Leaflet: information for the user

Ropivacaína B. Braun 2 mg/ml injectable solution and for infusion EFG

Ropivacaína hydrochloride

Read this leaflet carefully before starting to receive this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Ropivacaína B. Braun and how it is used

2. What you need to know before starting to receive Ropivacaína B. Braun

3. How you will be administered Ropivacaína B. Braun

4. Possible side effects

5. Storage of Ropivacaína B. Braun

6. Contents of the package and additional information

The active ingredient is ropivacaína hydrochloride.

Ropivacaína B. Braun belongs to a group of medicines called local anesthetics (pain relief medicines). Ropivacaína B. Braun injectable solution and for infusion is usedin adults and children of any age for the relief of acute pain. It numbs (anesthesia) parts of the body, for exampleafter surgery.

You should not be administered Ropivacaína B. Braun

• If you are allergic to hydrochloride ropivacaína or to any of the other components of this medication (listed in section 6).A hypersensitivity reaction may include skin rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
• If you are allergic to any other local anesthetic of the same class (e.g. lidocaína or bupivacaína).
• For injection into a blood vessel to numb a specific area of your body, or in the cervix to relieve pain during childbirth.
• If you have been told that you have a decrease in blood volume (hypovolemia).

If you are unsure if any of the above applies to you, speak with your doctor before they administer Ropivacaína B. Braun.

Warnings and precautions

Consult your doctor before starting to receive Ropivacaína B. Braun. Inform your doctor:

• If you have heart, liver or kidney problems. Your doctor may need to adjust the dose of Ropivacaína B. Braun.
• If you have ever been told that you have a rare disease of the blood pigment called "porfiria" or if someone in your family has it. Your doctor may need to administer a different anesthetic medication.
• If you have a weakened state of health due to advanced age or other reasons.
• About any medical condition or problem you have or have had in the past.

Children

Your doctor will take special care:

• With newborns, as they are more sensitive to ropivacaína.
• With children aged 12 years or younger, as the use of ropivacaína injections to numb body parts has not been established in younger children.

Your doctor will carefully adjust the necessary dose for your child and will closely monitor them.

Use of Ropivacaína B. Braun with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

This is especially important with the following medications that may make the effects of Ropivacaína B. Braun more potent:

• Other local anesthetics (e.g. lidocaína),
• Strong pain medications (e.g. morfina),
• Medications used to treat irregular heartbeat (e.g. amiodarona, mexiletina).

Prolonged use of ropivacaína should be avoided if you are being administered:

• Medications used to treat depression (e.g. fluvoxamina),
• Antibiotics used to treat bacterial infections (e.g. enoxacina).

It may be suitable for you to receive Ropivacaína B. Braun even with these treatments.Your doctor needs to know this to be able to decide what is appropriate for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before they administer this medication.

The effects of ropivacaína on the fetus or infant are unknown.

Driving and operating machinery

Ropivacaína B. Braun may cause drowsiness and alter your reaction time.After receiving this medication, do notdrive, operate machinery or work in hazardous situations until the next day.

Ropivacaína B. Braun contains sodium

This medication contains 3.3 mg of sodium (main component of table salt/for cooking) in each ml.

This is equivalent to 0.17% of the recommended daily maximum sodium intake for an adult.

This medication will be administered by a qualified doctor or under their supervision. Ropivacaína B. Braun will be administered in the form of an injection or infusion. The part of the body where it will be applied will depend on the reason for which it is being administered.

Your doctor will administer this medication in one of the following locations:

• The part of the body that needs to be numbed.
• Near the part of the body that needs to be numbed.
• In a distant area from the part of the body that needs to be numbed. This is the case if you are administered an epidural injection or infusion in the middle or lower back near the spinal column.

While you are being administered Ropivacaína B. Braun, you will be closely monitored by healthcare professionals. This medication makes the nerves stop transmitting pain messages to the brain. You will stop feeling pain, heat, or cold in the area where it is used, but you may still feel other sensations such as pressure or contact.

Dosage

Your doctor will decide the dosage of Ropivacaína B. Braun to be administered. The dosage depends on the type of pain relief you need and other factors such as body weight, age, and physical condition.

If you are administered more Ropivacaína B. Braun than you should

Since this medication will be administered by a doctor under carefully controlled conditions, it is unlikely that you will be administered a higher dose or miss a dose.

Severe side effects from receiving too much Ropivacaína B. Braun require special treatment. Your doctor is specialized to act in these situations.

The first signs of having received too much Ropivacaína B. Braun are usually the following::

• You feel dizziness or vertigo,
• You experience numbness of the lips and around the mouth,
• You experience numbness of the tongue,
• You experience hearing problems,
• You experience vision problems (vision).

Your doctor will stop administering this medication as soon as these signs appear to reduce the risk of severe adverse effects. This means that if you experience any of these or think you have received too much Ropivacaína B. Braun, you must inform your doctor immediately.

More severe side effects from receiving too much of this medication include, among others, speech problems, muscle spasms, tremors, convulsions, and loss of consciousness.

In case of acute toxicity, healthcare professionals will take the necessary corrective actions immediately.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

All medicines, including Ropivacaína B. Braun, may cause rare allergic reactions such as anaphylaxis, including anaphylactic shock (can affect up to 1 person in every 1,000). Inform your doctor immediately if you experience any of the following symptoms after receiving this medicine:

• Sudden appearance of skin rash, itching, or urticaria;
• Swelling of the eyelids, face, lips, tongue, throat, or other parts of the body;
• Difficulty breathing, sudden gasping, dizziness;
• A feeling of loss of consciousness.

Other possible side effects

Very common (can affect more than 1 person in every 10)

• Low blood pressure (hypotension) (may feel dizzy or lightheaded).
• Feeling sick (nausea).

Common (can affect up to 1 person in every 10)

• Tickling sensation.
• Dizziness.
• Feeling sick (vomiting).
• Slow or rapid heartbeat (bradycardia, tachycardia).
• High blood pressure (hypertension).
• Elevated body temperature (fever) or chills.
• Back pain.
• Headache.
• Difficulty urinating.

Uncommon (can affect up to 1 person in every 100)

• Anxiety.
• Fainting.
• Difficulty breathing.
• Low body temperature (hypothermia).
• Some symptoms may occur if the injection is administered accidentally into a blood vessel or if too much Ropivacaína B. Braun is administered (see also the section "If you are given more Ropivacaína B. Braun than you should"). These include, among others, convulsions, seizures, feeling dizzy or lightheaded, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, vision problems, speech problems, stiff muscles, decreased sensitivity or sensation in the skin, and tremors.

Rare (can affect up to 1 person in every 1,000)

• Heart attack (cardiac arrest)
• Irregular heartbeat (arrhythmia)

Frequency not known (cannot be estimated from available data)

• Uncontrolled movements (dyskinesia)

Possible side effects observed with other local anesthetics that may also be produced by Ropivacaína B. Braun:

• Nerve damage.Rarely this may cause permanent problems.
• The entire body may become numb (anesthetized), if too much Ropivacaína B. Braun is injected into the cerebrospinal fluid.

Children

In infants and children, side effects are the same as in adults except for low blood pressure, which occurs less frequently in infants and children (affects up to 1 child in every 10) and feeling sick occurs more frequently in children (affects more than 1 child in every 10).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the label after “CAD”. The expiration date is the last day of the month indicated.

Do not freeze.

Your doctor or pharmacist is responsible for the conservation of this medication. They are also responsible for the proper disposal of unused medication.

Composition of Ropivacaine B. Braun

The active ingredient is ropivacaine hydrochloride.

1 ml of Ropivacaine B. Braun contains 2 mg of ropivacaine hydrochloride (in the form of ropivacaine hydrochloride monohydrate).

1 vial of 10 ml solution contains 20 mg of ropivacaine hydrochloride in the form of ropivacaine hydrochloride monohydrate.

1 vial of 20 ml solution contains 40 mg of ropivacaine hydrochloride in the form of ropivacaine hydrochloride monohydrate.

1 bottle of 100 ml solution contains 200 mg of ropivacaine hydrochloride in the form of ropivacaine hydrochloride monohydrate.

1 bottle of 200 ml solution contains 400 mg of ropivacaine hydrochloride in the form of ropivacaine hydrochloride monohydrate.

1 bottle of 400 ml solution contains 800 mg of ropivacaine hydrochloride in the form of ropivacaine hydrochloride monohydrate.

1 bottle of 500 ml solution contains 1000 mg of ropivacaine hydrochloride in the form of ropivacaine hydrochloride monohydrate.

The other components are sodium chloride, hydrochloric acid 0.36% (for pH adjustment) and sodium hydroxide 0.4% (for pH adjustment), and water for injection.

Appearance of the product and contents of the package

Ropivacaine B. Braun is a transparent and colorless injectable and perfusion solution available in:

• 10 ml polyethylene vials in packs of 20.

• 20 ml polyethylene vials in packs of 20.
• 100 ml polyethylene bottles in packs of 1 and 10.
• 200 ml polyethylene bottles in packs of 1 and 10.
• 400 ml polyethylene bottles in packs of 1 and 10.
• 500 ml polyethylene bottles in packs of 1 and 10.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

B. Braun Melsungen AG

Carl-Braun-Strasse 1Postal address:

34212 Melsungen, Germany34209 Melsungen, Germany

Phone: +49/5661/71-0

Fax: +49/5661/71-4567

Responsible manufacturer

B. Braun Melsungen AG

Carl-Braun-Strasse 1Postal address:

34212 Melsungen, Germany34209 Melsungen, Germany

B. Braun Medical, SA

Carretera de Terrassa, 121

08191 – Rubí (Barcelona) – Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

1. Ropivacaine B. Braun 2 mg/ml injectable and perfusion solution

Austria, Germany, Luxembourg:Ropivacain-HCl B.Braun 2 mg/ml Injektions-/Infusionslösung

Denmark:Ropivacain B.Braun

Estonia:Ropivacaine B.Braun 2 mg/ml

1. Finland:Ropivacaine B. Braun 2 mg/ml injektio-/infuusioneste,liuos
2. France:Ropivacaine B Braun 2 mg/ml, solution injectable/pourperfusion
3. Italy:Ropivacaina B. Braun 2 mg/ml soluzione iniettabile o perinfusione
4. Lithuania:Ropivacaine B. Braun 2 mg/ml injekcinisar infuzinistirpalas
5. Netherlands:Ropivacaïne HCl B. Braun 2 mg/ml, oplossing voorinjectieof infusie
6. Portugal:Ropivacaína B. Braun 2 mg/ml, solução injetável ou paraperfusão
7. Spain:Ropivacaina B. Braun 2 mg/ml solución inyectable y paraperfusión

Date of the last review of this leaflet:10/2023

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Administration form

It is recommended to aspirate carefully before and during injection to prevent intravascular injection. When a higher dose is to be injected, a lidocaine with adrenaline (epinephrine) test dose is advised. An accidental intravascular injection may be recognized by a temporary increase in heart rate and an accidental intrathecal injection by signs of spinal block.

Ropivacaine hydrochloride should be injected slowly or in increasing doses, at a rate of 25‑50mg/min, while constantly observing the patient's vital functions and maintaining verbal contact with him. If symptoms of toxicity appear, the administration should be stopped immediately.

Warnings

Regional anesthesia procedures should always be performed in a suitably equipped area with specialized personnel. The necessary equipment and medications for emergency monitoring and resuscitation should be available at all times.

Patients undergoing a block should be in optimal general condition and have an intravenous line inserted before the procedure.

The responsible physician should take the necessary precautions to avoid intravascular injection (see section4.2 of the SmPC) and be adequately trained and familiar with the diagnosis and treatment of adverse effects, systemic toxicity, and other complications (see sections4.8 and 4.9 of the SmPC) such as accidental subarachnoid injection, which can cause high spinal block with apnea and hypotension. Convulsions have occurred more frequently after brachial plexus block and epidural block. This is likely due to accidental intravascular injection or rapid absorption from the injection site.

Block of peripheral nerve trunks may involve administration of a large volume of local anesthetic in highly vascularized areas, often close to large vessels, where there is a greater risk of intravascular injection and/or rapid systemic absorption, which can lead to high plasma concentrations.

Patients with hypovolemia due to any cause may develop severe hypotension during epidural anesthesia, regardless of the local anesthetic used.

Handling

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

For single use only.

The medication should be inspected visually before use.

Only use if the solution is transparent and colorless, and if the vials and their closure are intact.

Validity period after the first opening of the package

From a microbiological point of view, unless the opening method excludes the risk of microbial contamination, the product should be used. If not used immediately, the times and conditions of storage during use are the responsibility of the user.

See the SmPC for instructions on incompatibilities and all relevant information on prescription.