Oracort E

Active Ingredients

Each gram of the preparation contains:

• Triamcinolone Acetonide 1 mg
• Lidocaine Hydrochloride 30 mg

Indications

Therapeutic Group:

Triamcinolone acetonide: Synthetic corticosteroids for local treatment, with anti-inflammatory, antipruritic, and vasoconstrictive properties.

Lidocaine: Local anesthetic.

Oracort E is indicated as an adjunctive treatment for the temporary relief of symptoms and pain associated with oral inflammatory and ulcerative lesions.

Instructions

Do not swallow! This medicine is intended for use in the oral cavity only!

Oracort E is a yellow and viscous ointment, with a granular appearance.

Lightly spread, with the help of a cotton swab. Use a small amount, by pressing, until a thin film develops. A larger quantity may be required for coverage of some larger lesions.

For optimal results use only the amount needed to coat the lesion with a thin film.

Do not rub in. Attempting to spread this preparation may result in a granular, gritty sensation and

cause the preparation to break apart and crumble. In any event, after application, a smooth, slippery film develops.

The preparation should be applied at bedtime to permit steroid contact with the lesion throughout the night

Use the medicine after meals.  

The usual dosage is generally:

2-3 times a day after meals, and before bedtime.

Dosage for children: According to doctor's instructions.

Do not use the preparation in infants and children under 4 years of age for more than 3 weeks.

Discontinue use of the preparation after healing is achieved.

If there is no improvement in your condition within 7 days, contact the doctor.

Do not exceed the recommended dose.

Do not pass Oracort E on to others. It may harm them, even if it seems to you that their medical condition is similar.

Warnings

Do not use this medicine if you are sensitive (allergic) to the active ingredients or to any of the additional ingredients contained in the medicine.

Do not use Oracort E if there is exist viral (such as herpes), fungal and/or bacterial infections of the mouth and/or throat or tuberculosis of the skin, especially during prolonged use of the preparation.

Do not use this medicine frequently, or for a long period without consulting the doctor.

Special caution is required when using in children. Use in children must be carried out under medical supervision.

The medicine is not usually recommended for infants-and children under two years of age.

The safety and efficacy of using Oracort E when treating children is unknown. Children may demonstrate greater susceptibility than adults when using topical corticosteroid preparations. Therefore, use should be limited to the least amount necessary. Chronic corticosteroid therapy may interfere with the growth and development of children.

If local irritation develops stop treatment and refer to the doctor immediately.

Before treatment with Oracort E, tell the doctor if:

You suffer, or have suffered in the past, from impaired function of the immune system.

You suffer, or have suffered in the past, from diabetes mellitus.

Do not use the medicine without consulting the doctor before starting treatment if you are pregnant or breastfeeding.

Avoid contact with the eyes. If contact does occur, wash them immediately!

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist.
Read the patient package insert carefully before starting to take any medication.