Levobupivacaine Altan

Package leaflet: Information for the user

Levobupivacaine Altan 2.5 mg/ml injection and infusion solution

Levobupivacaine
Equivalent medicine
Please read all of this leaflet carefully before you use 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.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Levobupivacaine Altan 2.5 mg/ml is and what it is used for
2. What you need to know before you use Levobupivacaine Altan 2.5 mg/ml
3. How to use Levobupivacaine Altan 2.5 mg/ml
4. Possible side effects
5. How to store Levobupivacaine Altan 2.5 mg/ml
6. Contents of the pack and other information

1. What Levobupivacaine Altan 2.5 mg/ml is and what it is used for

Levobupivacaine Altan 2.5 mg/ml belongs to a group of medicines called local anaesthetics. This type of medicine is used to numb a part of the body or to relieve pain.

Adults:
Levobupivacaine Altan 2.5 mg/ml is used as a local anaesthetic to numb parts of the body before major surgery (e.g. epidural anaesthesia for caesarean section) or minor surgery (such as to the eyes or mouth).

It is also used for pain relief:

• after major surgical procedures
• during childbirth

Children:
Levobupivacaine Altan 2.5 mg/ml may also be used in children to numb parts of the body before surgery and for pain relief after minor surgical procedures, such as inguinal hernia repair.
Levobupivacaine Altan 2.5 mg/ml has not been studied in children under 6 months of age.

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

Do not use Levobupivacaine Altan 2.5 mg/ml

• if you are allergic (hypersensitive) to levobupivacaine, to any other similar local anaesthetic, 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 around the neck of the uterus (cervix) during early labour (paracervical block).
• to anaesthetize an area by intravenous injection of Levobupivacaine Altan 2.5 mg/ml.

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

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

Other medicines and Levobupivacaine Altan 2.5 mg/ml
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. In particular, inform them if you are taking medicines for:

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

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or nurse for advice before using this medicine.
Levobupivacaine Altan 2.5 mg/ml must not be administered during childbirth as analgesia by injection around the neck of the uterus or cervix (paracervical block).
The effect of Levobupivacaine Altan 2.5 mg/ml on the unborn baby during early pregnancy is unknown. Therefore, Levobupivacaine Altan 2.5 mg/ml should not be used during the first three months of pregnancy unless your doctor considers it 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.
Therefore, breastfeeding is possible after administration of a local anaesthetic.

Driving and using machines
The use of Levobupivacaine Altan 2.5 mg/ml may have significant effects on your ability to drive or use machinery. Do not drive or operate machinery until all effects of Levobupivacaine Altan 2.5 mg/ml and those of the surgical procedure have completely worn off. Make sure you receive appropriate advice from your treating doctor or nurse before leaving the hospital.

Important information about some of the ingredients of Levobupivacaine Altan 2.5 mg/ml
This medicine contains 3.5 mg/ml of sodium in the solution in bag or vial, and this should be taken into account for patients on a low-sodium diet.

3. How to use Levobupivacaine Altan 2.5 mg/ml

Your doctor will administer Levobupivacaine Altan 2.5 mg/ml by injection through a needle or
via a small catheter inserted into your back (epidural). Levobupivacaine 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.
Your doctor and nurse will closely monitor you while you are receiving
Levobupivacaine Altan 2.5 mg/ml.
Dosage
The amount of Levobupivacaine Altan 2.5 mg/ml you will receive and the frequency of administration will depend on the reason for which this medicine is being used, as well as your health status, age, and weight. The lowest effective dose required to anesthetize the part of the body to be treated will always be used. Your doctor will carefully evaluate the appropriate dose for you.
When Levobupivacaine Altan 2.5 mg/ml is used for pain relief during childbirth or for cesarean section (epidural), the dose must be carefully controlled.
If you receive more Levobupivacaine Altan 2.5 mg/ml than you should
If you are given an excessive dose of Levobupivacaine Altan 2.5 mg/ml, the following symptoms may occur: numbness of the tongue, dizziness, blurred vision, muscle twitching, severe breathing difficulties (including respiratory arrest), and even seizures. If you notice any of these symptoms, inform your doctor immediately. Sometimes, an excessive dose of Levobupivacaine Altan 2.5 mg/ml may also cause low blood pressure, an increased or decreased heart rate, and changes in heart rhythm. Your doctor may consider it necessary to administer other medicines to help relieve 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 everyone gets them. If you think you are experiencing any of the side effects listed below, inform your doctor or nurse immediately. Some of the side effects of Levobupivacaine Altan 2.5 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 anaemia)
• Low blood pressure
• Nausea

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

• Dizziness
• Headache
• Vomiting
• Fetal problems (fetal distress)
• Back pain
• Fever
• Pain after surgery

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

• Severe allergic reactions (hypersensitivity) causing severe breathing difficulties, difficulty swallowing, hives, and very low blood pressure
• Allergic reactions (hypersensitivity) characterized by red, itchy skin, sneezing, excessive sweating, rapid heartbeat, fainting, or swelling of the face, lips, and mouth
• Seizures
• Drowsiness
• Blurred vision
• Breathing stoppage
• Heart attack or heart block
• Localized tingling
• Tongue numbness
• Muscle weakness or muscle contraction
• Loss of bladder or bowel control
• Paralysis
• Tingling, numbness, or other abnormal sensations
• Prolonged penile erection which may be painful
• Nervous system disorders which may include drooping eyelid, pupil constriction (the black part in the centre of the eye), sunken eye socket, sweating and/or flushing on one side of the face

Bradycardia, tachycardia, or irregular heartbeat, as well as changes in heart rhythm detectable by electrocardiogram, have also been reported as side effects.

Rarely, some of these side effects may be long-term or permanent.

If you think any of the side effects you are experiencing worsen, or if you notice any side effects not mentioned in this leaflet, inform your doctor or nurse.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via 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 Levobupivacaine 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 stated on the label after 'Exp.'.
The expiry date refers to the last day of that month.
Your doctor will store this medicine for you.
The solution should be used immediately after opening.
Levobupivacaine Altan 2.5 mg/ml must not be used if it contains visible particles.
Do not dispose of medicines via 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 Levobupivacaine Altan 2.5 mg/ml contains
The active substance is levobupivacaine (as hydrochloride).
One millilitre of solution contains 2.5 mg of levobupivacaine (as hydrochloride). Each 10 ml vial contains 25 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 2.5 mg/ml is a clear, 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 solution for injection and infusion
Levobupivacaine Altan 7.5 mg/ml solution for injection and infusion
Levobupivacaine Altan 1.25 mg/ml infusion solution
Levobupivacaine Altan 0.625 mg/ml infusion solution

---

The following information is intended exclusively for physicians or healthcare professionals:
Instructions for use and handling
Levobupivacaine Altan 2.5 mg/ml is intended for single use only. Discard any unused solution.
From a microbiological standpoint, the medicinal product should be used immediately after opening. If not used immediately, the storage times and conditions prior to use are the responsibility of the user.
Experience regarding the safety of treatment with levobupivacaine for more than 24 hours is limited.
Shelf life after first opening: the product must be used immediately.
Shelf life after dilution in 0.9% sodium chloride solution: Chemical and physical stability under use conditions has been demonstrated in 0.9% sodium chloride solution for 7 days at 20-22°C.
As with all parenteral medicinal products, the solution/dilution should be visually inspected before use. Only clear solutions free from visible particles should be used.
Standard dilutions of levobupivacaine should be prepared under aseptic conditions using 9 mg/ml (0.9%) sodium chloride solution for injection.
It has been demonstrated that 8.4 micrograms/ml of clonidine, 0.05 mg/ml of morphine and 4 micrograms/ml of fentanyl are compatible with levobupivacaine in a 9 mg/ml (0.9%) sodium chloride solution for injection. Chemical and physical stability under use conditions has been demonstrated 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 those mentioned above.
Dissolution with alkaline solutions such as sodium bicarbonate may cause precipitation.

Method of administration
Levobupivacaine must be administered only by, or under the supervision of, a physician experienced and skilled in the techniques involved.
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 administration of a bolus dose, which should be injected slowly and increased at a rate of 7.5–30 mg/min, with close monitoring of vital functions and maintaining verbal contact with the patient.
If symptoms of toxicity occur, the injection must be immediately discontinued.

Package leaflet: information for the user

Levobupivacaine Altan 5 mg/ml injection solution and infusion solution

Levobupivacaine
Equivalent medicine
Please 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, consult your doctor, pharmacist or nurse.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Levobupivacaine Altan 5 mg/ml belongs to a group of medicines called local anaesthetics. This type of medicine is used to numb a part of the body or to relieve pain.
Adults:
Levobupivacaine Altan is used as a local anaesthetic to numb parts of the body before major surgery (e.g. epidural anaesthesia for caesarean section) or minor surgery (such as to the eye or mouth).
It is also used for pain relief:

• after major surgical procedures
• during childbirth

Children:
Levobupivacaine Altan can also be used in children to numb parts of the body before surgery and for pain relief after minor surgical procedures, such as repair of inguinal hernia.
Levobupivacaine Altan 5 mg/ml has not been studied in children under 6 months of age.

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

Do not use Levobupivacaine Altan 5 mg/ml

• if you are allergic (hypersensitive) to levobupivacaine, to any other similar local anaesthetic, 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 around the neck of the uterus (cervix) during early labour (paracervical block).

• for anaesthetizing an area by intravenous injection of Levobupivacaine Altan 5 mg/ml.

Warnings and precautions
Please consult your doctor, pharmacist, or nurse before being administered
Levobupivacaine Altan 5 mg/ml if you have any of the following diseases or conditions.
You may require more careful monitoring or a lower dose of the medicine.

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

Other medicines and Levobupivacaine Altan 5 mg/ml
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. In particular, inform them if you are taking medicines for:

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

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, please consult your doctor or nurse before using this medicine.
Levobupivacaine Altan 5 mg/ml must not be administered during childbirth as an analgesic by injection around the neck of the uterus or cervix (paracervical block).
The effect of Levobupivacaine Altan 5 mg/ml on the unborn baby during early pregnancy is unknown. Therefore, Levobupivacaine Altan 5 mg/ml should not be used during the first three months of pregnancy unless considered necessary by your doctor.
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.
Therefore, breastfeeding is possible after administration of a local anaesthetic.

Driving and using machines
The use of Levobupivacaine Altan may have significant effects on the ability to drive or operate machinery. Do not drive or operate machinery until all effects of Levobupivacaine Altan 5 mg/ml and the immediate effects of the surgical procedure have worn off. Make sure you receive appropriate advice from your treating doctor or nurse before leaving the hospital.

Important information about some of the components of Levobupivacaine Altan 5 mg/ml
This medicine contains 3.5 mg/ml of sodium in the solution in bag or vial, which should be taken into consideration for patients on a low-sodium diet.

3. How to use Levobupivacaine Altan 5 mg/ml

Your doctor will administer Levobupivacaine Altan 5 mg/ml to you via an injection with a needle or
through a small catheter inserted into your back (epidural). Levobupivacaine Altan 5 mg/ml may
also be injected into other parts of the body to numb the area to be treated, such as an eye, arm, or leg.
Your doctor and nurse will closely monitor you while you are receiving Levobupivacaine Altan 5 mg/ml.
Dosage
The amount of Levobupivacaine Altan 5 mg/ml you will receive and how often it is given depends on
the reason for which this medicine is being used, as well as your general health, age, and weight.
However, the lowest effective dose required to anaesthetize the part of the body to be treated will be used.
Your doctor will carefully assess the appropriate dose for you.
When Levobupivacaine Altan 5 mg/ml is used for pain relief during childbirth or for caesarean section
(epidural), the dose administered must be carefully controlled.
If you receive more Levobupivacaine Altan 5 mg/ml than you should
If you are given an excessive dose of Levobupivacaine Altan 5 mg/ml, the following symptoms may occur:
numbness of the tongue, dizziness, blurred vision, muscle twitching, severe breathing difficulties (including respiratory arrest), and even seizures.
If you notice any of these symptoms, inform your doctor immediately.
Sometimes, an excessive dose of Levobupivacaine Altan 5 mg/ml may also cause low blood pressure,
a rapid or slow heartbeat, and changes in heart rhythm.
Your doctor may consider it necessary to give you other medicines to help relieve 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 will experience them. If you think you are experiencing any of the side effects listed below, inform your doctor or nurse immediately. Some side effects of Levobupivacaine 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 anaemia)
• Low blood pressure
• Nausea

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

• Dizziness
• Headache
• Vomiting
• Fetal problems (fetal distress)
• Back pain
• Fever
• Pain after surgery

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

• Severe allergic reactions (hypersensitivity) causing severe breathing difficulties, trouble swallowing, hives, and very low blood pressure
• Allergic reactions (hypersensitivity) characterized by red, itchy skin, sneezing, excessive sweating, rapid heartbeat, fainting, or swelling of the face, lips, and mouth
• Seizures
• Drowsiness
• Blurred vision
• Respiratory arrest
• Heart attack or cardiac arrest
• Localized tingling
• Tongue numbness
• Muscle weakness or muscle contraction
• Loss of bladder or bowel control
• Paralysis
• Tingling, numbness, or other abnormal sensations
• Prolonged penile erection which may be painful
• Nerve disorders which may include drooping eyelid, pupil constriction (the black part in the centre of the eye), sunken eye socket, sweating and/or flushing on one side of the face

Bradycardia, tachycardia, or irregular heartbeat and changes in heart rhythm that may 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 any of the side effects you are experiencing worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or nurse.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via 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 Levobupivacaine Altan 5 mg/ml

This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date which is stated on the label after 'Exp.'.
The expiry date refers to the last day of that month.
Your doctor will store this medicine for you.
The solution should be used immediately after opening.
Levobupivacaine Altan 5 mg/ml must not be used if visible particles are present.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Levobupivacaine Altan 5 mg/ml contains
The active substance is levobupivacaine (as hydrochloride).
One millilitre of solution contains 5 mg of levobupivacaine (as hydrochloride). Each 10 ml vial contains 50 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 5 mg/ml is a clear, 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, 1st Floor, Office 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 solution for injection and infusion
Levobupivacaine Altan 7.5 mg/ml solution for injection and infusion
Levobupivacaine Altan 1.25 mg/ml solution for infusion
Levobupivacaine Altan 0.625 mg/ml solution for infusion

---

The following information is intended exclusively for physicians or healthcare professionals:
Instructions for use and handling
Levobupivacaine Altan 5 mg/ml is intended for single use only. Discard any unused solution.
From a microbiological standpoint, the medicinal product should be used immediately after opening. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user.
Experience regarding the safety of treatment with levobupivacaine for longer than 24 hours is limited.
Shelf life after first opening: the product must be used immediately.
Stability after dilution in 0.9% sodium chloride solution: Chemical and physical stability under use conditions has been demonstrated for 7 days at 20–22°C in 0.9% sodium chloride solution.
As with all parenteral medicinal products, the solution/dilution must be inspected visually before use. Only clear solutions free from visible particles should be used.
Standard dilutions of levobupivacaine should be performed with 9 mg/ml (0.9%) sodium chloride injectable solution under aseptic conditions.
It has been demonstrated that 8.4 micrograms/ml of clonidine, 0.05 mg/ml of morphine and 4 micrograms/ml of fentanyl are compatible with levobupivacaine in a 9 mg/ml (0.9%) sodium chloride injectable solution. Chemical and physical stability under use conditions has been demonstrated for 40 hours at 20–22°C when combined with clonidine, morphine or fentanyl.
Levobupivacaine Altan 5 mg/ml must not be mixed with other medicinal products except those mentioned above.
Dissolution with alkaline solutions such as sodium bicarbonate may cause precipitation.

Method of administration
Levobupivacaine must be administered only by a physician, or under the supervision of a physician, experienced and skilled in its use.
For dosage information, refer to the Summary of Product Characteristics.
To avoid intravascular injection, careful aspiration is recommended before and during injection.
Aspiration should be repeated before and during administration of a bolus dose, which must be injected slowly and increased at a rate of 7.5–30 mg/min, with close monitoring of vital functions and maintenance of verbal contact with the patient.
If signs of toxicity occur, the injection must be immediately discontinued.

Package leaflet: Information for the user

Levobupivacaine Altan 0.625 mg/ml infusion solution

Levobupivacaine
Equivalent medicine
Please 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, contact your doctor or nurse. See section 4.

Contents of this leaflet

1. What Levobupivacaine Altan 0.625 mg/ml is and what it is used for
2. What you need to know before being administered Levobupivacaine Altan 0.625 mg/ml
3. How to use Levobupivacaine Altan 0.625 mg/ml
4. Possible side effects
5. How to store Levobupivacaine Altan 0.625 mg/ml
6. Package contents and other information

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

Levobupivacaine Altan 0.625 mg/ml belongs to a group of medicines called local anaesthetics.
This type of medicine is used to numb a part of the body or to relieve pain.
Levobupivacaine Altan 0.625 mg/ml infusion solution is for use in adults only.
Levobupivacaine Altan 0.625 mg/ml is used to relieve pain:

• after major surgical procedures
• during childbirth

2. What you should know before being administered Levobupivacaine Altan 0.625 mg/ml

Do not use Levobupivacaine Altan 0.625 mg/ml:

• if you are allergic (hypersensitive) to levobupivacaine, to any other similar local anaesthetic, 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 around the neck of the uterus (cervix) during early labour (paracervical block).
• to anaesthetize an area by intravenous injection of Levobupivacaine Altan 0.625 mg/ml.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving
Levobupivacaine Altan 0.625 mg/ml if you have any of the following diseases or conditions.
You may require closer monitoring or 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 liver disease.

Other medicines and Levobupivacaine Altan 0.625 mg/ml
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. In particular, inform them if you are taking medicines for:

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

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or nurse before using this medicine.
Levobupivacaine Altan 0.625 mg/ml must not be administered during childbirth as an analgesic by injection around the neck of the uterus or cervix (paracervical block).
The effect of Levobupivacaine Altan 0.625 mg/ml on the baby during early pregnancy is unknown.
Therefore, Levobupivacaine Altan 0.625 mg/ml should not be used during the first three months of pregnancy unless your doctor considers it 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 anaesthetic.

Driving and using machines
The use of Levobupivacaine Altan may have significant effects on the ability to drive or operate machinery. Do not drive or operate machinery until all effects of Levobupivacaine Altan and the immediate effects of the surgical procedure have completely worn off. Make sure you receive appropriate advice from your treating doctor or nurse before leaving the hospital.

Important information about some of the ingredients of Levobupivacaine 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. This should be taken into consideration by patients on a low-sodium diet.

3. How to use Levobupivacaine Altan 0.625 mg/ml

Your doctor will administer Levobupivacaine Altan 0.625 mg/ml by injection using a needle or through a small catheter inserted into your back (epidural). Your doctor and nurse will closely monitor you while Levobupivacaine Altan 0.625 mg/ml is being administered.

Dosage

Adults
The amount of Levobupivacaine Altan 0.625 mg/ml you will receive and the frequency of administration will depend on the reason for which this medicine is being used, as well as on your health status, age, and weight. The lowest effective dose required to anesthetize the part of the body to be treated will always be used. Your doctor will carefully evaluate the appropriate dose for you.

When Levobupivacaine Altan 0.625 mg/ml is used as an analgesic during childbirth, the dose must be carefully controlled.

Children
Not recommended.

If you receive more Levobupivacaine Altan 0.625 mg/ml than you should
If you are given an excessive dose of Levobupivacaine Altan 0.625 mg/ml, the following symptoms may occur: numbness of the tongue, dizziness, blurred vision, muscle twitching, severe breathing difficulties (including respiratory arrest), and even seizures. If you notice any of these symptoms, inform your doctor immediately. Sometimes, an excessive dose of Levobupivacaine Altan 0.625 mg/ml may also cause low blood pressure, increased or decreased heart rate, and changes in heart rhythm. Your doctor may consider it necessary to administer other medicines to help relieve these symptoms.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you think you are experiencing any of the side effects listed below, tell your doctor or nurse immediately. Some of the side effects of Levobupivacaine Altan 0.625 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 anaemia)
• Low blood pressure
• Nausea

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

• Dizziness
• Headache
• Vomiting
• Fetal problems (fetal distress)
• Back pain
• Fever
• Pain after surgery

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

• Severe allergic reactions (hypersensitivity) causing severe breathing difficulties, difficulty swallowing, hives, and very low blood pressure
• Allergic reactions (hypersensitivity) with red, itchy skin, sneezing, excessive sweating, fast heartbeat, fainting, or swelling of the face, lips, and mouth
• Fainting
• Drowsiness
• Blurred vision
• Breathing stoppage
• Heart attack or cardiac arrest
• Localised tingling
• Tongue numbness
• Muscle weakness or muscle contraction
• Loss of bladder or bowel control
• Paralysis
• Convulsions
• Tingling, numbness, or other abnormal sensations
• Prolonged penile erection which may be painful
• Nervous system disorders which may include drooping eyelid, pupil constriction (the black part in the centre of the eye), sunken eye socket, sweating and/or redness on one side of the face

Bradycardia or tachycardia, irregular heartbeat, and changes in heart rhythm detectable on 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, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via 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 Levobupivacaine Altan 0.625 mg/ml

This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the label after 'Exp.'.
The expiry date refers to the last day of that month.
Your doctor will store this medicine for you.
The solution must be used immediately after opening.
Levobupivacaine Altan 0.625 mg/ml must not be used if it contains visible particles.
Do not dispose of medicines 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 Levobupivacaine Altan 0.625 mg/ml infusion solution contains
The active substance is levobupivacaine (as hydrochloride).
Levobupivacaine 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
amount of hydrochloric acid.

Description of the appearance and contents of the pack
Levobupivacaine Altan 0.625 mg/ml is a clear, colourless solution. Each polypropylene or
polyolefin non-PVC bag 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
Levobupivacaine Altan 0.625 mg/ml is intended for single-use epidural administration only and must not be used for intravenous administration. Do not use if the solution is not clear or if the packaging is damaged or not intact. Discard any unused solution.
As with all parenteral medicinal products, the solution/dilution must be visually inspected before use. Only clear solutions without visible particles should be used.
Safety experience with levobupivacaine treatment for periods exceeding 24 hours is limited.

Stability after dilution in 0.9% sodium chloride solution
Chemical and physical stability under use conditions has been demonstrated for 30 days at 2–8°C or 20–22°C for both levobupivacaine 0.625 mg/ml and 1.25 mg/ml containing 8.3–8.4 μg/ml clonidine, 50 μg/ml morphine and 2 μg/ml fentanyl.
Chemical and physical stability under use conditions has been demonstrated for 30 days at 2–8°C or 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 standpoint, the medicinal product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless the mixture was prepared under controlled and validated aseptic conditions.

Levobupivacaine Altan 0.625 mg/ml must not be mixed with other medicinal products except those mentioned above. Dissolution with alkaline solutions such as sodium bicarbonate may result in precipitation.

Method of administration
Levobupivacaine must be administered exclusively by a physician, or under the supervision of a physician, with adequate experience and expertise.
For dosage information, see the Summary of Product Characteristics.
To avoid intravascular injection, careful aspiration is recommended before infusion. If signs of toxicity occur, administration must be immediately discontinued.

Package leaflet: Information for the user

Levobupivacaine Altan 7.5 mg/ml solution for injection and infusion

Levobupivacaine
Equivalent medicinal product
Please read all of 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 get 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 Levobupivacaine Altan 7.5 mg/ml is and what it is used for
2. What you need to know before using 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 Levobupivacaine Altan 7.5 mg/ml is and what it is used for

Levobupivacaine Altan 7.5 mg/ml belongs to a group of medicines called local anaesthetics. This type of medicine is used to numb a part of the body or to relieve pain.
Adults:
Levobupivacaine Altan is used as a local anaesthetic to numb parts of the body before major surgery (except caesarean section) or minor surgery (such as eye or mouth procedures).
It is also used for:

• relief of pain after major surgical procedures

Children:
Levobupivacaine Altan can also be used in children to numb parts of the body before surgery and for pain relief after minor surgical procedures, such as inguinal hernia repair.
Levobupivacaine Altan 7.5 mg/ml has not been studied in children under 6 months of age.

2. What you need to know before using Levobupivacaine Altan 7.5 mg/ml

Do not use Levobupivacaine Altan 7.5 mg/ml

• if you are allergic (hypersensitive) to levobupivacaine, to any other similar local anaesthetic, or to any of the other ingredients of this medicine (listed in section 6).
• if you have very low blood pressure.
• to anaesthetize an area by intravenous injection of Levobupivacaine Altan 7.5 mg/ml.
• as a method of pain relief during childbirth.

Warnings and precautions
Please consult your doctor, pharmacist, or nurse before Levobupivacaine Altan 7.5 mg/ml is administered to you if you have any of the following diseases or conditions listed below. You may require closer monitoring or a lower dose of the medicine.

• If you have heart problems
• If you have diseases of the nervous system
• If you are weak or unwell
• If you are elderly
• If you have liver disease.

Other medicines and Levobupivacaine Altan 7.5 mg/ml
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. In particular, inform them if you are taking medicines for:

• irregular heartbeat (such as mexiletine)
• fungal infections (such as ketoconazole), as this may affect how long Levobupivacaine Altan 7.5 mg/ml remains in your body
• asthma (such as theophylline), as this may affect how long Levobupivacaine Altan 7.5 mg/ml remains in your body.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, please seek advice from your doctor or nurse before using this medicine.
Levobupivacaine Altan 7.5 mg/ml must not be administered for pain relief during labour or as a local anaesthetic during caesarean section.
The effect of Levobupivacaine Altan 7.5 mg/ml on the unborn baby during early pregnancy is unknown. Therefore, Levobupivacaine Altan 7.5 mg/ml should not be used during the first three months of pregnancy unless your doctor considers it 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.
Therefore, breastfeeding is possible after administration of a local anaesthetic.

Driving and using machines
The use of Levobupivacaine Altan may have considerable effects on the ability to drive or operate machinery. Do not drive or use machinery until all effects of Levobupivacaine Altan 7.5 mg/ml and any immediate effects of the surgical procedure have worn off. Make sure you receive appropriate information from your treating doctor or nurse before leaving the hospital.

Important information about some of the ingredients of Levobupivacaine Altan 7.5 mg/ml
This medicine contains 3.5 mg/ml of sodium in the solution in bag or vial, and this should be taken into consideration by patients on a low-sodium diet.

3. How to use Levobupivacaine Altan 7.5 mg/ml

Levobupivacaine Altan 7.5 mg/ml can be injected into specific areas of the body to numb the region to be treated, such as an eye, an arm or a leg.
Your doctor or nurse will closely monitor you while Levobupivacaine Altan 7.5 mg/ml is being administered.

Dosage
The amount of Levobupivacaine Altan 7.5 mg/ml you will receive and how often it is given depends on the reason for which this medicine is being used, as well as on your general health, age and weight. The lowest effective dose required to anesthetize the area of the body to be treated will always be used. Your doctor will carefully assess the appropriate dose for you.

If you receive more Levobupivacaine Altan 7.5 mg/ml than you should
If you are given too high a dose of Levobupivacaine Altan 7.5 mg/ml, the following symptoms may occur: numbness of the tongue, dizziness, blurred vision, muscle twitching, severe breathing difficulties (including respiratory arrest), and even seizures. If you notice any of these symptoms, inform your doctor immediately.

Sometimes, an excessive dose of Levobupivacaine Altan 7.5 mg/ml may also cause low blood pressure, a fast or slow heartbeat, and disturbances in heart rhythm. Your doctor may consider it necessary to administer other medicines to help relieve 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 everyone gets them. If you think you are experiencing any of the side effects listed below, inform your doctor or nurse immediately. Some of the side effects of Levobupivacaine 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 anaemia)
• 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 (frequency cannot be estimated from available data):

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

Bradycardia, tachycardia, or irregular heartbeat and changes in heart rhythm detectable 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 experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via 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 Levobupivacaine Altan 7.5 mg/ml

This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the label after 'Exp.'.
The expiry date refers to the last day of that month.
Your doctor will store this medicine for you.
The solution must be used immediately after opening.
Levobupivacaine Altan 7.5 mg/ml must not be used if visible particles are present.
Do not dispose of medicines 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 Levobupivacaine Altan 7.5 mg/ml contains
The active substance is levobupivacaine (as hydrochloride).
Each millilitre of solution contains 7.5 mg of levobupivacaine (as hydrochloride). Each 10 ml vial 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 clear, 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 solution for injection and infusion
Levobupivacaine Altan 5 mg/ml solution for injection and infusion
Levobupivacaine Altan 1.25 mg/ml solution for infusion
Levobupivacaine Altan 0.625 mg/ml solution for infusion

---

The following information is intended exclusively for physicians or healthcare professionals:
Instructions for use and handling
Levobupivacaine Altan 7.5 mg/ml is intended for single use only. Unused solution should be discarded.
From a microbiological standpoint, the medicinal product should be used immediately after opening. If not used immediately, the storage times and conditions prior to use are the responsibility of the user.
Experience regarding the safety of treatment with levobupivacaine for more than 24 hours is limited.
Shelf life after first opening: the product must be used immediately.
Shelf life after dilution in 0.9% sodium chloride solution: Chemical and physical stability under use conditions has been demonstrated in 0.9% sodium chloride solution for 7 days at 20–22°C.
As with all parenteral medicinal products, the solution/dilution must be inspected visually before use. Only clear solutions without visible particles should be used.
Standard dilutions of levobupivacaine should be prepared with 9 mg/ml (0.9%) sodium chloride injectable solution under aseptic conditions.
It has been demonstrated that 8.4 micrograms/ml of clonidine, 0.05 mg/ml of morphine and 4 micrograms/ml of fentanyl are compatible with levobupivacaine in a 9 mg/ml (0.9%) sodium chloride injectable solution. Chemical and physical stability under use conditions has been demonstrated 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 those mentioned above.
Dissolution with alkaline solutions such as sodium bicarbonate may cause precipitation.

Method of administration
Levobupivacaine must be administered exclusively by a physician, or under the supervision of a physician, with adequate experience and expertise.
For dosage information, refer to the summary of product characteristics.
To avoid intravascular injection, careful aspiration is recommended before and during injection.
Aspiration should be repeated before and during administration of a bolus dose, which must be injected slowly, with dosage increased at a rate of 7.5–30 mg/min, with close monitoring of vital functions and maintaining verbal contact with the patient.
If symptoms of toxicity occur, the injection must be immediately stopped.

Package leaflet: Information for the user

Levobupivacaine Altan 1.25 mg/ml infusion solution

Levobupivacaine
Equivalent medicine
Please 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 being given Levobupivacaine Altan 1.25 mg/ml
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 Levobupivacaine Altan 1.25 mg/ml is and what it is used for

Levobupivacaine Altan 1.25 mg/ml belongs to a group of medicines called local anaesthetics. This type of medicine is used to numb a part of the body or to relieve pain.
Levobupivacaine Altan 1.25 mg/ml solution for infusion is for use in adults only.
Levobupivacaine Altan 1.25 mg/ml is used for pain relief:

• after major surgery
• during childbirth

2. What you need to know before Levobupivacaine Altan 1.25 mg/ml is administered to you

Do not use Levobupivacaine Altan 1.25 mg/ml:

• if you are allergic (hypersensitive) to levobupivacaine, to any other similar local anaesthetic, 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 by injection around the neck of the uterus (cervix) during early labour (paracervical block).
• for anaesthetizing an area by intravenous injection of Levobupivacaine Altan 1.25 mg/ml.

Warnings and precautions
Please consult your doctor, pharmacist, or nurse before Levobupivacaine Altan 1.25 mg/ml is administered to you if you have any of the following diseases or conditions. You may require closer monitoring or 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 liver disease.

Other medicines and Levobupivacaine Altan 1.25 mg/ml
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. In particular, inform them if you are taking medicines for:

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

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, please seek advice from your doctor or nurse before using this medicine.
Levobupivacaine Altan 1.25 mg/ml must not be administered during childbirth as analgesia by injection around the neck of the uterus or cervix (paracervical block).
The effect of Levobupivacaine Altan 1.25 mg/ml on the unborn child during early pregnancy is unknown.
Therefore, Levobupivacaine Altan 1.25 mg/ml should not be used during the first three months of pregnancy unless your doctor considers it 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 anaesthetic.

Driving and using machines
The use of Levobupivacaine Altan may have a significant effect on your ability to drive or operate machinery. Do not drive or operate machinery until all effects of Levobupivacaine Altan and the immediate effects of the surgical procedure have worn off. Make sure you receive appropriate advice from your treating doctor or nurse before leaving the hospital.

Important information about some of the ingredients of Levobupivacaine 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, which should be taken into consideration for patients on a low-sodium diet.

3. How to use Levobupivacaine Altan 1.25 mg/ml

Your doctor will administer Levobupivacaine Altan 1.25 mg/ml by injection with a needle or through a small catheter inserted into your back (epidural). While you are receiving Levobupivacaine Altan 1.25 mg/ml, your doctor and nurse will closely monitor you.

Dosage

Adults
The amount of Levobupivacaine Altan 1.25 mg/ml you will receive and how often it is given depends on the reason for using this medicine, as well as your general health, age, and weight. The lowest effective dose required to anaesthetize the part of the body being treated will always be used. Your doctor will carefully assess the appropriate dose for you.

When Levobupivacaine Altan 1.25 mg/ml is used as an analgesic during childbirth, the dose must be carefully controlled.

Children
Not recommended.

If you receive more Levobupivacaine Altan 1.25 mg/ml than you should
If you are given an excessive dose of Levobupivacaine Altan 1.25 mg/ml, the following symptoms may occur: numbness of the tongue, dizziness, blurred vision, muscle twitching, severe breathing difficulties (including respiratory arrest), and even seizures. If you notice any of these symptoms, inform your doctor immediately. Sometimes, an overdose of Levobupivacaine Altan 1.25 mg/ml may also cause low blood pressure, a fast or slow heartbeat, and disturbances in heart rhythm. Your doctor may decide it is necessary to give you other medicines to help relieve these symptoms.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you think you are experiencing any of the side effects listed below, inform your doctor or nurse immediately. Some of the side effects of Levobupivacaine 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 anaemia)
• Low blood pressure
• Nausea

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

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

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

• Severe allergic reactions (hypersensitivity) causing severe breathing difficulties, difficulty swallowing, hives, and very low blood pressure.
• Allergic reactions (hypersensitivity) recognized by red, itchy skin, sneezing, excessive sweating, fast heartbeat, fainting, or swelling of the face, lips, and mouth
• Fainting
• Drowsiness
• Blurred vision
• Breathing arrest
• Heart attack or heart block
• Localized tingling
• Tongue numbness
• Muscle weakness or muscle contraction
• Loss of bladder or bowel control
• Paralysis
• Seizures
• Tingling, numbness, or other abnormal sensations
• Prolonged erection of the penis which may be painful
• Nerve disturbances which may include drooping eyelid, pupil constriction (black part in the centre of the eye), sunken eye socket, sweating and/or flushing on one side of the face

Bradycardia or tachycardia, irregular heartbeat, and changes in heart rhythm that may 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 of the side effects you have get worse, or if you notice any side effects not listed in this leaflet, inform your doctor or nurse.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via 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 Levobupivacaine Altan 1.25 mg/ml

This medicinal product requires no special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the label after 'Exp.'.
The expiry date refers to the last day of that month.
Your doctor will store this medicine for you.
The solution must be used immediately after opening.
Levobupivacaine Altan 1.25 mg/ml must not be used if visible particles are present.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Levobupivacaine Altan 1.25 mg/ml infusion solution contains
The active substance is levobupivacaine (as hydrochloride).
Levobupivacaine 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 amount of hydrochloric acid.

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

---

The following information is intended for healthcare professionals only:

Instructions for use and handling

Levobupivacaine 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 or if the packaging is damaged. Unused solution should be discarded.
As with all parenteral medicinal products, the solution/dilution must be visually inspected before use. Only clear solutions free from visible particles should be used.
Limited safety experience exists with levobupivacaine treatment for periods exceeding 24 hours.

Stability after dilution in 0.9% sodium chloride solution
Chemical and physical stability under conditions of use has been demonstrated for 30 days at 2–8°C or 20–22°C for both levobupivacaine 0.625 mg/ml and 1.25 mg/ml containing 8.3–8.4 μg/ml clonidine, 50 μg/ml morphine, and 2 μg/ml fentanyl. Chemical and physical stability under conditions of use has been demonstrated for 30 days at 2–8°C or 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 standpoint, the medicinal product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless the mixture has been prepared under controlled and validated aseptic conditions.

Levobupivacaine Altan 1.25 mg/ml must not be mixed with other medicinal products except those mentioned above. Dissolution with alkaline solutions such as sodium bicarbonate may cause precipitation.

Method of administration
Levobupivacaine must be administered exclusively by a physician or under the supervision of a physician with adequate experience and expertise.
For dosage information, refer to the summary of product characteristics.
To avoid intravascular injection, careful aspiration before infusion is recommended. If signs or symptoms of toxicity occur, administration must be immediately discontinued.