ORALSONE ADULTOS 2.5 mg LOZENGES

Introduction

Package Leaflet: Information for the User

Oralsone Adults 2.5 mg Lozenges

Hydrocortisone Hemisuccinate

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

Contents of the Package Leaflet

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

1. What Oralsone Adults is and what it is used for

It is a medication that contains hydrocortisone hemisuccinate as the active ingredient, which is a low-potency corticosteroid with anti-inflammatory activity, and is used in the mouth by dissolving slowly.

Oralsone Adults is indicated for the symptomatic relief of oral aphthae (ulcers) in adults over 12 years of age.

2. What you need to know before taking Oralsone Adults

Do not use Oralsone Adults

• If you are allergic to hydrocortisone hemisuccinate or any of the other components of this medication (listed in section 6).
• If you have fungal infections in the mouth or elsewhere in the body.
• In oral ulcers accompanied by fever or general malaise, in wounds caused by external agents (trauma) and prostheses, gum infections, or eruptions around the mouth (lips and commissures).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Oralsone Adults.

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

Corticosteroids, especially those with higher potency than the one contained in this medication, can affect the functioning of glands located near the kidneys and produce various disorders, especially with excessive, prolonged, or high-dose use.

Even in the case of sufficiently high absorption into the body, a disorder characterized by a rounded face, fat accumulation in the abdomen, and other symptoms (Cushing's syndrome) may occur.

You should use this medication with caution if you have digestive disorders such as gastrointestinal ulcers, diverticulitis, infection, or obstruction.

Treatments with corticosteroids increase the sensitivity to infections, or signs of existing infections may be masked. Other infections, such as measles or tuberculosis, may worsen.

You should use this medication with great caution if you have a strongyloidiasis (threadworm infestation), as it may worsen.

It also requires caution if you have kidney disease, hypertension, or myasthenia gravis (weakness in arms or legs, difficulty breathing, etc.).

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

Children and Adolescents

Do not use in children under 12 years of age, for safety reasons.

Other Medications and Oralsone Adults

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

Inform your doctor if you are taking other medications, including those purchased without a prescription.

Some medications may increase the effects of Oralsone, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

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.

In general, during the first trimester of pregnancy, topical preparations (local) containing corticosteroids should not be used.

Do not use Oralsone Adults during pregnancy or breastfeeding.

Driving and Using Machines

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

Oralsone Adults contains sucrose and lactose

This medication contains sucrose and lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Oralsone Adults

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Oral route (to dissolve in the mouth).

Adults and children over 12 years: slowly dissolve one lozenge in the mouth, near the lesion, without chewing or swallowing. Administer 2 or 3 lozenges per day.

Do not administer more than 4 lozenges per day.

If symptoms worsen or persist after 4 days, you should consult a doctor.

Children

Do not administer to children under 12 years of age.

If you take more Oralsone Adults than you should

In case of overdose or accidental ingestion, the adverse effects of corticoids may appear, even in various parts of the body.

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 Oralsone Adults

Do not use a double dose to make up for forgotten doses.

Continue treatment with the recommended dosage when the next dose is due.

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

4. Possible Side Effects

Like all medications, Oralsone Adults can cause side effects, although not everyone will experience them.

Side effects are unlikely if you use the medication under the recommended conditions.

With corticosteroid treatment, the following side effects have been reported, whose frequency cannot be established with precision:

Hypersensitivity reactions (allergic).

With continued administration of corticoid doses above the recommended ones, disorders in glands located near the kidneys may occur, manifesting as Cushing's syndrome (see the Warnings and Precautions section in section 2).

With corticosteroid treatment, the formation of cataracts in the eyes has been reported, although it is more frequent with systemic treatment (internal).

Acne, skin atrophy, skin inflammation (dermatitis), facial redness, delayed wound healing, fungal infections, skin stretch marks, and skin thinning have also been reported.

Blurred vision.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Oralsone Adults

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use Oralsone Adults after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use Oralsone Adults if you observe visible signs of deterioration in the appearance of the lozenges.

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

Composition of Oralsone Adults

• The active ingredient is hydrocortisone hemisuccinate. Each lozenge contains 2.5 mg of hydrocortisone hemisuccinate.
• The other components (excipients) are: sucrose, lactose, Macrogol 4000, magnesium stearate, povidone K-30, and lemon flavor.

Appearance of the Product and Package Contents

Oralsone Adults is presented in lozenges (dissolvable in the mouth).

It is presented in packages of 12 lozenges (2 blisters of 6 lozenges).

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Laboratorios Viñas, S.A.

Provenza, 386

08025 Barcelona

Spain

Manufacturer

Laboratorios Viñas, S.A.

Torrente de Vidalet, 29

08012 Barcelona

Spain

Laboratorios Viñas, S.A.

Polígono Industrial Can Rosés, Avenida Can Rosés, s/n,

08191 Rubí

Spain

Date of the Last Revision of this Leaflet:July 2025.

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/

Laboratorios Viñas Name and Logo