Oralson 2.5 mg lozenges for adults
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Oralsone adults 2.5 mg sucking tablets
Hydrocortisone hemisuccinate
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.
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Package leaflet contents
- What Oralsone adults is and what it is used for
- What you need to know before using Oralsone adults
- How to use Oralsone adults
- Possible side effects
- How to store Oralsone adults
- Contents of the pack and other information
1. What Oralsone adults is and what it is used for
It is a medicine containing as the active ingredient hydrocortisone hemisuccinate, a low-potency corticosteroid with anti-inflammatory activity, which is used in the mouth by dissolving slowly.
Oralsone adults is indicated for the symptomatic relief of oral aphthae (mouth ulcers) in adults over 12 years of age.
2. What you need to know before using Oralsone adults
Do not use Oralsone adults
- If you are allergic to hydrocortisone hemisuccinate or to any of the other ingredients of this medicine (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), dentures, gum infections, or in rashes around the mouth (lips and corners of the mouth).
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 of higher potency than the one contained in this medicine, may affect the function of glands located near the kidneys and cause various disorders, particularly with excessive, prolonged use or high doses.
Even in cases 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) could occur.
Use this medicine with caution if you have gastrointestinal disorders such as gastrointestinal ulcer, diverticulitis, infection, or obstruction.
Treatment with corticosteroids increases susceptibility to infections, or may mask signs of existing infection. Other infections, such as measles or tuberculosis, may worsen.
Use this medicine with great caution if you have a parasitic infestation (Strongyloides), as it could worsen.
Caution is also required 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 medicines and Oralsone adults
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Tell your doctor if you have recently taken other medicines, including those obtained without a prescription.
Some medicines may increase the effects of Oralsone, so your doctor will perform careful monitoring if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).
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.
In general, topical (local) preparations containing corticosteroids should not be used during the first trimester of pregnancy.
Do not use Oralsone adults during pregnancy or breastfeeding.
Driving and use of machines
The influence of this medicinal product on the ability to drive and use machines is none or negligible.
Oralsone adults contains sucrose and lactose
This medicine contains sucrose and lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Oralsone adults
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Oral route (to dissolve in the mouth).
Adults and children over 12 years of age: slowly dissolve one tablet in the mouth, near the affected area, without chewing or swallowing it. Administer 2 or 3 tablets per day.
Do not administer more than 4 tablets per day.
If symptoms worsen or persist after 4 days, 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, adverse effects of corticosteroids may occur, even in various internal parts of the body.
In the event of overdose or accidental ingestion, immediately consult your doctor or pharmacist, go to a medical center, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Oralsone adults
Do not take a double dose to make up for missed doses.
Continue treatment with the recommended dosage at the next scheduled dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Oralsone adults may cause adverse effects, although not everyone will experience them.
Adverse effects are unlikely if you use the medicine under the recommended conditions of use.
The following adverse effects have been reported with corticosteroid treatment, although their frequency cannot be accurately determined:
Hypersensitivity reactions (allergic).
With prolonged administration of corticoid doses above those recommended, disorders may occur in glands located near the kidneys, resulting in Cushing's syndrome (see section 2, Warnings and precautions).
Cataract formation in the eyes has been reported with corticosteroid treatment, although it is more frequent with systemic (internal) treatment.
Other reported effects include acne, skin atrophy, skin inflammation (dermatitis), facial redness, delayed wound healing, fungal infections, skin striae, red spots, and skin thinning.
Blurred vision.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Oralsone adults
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use Oralsone adults after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not use Oralsone adults if you notice any visible signs of deterioration in the appearance of the tablets.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Package contents and other information
Composition of Oralsone adults
- The active substance is hydrocortisone hemisuccinate. Each pastille contains 2.5 mg of hydrocortisone hemisuccinate.
- The other components (excipients) are: sucrose, lactose, Macrogol 4000, magnesium stearate, povidone K-30 and lemon flavour.
Nature of the product and pack contents
Oralsone adults is available as pastilles (orally disintegrating tablets).
Pack sizes: 12 pastilles (2 blisters of 6 pastilles).
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Laboratorios Viñas, S.A.
Provenza, 386
08025 Barcelona
Spain
Manufacturer
Laboratorios Viñas, S.A.
Torrente Vidalet, 29
08012 Barcelona
Spain
Laboratorios Viñas, S.A.
Polígono Industrial Can Rosés, Avenida Can Rosés, s/n,
08191 Rubí
Spain
Date of the most recent review of this leaflet: July 2025.
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/
Name and Logo Laboratorios Viñas