ROPIVACAINE B.BRAUN 2 mg/ml INJECTABLE SOLUTION AND INFUSION SOLUTION

2. What you need to know before you start receiving Ropivacaína B. Braun

Ropivacaína B. Braun must not be administered to you

• If you are allergic to Ropivacaína Hydrochloride or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include 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. lidocaine or bupivacaine).
• For injection into a blood vessel to numb a specific area of your body, or into 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

Talk to your doctor before you start receiving 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 blood pigment disease called "porphyria" or if anyone in your family has it. Your doctor may need to give you a different anesthetic medicine.
• If you have a weak state of health due to advanced age or other reasons.
• About any illness or medical problem that you have or have had in the past.

Children

Your doctor will be particularly careful:

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

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

Using Ropivacaína B. Braun with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

This is especially important with the following medicines that may make the effects of Ropivacaína B. Braun stronger:

• other local anesthetics (e.g. lidocaine),
• strong painkillers (e.g. morphine),
• medicines used to treat irregular heartbeat (e.g. amiodarone, mexiletine).

Prolonged use of ropivacaine should be avoided if you are being given:

• medicines used to treat depression (e.g. fluvoxamine),
• antibiotics used to treat bacterial infections (e.g. enoxacin).

It may be suitable for you to be given Ropivacaína B. Braun even if you are having these treatments. Your doctor needs to know 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 are planning to have a baby, ask your doctor for advice before you are given this medicine.

It is not known whether ropivacaine can pass into breast milk or if it can harm the baby.

Driving and using machines

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

Ropivacaína B. Braun contains sodium

This medicine contains 3.3 mg of sodium (a major component of cooking/table salt) in each ml.

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

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

This medicine will be administered to you by an expert doctor or under their supervision. Ropivacaína B. Braun will be administered to you as an injection or infusion. The part of the body where it will be applied will depend on the reason why you are being given this medicine.

Your doctor will administer this medicine to you 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 infusion in the middle or lower back near the spine.

While you are being given Ropivacaína B. Braun, you will be closely monitored by healthcare professionals. This medicine makes the nerves stop sending 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 the type of pain relief you need and other factors such as your build, age and physical condition.

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

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

Serious 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:

• 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 medicine as soon as these signs appear to reduce the risk of serious side 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 side effects from receiving too much of this medicine include, among others, speech problems, muscle spasms, tremors, shaking (convulsions), and loss of consciousness.

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

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• sudden appearance of rash, itching or hives;
• swelling of the eyelids, face, lips, tongue, throat or other parts of the body;
• difficulty breathing, sudden wheezing;
• a feeling of loss of consciousness.

Other possible side effects

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

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

Common (may affect up to 1 in 10 people)

• 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 in 100 people)

• Anxiety.
• Fainting.
• Breathing difficulties.
• Low body temperature (hypothermia).
• Some symptoms may occur if the injection is accidentally given into a blood vessel or if too much Ropivacaína B. Braun is given (see also section "If you are given more Ropivacaína B. Braun than you should"). These include, among others, convulsions, fits, 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 shaking.

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

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

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

• Sudden movements (dyskinesia)

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

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

Children

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ropivacaína B. Braun

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

Do not use this medicine after the expiry date which is stated on the carton and label after "EXP". The expiry date is the last day of the month shown.

Do not freeze.

Your doctor or pharmacist is responsible for the storage of this medicine. They are also responsible for the correct disposal of any unused medicine.

6. Container Content and Additional Information

Composition of Ropivacaína B. Braun

The active ingredient is ropivacaine hydrochloride.

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

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

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

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

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

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

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

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

Product Appearance and Container Content

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

• Polyethylene ampoules of 10 ml in packs of 20.

• Polyethylene ampoules of 20 ml in packs of 20.
• Polyethylene vials of 100 ml in packs of 1 and 10.
• Polyethylene vials of 200 ml in packs of 1 and 10.
• Polyethylene vials of 400 ml in packs of 1 and 10.
• Polyethylene vials of 500 ml in packs of 1 and 10.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

• Braun Melsungen AG

Carl-Braun-Strasse 1 Mailing Address:

34212 Melsungen, Germany 34209 Melsungen, Germany

Phone: +49/5661/71-0

Fax: +49/5661/71-4567

Manufacturer

• Braun Melsungen AG

Carl-Braun-Strasse 1 Mailing Address:

34212 Melsungen, Germany 34209 Melsungen, Germany

• 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 under the following names:

1. Ropivacaína B. Braun 2 mg/ml solution for injection and perfusion

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/pour perfusion
3. Italy: Ropivacaina B. Braun 2 mg/ml soluzione iniettabile o per infusione
4. Latvia: Ropivacaine B. Braun 2 mg/ml šķīdums injekcijām/infūzijām
5. Lithuania: Ropivacaine B. Braun 2 mg/ml injekcinis ar infuzinis tirpalas
6. Sweden: Ropivacaine B. Braun 2 mg/ml injektions‑/infusionsvätska, lösning
7. Netherlands: Ropivacaïne HCl B. Braun 2 mg/ml, oplossing voor injectie of infusie
8. Portugal: Ropivacaína B. Braun 2 mg/ml, solução injetável ou para perfusão
9. Spain: Ropivacaina B. Braun 2 mg/ml solución inyectable y para perfusión

Date of the Last Revision of this Leaflet:10/2023

Detailed and updated information on this medicinal product 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:

Administration Method

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

Ropivacaine 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 adequately equipped area with specialized personnel. The necessary equipment and medications for monitoring and emergency resuscitation should be available at all times.

Patients who are to receive a major block should have an optimal general condition and have an intravenous line inserted before performing the block procedure.

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, systemic 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. Seizures 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 close to large vessels, where there is a greater risk of intravascular injection and/or rapid systemic absorption, which can lead to elevated 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 medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.

For single use.

The medicinal product should be visually inspected before use.

It should only be used if the solution is clear and colorless, and if the ampoules and their closure are intact.

Shelf Life after First Opening of the Container

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 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.