ROPIVACAINE B.BRAUN 10 mg/ml INJECTABLE SOLUTION

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

Ropivacaína B. Braun should not be administered to you

• If you are allergic to ropivacaína hydrochloride or any of the other components of this medication (listed in section 6). An allergic 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 neck of the uterus to relieve pain during childbirth.
• If you have been told that you have a decrease in blood volume (hypovolemia).

If you are not sure if any of the above applies to you, talk to your doctor before you are given 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 been informed that you have a rare blood pigment disease called "porphyria" or if someone in your family has it. Your doctor may need to administer a different anesthetic medication.
• If you have a weak state of health due to advanced age or other reasons.
• About any disease or medical problem you have or have had in the past.

Children

In children up to 12 years, other concentrations (2 mg/ml, 5 mg/ml) may be more suitable.

Use of Ropivacaína B. Braun with other medications

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

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

• other local anesthetics (e.g., lidocaína),
• strong pain medications (e.g., morphine),
• 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 be administered Ropivacaína B. Braun even if you are undergoing 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, think you may be pregnant, or plan to become pregnant, consult your doctor before you are given this medication. It is not known if ropivacaína can pass into breast milk or if it can harm the breastfed baby.

Driving and using machines

Ropivacaína B. Braun may cause drowsiness and affect your reaction ability. After receiving this medication, do not drive, use machines, or work in hazardous situations until the next day.

Ropivacaína B. Braun contains sodium

This medication contains 2.7 mg of sodium (main component of table/cooking salt) per ml. This is equivalent to 0.14% of the maximum recommended daily sodium intake for an adult.

3. How Ropivacaína B. Braun will be administered to you

This medication will be administered to you by an expert doctor or under their supervision.

Ropivacaína B. Braun will be administered to you in the form of an injection. The part of the body where it will be applied will depend on the reason why you are being given this medication. Your doctor will administer this medication in one of the following places:

• 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 given an epidural injection or perfusion in the middle or lower back near the spine.

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 touch.

Dosage

Your doctor will decide the dose of Ropivacaína B. Braun that will be administered to you. The dosage depends on your build, age, and physical condition.

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

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

Serious adverse 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:

If you receive too much Ropivacaína B. Braun, inform your doctor immediatelyifyou experienceany of the following adverse effects:

• You feel dizzy or lightheaded.
• Numbness of the lips and around the mouth.
• Numbness of the tongue.
• Hearing problems.
• Vision problems (sight).

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

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

In case of acute toxicity, healthcare professionals will take immediate corrective actions.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

All medications, including Ropivacaína B. Braun, can rarely cause allergic reactions such as anaphylaxis, including anaphylactic shock (may affect up to 1 person in 1,000). You should inform your doctor immediately if you experience any of the following symptoms after receiving this medication:

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

Other possible adverse effects

Very common(may affect more than 1 person in 10)

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

Common (may affect up to 1 person in 10)

• Tingling.
• Dizziness.

• Feeling sick (vomiting).
• Slow or fast heart rate (bradycardia, tachycardia).
• High blood pressure (hypertension).

• High body temperature (fever) or chills (shivering).
• Back pain.
• Headache.
• Difficulty urinating.

Uncommon (may affect up to 1 person in 100)

• Anxiety.
• Fainting.
• Breathing difficulties.
• Low body temperature (hypothermia).
• Some symptoms may occur if the injection is accidentally administered into a blood vessel or if too much Ropivacaína B. Braun is administered (see also section "If you are given more Ropivacaína B. Braun than you should"). These include, among others, convulsions, seizures, feeling of dizziness or lightheadedness, 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(may affect up to 1 person in 1,000)

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

Frequency not known (cannot be estimated from available data)

• Sudden movements (dyskinesia).

Possible adverse effects observed with other local anesthetics that may also be caused by Ropivacaína B. Braun

• Nerve damage. This can rarely cause permanent problems.
• The entire body may become numb (anesthetized) if too much Ropivacaína B. Braun is injected into the spinal fluid.

Children

In infants and children, the adverse 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 10), and feeling sick, which occurs more frequently in children (affects more than 1 child in 10).

Reporting adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ropivacaína B. Braun

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

Do not use this medication after the expiration date stated on the packaging and label after "EXP". The expiration date is the last day of the month indicated.

Do not freeze.

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

6. Package contents and additional information

Composition of Ropivacaína B. Braun

The active ingredient is ropivacaína hydrochloride

1 ml of Ropivacaína B. Braun contains 10 mg of ropivacaína hydrochloride (in the form of ropivacaína hydrochloride monohydrate).

1 ampoule of 10 ml of injectable solution contains 100 mg of ropivacaína hydrochloride (in the form of ropivacaína hydrochloride monohydrate).

1 ampoule of 20 ml of injectable solution contains 200 mg of ropivacaína hydrochloride (in the form of ropivacaína 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 injectable preparations.

Appearance of the product and package contents

Ropivacaína B. Braun is a clear and colorless injectable solution:

1. Ropivacaína B. Braun 10 mg/ml injectable solution is available in:

• Polyethylene ampoules of 10 ml in packs of 20.
• Polyethylene ampoules of 20 ml in packs of 20.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

• Braun Melsungen AG

Carl-Braun-Strasse 1 Postal address:

34212 Melsungen, Germany 34209 Melsungen, Germany

Phone: +49/5661/71-0

Fax: +49/5661/71-4567

This medication is authorized in the Member States of the European Economic Area under the following names:

Austria, Germany, Luxembourg: Ropivacain-HCl B. Braun 10 mg/ml Injektionslösung

Denmark: Ropivacain B. Braun 10 mg/ml

Finland: Ropivacaine B. Braun 10 mg/ml injektioneste, liuos

France: Ropivacaine B. Braun 10 mg/ml, solution injectable en ampoule

Italy: Ropivacaina B. Braun 10 mg/ml soluzione iniettabile

Sweden: Ropivacaine B. Braun 10 mg/ml injektionsvätska, lösning

Netherlands: Ropivacaïne HCl B. Braun 10 mg/ml, oplossing voor injectie

Portugal: Ropivacaína B. Braun 10 mg/ml solução injetável

Spain: Ropivacaina B. Braun 10 mg/ml solución inyectable

Date of the last revision of this prospect:10/2023.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Method of administration

Careful aspiration is recommended before and during injection to prevent intravascular injection. When a higher dose is to be administered, a test dose of lidocaína with adrenaline (epinefrina) is recommended. Accidental intravascular injection can be recognized by a temporary increase in heart rate and accidental intrathecal injection by signs of spinal block.

Ropivacaína hydrochloride should be injected slowly or in increasing doses, at a rate of 25-50 mg/min, while constantly monitoring the patient's vital functions and maintaining verbal contact with them. If symptoms of toxicity appear, administration should be interrupted immediately.

Warnings

Regional anesthesia procedures should always be performed in an area equipped and staffed for such procedures. Equipment and medications necessary for monitoring and emergency resuscitation should be available at all times.

Patients undergoing major blocks should be in optimal general health and have an accessible intravenous line before the block procedure is performed.

The responsible physician should take the necessary precautions to avoid intravascular injection (see section 4.2 of the Summary of Product Characteristics) and be adequately trained and familiar with the diagnosis and treatment of adverse effects, toxicity, and other complications (see sections 4.8 and 4.9 of the Summary of Product Characteristics), 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 probably due to accidental intravascular injection or rapid absorption from the injection site.

Peripheral nerve trunk block may involve the administration of a large volume of local anesthetic in highly vascularized areas, often near 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 suddenly develop severe hypotension during epidural anesthesia, regardless of the local anesthetic used.

Handling

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

For single use only.

The medication should be visually inspected before use.

It should only be used if the solution is clear and colorless and if the packaging and its closure are intact.

Validity period after opening the packaging

From a microbiological point of view, unless the opening method excludes the risk of microbial contamination, the product should be used immediately.

If not used immediately, the storage times and conditions during use are the responsibility of the user.

Consult the Summary of Product Characteristics for instructions on incompatibilities and all information related to prescribing.