ORTODERMINA*CREAM 10G 5%

Ortodermina 5% cream
Lidocaine hydrochloride

What it is and what it is used for
Ortodermina is a cream containing lidocaine, and belongs to a class of medicines called local (topical) anaesthetics.
Ortodermina works by temporarily decreasing or eliminating sensitivity (anaesthetic activity), and therefore also the perception of painful stimuli, at the skin level.

Ortodermina is indicated:
- as an anaesthetic on the soft tissues (mucous membranes) of the mouth (gums, inside of cheeks, palate, throat, floor of the mouth under the tongue, inner surface of the lips and tongue);
- in case of localised itching at the level of the anus or rectum;
- as an anaesthetic in case of minor skin lesions.

What you need to know before taking the medicine
Do not use Ortodermina
- if you are allergic to lidocaine or any of the other ingredients of this medicine (listed in paragraph 6);
- if you have had an allergic reaction to other medicines similar to Ortodermina, such as local anaesthetics classified as amino-amides.

Warnings and precautions
Talk to your doctor or pharmacist before using Ortodermina if:
- the mucous membrane on which you need to apply Ortodermina is particularly damaged and infected;
- you are pregnant (see paragraph "Pregnancy and breastfeeding");
- you need to apply Ortodermina to children (see paragraph "Children and adolescents").

Children
In early childhood, Ortodermina should only be used if strictly necessary and under direct medical supervision.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop treatment with Ortodermina 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 the most severe cases, can lead to anaphylactoid manifestations;
- rare reactions (may affect up to 1 in 1,000 people), affecting the entire body (systemic reactions) such as decreased heart and blood vessel function (cardiovascular depression), nervous excitement followed by sedation, accompanied by drowsiness or loss of consciousness. These effects may be due to a possible overdose, rapid absorption of the cream, excessive sensitivity or reduced tolerance to Ortodermina.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.