LIDOCAINA 2,5 % W/W Krem

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1. Lidocaina e Prilocaina Teva (2.5/2.5)% w/w cream
   1. What is Lidocaine and Prilocaine Teva and what it is used for
   2. What you need to know before using Lidocaina e Prilocaina Teva
   3. How to use Lidocaina e Prilocaina Teva
   4. Possible side effects
   5. How to store Lidocaina e Prilocaina Teva
   6. Contents of the pack and other information

Lidocaina e Prilocaina Teva (2.5/2.5)% w/w cream

Generic medicine
Read this leaflet carefully before you start using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Lidocaine and Prilocaine Teva and what it is used for

Lidocaine and Prilocaine Teva contains two active ingredients called lidocaine and prilocaine. These
belong to a group of medicines called local anesthetics.
Lidocaine and Prilocaine Teva works by making the surface of the skin insensitive for a short period.
It is applied to the skin before certain medical procedures. This helps to block pain on the
skin; however, sensations such as pressure and touch may still be felt.

Adults, adolescents and children
It can be used to numb the skin before:

• Needle insertions (for example if you need to have an injection or a blood test).
• Minor surgical procedures on the skin.

Adults and adolescents
It can also be used to:

• Anesthetize the genital organs before: o Having an injection or Medical procedures such as wart removal A doctor or nurse must supervise the use of Lidocaine and Prilocaine Teva on the genital organs.

Adults
It can be used to anesthetize the skin before:

• Cleaning or removing damaged skin from leg ulcers

2. What you need to know before using Lidocaina e Prilocaina Teva

Do not use Lidocaina e Prilocaina Teva:

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Lidocaina e Prilocaina Teva:

• If you, or your child, have a rare inherited blood disorder called “glucose-6-phosphate dehydrogenase deficiency”
• If you, or your child, have a problem concerning the levels of pigment in the blood called “methemoglobinemia”.
• Do not use Lidocaina e Prilocaina Teva on areas affected by rash, cuts, abrasions or other open wounds, except for leg ulcers. If you have any of these problems, consult your doctor or pharmacist before using the cream.
• If you, or your child, have a skin condition that causes itching called “atopic dermatitis”, a shorter application time may be sufficient. Longer application times than 30 minutes may increase the incidence of local skin reactions (see also section 4 “Possible side effects”).
• If you are taking specific medicines for heart rhythm disorders (Class III antiarrhythmics, such as amiodarone). In this case, your doctor will monitor your heart function.

Due to the potential increase in absorption on freshly shaved skin, it is important to follow the
recommended dosage, area and application time.
Avoid contact of Lidocaina e Prilocaina Teva with the eyes, as it may cause irritation. If,
accidentally, Lidocaina e Prilocaina Teva comes into contact with the eyes, you should immediately
rinse thoroughly with lukewarm water or saline solution (sodium chloride). Be careful not to
insert anything into the eye until sensitivity is restored.
Lidocaina e Prilocaina Teva should not be applied to a damaged eardrum.
When using Lidocaina e Prilocaina Teva before being vaccinated with live vaccines (e.g. vaccine
against tuberculosis), you should return to your doctor or nurse after the required period of time
to verify the vaccination result.

Children and adolescents
In infants/newborns under 3 months of age, a transient, not
clinically relevant increase in blood pigment levels, or "methemoglobinemia", is commonly observed, up
to 12 hours after the application of Lidocaina e Prilocaina Teva
The effectiveness of Lidocaina e Prilocaina Teva in blood sampling from the heel of newborns, or in providing
adequate analgesia for circumcision, has not been confirmed in clinical studies.
Lidocaina e Prilocaina Teva should not be applied to the genital mucosa (e.g. in the vagina)
of children (under 12 years of age) as data on the absorption of the active ingredients are not
sufficient.
Lidocaina e Prilocaina Teva should not be used in children under 12 months of age who are
being treated simultaneously with other drugs that affect blood pigment levels, or
"methemoglobinemia" (e.g. sulfonamides, see also section 2 “Other medicines and
Lidocaina e Prilocaina Teva”).
Lidocaina e Prilocaina Teva should not be used in premature newborns.

Other medicines and Lidocaina e Prilocaina Teva
Tell your doctor, pharmacist or nurse if you are taking, have recently
taken or are planning to take any other medicines. This includes medicines that
you buy without a prescription and herbal products. This is because Lidocaina e Prilocaina
Teva can affect the way some medicines work and some medicines can have an
effect on Lidocaina e Prilocaina Teva. In particular, tell your doctor or pharmacist if you, or your
child, have recently used, or have been given, any of the following medicines:

• Medicines used to treat infections, called "sulfonamides" and nitrofurantoin.
• Medicines used to treat epilepsy, called phenytoin and phenobarbital.
• Other local anesthetics.
• Medicines used to treat irregular heartbeat, such as amiodarone.
• Cimetidine or beta-blockers, which can cause an increase in lidocaine levels in the blood. This interaction is not clinically relevant in short-term treatments with Lidocaina e Prilocaina Teva at the recommended doses.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Occasional use of Lidocaina e Prilocaina Teva during pregnancy is unlikely to
cause adverse effects on the fetus.
The active ingredients in Lidocaina e Prilocaina Teva (lidocaine and prilocaine) are excreted into
breast milk. However, the amounts are very small and generally do not pose a risk to the
child.
Studies conducted on animals have shown no alteration of male and
female fertility.

Driving and using machines
Lidocaina e Prilocaina Teva does not affect, or has a negligible effect on, the ability to drive and
operate machinery, when used at the recommended doses.

Lidocaina e Prilocaina Tevacontains macrogol hydroxystearate
This may cause skin reactions.

3. How to use Lidocaina e Prilocaina Teva

Use this medicine following the instructions of your doctor, pharmacist or nurse exactly. If you have any doubts, ask your doctor, pharmacist or nurse.

How to useLidocaina e Prilocaina Teva

• The area of application, the amount to use and how long to leave it on will depend on the reason why you need to use it.
• The doctor, pharmacist or nurse will apply the cream, or show you how to do it yourself.
• When Lidocaina e Prilocaina Teva is used on the genitals, its use must be monitored by a doctor or nurse.

Do not use Lidocaina e Prilocaina Teva in the following areas:

• Cuts, abrasions or wounds, excluding leg ulcers.
• In case of rash or eczema.
• Inside the eyes or near the eyes.
• Inside the nose, ears or mouth.
• In the anus.
• On the genitals of children.

People who frequently apply or remove the cream should try to avoid contact with it to prevent the development of hypersensitivity.
The protective membrane of the tube is perforated by applying the cap.

Use on the skin before minor procedures (such as, for example, inserting a needle or small skin interventions):

• A thick layer of cream is applied to the skin. The doctor, pharmacist or nurse will tell you where to apply it.
• The cream is then covered with an occlusive bandage (transparent film). This is removed before the procedure begins. If you are applying the cream yourself, make sure the occlusive bandage has been provided by the doctor, pharmacist or nurse.
• The usual dose for adults and adolescents over 12 years of age is 2 g (grams).
• For adults and adolescents over 12 years of age, apply the cream at least 60 minutes before the procedure (unless the cream is applied to the genitals). However, do not apply it more than 5 hours before.
• For children, the amount of Lidocaina e Prilocaina Teva to use and the application time depend on their age. The doctor, nurse or pharmacist will tell you the amount to use and when it should be applied.

When applying the cream, it is very important that you follow the instructions below exactly:

• 1. Squeeze a thick layer of cream onto the skin, where required (for example where the needle will be inserted). A strip of cream about 3.5 cm long, squeezed out of the tube from 30 mg, corresponds to 1 g of cream. Half a 5 g tube corresponds to approximately 2 g of Lidocaina e Prilocaina Teva.

• 2. Do not spread the cream
• 3. Remove the paper layer from the patch

• 4. Remove the patch protectors. Then, carefully position the patch over the layer of cream. Do not spread the cream under the patch.

• 5. Remove the plastic layer. Smooth the edges of the patch carefully, then leave the patch applied for at least 60 minutes.

• 6. The doctor or nurse will remove the patch and remove the cream just before the procedure is performed (for example just before the needle is inserted).

Use on larger areas of skin freshly shaved before outpatient procedures (e.g. hair removal techniques):
The usual dose is 1 g of cream for each area of skin that has dimensions of 10 cm² (10 square centimeters), applied for 1-5 hours under a patch. Lidocaina e Prilocaina Teva should not be used on a freshly shaved skin surface larger than 600 cm² (600 square centimeters, for example 30 cm by 20 cm) in size. The maximum dose is 60 g.

Use on the skin before hospital procedures (such as split-thickness skin grafts) that require deeper skin anesthesia:

• Lidocaina e Prilocaina Teva can be used for this purpose in adults and adolescents over 12 years of age.
• The usual dose is 1.5 g to 2 g of cream for each area of skin of 10 cm (10 square centimeters) in size.
• The cream is applied under an occlusive bandage for 2-5 hours.

Use on the skin before removing wart-like spots called "mollusca":

• Lidocaine and Prilocaine Teva can be used in children and adolescents with a skin condition called "atopic dermatitis".
• The usual dose depends on the child's age and is used for 30-60 minutes (30 minutes if the patient has atopic dermatitis). The doctor, nurse or pharmacist will tell you how much cream to use and when it should be applied.

Use on the skin of the genitals before injections of local anesthetics

• Lidocaina e Prilocaina Teva can only be used in this case in adults and adolescents over 12 years of age.
• The usual dose is 1 g of cream (from 1 g to 2 g for female genital skin) for each area of skin of 10 cm (10 square centimeters).
• The cream is applied under an occlusive bandage for 15 minutes on male genital skin and for 60 minutes on female genital skin.

Use on the genitals before minor skin surgery (e.g. wart removal)
Lidocaina e Prilocaina Teva can only 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 for 10 minutes. The occlusive bandage is not used. The medical procedure should then begin immediately.

Use on leg ulcers before cleaning or removing damaged skin

• The usual dose is 1 g to 2 g of cream for each area of skin of 10 cm up to a total of 10 g.
• The cream is applied under an occlusive bandage such as a transparent film. This is done 30 to 60 minutes before the ulcer is cleaned. Remove the cream with a cotton gauze and start cleaning immediately.
• Lidocaina e Prilocaina Teva can be used before cleaning leg ulcers up to 15 times over a period of 1-2 months.
• The tube of Lidocaina e Prilocaina Teva is for single use if used on leg ulcers: The tube, whatever the remaining content, must be discarded after each time a patient has used it.

If you use more Lidocaina e Prilocaina Teva than you should
If you use more Lidocaina e Prilocaina Teva than your doctor, pharmacist or nurse told you, contact one of them immediately, even if you do not feel any symptoms.
The symptoms related to excessive use of Lidocaina e Prilocaina Teva are listed below. These symptoms are unlikely to occur if you use Lidocaina e Prilocaina Teva as recommended.

• Feeling lightheaded or dizzy.
• Tingling of the skin around the mouth and numbness of the tongue.
• Changes in taste.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of "acute methemoglobinemia" (a problem associated with pigment levels in the blood). This is more likely when certain medications are taken at the same time. If this happens, the skin will turn bluish-gray due to lack of oxygen.

In the most severe cases of overdose, symptoms may include convulsions, low blood pressure, slowed breathing, respiratory arrest, and altered heartbeat. These effects can be potentially fatal.
If you have any doubts about using this medicine, contact your doctor, pharmacist or nurse

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or pharmacist if any of the following side effects occur or
seem to not go away. Tell your doctor about anything else that makes you feel unwell while you are
using Lidocaina e Prilocaina Teva.
A mild reaction (paleness or redness of the skin, slight swelling, burning or initial itching)
may occur on the area where you have used Lidocaina e Prilocaina Teva. These are normal reactions
to the cream and anesthetics and will disappear shortly, without the need to take any
action.
If you experience bothersome or unusual effects during the use of Lidocaina e Prilocaina Teva, stop
using it and consult your doctor or pharmacist as soon as possible.

Common(may affect up to 1 in 10 people)

• Transient local skin reactions in the application area (paleness, redness, swelling) during the treatment of skin, genital mucosa and leg ulcers.
• Initial and generally mild sensation of burning, itching or warmth at the application site during treatment of the genital mucosa or leg ulcers.

Uncommon(may affect up to 1 in 100 people)

• Initial mild sensation of burning, itching or warmth at the application site during treatment of the skin.
• Numbness (tingling) at the application site during treatment of the genital mucosa.
• Irritation of the skin treated during the treatment of leg ulcers. Rare(may affect up to 1 in 1000)
• Allergic reactions, which in rare cases can develop into anaphylactic shock (rash, swelling, fever, difficulty breathing and fainting) during the treatment of skin, genital mucosa or leg ulcers.
• Methemoglobinemia (blood disease) during the treatment of the skin.
• Appearance of bleeding spots on the treated area (especially in children with eczema, after longer application times) during the treatment of the skin.
• Eye irritation in case of accidental contact with Lidocaina e Prilocaina Teva, during the treatment of the skin.

Additional side effects in children
Methemoglobinemia, a blood disease, which is observed more frequently, often in
association with overdose in newborns and infants aged between 0 and 12 months.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Lidocaina e Prilocaina Teva

This medicine does not require any special storage conditions. Do not refrigerate or
freeze.
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 pack after EXP. The expiry
date refers to the last day of that month.
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 Lidocaina e Prilocaina Teva contains

• The active ingredients are lidocaine and prilocaine. Each gram of cream contains 25 mg of lidocaine and 25 mg of prilocaine.
• The other ingredients are Macrogol glycerol hydroxystearate, carbomer 974P, sodium hydroxide, purified water.

Description of the appearance of Lidocaina e Prilocaina Teva and contents of the pack
Lidocaina e Prilocaina Teva is a soft white cream. It is presented in collapsible aluminium tubes of 5 g and 30 g, internally coated with a phenolic epoxy lacquer.
Packs:
1 x 30 g tube
1 x 5 g tube with 2 patches
5 x 5 g tubes with 12 patches
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4-20123 Milano
Italy

Manufacturer:
Rafarm SA,
Thesi Pousi-Xatzi,
Agiou Louka,
Paiania, Attiki-19002,
P.O. Box 37, Greece.
National and Kapodistrian university of Athens, Department of Chemistry, Service Laboratory
“Chemical Analysis-Quality Control”,
Panepistimiopolis Zografou, 15771,
Attiki, Athens, Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following designations:
Denmark: Lidocain/Prilocain Terix (2.5/2.5)% w/w cream
Netherlands: Lidocaine/Prilocaine Teva, (2.5+2.5)% w/w cream
Italy: Lidocaina e Prilocaina Teva