus 2 mg/ml + 0.1 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aftajuventus 2 mg/ml + 0,1 mg/ml oral solution

Hydrocortisone hemisuccinate/Benzalkonium chloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• 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.

Leaflet contents

1. What Aftajuventus is and what it is used for
2. What you need to know before using Aftajuventus
3. How to use Aftajuventus
4. Possible side effects
5. How to store Aftajuventus
6. Contents of the pack and other information

1. What Aftajuventus is and what it is used for

Aftajuventus is a medicine containing as active ingredients hydrocortisone and benzalkonium chloride, for oral use. Hydrocortisone is a corticosteroid with anti-inflammatory activity. Benzalkonium chloride is a topical antiseptic.

This medicine is indicated for the symptomatic relief of superficial ulcerations or mouth sores (oral aphthae), non-infectious stomatitis (inflammation).

2. What you need to know before starting to use Aftajuventus

Do not use Aftajuventus

• If you are allergic to hydrocortisone, benzalkonium chloride, or any of the other components of this medicine (listed in section 6).
• In mouth ulcers accompanied by fever or general malaise, injuries caused by trauma or dentures, gum infections, and rashes around the mouth (lips and corners of the mouth).
• Fungal infections.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Aftajuventus.

Children

This medicine is not intended for children under 3 years of age due to safety and efficacy concerns.

Contact your doctor if you experience blurred vision or other visual disturbances.

Do not use in conditions such as herpes.

Do not use for more than 4 days without consulting a doctor.

Other medicines and Aftajuventus

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

No interactions have been reported.

Do not use simultaneously with other oral medications without consulting your doctor or pharmacist.

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 use during pregnancy or breastfeeding.

Driving and operating machinery

The effect of this medicine on the ability to drive and operate machinery is negligible or none.

3. How to use Aftajuventus

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with Aftajuventus.

Use in children

Aftajuventus must not be used in children under 3 years of age due to safety and efficacy reasons.

The recommended dose is:

• Children over 3 years: 1 touch per day on the affected area.
• Adults: 2 or 3 touches per day on the affected area.

Method of application

The product should be applied using the spatula provided in the bottle. Immerse the spatula into the product and then apply the product onto the affected area.

It is advisable to clean the spatula with a cotton pad soaked in alcohol after each use and before placing it back into the bottle to take more liquid.

If symptoms worsen or persist after 4 days, consult your doctor or pharmacist.

If you use more Aftajuventus than you should

In case of accidental ingestion, treatment is symptomatic; dilute with fluids (plenty of water or milk may be taken).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone number 91 562 04 20, or go to a medical centre, indicating the medicine and the amount ingested.

If you forget to use Aftajuventus

Do not use a double dose to make up for missed doses. Continue treatment with the recommended dosage.

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 can cause adverse effects, although not everyone will experience them.

Local reactions that may occur after application are those commonly seen with any topical corticosteroid and are more likely if the product is used for long periods, over large areas of skin, with occlusive dressings, or in children:

Hypersensitivity reactions (allergic reactions), contact dermatitis/dermatitis, stinging, itching or pain at the application site, thinning of the skin (atrophy), dryness or peeling of the skin, delayed wound healing, bruising (hematomas), spider veins (dilated blood vessels appearing near the skin surface), inflammation around the mouth (perioral dermatitis), acne, red spots.

Adverse effects may occur not only in the treated area but also in completely different parts of the body, particularly if the active substances are absorbed into the body through the skin—more likely with systemic exposure. For example, weight gain/obesity, delayed weight gain or growth in children, Cushingoid appearance (e.g., moon face, central obesity), decreased cortisol levels (a steroid hormone), fluid retention (edema), and blurred vision may occur.

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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aftajuventus

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

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Package contents and other information

Composition of Aftajuventus

• The active substances are hydrocortisone hemisuccinate and benzalkonium chloride. Each ml of solution contains 2 mg of hydrocortisone hemisuccinate (0.2%) and 0.1 mg of benzalkonium chloride (0.01%).
• The other component is: glycerol (E-422).

Appearance of the product and contents of the package

Aftajuventus is supplied in a bottle containing 30 ml of oral solution. Each package includes an applicator spatula.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturer

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188 – 08210 Barberà del Vallès, Barcelona, Spain

Date of latest revision of this leaflet: September 2021.

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