ORTODERMINA 5% Krem

Treść ulotki

1. Ortodermina cream 5%
   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

Ortodermina cream 5%

Lidocaine hydrochloride

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse 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 you use 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 that contains lidocaine, and belongs to a class of medicines
defined as local (topical) anesthetics.
Ortodermina works by temporarily decreasing or eliminating sensitivity (anesthetic activity), and therefore also the perception of painful stimuli, at the skin level.
Ortodermina is indicated:

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

2. What you need to know before using Ortodermina

Do not use Ortodermina

• if you are allergic to lidocaine or 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 mucous membrane on which you need 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 early infancy, Ortodermina should only be used if absolutely necessary and
under the direct supervision of a doctor.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before using
this medicine.
Do not use Ortodermina if you are pregnant, unless it is strictly
necessary and under the direct supervision of a doctor.

Driving and operating machinery
There are no known effects of Ortodermina on the ability to drive vehicles and operate
machinery.

Ortodermina contains

• cetostearyl alcoholwhich can cause local skin reactions (e.g. contact dermatitis);
• methyl p-hydroxybenzoatemay cause allergic reactions (including delayed reactions).

3. How to use Ortodermina

Use this medicine following always exactly the instructions of the doctor or the
pharmacist. If you have doubts consult the doctor or the pharmacist.
Apply a uniform layer of cream on the affected skin area.
If the area on which you have to apply Ortodermina has open wounds, spread the cream
using a sterile gauze pad.
If you have to apply Ortodermina on the oral mucosa, dry first the affected part
with the help of a cotton ball, 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. In
case you should not notice an improvement, consult the doctor.

Use of Ortodermina in dentistry
In case of anesthesia of the oral mucosa, before the application of Ortodermina, the dentist
will use a saliva ejector to reduce the possibility that the cream is diluted by saliva and
to increase therefore the absorption of lidocaine.
If you have a new removable dental prosthesis, you may experience irritation or small blisters
on the gums or discomfort in the mouth. During this period (settling phase),
spread the cream on the surface of the prosthesis in contact with the gums to relieve the
discomfort. In this phase always follow the instructions provided by your dentist.

Ano – rectal use of Ortodermina
In case of ano – rectal itching, to facilitate administration, you can use the applicator
cannula (included in the 3 g package) following the instructions below:

• 1. Unscrew the cap of the tube and use it (inverted) to pierce the sealing membrane of the tube.
• 2. Remove the cannula from its protective wrapper and screw it onto the tube.
• 3. Gently insert the cannula into the anal opening and squeeze the tube, squeezing it with two fingers (thumb and index finger), so as to administer the desired amount of cream.
• 4. Spread around the perianal area, any excess cream that has leaked from the anus.

Use in children and adolescents
The dose in the child must be adapted to age and health status, in this case ask
advice to the doctor or pharmacist.

Use in the elderly and severely ill patients
The dose must be adapted to age and health status, in this case ask advice to the
doctor or pharmacist.

If you use more Ortodermina than you should
In case of ingestion/accidental intake of an excessive dose of Ortodermina, immediately warn
the doctor or go to the nearest hospital.
Overdose may cause a decrease in heart and blood vessel function (cardiovascular depression), nervous excitement followed by sedation,
accompanied by drowsiness or loss of consciousness. If you should experience
these symptoms, consult a doctor immediately.

If you forget to use Ortodermina
If you forgot to apply the cream, do so as soon as you remember. Do not use a double
dose to compensate for the forgotten dose.

4. 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, in the event that 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, may result in anaphylactoid reactions;
• rare reactions (may affect up to 1 in 1,000 people) that affect the whole 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 experience any side effects, including those not listed in this leaflet,
tell your doctor or pharmacist. You can also report side effects
directly through 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 which is stated on the packaging after
“Expiry.” 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 in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ortodermina contains

• The active ingredient is lidocaine hydrochloride. 100 g of cream contain 6.15 g of lidocaine hydrochloride equivalent to 5 g of lidocaine base.
• The other ingredients are: cetostearyl alcohol, Macrogol cetostearyl ether, petrolatum, white soft paraffin, methyl p-hydroxybenzoate, purified water.

Description of the appearance of Ortodermina and contents of the pack
Ortodermina is a cream dispensed in a tube of 3 g, 10 g and 50 g.
The 3 g tube presentation is available in packs of 1 tube or 10 tubes and includes
inside, respectively, one or ten applicator cannulae.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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