AFTAJUVENTUS 2 mg/ml + 0.1 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Aftajuventus 2 mg/ml + 0.1 mg/ml Oral Solution

Hydrocortisone Hemisuccinate/Benzalkonium Chloride

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Aftajuventus and what is it used for

Aftajuventus is a medicine that contains hydrocortisone and benzalkonium chloride as active ingredients, 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 oral ulcers or sores (oral aphthae), non-infectious stomatitis (inflammation).

2. What you need to know before you start using Aftajuventus

Do not use Aftajuventus

• If you are allergic to hydrocortisone, benzalkonium chloride, or any of the other ingredients of this medicine (listed in section 6).
• In oral ulcers accompanied by fever or general malaise, wounds caused by trauma and prostheses, gum infections, and eruptions around the mouth (lips and commissure).
• Fungal infections.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Aftajuventus.

Children

This medicine is not indicated for children under 3 years of age for safety and efficacy reasons.

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

Do not use in conditions of the herpes type.

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

Other medicines and Aftajuventus

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

No interactions have been described.

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

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Do not use during pregnancy or breast-feeding.

Driving and Using Machines

The influence of this medicine on the ability to drive and use machines is negligible.

3. How to use Aftajuventus

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

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

Use in Children

Aftajuventus should not be used in children under 3 years of age for safety and efficacy reasons.

The recommended dose is:

• Children over 3 years: 1 application per day to the affected area.
• Adults: 2 or 3 applications per day to the affected area.

Method of application

The product will be applied with the spatula included in the bottle. Soak the spatula in the product and then apply the product to the affected area.

It is advisable to clean the spatula with a cotton swab soaked in alcohol after each use and before inserting it into the bottle to take the liquid again.

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; dilution with liquids (you can take plenty of water or milk).

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

If you forget to use Aftajuventus

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Local effects that can occur after administration are common to any topical corticosteroid and are more likely if the product is used for a long period, in extensive areas, or with occlusive materials, and in children:

Hypersensitivity reactions (allergic), contact dermatitis/dermatitis, itching, stinging, or pain in the application area, skin thinning (atrophy), dryness/exfoliation of the skin, delayed wound healing, bruising (hematomas), spider veins (dilated blood vessels that can appear near the skin), inflammation around the mouth (perioral dermatitis), acne, red spots.

Side effects can occur not only in the treated area but also in completely different areas of the body, which happens if the active ingredients pass into the body through the skin, more frequent in systemic administration. For example, weight gain/obesity, delayed weight gain/growth in children, Cushingoid appearance (e.g., moon face, central obesity), decreased cortisol levels (steroid hormone), fluid retention (edema), and blurred vision.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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 which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Aftajuventus

• The active ingredients 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 ingredients are: glycerol (E-422).

Appearance and Packaging of the Product

Aftajuventus is presented in a bottle with 30 ml of oral solution. Each pack includes a spatula.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturer

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188 – 08210 Barberá del Vallés, Barcelona, Spain

Date of Last Revision of this Package Leaflet:September 2021.

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