Motti

Package leaflet: Information for the patient

Motti 25 mg/g + 25 mg/g cream
Lidocaine + Prilocaine
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Motti is and what it is used for

Motti contains two active substances called lidocaine and prilocaine. They belong to a group of medicines known as local anaesthetics.
The action of Motti is to temporarily numb the sensation in the superficial layers of the skin. The cream is applied to the skin before medical procedures to help relieve pain. However, the patient may still feel pressure and touch.

Adults, adolescents and children
May be used to anaesthetize the skin before:

• inserting a needle into the skin (for example, during an injection or blood sampling),
• minor surgical procedures on the skin.

Adults and adolescents
May also be used to anaesthetize the genital organs before:

• an injection,
• medical procedures such as removal of genital warts.

Application of Motti cream to the genital organs should be performed by a doctor or nurse.

Adults
May also be used to anaesthetize the skin before:

• debridement or removal of damaged skin from venous leg ulcers.

2. Important information before using Motti

When not to use Motti

• if the patient is allergic to lidocaine, prilocaine, other similar local anaesthetics, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Motti, discuss with your doctor or pharmacist:

• if the patient or child has a rare inherited disorder affecting the blood called glucose-6-phosphate dehydrogenase deficiency,
• if the patient or child has a condition involving blood pigment called methemoglobinemia,
• do not apply Motti to areas of skin with rashes, cuts, scratches, or other open wounds, except for leg ulcers. If any of these skin conditions are present, contact your doctor or pharmacist before using the cream,
• if the patient or child has a skin disorder characterized by itching known as "atopic dermatitis", shorter application time may be sufficient. Prolonged application beyond 30 minutes increases the likelihood of local skin reactions (see also section 4, "Possible side effects"),
• if the patient is taking certain medicines used to treat heart rhythm disorders (class III antiarrhythmics such as amiodarone). In such cases, the doctor will monitor the patient's heart function.

Due to the possibility of increased absorption through freshly shaved skin, it is important to follow the recommended dosage, size of the application area, and duration of skin application.
Avoid contact of Motti with the eyes, as it may cause irritation.
If Motti cream accidentally gets into the eye, immediately rinse the eye with lukewarm water or saline solution (sodium chloride). Exercise caution to prevent anything from entering the eye until sensation returns.
Do not apply Motti to diseased eardrum membranes.
When Motti is used before administration of a live vaccine (e.g. tuberculosis vaccine), remember to report to your doctor or nurse after vaccination to assess vaccine effectiveness.

Children and adolescents
In infants/newborns under 3 months of age, a transient, clinically insignificant increase in blood methemoglobin levels is commonly observed within 12 hours after application of Motti.
The efficacy of Motti during heel prick blood sampling in newborns or for providing adequate analgesia during circumcision has not been confirmed in clinical studies.
Motti should not be applied to the genital skin (e.g. penis) or mucous membranes of genital organs (e.g. vagina) in children (under 12 years of age) due to insufficient data on absorption of active substances.
Motti should not be used in children under 12 months of age who are concurrently being treated with other medicines affecting blood pigment and which may cause methemoglobinemia (e.g. sulfonamides; see also section 2, "Motti and other medicines").
Motti should not be used in premature newborns.

Motti and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
This includes medicines available without prescription and herbal medicines. This is important because the active ingredients in Motti may affect the action of certain other medicines, and some other medicines may affect the action of Motti.
In particular, the patient should inform their doctor or pharmacist if they have recently used or taken any of the following medicines:

• Medicines used to treat infections called sulfonamides and nitrofurantoin.
• Medicines used to treat epilepsy: phenytoin and phenobarbital.
• Other local anaesthetics.
• Medicines used to treat irregular heartbeats, such as amiodarone.
• Cimetidine or beta-blockers, which may increase lidocaine blood levels. This interaction is not clinically significant with short-term use of Motti at recommended doses.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Occasional use of Motti during pregnancy is not associated with risk of adverse effects on the fetus.
The active substances in Motti (lidocaine and prilocaine) pass into breast milk. However, the amount transferred is so small that there is essentially no risk to the breastfed infant.
Animal studies have shown no impairment of fertility in males or females.

Driving and operating machinery
Motti has no effect or negligible effect on the ability to drive and operate machinery when used at recommended doses.

Motti contains polyoxylated hydrogenated castor oil
Polyoxylated hydrogenated castor oil may cause skin reactions.

3. How to use Motti

This medicine should always be used exactly as directed by a doctor, pharmacist, or nurse. If in
doubt, consult a doctor, pharmacist, or nurse.
How to use Motti cream

• The site of application, amount of cream, and duration of use depend on the intended purpose.
• A doctor, pharmacist, or nurse will apply the cream to the appropriate area or show the patient how to do it independently.
• When Motti is used on genital areas, its application should be supervised by a doctor or nurse.

Do not apply Motti cream to the following areas:

• Broken, scratched, or wounded skin, except for leg ulcers.
• Areas with skin rash or eruptions.
• Into or near the eyes.
• Inside the nose, ears, or mouth.
• Into the rectum.
• On genital organs in children.

Individuals who frequently apply or remove the cream from a patient's skin should ensure they effectively
avoid contact with the cream to prevent the development of hypersensitivity.
The protective seal of the tube is pierced using the cap of the tube.
Application to skin prior to minor procedures (such as needle insertion or minor skin
surgical procedures):

• Apply the cream in a thick layer directly to the skin. The doctor, pharmacist, or nurse will inform the patient where to apply the cream.
• The cream layer is then covered with an occlusive dressing (plastic film). The dressing is removed immediately before the procedure begins. If the patient applies the cream independently, they should ensure they have received appropriate dressings from the doctor, pharmacist, or nurse.
• The usual dose in adults and adolescents over 12 years of age is 2 g (grams).
• In adults and adolescents over 12 years of age, the cream should be applied at least 60 minutes before the planned procedure (except when applied to genital areas). However, the cream should not be applied more than 5 hours before the procedure.
• The amount and duration of Motti cream application in children depend on the child's age. The doctor, nurse, or pharmacist will advise the patient on the correct amount and timing of application.

When applying the cream, it is very important to strictly follow these instructions:

1. Squeeze a portion of cream from the tube to form a small mound exactly where it is needed on the skin (e.g., where a needle will be inserted). A line of cream approximately 3.5 cm long from a 30 g tube corresponds to 1 g of cream. Half the content of a 5 g tube corresponds to approximately 2 g of Motti cream.

Do not rub the cream into the skin.

2. Peel off the paper layer from the dressing.

3. Carefully place the dressing over the cream mound. Do not spread the cream under the dressing.

4. Remove the paper stiffener. Gently smooth the edges of the dressing. Leave it in place for at least 60 minutes if the skin is intact. The cream should not be left on for longer than 60 minutes in children under 3 months of age or longer than 30 minutes in children with itchy skin known as "atopic dermatitis." If the cream is applied to genital areas or ulcers, a shorter application time may be used, as described below.

5. The doctor or nurse will remove the dressing and wipe off the cream immediately before the medical procedure (e.g., needle insertion).

Application to larger areas of freshly shaved skin prior to outpatient procedures (such as
hair removal):
The usual dose is 1 g of cream per 10 cm (10 square centimeters) of skin surface, applied for 1 to 5 hours under an occlusive dressing. Motti should not be applied to freshly shaved skin areas larger than 600 cm (600 square centimeters, e.g., 30 cm by 20 cm). The maximum dose is 60 g.
Application to skin prior to hospital procedures (e.g., medium-thickness skin grafting)
requiring deeper skin anaesthesia:

• Motti may be used in this way in adults and adolescents over 12 years of age.
• The usual dose is 1.5 g to 2 g of cream per 10 cm (10 square centimeters) of skin surface.
• The cream is applied and covered with an occlusive dressing for 2 to 5 hours.

Application to skin prior to removal of wart-like lesions ("genital warts")

• Motti may be used in children and adolescents with a skin condition called "atopic dermatitis."
• The usual dose depends on the child's age and is applied for 30 to 60 minutes (30 minutes if the patient has atopic dermatitis). The doctor, nurse, or pharmacist will advise the patient on the correct amount of cream to use.

Application to genital skin prior to local anaesthetic injections

• Motti may be used in this way only in adults and adolescents over 12 years of age.
• The usual dose is 1 g of cream (1 g to 2 g in the case of female genital skin) per 10 cm (10 square centimeters) of skin surface.
• The cream is applied and covered with an occlusive dressing. The dressing is left in place for 15 minutes in males and for 60 minutes in females.

Application to genital skin prior to minor skin surgical procedures
(such as removal of genital warts)

• Motti may be used in this way in adults and adolescents over 12 years of age.
• The usual dose is 5 g to 10 g of cream applied for 10 minutes. No dressing is used. The procedure should begin immediately after cream removal.

Application to leg ulcers prior to debridement or removal of damaged skin

• The usual dose is 1 g to 2 g of cream per 10 cm of skin surface, not exceeding 10 g in total.
• The cream is applied and covered with an occlusive dressing, e.g., plastic film. The cream and dressing are applied 30 to 60 minutes before the debridement procedure. The cream should be removed with cotton gauze, and debridement should begin immediately.
• Motti may be used prior to leg ulcer debridement up to 15 times within a 1–2 month period.
• When Motti cream is used on leg ulcers, the tube should be treated as a single-use product: after each patient use, the tube with any remaining cream must be discarded.

Use of a higher than recommended dose of Motti
If more Motti cream has been applied than recommended by the doctor, pharmacist, or nurse, contact them immediately, even if no symptoms are present.
The symptoms that may occur after an overdose of Motti are listed below. These symptoms should not occur when Motti is used as directed.

• Sensation of "emptiness in the head" or dizziness.
• Tingling around the mouth and numbness or loss of sensation in the tongue.
• Altered taste sensation.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of methemoglobinemia (a condition affecting the pigment in the blood). This is more likely if the patient is simultaneously taking certain other medicines. In such cases, the skin may turn bluish-grey due to insufficient oxygen in the blood.

In severe cases of overdose, symptoms such as seizures, low blood pressure, reduced breathing rate, respiratory arrest, and irregular heartbeat may occur. These symptoms can be life-threatening.
If there are any further doubts about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse effects listed below occur or persist in the patient, the patient should contact their doctor or pharmacist.
The patient should inform the doctor about any symptoms causing discomfort during treatment with Motti.

A mild reaction (pallor or redness of the skin, slight swelling, initial sensation of burning or itching) may occur at the site of application of Motti. These are common reactions to the cream and local anaesthetics, which resolve within a short time without requiring any medical intervention.

If the patient experiences any worrying or unusual effects or reactions during treatment with Motti, use should be discontinued immediately and the patient should contact their doctor or pharmacist as soon as possible.

Common (may affect up to 1 in 10 people)

• Transient local skin reactions (pallor, redness, swelling) at the site of drug exposure during application to the skin, genital mucosa, or lower limb ulcers.
• Initial mild sensation of burning, itching, or warmth at the site of drug exposure during application to the genital mucosa or lower limb ulcers.

Uncommon (may affect up to 1 in 100 people)

• Initial mild sensation of burning, itching, or warmth at the site of drug exposure during application to the skin.
• Loss of sensation (numbness) at the site of drug exposure during application to the genital mucosa.
• Skin irritation at the site of drug exposure during application to lower limb ulcers.

Rare (may affect up to 1 in 1,000 people)

• Allergic reactions, which in rare cases may lead to anaphylactic shock (skin rash, swelling, fever, breathing difficulty, and fainting) during application to the skin, genital mucosa, or lower limb ulcers.
• Methemoglobinemia (a blood disorder) during application to the skin.
• Minor pinpoint bleeding (petechiae) at the site of drug exposure (particularly in children with eczema after prolonged exposure to the drug) during application to the skin.
• Eye irritation, if accidental contact with Motti cream occurs during application to the skin.

Additional adverse effects in children
Methemoglobinemia, a blood disorder, which is more frequently observed in children, often associated with overdose in newborns and infants aged 0 to 12 months.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Motti medicine

Store below 30°C. Do not store in the refrigerator or freeze.
After first opening, use within 6 months.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube. The expiry date refers to the last day of the stated month.
The marking on the packaging: EXP indicates the expiry date, and Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Motti contains

• The active substances are lidocaine and prilocaine. Each gram of cream contains 25 mg of lidocaine and 25 mg of prilocaine.
• The other ingredients are: polyoxyl 40 hydrogenated castor oil, carbomer 974P, sodium hydroxide (for pH adjustment), purified water.

What Motti looks like and contents of the pack
Motti is a white, soft cream. It is packed in tubes with a capacity of 5 g and 30 g, internally
coated with an epoxy-phenolic lacquer, with a PP cap and a piercing device.
Pack sizes:
1 tube x 30 g
1 tube x 5 g
1 tube x 5 g with 2 dressings
1 tube x 5 g with 3 dressings
5 tubes x 5 g
5 tubes x 5 g with 12 dressings
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA SA
ul. Pelplińska 19, 83-200 Starogard Gdański

Manufacturer
Rafarm SA,
Thesi Pousi-Xatzi,
Agiou Louka,
Paiania, Attiki-19002,
P.O. Box 37, Greece
Qualimetrix SA
579 Mesogeion avenue, Agia Paraskevi,
Athens, 15343, Greece

For further information about the medicinal product and its names in the countries of the European Economic Area, please contact the local representative of the Marketing Authorisation Holder:
POLPHARMA Biuro Handlowe Sp. z o.o.
ul. Bobrowiecka 6, 00-728 Warsaw
tel. 22 364 61 01