Lidocaine and prilocaine Teva

Package leaflet: Information for the patient

Lidocaine and Prilocaine Teva (2.5/2.5)% w/w cream

Generic medicine
Please read all of this leaflet carefully before you start using this medicine because 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Lidocaine and Prilocaine Teva contains two active substances called lidocaine and prilocaine.
These belong to a group of medicines known as local anaesthetics.
Lidocaine and Prilocaine Teva works by numbing the surface of the skin for a short period.
It is applied to the skin before certain medical procedures. This helps to block pain in 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 (e.g. if you need an injection or a blood draw).
• Minor surgical procedures on the skin.

Adults and adolescents
It can also be used to:

• Anaesthetize the genital organs before:
  o Receiving an injection
  o Medical procedures such as wart removal
  A doctor or nurse must supervise the use of Lidocaine and Prilocaine Teva when applied to the genital area.

Adults
It can be used to anaesthetize the skin before:

• Cleaning or removing damaged skin from leg ulcers

2. What you should know before using Lidocaine and Prilocaine Teva

Do not use Lidocaine and Prilocaine Teva:

• if you are allergic to lidocaine or prilocaine, to other similar local anaesthetics, 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 Lidocaine and Prilocaine Teva:

• If you or your child has a rare inherited blood disorder called “glucose-6-phosphate dehydrogenase deficiency”.
• If you or your child has a blood pigment disorder called “methaemoglobinaemia”.
• Do not use Lidocaine and Prilocaine Teva on areas of skin affected by rashes, cuts, abrasions, or other open wounds, except for leg ulcers. If you have any of these conditions, consult your doctor or pharmacist before using the cream.
• If you or your child has a skin condition causing itching called “atopic dermatitis”, a shorter application time may be sufficient. Longer application times exceeding 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 for increased absorption through recently shaved skin, it is important to follow the recommended dosage, application area, and duration of application.
Avoid contact of Lidocaine and Prilocaine Teva with the eyes, as it may cause irritation. If, accidentally, Lidocaine and Prilocaine Teva comes into contact with the eyes, immediately rinse thoroughly with lukewarm water or saline solution (sodium chloride). Be careful not to insert anything into the eye until sensation has returned.
Lidocaine and Prilocaine Teva must not be applied to a damaged eardrum.
When using Lidocaine and Prilocaine Teva before receiving live vaccines (e.g. tuberculosis vaccine), you must return to your doctor or nurse after the required time interval to check the vaccination result.

Children and adolescents
In infants/neonates under 3 months of age, a transient increase in blood pigment levels, or "methaemoglobinaemia", is commonly observed, which is not clinically significant, up to 12 hours after application of Lidocaine and Prilocaine Teva.
The efficacy of Lidocaine and Prilocaine Teva for heel prick blood sampling in newborns or for providing adequate analgesia for circumcision has not been confirmed in clinical studies.
Lidocaine and Prilocaine Teva must not be applied to the genital mucosa (e.g. in the vagina) of children (under 12 years of age), as data on absorption of the active substances are insufficient.
Lidocaine and Prilocaine Teva must not be used in children under 12 months of age who are being treated simultaneously with other medicines affecting blood pigment levels, or "methaemoglobinaemia" (e.g. sulfonamides, see also section 2 “Other medicines and Lidocaine and Prilocaine Teva”).
Lidocaine and Prilocaine Teva must not be used in premature infants.

Other medicines and Lidocaine and Prilocaine Teva
Inform your doctor, pharmacist, or nurse if you are using/are taking, have recently used/taken, or might use/take any other medicines. This includes medicines purchased without a prescription and herbal products. This is because Lidocaine and Prilocaine Teva may affect how some medicines work, and some medicines may affect Lidocaine and Prilocaine Teva. In particular, inform your doctor or pharmacist if you or your child has recently used or been administered 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 anaesthetics.
• Medicines used to treat irregular heartbeat, such as amiodarone.
• Cimetidine or beta-blockers, which may increase blood levels of lidocaine. This interaction is not clinically relevant when Lidocaine and Prilocaine Teva is used short-term at recommended doses.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Occasional use of Lidocaine and Prilocaine Teva during pregnancy is unlikely to cause adverse effects on the foetus.
The active substances in Lidocaine and Prilocaine Teva (lidocaine and prilocaine) are excreted in breast milk. However, the amounts are very small and generally do not pose risks to the infant.
Animal studies have shown no effects on male or female fertility.

Driving and using machines
Lidocaine and Prilocaine Teva does not affect, or has a negligible effect on, the ability to drive and use machines, when used at recommended doses.

Lidocaine and Prilocaine Teva contains macrogol glycerol hydroxystearate
This may cause skin reactions.

3. How to use Lidocaine and Prilocaine Teva

Use this medicine exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.

How to use Lidocaine and Prilocaine Teva

• The application site, amount to use, and duration of application will depend on the reason for use.
• Your doctor, pharmacist, or nurse will apply the cream or show you how to do it yourself.
• When Lidocaine and Prilocaine Teva is used on genital areas, its use must be monitored by a doctor or nurse.

Do not use Lidocaine and Prilocaine Teva in the following areas:

• Cuts, abrasions, or wounds, except leg ulcers.
• Areas with skin rash or eczema.
• Inside or near the eyes.
• Inside the nose, ears, or mouth.
• In the anal area.
• On the genital organs of children.

Individuals who frequently apply or remove the cream should avoid contact with it as much as possible to prevent the development of hypersensitivity.
The protective seal of the tube is pierced by applying the cap.

Use on skin before minor procedures (such as needle insertion or minor skin interventions):

• A thick layer of cream is applied to the skin. Your doctor, pharmacist, or nurse will tell you where to apply it.
• The cream is then covered with an occlusive dressing (transparent film). This is removed before the procedure begins. If you are applying the cream yourself, ensure that the occlusive dressing has been provided by your 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 genital areas). However, do not apply it more than 5 hours before the procedure.
• For children, the amount of Lidocaine and Prilocaine Teva to use and the application time depend on their age. Your doctor, nurse, or pharmacist will advise you on the correct amount and timing.

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

1. Squeeze a thick layer of cream onto the skin at the required site (e.g., where the needle will be inserted). A strip of cream approximately 3.5 cm long squeezed from the 30 mg tube corresponds to 1 g of cream. Half of a 5 g tube corresponds to approximately 2 g of Lidocaine and Prilocaine Teva.

2. Do not rub in the cream.
3. Remove the paper layer from the patch.

4. Remove the patch protectors. Then carefully place 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 and leave it in place for at least 60 minutes.

6. Your doctor or nurse will remove the patch and wipe off the cream just before the procedure (e.g., just before needle insertion).

Use on larger areas of freshly shaved skin before outpatient procedures (e.g., hair removal techniques):
The usual dose is 1 g of cream per 10 cm² (10 square centimeters) of skin area, applied for 1–5 hours under an occlusive dressing. Lidocaine and Prilocaine Teva must not be used on a freshly shaved skin surface larger than 600 cm² (600 square centimeters, e.g., 30 cm by 20 cm). The maximum dose is 60 g.

Use on skin before hospital procedures (such as split-thickness skin grafts) requiring deeper skin anaesthesia:

• Lidocaine and Prilocaine Teva may 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 per 10 cm² (10 square centimeters) of skin area.
• The cream is applied under an occlusive dressing for 2–5 hours.

Use on skin before removal of wart-like lesions called "molluscum"

• Lidocaine and Prilocaine Teva 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 used for 30–60 minutes (30 minutes if the patient has atopic dermatitis). Your doctor, nurse, or pharmacist will tell you how much cream to use.

Use on genital skin before local anaesthetic injections

• Lidocaine and Prilocaine Teva may be used in this case only in adults and adolescents over 12 years of age.
• The usual dose is 1 g of cream (1 g to 2 g for female genital skin) per 10 cm² (10 square centimeters) of skin area.
• The cream is applied under an occlusive dressing for 15 minutes on male genital skin and for 60 minutes on female genital skin.

Use on genital areas before minor skin surgical procedures (e.g., removal of warts)
Lidocaine and Prilocaine Teva may be used in this way only in adults and adolescents over 12 years of age. The usual dose is 5 g to 10 g of cream for 10 minutes. An occlusive dressing is not used. The medical procedure should begin immediately afterward.

Use on leg ulcers before cleaning or removal of damaged skin

• The usual dose is 1 g to 2 g of cream per 10 cm² of skin area, up to a total of 10 g.
• The cream is applied under an occlusive dressing, such as a transparent film, 30 to 60 minutes before cleaning the ulcer. Remove the cream with a cotton swab and begin cleaning immediately.
• Lidocaine and Prilocaine Teva may be used before cleaning leg ulcers up to 15 times within a 1–2 month period.
• The Lidocaine and Prilocaine Teva tube is intended for single use when treating leg ulcers: The tube, regardless of any remaining content, must be discarded after each patient use.

If you use more Lidocaine and Prilocaine Teva than you should
If you use more Lidocaine and Prilocaine Teva than instructed by your doctor, pharmacist, or nurse, contact one of them immediately, even if you do not experience any symptoms.
Symptoms associated with excessive use of Lidocaine and Prilocaine Teva are listed below. These symptoms are unlikely to occur if you use Lidocaine and Prilocaine Teva as recommended.

• Feeling lightheaded or dizzy.
• Tingling around the mouth and numbness of the tongue.
• Taste disturbances.
• Blurred vision.
• Ringing in the ears.
• There is also a risk of acute "methaemoglobinaemia" (a condition related to blood pigment levels). This is more likely when certain medicines are taken at the same time. If this occurs, the skin may turn bluish-grey due to lack of oxygen.

In more severe cases of overdose, symptoms may include seizures, low blood pressure, slowed breathing, respiratory arrest, and irregular heartbeat. These effects can potentially be fatal.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor or pharmacist if any of the following side effects occur or do not go away. Inform your doctor of any other symptoms causing discomfort while using Lidocaine and Prilocaine Teva.
A mild reaction (pale or reddened skin, slight swelling, initial burning or itching) may occur at the site where you applied Lidocaine and Prilocaine Teva. These are normal reactions to the cream and to the anesthetics and will disappear shortly without requiring any intervention.
If you experience bothersome or unusual effects while using Lidocaine and Prilocaine 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 at the application site (pallor, redness, swelling) during treatment of skin, genital mucosa, and leg ulcers.
• Initial, generally mild sensation of burning, itching, or warmth at the application site during treatment of genital mucosa or leg ulcers.

Uncommon (may affect up to 1 in 100 people)

• Mild initial sensation of burning, itching, or warmth at the application site during treatment of the skin.
• Numbness (tingling) at the application site during treatment of genital mucosa.
• Irritation of treated skin during treatment of leg ulcers.

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

• Allergic reactions, which in rare cases may progress to anaphylactic shock (skin rash, swelling, fever, breathing difficulties, and fainting) during treatment of the skin, genital mucosa, or leg ulcers.
• Methemoglobinemia (a blood disorder) during treatment of the skin.
• Appearance of bleeding spots in the treated area (particularly in children with eczema, after longer application times) during treatment of the skin.
• Eye irritation in case of accidental contact with Lidocaine and Prilocaine Teva during treatment of the skin.

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You can also report side effects directly via 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 Lidocaine and Prilocaine 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 stated on the carton after EXP. The expiry
date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Lidocaine and Prilocaine Teva contains

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

Description of the appearance of Lidocaine and Prilocaine Teva and package contents
Lidocaine and Prilocaine Teva is a soft white cream. It is supplied in collapsible aluminium tubes
with an internal coating of phenolic epoxy lacquer.
Pack sizes:
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 European Economic Area countries under the
following names:
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