Motti

Leaflet attached to the packaging: patient information

Motti 25 mg/g + 25 mg/g cream

Lidocaine + Prilocaine

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of 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 packaging 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 called local anesthetics. Motti works by temporarily numbing the sensation in the outer layers of the skin. The cream is applied to the skin before medical procedures. This helps to numb the skin pain; however, the patient may still feel pressure and touch.

Adults, adolescents, and children

It can be used for skin anesthesia before:

• injecting a needle into the skin (e.g., during injection or blood sampling),
• minor surgical procedures on the skin.

Adults and adolescents

It can also be used:

• to anesthetize the genital area before:
• injection,
• medical procedures, such as removal of warts.

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

Adults

It can also be used for skin anesthesia before:

• debridement or removal of damaged skin on lower limb ulcers.

2. Important information before using Motti

When not to use Motti

Warnings and precautions

Before starting to use Motti, discuss it with your doctor or pharmacist:

• do not use Motti on areas of skin with a rash, cuts, scrapes, or other open wounds, except for lower limb ulcers. If the patient has any of these changes, consult a doctor or pharmacist before using the cream,

Due to the possibility of increased absorption from freshly shaved skin, it is essential to follow the recommended dosage, area of application, and duration of application on the skin. Avoid contact of Motti with the eyes, as it may cause irritation. If the cream accidentally gets into the eye, rinse it immediately with lukewarm water or physiological saline solution (sodium chloride). Be careful not to get anything in the eye until sensation returns. Do not use Motti on a diseased eardrum. When Motti is used in a patient before administering a live vaccine (e.g., tuberculosis vaccine), remember to report to the doctor or nurse after vaccination to assess the effectiveness of the vaccination.

Children and adolescents

In infants/newborns under 3 months, a transient, clinically insignificant increase in methemoglobin concentration in the blood is commonly observed within 12 hours after application of Motti. The efficacy of Motti during blood sampling from the heel in newborns or to ensure adequate pain relief during circumcision has not been confirmed in clinical trials. Motti should not be used on the genital skin (e.g., penis) or mucous membranes of the genital area (e.g., vagina) in children (under 12 years) due to insufficient data on the absorption of active substances. Motti should not be used in children under 12 months who are being treated with other medicines that 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 you are taking, have recently taken, or might take. This includes medicines that can be bought without a prescription and herbal medicines. This is important because the ingredients of Motti can affect the action of some other medicines, and some other medicines can affect the action of Motti. In particular, the patient should inform their doctor or pharmacist if they have taken or used any of the following medicines:

• Medicines used to treat infections called sulfonamides and nitrofurantoin.
• Medicines used to treat epilepsy: phenytoin and phenobarbital.
• Other local anesthetics.
• Medicines used to treat irregular heart rhythm, such as amiodarone.
• Cimetidine or beta-adrenergic blockers, which may increase the concentration of lidocaine in the blood. This interaction is not clinically significant in short-term use of Motti in recommended doses.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Occasional use of Motti during pregnancy is not associated with any risk of adverse effects on the fetus. The active substances of Motti (lidocaine and prilocaine) pass into breast milk. However, the amount that passes into milk is so small that there is essentially no risk to the breastfed child. In animal studies, no fertility disorders were found in male or female animals.

Driving and using machines

Motti has no or negligible influence on the ability to drive and use machines when used as recommended.

Motti contains hydrogenated polyoxyethylene ricinoleate

Hydrogenated polyoxyethylene ricinoleate may cause skin reactions.

3. How to use Motti

This medicine should always be used exactly as your doctor, pharmacist, or nurse has told you. If you are not sure, ask your doctor, pharmacist, or nurse.

Using Motti

• The place where the cream is applied, the amount of cream, and the time it is applied depend on the purpose of use.
• The doctor, pharmacist, or nurse will apply the cream to the appropriate area or show the patient how to do it themselves.
• When Motti is used on the genital area, the doctor or nurse should supervise its use.

Do not use Motti on the following areas:

• Cuts, scrapes, or wounds, except for lower limb ulcers.
• Areas with skin rash or eczema.
• Eyes or near the eyes.
• Inside the nose, ears, or mouth.
• Rectum.
• Genital area in children.

People who frequently apply or remove the cream from the patient's body should ensure that they effectively avoid contact with the cream to prevent the development of hypersensitivity. The protective membrane of the tube is pierced using the tube cap.

Application to the skin before minor procedures (such as needle insertion or minor surgical procedures on the skin):

• The cream is applied to the skin in a thick layer. The doctor, pharmacist, or nurse will tell the patient where to apply the cream.
• Then, the layer of cream is covered with a dressing (plastic foil). The dressing is removed immediately before the procedure starts. If the patient applies the cream themselves, they should ensure they have received dressings from the doctor, pharmacist, or nurse.
• The usual dose for adults and adolescents over 12 years is 2 g (grams).
• For adults and adolescents over 12 years, the cream should be applied at least 60 minutes before the planned procedure time (except when the cream is applied to the genital area). However, the cream should not be applied more than 5 hours before the procedure.
• For children, the amount of Motti cream and the time of application depend on the child's age. The doctor, nurse, or pharmacist will inform the patient about the amount of cream to use and when to apply it.

When applying the cream, it is essential to follow the instructions carefully:

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

Do not rub the cream into the skin.

• 2. Peel off the paper layer from the dressing.

• 3. Then, carefully place the dressing over the mound of cream. Do not spread the cream under the dressing.

• 4. Remove the paper stiffener. Gently smooth the edges of the dressing. Then, leave it in place for at least 60 minutes, unless the skin is damaged. The cream should not be left on for more than 60 minutes in children under 3 months or more than 30 minutes in children with atopic dermatitis. If the cream is applied to the genital area or ulcers, a shorter application time may be used, as described below.

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

Application to larger areas of freshly shaved skin before procedures in outpatient settings (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 a dressing. Motti should not be applied to an area of freshly shaved skin larger than 600 cm (600 square centimeters, e.g., 30 cm x 20 cm). The maximum dose is 60 g.

Application to the skin before procedures performed in hospital settings (e.g., before skin grafting), which require deeper skin anesthesia:

• Motti can be used in this way in adults and adolescents over 12 years.
• 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 a dressing for 2 to 5 hours.

Application to the skin before removing warts

• Motti can be used in children and adolescents with 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 tell the patient how much cream to use.

Application to the genital skin before injection of local anesthetics

• Motti can be used in this way only in adults and adolescents over 12 years.
• 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 a dressing. The dressing is left on for 15 minutes in the case of male genital skin and for 60 minutes in the case of female genital skin.

Application to the genital skin before minor surgical procedures on the skin (such as removal of warts)

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

Application to lower limb ulcers before debridement or removal of damaged skin

• The usual dose is 1 g to 2 g of cream per 10 cm of skin surface and no more than 10 g.
• The cream is applied and covered with a tight dressing, e.g., plastic foil. The cream and dressing are applied 30 to 60 minutes before the debridement procedure. The cream should be removed with a cotton swab and the debridement started immediately.
• Motti can be used before debridement of lower limb ulcers up to 15 times over a period of 1-2 months.
• When using the cream on lower limb ulcers, the Motti tube is for single use: after each use, the tube with the remaining cream should be discarded.

Using more Motti than recommended

If more Motti is used than recommended by the doctor, pharmacist, or nurse, contact them immediately, even if the patient does not feel unwell. Symptoms that may occur after using too much Motti are listed below. These symptoms should not occur when using Motti as recommended.

• Feeling of "emptiness" in the head or dizziness.
• Numbness or tingling of the skin around the mouth and numbness or lack of sensation of the tongue.
• Disturbed sense of taste.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of methemoglobinemia (a problem with the concentration of a blood pigment). This is more likely if the patient is taking certain other medicines. In case of this condition, the skin turns blue-gray due to insufficient oxygen in the blood.

In severe cases of overdose, symptoms such as seizures, low blood pressure, decreased breathing rate, respiratory arrest, and abnormal heart rhythm may occur. These symptoms can be life-threatening. If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Motti can cause side effects, although not everybody gets them. If the patient experiences any of the following side effects, they should contact their doctor or pharmacist. Tell your doctor about everything that makes you feel unwell when using Motti. At the site of application of Motti, a mild reaction may occur (pallor or redness of the skin, slight swelling, initial burning or itching sensation). These are common reactions to the cream and anesthetics, which resolve after a short time without the need for medical intervention. If the patient experiences any worrying or unusual effects or reactions while using Motti, they should stop using it and 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 application during use on the skin, mucous membranes of the genital area, or lower limb ulcers.
• Initial mild burning, itching, or warm sensation at the site of application during use on the mucous membranes of the genital area or lower limb ulcers.

Uncommon(may affect up to 1 in 100 people)

• Initial mild burning, itching, or warm sensation at the site of application during use on the skin.
• Lack of sensation (numbness) at the site of application during use on the mucous membranes of the genital area.
• Skin irritation at the site of application during use on lower limb ulcers.

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

• Allergic reactions, which in rare cases can lead to anaphylactic shock (skin rash, swelling, fever, difficulty breathing, and fainting) during use on the skin, mucous membranes of the genital area, or lower limb ulcers.
• Methemoglobinemia (blood disorder) during use on the skin.
• Minor pinpoint bleeding (petechiae) at the site of application (especially in children with eczema after longer application time) during use on the skin.
• Eye irritation if the eyes accidentally come into contact with Motti cream during its application on the skin.

Additional side effects in children

Methemoglobinemia, a blood disorder that is more commonly observed in children, often in association with overdose in newborns and infants under 12 months.

Reporting side effects

If side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of the 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Motti

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 month stated. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Motti contains

• The active substances of Motti are lidocaine and prilocaine. Each gram of cream contains 25 mg of lidocaine and 25 mg of prilocaine.
• The other ingredients are: hydrogenated polyoxyethylene ricinoleate, carbomer 974P, sodium hydroxide (to adjust pH), purified water.

What Motti looks like and contents of the pack

Motti is a white, gentle cream. It is packaged in tubes of 5 g and 30 g, internally coated with epoxy-phenolic lacquer with a PP cap and a piercer. 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 authorization holder and manufacturer

Marketing authorization holder

Pharmaceutical Works POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański

Manufacturer

Rafarm S.A., Thesi Pousi-Xatzi, Agiou Louka, Paiania, Attiki-19002, P.O. Box 37, Greece, Qualimetrix S.A., 579 Mesogeion avenue, Agia Paraskevi, Athens, 15343, Greece. For more information about this medicine and its names in the Member States of the European Economic Area, contact the local representative of the marketing authorization holder: POLPHARMA Commercial Office Ltd., ul. Bobrowiecka 6, 00-728 Warsaw, tel. 22 364 61 01. Date of last revision of the leaflet:June 2020