Ortodermina Cream 5% Lidocaine Anesthetic 10 g

Topical anesthetic cream based on lidocaine hydrochloride .

Therapeutic indications

Ortodermina acts by decreasing or temporarily eliminating sensitivity (anesthetic activity), and therefore also the perception of painful stimuli, at the level of the skin. Ortodermina is indicated:

• as an anesthetic on the soft tissues (mucous membranes) of the mouth (gums, inner cheeks, palate, throat, lower part of the mouth under the tongue, inner surface of the lips and tongue);
• in case of localized itching in the anus or rectum;
• as an anesthetic in case of minor skin lesions.

Dosage and Posology

Apply an even layer of cream on the affected area of skin. If the area on which Ortodermina is to be applied has open wounds, spread the cream with the help of a sterile gauze pad.

If you have to apply Ortodermina on the mucous membrane of the oral cavity, first dry the affected part with the help of a cotton swab, then apply the cream. Do not exceed the maximum daily dose of 35 g of cream. Use Ortodermina only for short periods of treatment, do not exceed the indicated dose. If you do not notice an improvement, please contact your doctor.

Use of Ortoderminina in dentistry

In case of anesthesia of the oral mucosa, before the application of Ortodermina, the dentist will use a saliva aspirator to reduce the possibility of the cream being diluted by the saliva and therefore to increase the absorption of lidocaine.

If you have a new removable dental prosthesis, you may experience irritation or small blisters in your gums or discomfort in your mouth. During this period (the settling phase), spread the cream on the surface of the prosthesis in contact with the gums to relieve the discomfort. At this stage, always follow the instructions provided by your dentist.

Use in children and adolescents

The dose in the child must be adapted to the age and state of health, in this case ask your doctor or pharmacist for advice.

Use in the elderly and seriously ill subjects

The dose must be adapted to age and state of health, in this case ask your doctor or pharmacist for advice.

Overdose

In case of accidental ingestion / intake of an overdose of Ortodermina, notify your doctor immediately or go to the nearest hospital. Overdose can cause decreased function of the heart and blood vessels (cardiovascular depression), nervous excitement followed by sedation, accompanied by drowsiness or loss of consciousness. If you experience these symptoms, please contact your doctor immediately.

Contraindications

Do not use Ortodermina:

• if you are allergic to lidocaine or any of the other ingredients of this medicine
• if you have ever had an allergic reaction to other medicines similar to Ortodermin, such as local anesthetics classified as amino-amides.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Ortoderminina and contact your doctor immediately if you experience the following side effects:

• allergic reaction at the application site or in other parts of the body which, in severe cases, can lead to anaphylactoid manifestations;
• rare reactions (may affect up to 1 in 1,000 people), affecting the whole body (systemic reactions) such as decreased function of the heart and blood vessels (cardiovascular depression), nervous excitement followed by sedation, accompanied by sleepiness or loss of consciousness . These effects are attributable to a possible overdose, a rapid absorption of the cream, an excessive sensitivity or a reduced tolerance to Ortodermina.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Do not use Ortodermina if you are pregnant, unless this is strictly necessary and under direct medical supervision.

Special warnings

Talk to your doctor or pharmacist before using Ortodermina if:

• the mucosa on which Ortodermina has to be applied is particularly damaged and infected;
• you are pregnant;
• you have to apply Ortodermina on children

In very early childhood, Ortodermina should be used only in case of real need and under the direct supervision of the doctor. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Ortodermina contains:

• cetostearyl alcohol which can cause local skin reactions (e.g. contact dermatitis);
• Methyl p-hydroxybenzoate can cause allergic reactions (possibly delayed).

Expiry and retention

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the package after “EXP”. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Composition

100 g of Ortodermina cream contain:

Active principle

6.15 g of lidocaine hydrochloride equal to 5 g of base lidocaine.

Excipients

Cetostearyl alcohol, sodium lauryl sulfate, petroleum jelly, white stringy petroleum jelly, methyl p-hydroxybenzoate, deionized water.