Label: information for the user

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

Hydrocortisone hemisuccinate/Benzalkonium chloride

Read this label carefully before starting to use this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Aftajuventus is a medication that contains 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 medication is indicated for the symptomatic relief of superficial oral ulcers or sores (oral aphthae), non-infectious stomatitis (inflammation).

Do not use Aftajuventus

• If you are allergic to hydrocortisone, benzalkonium chloride, or any of the other components of this medication (listed in section 6).
• On mouth ulcers accompanied by fever or general discomfort, wounds caused by trauma and prostheses, gum infections, and eruptions around the mouth (lips and corners).
• Fungal infections.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Aftajuventus.

Children

This medication is not indicated for children under 3 years old due to safety and efficacy reasons.

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

Do not use in herpes-type conditions.

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

Other medications and Aftajuventus

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

No interactions have been described.

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

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.

Do not use during pregnancy or breastfeeding.

Driving and operating machines

The influence of this medicationon the ability to drive and operate machinesis negligible or insignificant.

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

Your doctor will inform you of the duration of your treatment with Aftajuventus.

Use in children

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

The recommended dose is:

- Children over 3 years old: 1 application per day on the affected area.

- Adults: 2 or 3 applications per day on 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 on the affected area.

It is advisable to clean the spatula with an alcohol-soaked cotton swab after each use and before introducing it into the bottle to take 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, symptomatic treatment is recommended; 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 Toxicological Information Service, phone 91 562 04 20, or go to a medical center, indicating the medication and the amount ingested.

If you forgot to use Aftajuventus

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

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

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

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

Allergic reactions, contact dermatitis, itching, stinging, or pain at the application site, skin thinning (atrophy), skin dryness/exfoliation, delayed wound healing, bruising (hematomas), vascular streaks (dilated blood vessels that may appear near the skin),inflammation around the mouth(perioral dermatitis), acne, red spots.

Adverse effects can occur not only in the treated area, but also in completely different areas of the body, which occurs if the active principles pass through the skin into the body, more frequent in systemic administration. For example, it could produce 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

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 disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Aftajuventus

Appearance of the product and content of the container

Aftajuventus is presented in a 30 ml oral solution bottle. Each container comes with a built-in spatula.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Responsible for manufacturing

LABORATORIOS ERN, S.A.

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

Last review date of this leaflet: September 2021.

The detailed information of this medication is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS) web . http://www.aemps.gob.es/ .