Romla anesthetic cream, 30 g, Elantis Farma

ROMLA contains two active substances called lidocaine and prilocaine. These substances belong to a group of medicines called local anaesthetics.

ROMLA numbs the surface of the skin for a short period of time. It is applied to the skin before certain medical procedures. This helps block pain in the skin, however, you may still feel pressure and tenderness.

Composition:

The active substances are lidocaine and prilocaine. Each gram of cream contains lidocaine 25 mg and prilocaine 25 mg

Other ingredients are polyoxyl hydrogenated castor oil, carbomer 974P, sodium hydroxide 10% (for pH adjustment), and purified water.

Method of administration:

Adults, adolescents and children:

It can be used to numb the skin before:

Inserting a needle (for example, if you are having an injection or blood test)

Minor skin surgeries.

Adults and adolescents

It can also be used for:

To numb the genitals before:

To give an injection

Medical procedures such as wart removal

A doctor or nurse should apply ROMLA to the genitals.

Adults:

It can also be used to numb the skin before:

Cleaning or removing affected skin from lower limb ulcers

For application to areas where the skin is not intact, the medicine should only be used on the recommendation of a doctor, nurse or pharmacist.

Contraindications:

Do not use ROMLA if you are allergic to lidocaine or prilocaine, other similar local anesthetics, or any of the other ingredients of this medicine.

Precautions:

Talk to your doctor, pharmacist or nurse before using ROMLA.

If you or your child have a rare genetic disease affecting the blood called “glucose-6-phosphate dehydrogenase deficiency”

If you or your child have a problem with the concentration of a pigment in the blood called "methaemoglobinaemia"

Do not use ROMLA on areas of skin with rashes, cuts, scrapes or other open wounds, except for leg ulcers.

If any of these problems are present, talk to your doctor, pharmacist or nurse before using the cream.

if you or your child have an itchy skin condition called "atopic dermatitis", a shorter application time may be sufficient. Application times longer than 30 minutes may increase the incidence of local skin reactions

if you are taking certain products for heart rhythm disorders (class III antiarrhythmics such as amiodarone). In this case, your doctor will monitor your heart function

Due to the potentially increased absorption on freshly shaved skin, it is important to adhere to the recommended dose, area and application time.

Avoid contact of ROMLA with the eyes as it may cause irritation. If ROMLA accidentally gets into the eyes, you should immediately rinse thoroughly with lukewarm water or saline (sodium chloride) solution.

Be careful to avoid eye contact with anything else until sensation returns. ROMLA should not be applied in case of eardrum damage.

When used before vaccinations with live vaccines (e.g. tuberculosis vaccine), you should return to your doctor or nurse after the period of time required to follow up on the result of the vaccination.

Pregnancy, lactation and fertility:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Occasional use of ROMLA during pregnancy is unlikely to have adverse effects on the fetus.

The active substances in ROMLA (lidocaine and prilocaine) pass into breast milk. However, the amount is so small that, in general, there is no risk to the child.

Animal studies have shown that male and female fertility is not affected.

Driving and using machines:

ROMLA has no or negligible influence on the ability to drive and use machines when used at the recommended dose.

Presentation: 30 g