ORTODERMINA

Package leaflet: Information for the user

Ortodermina 5% cream

Lidocaine hydrochloride
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

1. What Ortodermina is and what it is used for
2. What you need to know before using Ortodermina
3. How to use Ortodermina
4. Possible side effects
5. How to store Ortodermina
6. Contents of the pack and other information

1. What Ortodermina is and what it is used for

Ortodermina is a cream containing lidocaine and belongs to a class of medicines known as local (topical) anesthetics.
Ortodermina works by temporarily reducing or eliminating sensitivity (anesthetic effect), thereby also reducing the perception of painful stimuli at the skin level.

Ortodermina is indicated:

• as an anesthetic on soft tissues (mucous membranes) of the mouth (gums, inner cheeks, palate, throat, underside of the mouth beneath the tongue, inner surface of the lips, and tongue);
• for localized itching affecting the anus or rectum;
• as an anesthetic for minor skin injuries.

2. What you need to know before using Ortodermina

Do not use Ortodermina

• if you are allergic to lidocaine or to any of the other ingredients of this medicine (listed in section 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 mucosa on which you intend to apply Ortodermina is particularly damaged and infected;
• you are pregnant (see section “Pregnancy and breastfeeding”);
• you need to apply Ortodermina to children (see section “Children and adolescents”).

Children
In the earliest infancy, Ortodermina should be used only if clearly necessary and under direct medical supervision.

Other medicines and Ortodermina
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use Ortodermina during pregnancy unless strictly necessary and under direct medical supervision.

Driving and using machines
No effects of Ortodermina on the ability to drive or operate machinery are known.

Ortodermina contains

• cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis);
• methyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to use Ortodermina

Use this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply an even layer of cream to the affected area of skin.
If the area where you need to apply Ortodermina has open wounds, spread the cream using a sterile gauze pad.
If you need to apply Ortodermina to the oral mucosa, first dry the area with a cotton swab, then apply the cream.
Do not exceed the maximum daily dose of 35 g of cream.
Use Ortodermina only for short-term treatment and do not exceed the recommended dose. If you do not notice any improvement, consult your doctor.

Use of Ortodermina in dentistry
For oral mucosal anaesthesia, prior to applying Ortodermina, the dentist will use a saliva aspirator to reduce the risk of the cream being diluted by saliva and thus enhance lidocaine absorption.
If you have a new removable dental prosthesis, you may experience irritation, small blisters on the gums, or discomfort in the mouth. During this adjustment period, apply the cream to the surface of the prosthesis that contacts the gums to relieve discomfort. During this phase, always follow the instructions provided by your dentist.

Ano-rectal use of Ortodermina
For ano-rectal itching, to facilitate administration, you may use the applicator nozzle (included in the 3 g pack) following the instructions below:

1. Unscrew the cap from the tube and use it (inverted) to pierce the sealed membrane of the tube.
2. Remove the nozzle from its protective packaging and screw it onto the tube.
3. Gently insert the nozzle into the anal orifice and squeeze the tube with two fingers (thumb and index finger) to administer the desired amount of cream.
4. Spread any excess cream that comes out from the anus around the perianal area.

Use in children and adolescents
The dose in children should be adjusted according to age and health status. In such cases, consult your doctor or pharmacist.
Use in elderly and severely ill patients
The dose should be adjusted according to age and health status. In such cases, consult your doctor or pharmacist.

If you use more Ortodermina than you should
In case of accidental ingestion or overdose of Ortodermina, contact your doctor immediately or go to the nearest hospital.
Overdose may cause reduced heart and blood vessel function (cardiovascular depression), nervous system excitation followed by sedation, accompanied by drowsiness or loss of consciousness. If you experience these symptoms, seek immediate medical attention.

If you forget to use Ortodermina
If you forget to apply the cream, do so as soon as you remember. Do not use a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Discontinue treatment with Ortodermina and contact your doctor immediately if you experience any of the following side effects:

• allergic reaction at the application site or in other parts of the body, which in severe cases may lead to anaphylactoid reactions;
• rare reactions (may affect up to 1 in 1,000 people) affecting the whole body (systemic reactions), such as reduced 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ortodermina

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

6. Package contents and other information

What Ortodermina contains

• The active substance is lidocaine hydrochloride. 100 g of cream contain 6.15 g of lidocaine hydrochloride, equivalent to 5 g of lidocaine base.
• The other components are: cetyl stearyl alcohol, Macrogol cetyl stearyl ether, mineral oil, white soft paraffin, methyl p-hydroxybenzoate, purified water.

Description of the appearance of Ortodermina and contents of the pack
Ortodermina is a cream supplied in tubes of 3 g, 10 g and 50 g.
The 3 g tube presentation is available in packs containing either 1 tube or 10 tubes, each including inside, respectively, one or ten application cannulae.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer
SOFAR S.p.A.,
Via Firenze 40,
20060 Trezzano Rosa (MI)
Italy