LEVOBUPIVACAINA 0.625 MG/ML Roztwór do infuzji

Treść ulotki

1. Levobupivacaina Altan 2,5 mg/ml injectable solution and infusion
   1. What is Levobupivacaina Altan 2,5 mg/ml and what is it used for
   2. What you need to know before using Levobupivacaina Altan 2.5 mg/ml
2. Levobupivacaine Altan 2.5 mg/ml and those immediately following the surgical intervention have not
   1. How to use Levobupivacaina Altan 2,5 mg/ml
   2. Possible side effects
   3. How to store Levobupivacaina Altan 2,5 mg/ml
   4. Package Contents and Other Information
3. Levobupivacaina Altan 5 mg/ml injectable solution and infusion
   1. What is Levobupivacaina Altan 5 mg/ml and what is it used for
   2. What you need to know before using Levobupivacaina Altan 5 mg/ml
4. Levobupivacaina Altan 5 mg/ml and those immediately following the surgical intervention have not
   1. How to use Levobupivacaina Altan 5 mg/ml
   2. Possible side effects
   3. How to store Levobupivacaina Altan 5 mg/ml
   4. Package contents and other information
5. Levobupivacaina Altan 0.625 mg/ml solution for infusion
   1. What is Levobupivacaina Altan 0.625 mg/ml and what is it used for
   2. What you need to know before you are given Levobupivacaina Altan 0.625 mg/ml
   3. How to use Levobupivacaina Altan 0.625 mg/ml
   4. Possible side effects
   5. How to store Levobupivacaina Altan 0.625 mg/ml
   6. Package contents and other information
6. Levobupivacaine Altan 7.5 mg/ml injectable solution and infusion
   1. What is Levobupivacaina Altan 7,5 mg/ml and what is it used for
   2. What you need to know before using Levobupivacaina Altan 7,5 mg/ml
   3. How to use Levobupivacaina Altan 7,5 mg/ml
   4. Possible side effects
   5. How to store Levobupivacaina Altan 7,5 mg/ml
   6. Package Contents and Other Information
7. Levobupivacaine Altan 1.25 mg/ml solution for infusion
   1. What is Levobupivacaina Altan 1.25 mg/ml and what is it used for
   2. What you need to know before you are given Levobupivacaina Altan 1.25 mg/ml
   3. How to use Levobupivacaina Altan 1.25 mg/ml
   4. Possible side effects
   5. How to store Levobupivacaina Altan 1.25 mg/ml
   6. Package contents and other information

Levobupivacaina Altan 2,5 mg/ml injectable solution and infusion

Levobupivacaina
Equivalent medicine

Read this leaflet carefully before 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.
• 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 Levobupivacaina Altan 2,5 mg/ml is and what it is used for
• 2. What you need to know before you use Levobupivacaina Altan 2,5 mg/ml
• 3. How to use Levobupivacaina Altan 2,5 mg/ml
• 4. Possible side effects
• 5. How to store Levobupivacaina Altan 2,5 mg/ml
• 6. Contents of the pack and other information

1. What is Levobupivacaina Altan 2,5 mg/ml and what is it used for

Levobupivacaina Altan 2,5 mg/ml belongs to a group of medicines called local anesthetics.
This type of medicine is used to make a part of the body insensitive or to
eliminate pain.

Adults:
Levobupivacaina Altan 2,5 mg/ml is used as a local anesthetic to make parts
of the body insensitive before major (e.g. as an epidural for a cesarean section) or minor (such as to the eyes and mouth) surgery.

It is also used for pain relief:

• after major surgery
• during childbirth

Children:
Levobupivacaina Altan 2,5 mg/ml can also be used in children to make
parts of the body insensitive before surgery and for pain relief after minor surgery, such as the treatment of an inguinal hernia.
Levobupivacaina Altan 2,5 mg/ml has not been tested in children under 6 months of age.

2. What you need to know before using Levobupivacaina Altan 2.5 mg/ml

Do not use Levobupivacaina Altan 2.5 mg/ml

• if you are allergic (hypersensitive) to levobupivacaine, to any similar local anesthetic, or to

any of the other ingredients of this medicine (listed in section 6).

• if you have very low blood pressure.
• as a method of pain relief administered by injection into the area around the cervix during the early stages of labour (paracervical block).
• to anesthetize an area by intravenous injection of Levobupivacaina Altan 2.5 mg/ml.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given
Levobupivacaina Altan 2.5 mg/ml if you have any of the diseases or conditions
described below. You may need to have more careful monitoring or be given a
lower dose of the medicine.

• If you suffer from heart problems
• If you suffer from diseases of the nervous system
• If you are weak or ill
• If you are elderly
• If you have a liver disease.

Other medicines and Levobupivacaina Altan 2.5 mg/ml
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or
may take any other medicines, including over-the-counter medicines. In particular, tell them if you are taking medicines for the treatment of:

• irregular heartbeat (such as mexiletine)
• fungal infections (such as ketoconazole) as this may affect how long Levobupivacaina Altan 2.5 mg/ml stays in your body
• asthma (such as theophylline) as this may affect how long Levobupivacaina Altan 2.5 mg/ml stays in your body.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are
breastfeeding with breast milk, ask your doctor or nurse for advice before using this medicine.
Levobupivacaina Altan 2.5 mg/ml should not be given during labour as
pain relief by injection into the area around the cervix or the cervix (paracervical
block).
The effect of Levobupivacaina Altan 2.5 mg/ml on the baby during the early stages of pregnancy
is not known. Therefore, Levobupivacaina Altan 2.5 mg/ml should not be used during the first
three months of pregnancy, unless your doctor thinks it is necessary.
It is not known whether levobupivacaine passes into breast milk. However, based on experience with similar medicines, it is believed that only small amounts of levobupivacaine may pass into breast milk.
Consequently, breastfeeding is possible after administration of a local anesthetic.

Driving and using machines
The use of Levobupivacaina Altan 2.5 mg/ml may have significant effects on your ability to drive
vehicles or use machines. Do not drive vehicles or use machines until all the effects of

Levobupivacaine Altan 2.5 mg/ml and those immediately following the surgical intervention have not

disappeared. Ensure you are informed about this by the doctor or nurse treating you, before leaving the hospital.

Important information about some of the components ofLevobupivacaine Altan 2.5 mg/ml
This medicine contains 3.5 mg/ml of sodium in the bag or vial solution and this must
be taken into consideration by patients who are following a low-sodium diet.

3. How to use Levobupivacaina Altan 2,5 mg/ml

Your doctor will administer Levobupivacaina Altan 2,5 mg/ml by injection with a needle or
with a small catheter inserted into your back (epidural). Levobupivacaina Altan 2,5 mg/ml may
also be injected into other parts of the body to numb the area to be treated,
such as an eye, an arm, or a leg.
The doctor and nurse will closely monitor you while Levobupivacaina Altan 2,5 mg/ml is administered.

Dosage
The amount of Levobupivacaina Altan 2,5 mg/ml that will be administered to you and the frequency of
administration will depend on the reason why this medicine is being used and
also on your state of health, age, and weight. However, the lowest dose necessary
to anesthetize the part of the body that needs to be treated will always be used. The doctor will carefully evaluate
which dose should be administered to you.
When Levobupivacaina Altan 2,5 mg/ml is used for pain relief during
labor or for cesarean section (epidural), the dose used must be carefully controlled.

If you receive more Levobupivacaina Altan 2,5 mg/ml than you should
If you are given an excessive dose of Levobupivacaina Altan 2,5 mg/ml,
the following symptoms may occur: numbness of the tongue, dizziness, blurred vision,
muscle contractions, severe difficulty breathing (including respiratory arrest), and even
convulsions. If you notice any of these symptoms, inform
your doctor immediately. Sometimes, an excessive dose of Levobupivacaina Altan 2,5 mg/ml may
also cause a drop in blood pressure, an acceleration or slowing of the
heart rate, and cause changes in heart rhythm. The doctor may deem it necessary
to administer other medicines to help eliminate these symptoms. If you have any other questions
about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you think you have any of the side effects listed below, tell your doctor or nurse immediately. Some side effects of Levobupivacaina Altan 2,5 mg/ml may be serious.
Very common side effects (may affect more than 1 in 10 people):

• Feeling tired or weak, shortness of breath, paleness (these are all signs of anaemia)
• Low blood pressure
• Nausea

Common side effects (may affect up to 1 in 10 people)

• Dizziness
• Headache
• Vomiting
• Problems affecting the fetus (fetal distress)
• Back pain
• Fever
• Pain after surgery

Frequency not known (the frequency cannot be estimated from the available data):

• Severe allergic reactions (hypersensitivity) causing severe difficulty in breathing, difficulty swallowing, hives and very low blood pressure.
• Allergic reactions (hypersensitivity) recognised by red, itchy skin, sneezing, heavy sweating, fast heartbeat, fainting or swelling of the face, lips and mouth
• Convulsions
• Drowsiness
• Blurred vision
• Respiratory arrest
• Heart attack or cardiac block
• Localised tingling
• Numbness of the tongue
• Muscle weakness or muscle contraction
• Loss of bladder or bowel control
• Paralysis
• Tingling, numbness or other abnormal sensation
• Prolonged erection of the penis which may be painful
• Nerve disorders that may include drooping of the eyelid, narrowing of the pupil (black part in the centre of the eye), sunken orbit, sweating and/or redness on one side of the face

Bradycardia, tachycardia, or irregular heartbeat and changes in heart rate that can be detected by electrocardiogram have also been reported as side effects.
Rarely some of these effects may be long-term or permanent.
If you think that any of the side effects you are experiencing get worse or if you notice any side effects

Reporting of side effects
If you get any side effects, even those 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/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levobupivacaina Altan 2,5 mg/ml

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the label after ‘Exp.’ The
expiry date refers to the last day of that month.
The doctor will store this medicine for you.
The solution must be used immediately after opening.
Levobupivacaina Altan 2,5 mg/ml must not be used if it contains visible particles.
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. Package Contents and Other Information

What the package containsLevobupivacaine Altan 2.5 mg/ml
The active ingredient is levobupivacaine (as hydrochloride).
One millilitre of solution contains 2.5 mg of levobupivacaine (as hydrochloride). Each vial of 10
ml contains 25 mg.
The excipients are water for injections, sodium chloride, sodium hydroxide and hydrochloric
acid.

Description of appearance and package contents
Levobupivacaine Altan 2.5 mg/ml is a transparent, colourless solution in type I glass vials.
Each vial contains 25 mg of levobupivacaine in a 10 ml vial. It is available in packs of 5
and 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Altan Pharmaceuticals, S.A.
C/ Cólquide Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma
Las Rozas, 28230 Madrid, Spain

Manufacturer
Altan Pharmaceuticals S.A.
Avda. de la Constitución 198-199, Pol. Ind. Monte Boyal
45950 Casarrubios del Monte, Toledo
Spain

OTHER PRESENTATIONS
Levobupivacaine Altan 5.0 mg/ml injectable and infusion solution
Levobupivacaine Altan 7.5 mg/ml injectable and infusion solution
Levobupivacaine Altan 1.25 mg/ml infusion solution
Levobupivacaine Altan 0.625 mg/ml infusion solution
------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for doctors or healthcare professionals:
Instructions for use and handling
Levobupivacaine Altan 2.5 mg/ml is intended for single use. Discard any unused solution.
From a microbiological point of view, the medicinal product must be used immediately after
opening. If not used immediately, the storage times in use and the conditions of storage before
use are the responsibility of the user.
Experience regarding the safety of treatment with levobupivacaine for more than 24 hours is limited.
Validity after first opening: the product must be used immediately.
Validity after dilution in 0.9% sodium chloride solution: Chemical and physical stability has been demonstrated in use conditions in 0.9% sodium chloride solution for 7 days at 20-22°C.
As with all medicinal products for parenteral use, the solution/dilution must be visually
inspected before use. Only clear and particle-free solutions can
be used.
Standard dilutions of levobupivacaine should be made with a sodium chloride injectable
solution 9 mg/ml (0.9%) under aseptic conditions.
8.4 micrograms/ml of clonidine, 0.05 mg/ml of morphine and 4
micrograms/ml of fentanyl have been shown to be compatible with levobupivacaine in a sodium chloride injectable
solution 9 mg/ml (0.9%). Chemical and physical stability has been demonstrated in use conditions
with clonidine, morphine or fentanyl for 40 hours at 20-22°C.
Levobupivacaine Altan 2.5 mg/ml must not be mixed with other medicinal products except for
those mentioned above.
Dissolution with alkaline solutions such as sodium bicarbonate may produce precipitates.

Route of administration
Levobupivacaine must be administered exclusively by a doctor, or under the
supervision of a doctor, who has appropriate experience and skills.

For information on dosage, see the summary of product characteristics.
To avoid intravascular injection, careful aspiration is recommended before and during
the injection.
Aspiration must be repeated before and during the administration of a bolus dose, which
should be injected slowly and increasing the dosage at a rate of 7.5-30 mg/min,
closely monitoring vital functions and maintaining verbal contact with the
patient.
If symptoms of toxicity occur, the injection must be stopped immediately.

Levobupivacaina Altan 5 mg/ml injectable solution and infusion

Levobupivacaina
Equivalent medicinal product

Read this leaflet carefully before 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.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Levobupivacaina Altan 5 mg/ml is and what it is used for
• 2. What you need to know before using Levobupivacaina Altan 5 mg/ml
• 3. How to use Levobupivacaina Altan 5 mg/ml
• 4. Possible side effects
• 5. How to store Levobupivacaina Altan 5 mg/ml
• 6. Contents of the pack and other information

1. What is Levobupivacaina Altan 5 mg/ml and what is it used for

Levobupivacaina Altan 5 mg/ml belongs to a group of medicines called local anesthetics.
This type of medicine is used to make a part of the body insensitive or to eliminate pain.

Adults:
Levobupivacaina Altan is used as a local anesthetic to make parts of the body insensitive
before a major (e.g. as an epidural for a cesarean section) or minor (such as to the eyes and mouth) surgical procedure.

It is also used for pain relief:

• after major surgery
• during childbirth

Children:
Levobupivacaina Altan can also be used in children to make parts of the body insensitive
before a surgical procedure and for pain relief after minor surgeries,
such as the treatment of an inguinal hernia.
Levobupivacaina Altan 5 mg/ml has not been tested in children under 6 months of age.

2. What you need to know before using Levobupivacaina Altan 5 mg/ml

Do not use Levobupivacaina Altan 5 mg/ml

• if you are allergic (hypersensitive) to levobupivacaine, to any similar local anesthetic, or to

any of the other ingredients of this medicine (listed in section 6).

• if you have very low blood pressure.
• as a method of pain relief administered by injection in the area around the cervix during the early stages of labor (paracervical block).
• to anesthetize an area by intravenous injection of Levobupivacaina Altan 5 mg/ml.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given
Levobupivacaina Altan 5 mg/ml if you have any of the diseases or conditions described below.
You may need more careful monitoring or be given a lower dose of the medicine.

• If you suffer from heart problems
• If you suffer from diseases of the nervous system
• If you are weak or ill
• If you are elderly
• If you have a liver disease.

Other medicines and Levobupivacaina Altan 5 mg/ml
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or
may take any other medicines, including over-the-counter medicines. In particular, tell them if you are taking medicines for the treatment of:

• irregular heartbeat (such as mexiletine)
• fungal infections (such as ketoconazole) as this may affect how long Levobupivacaina Altan 5 mg/ml stays in your body
• asthma (such as theophylline) as this may affect how long Levobupivacaina Altan 5 mg/ml stays in your body.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or nurse for advice before using this medicine.
Levobupivacaina Altan 5 mg/ml should not be administered during labor as a pain reliever
by injection in the area around the cervix (paracervical block).
The effect of Levobupivacaina Altan 5 mg/ml on the baby during the early stages of pregnancy
is unknown. Therefore, Levobupivacaina Altan 5 mg/ml should not be used during the first
three months of pregnancy, unless your doctor thinks it is necessary.
It is not known whether levobupivacaine passes into breast milk. However, based on experience with similar medicines, it is believed that only small amounts of levobupivacaine may pass into breast milk.
Consequently, breastfeeding is possible after administration of a local anesthetic.

Driving and using machines
The use of Levobupivacaina Altan can have significant effects on your ability to drive vehicles or
use machines. Do not drive vehicles or use machines until all the effects of

Levobupivacaina Altan 5 mg/ml and those immediately following the surgical intervention have not

disappeared. Ensure you are informed about this by the doctor or nurse treating you, before leaving the hospital.

Important information about some of the ingredients ofLevobupivacaina Altan 5 mg/ml
This medicine contains 3.5 mg/ml of sodium in the bag or vial solution and this must
be taken into consideration by patients following a low-sodium diet.

3. How to use Levobupivacaina Altan 5 mg/ml

The doctor will administer Levobupivacaina Altan 5 mg/ml to you via an injection with a needle or
with a small catheter inserted into your back (epidural). Levobupivacaina Altan 5 mg/ml may
also be injected into other parts of the body to numb the area that needs to be treated,
such as an eye, an arm, or a leg. The doctor and nurse will closely monitor you while
Levobupivacaina Altan 5 mg/ml is administered.

Dosage
The amount of Levobupivacaina Altan 5 mg/ml that will be administered to you and the frequency of
administration will depend on the reason why this medicine is being used and
also on your state of health, age, and weight. However, the lowest dose necessary
to anesthetize the part of the body that needs to be treated will always be used. The doctor will carefully assess
which dose should be administered to you.
When Levobupivacaina Altan 5 mg/ml is used for pain relief during labor
or for cesarean section (epidural), the dose used must be carefully controlled.

If you receive more Levobupivacaina Altan 5 mg/ml than you should
In the event that you are administered an excessive dose of Levobupivacaina Altan 5 mg/ml,
the following symptoms may occur: numbness of the tongue, dizziness, blurred vision,
muscle contractions, severe difficulty breathing (including respiratory arrest), and even
convulsions. If you should notice any of these symptoms, inform
the doctor immediately. Sometimes, an excessive dose of Levobupivacaina Altan 5 mg/ml may
also cause a drop in blood pressure, an acceleration or slowing of the
heartbeat, and cause variations in heart rhythm. The doctor may deem it necessary
to administer other medicines that help eliminate these symptoms. If you have any other questions
about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you think you have any of the side effects listed below, inform your doctor or nurse immediately. Some side effects of Levobupivacaina Altan 5 mg/ml can be serious.
Very common side effects (may affect more than 1 in 10 people):

• Feeling tired or weak, shortness of breath, paleness (these are all signs of anemia)
• Low blood pressure
• Nausea

Common side effects (may affect up to 1 in 10 people)

• Dizziness
• Headache
• Vomiting
• Problems affecting the fetus (fetal distress)
• Back pain
• Fever
• Pain after surgery

Frequency not known (the frequency cannot be estimated from the available data):

• Severe allergic reactions (hypersensitivity) causing severe difficulty breathing, difficulty swallowing, hives and very low blood pressure.
• Allergic reactions (hypersensitivity) recognized by red, itchy skin, sneezing, profuse sweating, fast heartbeat, fainting or swelling of the face, lips and mouth
• Convulsions
• Drowsiness
• Blurred vision
• Respiratory arrest
• Heart attack or cardiac block
• Localized tingling
• Numbness of the tongue
• Muscle weakness or muscle contraction
• Loss of bladder or bowel control
• Paralysis
• Tingling, numbness or other abnormal sensation
• Prolonged erection of the penis which may be painful
• Nerve disorders that may include drooping of the eyelid, constriction of the pupil (black part in the center of the eye), sunken orbit, sweating and/or redness on one side of the face

Bradycardia, tachycardia, or irregular heartbeat and changes in heart rate that can be detected by electrocardiogram have also been reported as side effects.
Rarely, some of these effects may be long-term or permanent.
If you think that any of the side effects you are experiencing worsen or if you notice any side effects

Reporting of side effects
If you get any side effects, even those 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/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levobupivacaina Altan 5 mg/ml

This medicine does not require any special storage conditions.
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 label after ‘Exp.’ The
expiry date refers to the last day of that month.
The doctor will store this medicine for you.
The solution must be used immediately after opening.
Levobupivacaina Altan 5 mg/ml must not be used if it contains visible particles.
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. Package contents and other information

What the product containsLevobupivacaine Altan 5 mg/ml
The active ingredient is levobupivacaine (as hydrochloride).
One millilitre of solution contains 5 mg of levobupivacaine (as hydrochloride). Each vial of 10 ml
contains 50 mg.
The excipients are water for injections, sodium chloride, sodium hydroxide and hydrochloric
acid.

Description of appearance and package contents
Levobupivacaine Altan 5 mg/ml is a transparent, colourless solution in type I glass vials.
Each vial contains 50 mg of levobupivacaine in a 10 ml vial. It is available in packs of 5
and 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Altan Pharmaceuticals, S.A.
C/ Cólquide Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma
Las Rozas, 28230 Madrid, Spain

Manufacturer
Altan Pharmaceuticals S.A.
Avda. de la Constitución 198-199, Pol. Ind. Monte Boyal
45950 Casarrubios del Monte, Toledo
Spain

OTHER PRESENTATIONS
Levobupivacaine Altan 2.5 mg/ml injectable and infusion solution
Levobupivacaine Altan 7.5 mg/ml injectable and infusion solution
Levobupivacaine Altan 1.25 mg/ml infusion solution
Levobupivacaine Altan 0.625 mg/ml infusion solution
------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for doctors or healthcare professionals:
Instructions for use and handling
Levobupivacaine Altan 5 mg/ml is intended for single use. Discard any unused solution.
From a microbiological point of view, the medicinal product must be used immediately after
opening. If not used immediately, the storage times under in-use conditions and the
storage conditions before use are the responsibility of the user.
Experience with the safety of treatment with levobupivacaine for more than 24 hours is limited.
Validity after first opening: the product must be used immediately.
Validity after dilution in 0.9% sodium chloride solution: Chemical and physical stability has been demonstrated
in use conditions in 0.9% sodium chloride solution for 7 days at 20-22°C.
As with all medicinal products for parenteral use, the solution/dilution must be visually
inspected before use. Only clear and particle-free solutions can
be used.
Standard dilutions of levobupivacaine should be made with an injectable
solution of sodium chloride 9 mg/ml (0.9%) under aseptic conditions.
8.4 micrograms/ml of clonidine, 0.05 mg/ml of morphine and 4
micrograms/ml of fentanyl have been shown to be compatible with levobupivacaine in an injectable
solution of sodium chloride 9 mg/ml (0.9%). Chemical and physical stability has been demonstrated
in use conditions with clonidine, morphine or fentanyl for 40 hours at 20-22°C.
Levobupivacaine Altan 5 mg/ml must not be mixed with other medicinal products except for
those mentioned above.
Dissolution with alkaline solutions such as sodium bicarbonate may produce precipitates.

Route of administration
Levobupivacaine must be administered exclusively by a doctor, or under the
supervision of a doctor, who has adequate experience and competence.

For information on dosage, see the summary of product characteristics.
To avoid intravascular injection, careful aspiration is recommended before and during
injection.
Aspiration should be repeated before and during the administration of a bolus dose, which
should be injected slowly and increasing the dosage at a rate of 7.5-30 mg/min,
keeping vital functions under close observation and maintaining verbal contact with the
patient.
If symptoms of toxicity occur, the injection must be stopped immediately.

Levobupivacaina Altan 0.625 mg/ml solution for infusion

Levobupivacaina

Generic medicine

Read this leaflet carefully before 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.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

• 1. What Levobupivacaina Altan 0.625 mg/ml is and what it is used for
• 2. What you need to know before Levobupivacaina Altan 0.625 mg/ml is given to you
• 3. How to use Levobupivacaina Altan 0.625 mg/ml
• 4. Possible side effects
• 5. How to store Levobupivacaina Altan 0.625 mg/ml
• 6. Contents of the pack and other information

1. What is Levobupivacaina Altan 0.625 mg/ml and what is it used for

Levobupivacaina Altan 0.625 mg/ml belongs to a group of medicines called local anesthetics.
This type of medicine is used to make a part of the body insensitive or to eliminate pain.
Levobupivacaina Altan 0.625 mg/ml solution for infusion is for use in adults only.
Levobupivacaina Altan 0.625 mg/ml is used for pain relief:

• after major surgical procedures
• during childbirth

2. What you need to know before you are given Levobupivacaina Altan 0.625 mg/ml

Do not use Levobupivacaina Altan 0.625 mg/ml:

• if you are allergic (hypersensitive) to levobupivacaine, to any similar local anesthetic, or to any of the other ingredients of this medicine (listed in section 6).
• if you have very low blood pressure.
• as a method of pain relief administered by injection into the area around the cervix during the early stages of labor (paracervical block).
• to anesthetize an area by intravenous injection of Levobupivacaina Altan 0.625 mg/ml.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given
Levobupivacaina Altan 0.625 mg/ml if you have any of the diseases or conditions
described below. You may need to have more frequent checks or be given a
lower dose of the medicine.

• If you suffer from diseases of the nervous system
• If you are weak or ill
• If you are elderly
• If you have a liver disease.

Other medicines and Levobupivacaina Altan 0.625 mg/ml
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or
may take any other medicines, including those available without a
prescription. In particular, tell them if you are taking medicines for the treatment of:

• irregular heartbeat (such as mexiletine)
• fungal infections (such as ketoconazole) as this may affect how long Levobupivacaina Altan 0.625 mg/ml stays in your body
• asthma (such as theophylline) as this may affect how long Levobupivacaina Altan 0.625 mg/ml stays in your body.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are
breastfeeding with breast milk, ask your doctor or nurse for advice before using this medicine.
Levobupivacaina Altan 0.625 mg/ml should not be administered during labor as
a pain reliever by injection into the area around the cervix (paracervical
block).
The effect of Levobupivacaina Altan 0.625 mg/ml on the baby during the early stages of
pregnancy is not known.
Therefore, Levobupivacaina Altan 0.625 mg/ml should not be used during the first three months
of pregnancy, unless your doctor thinks it is necessary.
It is not known whether levobupivacaine passes into breast milk, however, based on experience with a
similar medicine, it is believed that only small amounts of levobupivacaine may pass into
breast milk. Consequently, breastfeeding is possible after administration of a local
anesthetic.

Driving and operating machinery
The use of Levobupivacaina Altan may have significant effects on your ability to drive vehicles or
operate machinery. Do not drive vehicles or operate machinery until all the effects of
Levobupivacaina Altan and those immediately following surgery have worn off. Make
sure you are informed about this by the doctor or nurse treating you, before
leaving the hospital.

Important information about some of the ingredients of Levobupivacaina Altan 0.625 mg/ml:
This medicine contains 15 mmol (3.5 mg/ml) of sodium per 100 ml bag and 30 mmol (3.5
mg/ml) of sodium per 200 ml bag and this should be taken into consideration by patients
who are on a low sodium diet.

3. How to use Levobupivacaina Altan 0.625 mg/ml

Your doctor will administer Levobupivacaina Altan 0.625 mg/ml by injection with a needle
or with a small catheter inserted into your back (epidural). The doctor and nurse will keep you
under close supervision while Levobupivacaina Altan 0.625 mg/ml is administered to you.

Dosage
Adults
The amount of Levobupivacaina Altan 0.625 mg/ml that will be administered to you and the frequency of
administration will depend on the reason why this medicine is being used and
also on your state of health, age and weight. However, the lowest dose necessary will be used
to anesthetize the part of the body that needs to be treated. The doctor will carefully assess
which dose should be administered to you.
When Levobupivacaina Altan 0.625 mg/ml is used as an analgesic during labor, the
dose used must be carefully controlled.

Children
Not recommended.

If you receive more Levobupivacaina Altan 0.625 mg/ml than you should
If you are given an excessive dose of Levobupivacaina Altan 0.625 mg/ml,
the following symptoms may occur: numbness of the tongue, dizziness, blurred vision,
muscle contractions, severe difficulty breathing (including respiratory arrest) and even
convulsions. If you notice any of these symptoms, inform
your doctor immediately. Sometimes, an excessive dose of Levobupivacaina Altan 0.625 mg/ml
can also cause a drop in blood pressure, an acceleration or slowing down of the
heart rate and cause changes in heart rhythm. The doctor may deem it necessary to
administer other medicines that help eliminate these symptoms.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you believe you have any of the side effects listed below, inform your doctor or nurse immediately. Some side effects of Levobupivacaina Altan 0,625 mg/ml may be serious.
Very common side effects (may affect more than 1 in 10 people):

• Feeling tired or weak, shortness of breath, paleness (these are all signs of anemia)
• Low blood pressure
• Nausea

Common side effects (may affect up to 1 in 10 people)

• Dizziness
• Headache
• Vomiting
• Problems affecting the fetus (fetal distress)
• Back pain
• Fever
• Pain after surgery

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Serious allergic reactions (hypersensitivity) causing severe difficulty breathing, difficulty swallowing, hives and very low blood pressure.
• Allergic reactions (hypersensitivity) recognized by red, itchy skin, sneezing, heavy sweating, fast heartbeat, fainting or swelling of the face, lips and mouth
• Fainting
• Drowsiness
• Blurred vision
• Stoppage of breathing
• Heart attack or heart block
• Localized tingling
• Numbness of the tongue
• Muscle weakness or muscle contraction
• Loss of bladder or bowel control
• Paralysis
• Convulsions
• Tingling, numbness or other abnormal sensation
• Prolonged erection of the penis which may be painful
• Nervous system disorders that may include drooping of the eyelid, narrowing of the pupil (black part in the center of the eye), sunken orbit, sweating and/or redness on one side of the face

Bradycardia or tachycardia, or irregular heartbeat and changes in heart rhythm that can be detected by electrocardiogram have also been reported as side effects.
Rarely, some of these effects may be long-term or permanent.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levobupivacaina Altan 0.625 mg/ml

This medicine does not require any special storage conditions.
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 label after ‘Exp.’ The
expiry date refers to the last day of that month.
The doctor will store this medicine for you.
The solution must be used immediately after opening.
Levobupivacaina Altan 0.625 mg/ml must not be used if it contains visible particles.
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. Package contents and other information

ContentsLevobupivacaina Altan 0.625 mg/ml solution for infusion
The active ingredient is levobupivacaine (as hydrochloride).
Levobupivacaina Altan 0.625 mg/ml: 1 ml contains 0.625 mg of levobupivacaine (as
hydrochloride).
The excipients are water for injections, sodium chloride, sodium hydroxide and a small
quantity of hydrochloric acid.

Description of appearance and package contents
Levobupivacaina Altan 0.625 mg/ml is a transparent, colourless solution. Each bag of
polypropylene or PVC-free polyolefin contains 100 ml of solution. It is supplied in packs of 5
and 24 bags of 100 ml of solution.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Altan Pharmaceuticals, S.A.
C/ Cólquide Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma
Las Rozas, 28230 Madrid, Spain

Manufacturer
Altan Pharmaceuticals S.A.
Polígono Industrial de Bernedo s/n
01118 Bernedo (Álava),Spain
-----------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for physicians or healthcare professionals:

Instructions for use and handling
Levobupivacaina Altan 0.625 mg/ml is intended for single epidural use only and must not be
used for intravenous administration. Do not use if the solution is not clear and the
packaging is not intact. Discard any unused solution.
As with all medicinal products for parenteral use, the solution/dilution must be visually
inspected before use. Only clear solutions without visible particles may
be used.
There is limited safety experience with treatment with levobupivacaine for periods
longer than 24 hours.
Stability after dilution in 0.9% sodium chloride solution
Physico-chemical stability has been demonstrated under use conditions for 30 days at 2-8º C or 20-22°C,
for both levobupivacaine 0.625 mg/ml and 1.25 mg/ml with 8.3-8.4 μg/ml of clonidine, 50 μg/ml
of morphine and 2 μg/ml of fentanyl. Physico-chemical stability has been demonstrated under use conditions
for 30 days at 2-8º C or for 7 days at 20-22°C for both levobupivacaine 0.625 mg/ml and 1.25
mg/ml, with sufentanil added at a concentration of 0.4 μg/ml.
From a microbiological point of view, the medicinal product must be used immediately. If not
used immediately, the storage times under use conditions and the storage conditions before use are the
responsibility of the user and should normally not exceed 24 hours at 2-8º C, unless the mixture has been
prepared in controlled and validated aseptic conditions.
Levobupivacaina Altan 0.625 mg/ml must not be mixed with other medicinal products except
for those mentioned above. Dissolution with alkaline solutions such as sodium bicarbonate may produce
precipitates.

Route of administration
Levobupivacaine must be administered exclusively by a physician, or under the
supervision of a physician, who has appropriate experience and competence.
For information on dosage, see the summary of product characteristics.
To avoid intravascular injection, careful aspiration is recommended before
infusion. If symptoms of toxicity occur, administration must be
immediately stopped.

Levobupivacaine Altan 7.5 mg/ml injectable solution and infusion

Levobupivacaine
Equivalent medicine

Read this leaflet carefully before 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.
• If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Levobupivacaine Altan 7.5 mg/ml is and what it is used for
• 2. What you need to know before you use Levobupivacaine Altan 7.5 mg/ml
• 3. How to use Levobupivacaine Altan 7.5 mg/ml
• 4. Possible side effects
• 5. How to store Levobupivacaine Altan 7.5 mg/ml
• 6. Contents of the pack and other information

1. What is Levobupivacaina Altan 7,5 mg/ml and what is it used for

Levobupivacaina Altan 7,5 mg/ml belongs to a group of medicines called local anesthetics.
This type of medicine is used to make a part of the body insensitive or to
eliminate pain.

Adults:
Levobupivacaina Altan is used as a local anesthetic to make parts of the body
insensitive before a major (except for caesarean sections) or minor
surgical procedure (such as to the eyes and mouth).
It is also used for:

• pain relief after major surgery

Children:
Levobupivacaina Altan can also be used in children to make parts of the body
insensitive before a surgical procedure and for pain relief after minor
surgery, such as the treatment of an inguinal hernia.
Levobupivacaina Altan 7,5 mg/ml has not been tested in children under 6 months of age.

2. What you need to know before using Levobupivacaina Altan 7,5 mg/ml

Do not use Levobupivacaina Altan 7,5 mg/ml

• if you are allergic (hypersensitive) to levobupivacaine, to any similar local anesthetic, or to any of the other ingredients of this medicine (listed in section 6).
• if you have very low blood pressure.
• to anesthetize an area by intravenous injection of Levobupivacaina Altan 7,5 mg/ml.
• as a method of pain relief during childbirth.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given
Levobupivacaina Altan 7,5 mg/ml if you have any of the diseases or conditions
described below. You may need more careful monitoring or be given a
lower dose of the medicine.

• If you suffer from heart problems
• If you suffer from nervous system diseases
• If you are weak or ill
• If you are elderly
• If you have a liver disease.

Other medicines and Levobupivacaina Altan 7,5 mg/ml
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or
may take any other medicines, including over-the-counter medicines. In particular, tell them if you are taking medicines for the treatment of:

• irregular heartbeat (such as mexiletine)
• fungal infections (such as ketoconazole) as this may affect how long Levobupivacaina Altan 7,5 mg/ml stays in your body
• asthma (such as theophylline) as this may affect how long Levobupivacaina Altan 7,5 mg/ml stays in your body.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or nurse for advice before using this medicine.
Levobupivacaina Altan 7,5 mg/ml should not be given for pain relief
during labour or as a local anesthetic during a caesarean section.
The effect of Levobupivacaina Altan 7,5 mg/ml on the baby during the early stages of pregnancy
is unknown. Therefore, Levobupivacaina Altan 7,5 mg/ml should not be used during the first
three months of pregnancy, unless your doctor thinks it is necessary.
It is not known whether levobupivacaine passes into breast milk. However, based on experience with similar medicines, it is believed that only small amounts of levobupivacaine may pass into breast milk.
Consequently, breastfeeding is possible after administration of a local anesthetic.

Driving and using machines
The use of Levobupivacaina Altan can have significant effects on your ability to drive vehicles or
operate machinery. Do not drive vehicles or operate machinery until all effects of
Levobupivacaina Altan 7,5 mg/ml and those immediately following surgery have
subsided. Make sure you are informed about this by the doctor or nurse treating you, before leaving the hospital.

Important information about some of the ingredients ofLevobupivacaina Altan 7,5 mg/ml
This medicine contains 3.5 mg/ml of sodium in the solution in bag or vial, and this
must be taken into consideration by patients who are on a low-sodium diet.

3. How to use Levobupivacaina Altan 7,5 mg/ml

Levobupivacaina Altan 7,5 mg/ml can be injected into parts of the body to numb the area that needs to be treated, such as an eye, an arm or a leg.
The doctor and nurse will closely monitor you while Levobupivacaina Altan 7,5 mg/ml is administered.

Dosage
The amount of Levobupivacaina Altan 7,5 mg/ml that will be administered to you and the frequency of administration will depend on the reason why this medicine is being used and also on your health status, age and weight. However, the lowest possible dose necessary to anesthetize the part of the body that needs to be treated will be used. The doctor will carefully assess which dose should be administered to you.

If you receive too much Levobupivacaina Altan 7,5 mg/ml
If you are given an excessive dose of Levobupivacaina Altan 7,5 mg/ml, the following symptoms may occur: numbness of the tongue, dizziness, blurred vision, muscle contractions, severe difficulty breathing (including respiratory arrest) and even convulsions. If you notice any of these symptoms, inform your doctor immediately.
Sometimes, an excessive dose of Levobupivacaina Altan 7,5 mg/ml can also cause a drop in blood pressure, an acceleration or slowing of the heartbeat and cause changes in heart rhythm. The doctor may deem it necessary to administer other medicines that help eliminate these symptoms.
If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you believe you have any of the side effects listed below, inform your doctor or nurse immediately. Some side effects of Levobupivacaina Altan 7.5 mg/ml may be serious.
Very common side effects (may affect more than 1 in 10 people):

• Feeling tired or weak, shortness of breath, paleness (these are all signs of anemia)
• Low blood pressure
• Nausea

Common side effects (may affect up to 1 in 10 people)

• Dizziness
• Headache
• Vomiting
• Back pain
• Fever
• Pain after surgery

Frequency not known (the frequency cannot be estimated from the available data):

• Severe allergic reactions (hypersensitivity) causing severe difficulty breathing, difficulty swallowing, hives and very low blood pressure and swelling of the tongue or throat.
• Allergic reactions (hypersensitivity) recognised by red, itchy skin, sneezing, profuse sweating, fast heartbeat, fainting or swelling of the face, lips and mouth
• Convulsions
• Drowsiness
• Blurred vision
• Respiratory arrest
• Heart attack or cardiac block
• Localized tingling
• Numbness of the tongue
• Muscle weakness or muscle contraction
• Loss of bladder or bowel control
• Paralysis
• Loss of consciousness
• Tingling, numbness or other abnormal sensation
• Prolonged erection of the penis which may be painful
• Nervous system disorders that may include drooping of the eyelid, constriction of the pupil (black part in the center of the eye), sunken orbit, sweating and/or redness on one side of the face

Bradycardia, tachycardia, or irregular heartbeat and changes in heart rate that can be detected by electrocardiogram have also been reported as side effects.
Rarely, some of these effects may be long-term or permanent.

Reporting of side effects
If you get any side effects, even those 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/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levobupivacaina Altan 7,5 mg/ml

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the label after ‘Exp.’ The
expiry date refers to the last day of that month.
The doctor will store this medicine for you.
The solution must be used immediately after opening.
Levobupivacaina Altan 7,5 mg/ml must not be used if it contains visible particles.
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. Package Contents and Other Information

What the medicine containsLevobupivacaine Altan 7.5 mg/ml
The active ingredient is levobupivacaine (as hydrochloride).
One millilitre of solution contains 7.5 mg of levobupivacaine (as hydrochloride). Each vial of 10
ml contains 75 mg.
The excipients are water for injections, sodium chloride, sodium hydroxide and hydrochloric
acid.

Description of the appearance and contents of the pack
Levobupivacaine Altan 7.5 mg/ml is a transparent, colourless solution in type I glass vials.
Each vial contains 75 mg of levobupivacaine in a 10 ml vial. It is available in packs of 5
and 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Altan Pharmaceuticals, S.A.
C/ Cólquide Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma
Las Rozas, 28230 Madrid, Spain

Manufacturer
Altan Pharmaceuticals S.A.
Avda. de la Constitución 198-199, Pol. Ind. Monte Boyal
45950 Casarrubios del Monte, Toledo
Spain

OTHER PRESENTATIONS
Levobupivacaine Altan 2.5 mg/ml injectable solution and infusion solution
Levobupivacaine Altan 5 mg/ml injectable solution and infusion solution
Levobupivacaine Altan 1.25 mg/ml infusion solution
Levobupivacaine Altan 0.625 mg/ml infusion solution
------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for doctors or healthcare professionals:
Instructions for use and handling
Levobupivacaine Altan 7.5 mg/ml is intended for single use. Discard any unused solution.
From a microbiological point of view, the medicinal product must be used immediately after
opening. If not used immediately, the storage times in use and the conditions of storage before use are the
responsibility of the user.
Experience with the safety of treatment with levobupivacaine for more than 24 hours is limited.
Validity after first opening: the product must be used immediately.
Validity after dilution in 0.9% sodium chloride solution: Stability has been demonstrated
physico-chemical in use conditions in 0.9% sodium chloride solution for 7 days at 20-22°C.
As with all medicinal products for parenteral use, the solution/dilution must be visually
inspected before use. Only clear and particle-free solutions can
be used.
Standard dilutions of levobupivacaine should be made with a sodium chloride injectable
solution 9 mg/ml (0.9%) under aseptic conditions.
8.4 micrograms/ml of clonidine, 0.05 mg/ml of morphine and 4
micrograms/ml of fentanyl have been shown to be compatible with levobupivacaine in a sodium chloride injectable
solution 9 mg/ml (0.9%). Physico-chemical stability has been demonstrated in use conditions
with clonidine, morphine or fentanyl for 40 hours at 20-22°C.
Levobupivacaine Altan 7.5 mg/ml must not be mixed with other medicinal products except for
those mentioned above.
Dissolution with alkaline solutions such as sodium bicarbonate can produce precipitates.

Route of administration
Levobupivacaine must be administered exclusively by a doctor, or under the
supervision of a doctor, who has adequate experience and skills.

For information on dosage, see the summary of product characteristics.
To avoid intravascular injection, careful aspiration is recommended before and during
the injection.
Aspiration must be repeated before and during the administration of a bolus dose, which
should be injected slowly and increasing the dosage at a rate of 7.5-30 mg/min,
keeping vital functions under close observation and maintaining verbal contact with the
patient.
If symptoms of toxicity occur, the injection should be stopped immediately.

Levobupivacaine Altan 1.25 mg/ml solution for infusion

Levobupivacaine

Generic medicine

Read this leaflet carefully before 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.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

• 1. What Levobupivacaine Altan 1.25 mg/ml is and what it is used for
• 2. What you need to know before Levobupivacaine Altan 1.25 mg/ml is given to you
• 3. How to use Levobupivacaine Altan 1.25 mg/ml
• 4. Possible side effects
• 5. How to store Levobupivacaine Altan 1.25 mg/ml
• 6. Contents of the pack and other information

1. What is Levobupivacaina Altan 1.25 mg/ml and what is it used for

Levobupivacaina Altan 1.25 mg/ml belongs to a group of medicines called local anesthetics.
This type of medicine is used to make a part of the body insensitive or to
eliminate pain.
Levobupivacaina Altan 1.25 mg/ml solution for infusion is for use in adults only.
Levobupivacaina Altan 1.25 mg/ml is used for pain relief:

• after major surgical procedures
• during childbirth

2. What you need to know before you are given Levobupivacaina Altan 1.25 mg/ml

Do not use Levobupivacaina Altan 1.25 mg/ml:

• if you are allergic (hypersensitive) to levobupivacaine, to any similar local anesthetic, or to any of the other ingredients of this medicine (listed in section 6).
• if you have very low blood pressure.
• as a method of pain relief administered by injection into the area around the cervix during the early stages of labor (paracervical block).
• to anesthetize an area by intravenous injection of Levobupivacaina Altan 1.25 mg/ml.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given
Levobupivacaina Altan 1.25 mg/ml if you have any of the diseases or conditions
described below. You may need to have more frequent checks or be given a
lower dose of the medicine.

• If you suffer from diseases of the nervous system
• If you are weak or ill
• If you are elderly
• If you have a liver disease.

Other medicines and Levobupivacaina Altan 1.25 mg/ml
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or
might take any other medicines, including medicines you buy without a
prescription. In particular, tell them if you are taking medicines for the treatment of:

• irregular heartbeat (such as mexiletine)
• fungal infections (such as ketoconazole) as this may affect how long Levobupivacaina Altan 1.25 mg/ml stays in your body
• asthma (such as theophylline) as this may affect how long Levobupivacaina Altan 1.25 mg/ml stays in your body.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you might be pregnant, are planning to become pregnant, or if you are
breastfeeding with breast milk, ask your doctor or nurse for advice before using this medicine.
Levobupivacaina Altan 1.25 mg/ml should not be given during labor as
pain relief by injection into the area around the cervix or the cervix (paracervical
block).
The effect of Levobupivacaina Altan 1.25 mg/ml on the baby during the early stages of pregnancy
is not known.
Therefore, Levobupivacaina Altan 1.25 mg/ml should not be used during the first three months
of pregnancy, unless your doctor thinks it is necessary.
It is not known whether levobupivacaine passes into breast milk, however, from experience with a
similar medicine, it is believed that only small amounts of levobupivacaine may pass into
breast milk. Consequently, breastfeeding is possible after administration of a local anesthetic.

Driving and operating machinery
The use of Levobupivacaina Altan can have significant effects on your ability to drive vehicles or
operate machinery. Do not drive vehicles or operate machinery until all the effects of
Levobupivacaina Altan and those immediately following surgery have worn off. Make
sure you are informed about this by the doctor or nurse treating you, before you
leave the hospital.

Important information about some of the ingredients of Levobupivacaina Altan 1.25 mg/ml:
This medicine contains 15 mmol (3.5 mg/ml) of sodium per 100 ml bag and 30 mmol (3.5
mg/ml) of sodium per 200 ml bag and this should be taken into consideration by patients
who are on a low sodium diet.

3. How to use Levobupivacaina Altan 1.25 mg/ml

The doctor will administer Levobupivacaina Altan 1.25 mg/ml to you via an injection with a needle
or with a small catheter inserted into your back (epidural). The doctor and nurse will keep you
under close monitoring while Levobupivacaina Altan 1.25 mg/ml is administered to you.

Dosage
Adults
The amount of Levobupivacaina Altan 1.25 mg/ml that will be administered to you and the frequency of
administration will depend on the reason why this medicine is being used and
also on your state of health, age and weight. However, the lowest dose necessary will always be used
to anesthetize the part of the body that needs to be treated. The doctor will carefully evaluate
which dose should be administered to you.
When Levobupivacaina Altan 1.25 mg/ml is used as an analgesic during labor, the
dose used must be carefully controlled.

Children
Not recommended.

If you receive more Levobupivacaina Altan 1.25 mg/ml than you should
In the event that you are administered an excessive dose of Levobupivacaina Altan 1.25 mg/ml,
the following symptoms may occur: numbness of the tongue, dizziness, blurred vision,
muscle contractions, severe difficulty breathing (including respiratory arrest) and even
convulsions. If you notice any of these symptoms, inform
your doctor immediately. Sometimes, an excessive dose of Levobupivacaina Altan 1.25 mg/ml can
also cause a drop in blood pressure, an acceleration or slowing down of the
heartbeat and cause changes in heart rhythm. The doctor may deem it necessary to
administer other medicines to help eliminate these symptoms.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you think you have any of the side effects listed below, tell your doctor or nurse immediately. Some side effects of Levobupivacaina Altan 1.25 mg/ml can be serious.
Very common side effects (may affect more than 1 in 10 people):

• Feeling tired or weak, shortness of breath, paleness (these are all signs of anemia)
• Low blood pressure
• Nausea

Common side effects (may affect up to 1 in 10 people)

• Dizziness
• Headache
• Vomiting
• Problems affecting the fetus (fetal distress)
• Back pain
• Fever
• Pain after surgery

Other side effects (frequency not known, the frequency cannot be estimated from available data):

• Severe allergic reactions (hypersensitivity) causing severe difficulty breathing, difficulty swallowing, hives and very low blood pressure.
• Allergic reactions (hypersensitivity) recognised by red skin with itching, sneezing, excessive sweating, fast heartbeat, fainting or swelling of the face, lips and mouth
• Fainting
• Drowsiness
• Blurred vision
• Stoppage of breathing
• Heart attack or heart block
• Localized tingling
• Numbness of the tongue
• Muscle weakness or muscle contraction
• Loss of bladder or bowel control
• Paralysis
• Convulsions
• Tingling, numbness or other abnormal sensation
• Prolonged erection of the penis which may be painful
• Nerve disorders that may include drooping of the eyelid, narrowing of the pupil (black part in the center of the eye), sunken eye socket, sweating and/or redness on one side of the face

Bradycardia or tachycardia, or irregular heartbeat and changes in heart rate that can be detected by electrocardiogram have also been reported as side effects.
Rarely, some of these side effects may be long-term or permanent.
If you notice that any side effects worsen or if you notice any side effect not listed here
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levobupivacaina Altan 1.25 mg/ml

This medicine does not require any special storage conditions.
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 label after ‘Exp.’ The
expiry date refers to the last day of that month.
The doctor will store this medicine for you.
The solution must be used immediately after opening.
Levobupivacaina Altan 1.25 mg/ml must not be used if it contains visible particles.
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. Package contents and other information

What the medicine containsLevobupivacaina Altan 1.25 mg/ml solution for infusion
The active ingredient is levobupivacaine (as hydrochloride).
Levobupivacaina Altan 1.25 mg/ml: 1 ml contains 1.25 mg of levobupivacaine (as hydrochloride).
The excipients are water for injections, sodium chloride, sodium hydroxide and a small
quantity of hydrochloric acid.

Description of the appearance and contents of the pack
Levobupivacaina Altan 1.25 mg/ml is a transparent, colourless solution. Each bag of
polypropylene or PVC-free polyolefin contains 100 ml or 200 ml of solution. It is supplied in
packs of 5 bags and 24 bags of 100 ml of solution and 12 bags of 200 ml of solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Altan Pharmaceuticals, S.A.
C/ Cólquide Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma
Las Rozas, 28230 Madrid, Spain

Manufacturer
Altan Pharmaceuticals S.A.
Polígono Industrial de Bernedo s/n
01118 Bernedo (Álava)
Spain
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The following information is intended exclusively for doctors or healthcare professionals:

Instructions for use and handling
Levobupivacaina Altan 1.25 mg/ml is intended for single epidural use only and must not be
used for intravenous administration. Do not use if the solution is not clear and the
packaging is not intact. Discard any unused solution.
As with all medicinal products for parenteral use, the solution/dilution must be visually
inspected before use. Only clear solutions without visible particles can
be used.
There is limited safety experience with treatment with levobupivacaine for periods
longer than 24 hours.
Stability after dilution in 0.9% sodium chloride solution
Physico-chemical stability has been demonstrated under use conditions for 30 days at 2-8ºC or 20-22ºC,
for both levobupivacaine 0.625 mg/ml and 1.25 mg/ml with 8.3-8.4 μg/ml of clonidine, 50 μg/ml
of morphine and 2 μg/ml of fentanyl. Physico-chemical stability has been demonstrated under use conditions
for 30 days at 2-8ºC or for 7 days at 20-22ºC for both levobupivacaine 0.625 mg/ml and 1.25
mg/ml, with sufentanil added at a concentration of 0.4 μg/ml.
From a microbiological point of view, the medicinal product must be used immediately. If not
used immediately, the storage times under use conditions and the storage conditions before use are the responsibility of the user and should normally not exceed 24 hours at 2-8ºC, unless the mixture has been prepared in controlled and validated aseptic conditions.
Levobupivacaina Altan 1.25 mg/ml must not be mixed with other medicinal products except for
those mentioned above. Dissolution with alkaline solutions such as sodium bicarbonate may produce
precipitates.

Route of administration
Levobupivacaine must be administered exclusively by a doctor, or under the
supervision of a doctor, with adequate experience and skills.
For information on dosage, see the summary of product characteristics.
To avoid intravascular injection, careful aspiration is recommended before
infusion. If symptoms of toxicity occur, administration must be
immediately stopped.