Leaflet: information for the user

Oralsone adults 2.5 mg chewable tablets

Hydrocortisone hemisuccinate

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

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

2. What you need to know before starting to take Oralsone adults

3. How to use Oralsone adults

4. Possible side effects

5. Storage of Oralsone adults

6. Contents of the pack and additional information

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

Oralsone for adults is indicated for symptomatic relief of oral ulcers (mouth sores) in adults over 12 years old.

No use Oralsone adultos

- If you are allergic to hydrocortisone hemisuccinate or to 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 mouth ulcers accompanied by fever or general discomfort, in wounds caused by an external agent (trauma) and prostheses, gum infections, or eruptions around the mouth (lips and corners).

Warnings and precautions

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

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

Corticosteroids, especially those of high potency like the one in this medication, may affect the functioning of glands located near the kidneys and cause various disorders, especially with excessive, prolonged, or high-dose use.

Even with sufficient absorption into the body, it may cause a disorder characterized by a rounded face, accumulation of fat in the abdomen, and other symptoms (Cushing's syndrome).

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

Corticosteroid treatments increase the sensitivity to infections, or they may mask signs of existing infection. Other infections, such as measles or tuberculosis, may worsen.

You should use this medication with great caution if you have a strongyloid infestation, as it may worsen.

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

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

Children and adolescents

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

Other medications and Oralsone adults

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

Inform your doctor if you are taking other medications, even those obtained 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 operating machines

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

Oralsone adults contains saccharose and lactose

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in 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 tablet in the mouth, near the lesion, without chewing or swallowing it. Administer 2 or 3 tablets a day.

Do not administer more than 4 tablets a day.

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

Children

Do not administer to children under 12 years.

If you take more Oralsone for adults than you should

In case of overdose or accidental ingestion, adverse effects of corticosteroids 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Oralsone for adults

Do not use a double dose to compensate for the missed doses.

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

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

Like all medications, Oralsone for adults may produce adverse effects, although not all people will experience them.

Adverse effects are unlikely if you use the medication in the recommended conditions of use.

With corticosteroid treatment, the following adverse effects have been reported, whose frequency has not been established with precision:

Hypersensitivity reactions (allergic reactions).

With the continued administration of corticosteroid doses above the recommended levels, disorders in some glands located near the kidneys may occur, manifesting the Cushing syndrome (see the section Warnings and Precautions 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).

Also, the appearance of acne, skin atrophy, skin inflammation (dermatitis), facial redness, delayed wound healing, fungal infections, skin striations, red spots, and skin thinning has been reported.

Blurred vision.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is

possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on 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 Oralsone Adults after the expiration date that appears 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 tablets.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection pointof 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 Oralsone for 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 essence.

Appearance of the product and contents of the packaging

Oralsone for adults is presented in lozenges (dissolvable in the mouth).

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

Holder of the marketing authorization and responsible for manufacturing:

Laboratorios Viñas, S.A.

Provenza, 386

08025 Barcelona

Date of the last review of this leaflet:July 2020.

The detailed information about this medicine is available on the website ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

Name and Logo Laboratorios Viñas