Ropivacaine B. Braun 10 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ropivacaine B. Braun 10 mg/ml solution for injection EFG

Ropivacaine hydrochloride

Read this entire leaflet carefully before you start receiving this medicine, because 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ropivacaine B. Braun is and what it is used for
2. What you need to know before receiving Ropivacaine B. Braun
3. How Ropivacaine B. Braun is administered
4. Possible side effects
5. How to store Ropivacaine B. Braun
6. Contents of the pack and other information

1. What Ropivacaine B. Braun is and what it is used for

The active substance is ropivacaine hydrochloride.

Ropivacaine B. Braun belongs to a group of medicines called local anaesthetics (medicines used to numb).

Ropivacaine B. Braun injection and infusion solution is used in adults and adolescents (over 12 years of age) to numb (anaesthetize) parts of the body during surgery, including caesarean section. It is used to prevent pain from occurring or to relieve pain. It can be used for:

• numbing parts of the body during surgery, including delivery by caesarean section.
• relieving pain during childbirth, after surgery, or following an injury.

2. What you need to know before starting to receive or use Ropivacaine B. Braun

Do not use Ropivacaine B. Braun if:

• You are allergic to ropivacaine hydrochloride or to 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.
• You are allergic to any other local anaesthetic 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 cervix to relieve pain during childbirth.
• You have been diagnosed with reduced blood volume (hypovolemia).

If you are unsure whether any of the above apply to you, speak with your doctor before receiving Ropivacaine B. Braun.

Warnings and precautions

Talk to your doctor before starting to receive Ropivacaine B. Braun. Inform your doctor:

• If you have heart, liver, or kidney problems. Your doctor may need to adjust the dose of Ropivacaine B. Braun.
• If you have ever been diagnosed with a rare blood pigment disorder called "porphyria" or if anyone in your family has it. Your doctor may need to use a different anaesthetic medicine.
• If you are in a weakened state due to old age or other reasons.
• About any medical conditions or health problems you currently have or have had in the past.

Children

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

Use of Ropivacaine B. Braun with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This is especially important with the following medicines, which may increase the effects of Ropivacaine B. Braun:

• Other local anaesthetics (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 taking:

• Medicines used to treat depression (e.g. fluvoxamine),
• Antibiotics used to treat bacterial infections (e.g. enoxacin).

It may still be suitable for you to receive Ropivacaine B. Braun while on these treatments. Your doctor needs to know so they can 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 receiving this medicine. It is unknown whether ropivacaine passes into breast milk or if it could harm a breastfed infant.

Driving and using machines

Ropivacaine B. Braun may cause drowsiness and affect your reaction time. After receiving this medicine, you should not drive, operate machinery, or work in hazardous situations until the following day.

Ropivacaine B. Braun contains sodium

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

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

This medicine will be administered by an experienced doctor or under the supervision of one.

Ropivacaine B. Braun will be given to you as an injection. The part of the body where it will be administered depends on the reason for which this medicine is being given to you. Your doctor will administer this medicine at one of the following sites:

• The part of the body that needs to be numbed.
• Near the part of the body that needs to be numbed.
• In an area distant 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 Ropivacaine B. Braun is being administered, you will be closely monitored by healthcare professionals.

This medicine causes nerves to stop transmitting pain signals to the brain. You will lose the sensation of pain, heat, or cold in the treated area, but you may still feel other sensations such as pressure or touch.

Dosage

Your doctor will determine the dose of Ropivacaine B. Braun to be administered to you. The dosage depends on your physical build, age, and general health condition.

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

Since this medicine will be administered by a doctor under carefully controlled conditions, it is unlikely that you will receive too high a dose or that a dose will be omitted.

Serious side effects due to an overdose of Ropivacaine B. Braun require special treatment. Your doctor is trained to manage such situations.

The first signs of receiving too much Ropivacaine B. Braun are usually the following:

If you receive too much Ropivacaine B. Braun, inform your doctor immediately if you experience any of the following adverse effects:

• Dizziness or lightheadedness.
• Numbness of the lips and around the mouth.
• Numbness of the tongue.
• Hearing disturbances.
• Vision problems.

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

More serious adverse effects due to excessive amounts of this medicine include, among others, speech difficulties, muscle spasms, tremors, seizures, fits, and loss of consciousness.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

Other possible adverse 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 sensation.
• Dizziness.
• Feeling sick (vomiting).
• Slow or fast heartbeat (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 0 people out of 100)

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

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)

• Involuntary muscle movements (dyskinesia).

Possible adverse reactions observed with other local anaesthetics that could also occur with Ropivacaine B. Braun

• Nerve damage. This may rarely lead to permanent problems.
• The entire body may become numb (anaesthetized) if too much Ropivacaine B. Braun is injected into the cerebrospinal fluid.

Children

In infants and children, adverse reactions 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 unwell, which occurs more frequently in children (affecting more than 1 in 10 children).

Reporting of adverse reactions

If you experience any adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Ropivacaine B. Braun

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

Do not use this medicine after the expiry date stated on the container and label after "EXP". The expiry date refers to the last day of the month indicated.

Do not freeze.

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

6. Contents of the pack and other information

Composition of Ropivacaine B. Braun

The active substance is ropivacaine hydrochloride.

1 ml of Ropivacaine B. Braun contains 10 mg of ropivacaine hydrochloride (as ropivacaine hydrochloride monohydrate).

One 10 ml vial of injectable solution contains 100 mg of ropivacaine hydrochloride (as ropivacaine hydrochloride monohydrate).

One 20 ml vial of injectable solution contains 200 mg of ropivacaine hydrochloride (as ropivacaine hydrochloride monohydrate).

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

Appearance of the product and contents of the pack

Ropivacaine B. Braun is a clear, colourless injectable solution:

1. Ropivacaine B. Braun 10 mg/ml solution for injection is available in:

• 10 ml polyethylene vials in packs of 20.
• 20 ml polyethylene vials in packs of 20.

Only certain 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

Telephone: +49/5661/71-0

Fax: +49/5661/71-4567

This medicinal product 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 most recent review of this leaflet: 10/2023.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Method of administration

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

Ropivacaine hydrochloride should be injected slowly or in incremental doses at a rate of 25–50 mg/min, with continuous monitoring of the patient's vital functions and verbal contact maintained throughout. If symptoms of toxicity occur, administration must be stopped immediately.

Warnings

Regional anaesthesia procedures should always be performed in adequately equipped areas with trained personnel. Equipment and medications necessary for monitoring and emergency resuscitation must be readily available at all times.

Patients undergoing major nerve blocks should be in optimal general condition and have an intravenous access established prior to the block procedure.

The responsible physician must take necessary precautions to avoid intravascular injection (see section 4.2 of the Summary of Product Characteristics) and must be adequately trained and familiar with the diagnosis and management 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 may lead to high spinal block with apnoea and hypotension. Seizures have occurred more frequently following brachial plexus block and epidural block, likely due to accidental intravascular injection or rapid absorption from the injection site.

Peripheral nerve trunk blocks may involve administration of large volumes of local anaesthetic in highly vascularized areas, often near large vessels, where there is an increased risk of intravascular injection and/or rapid systemic absorption, potentially leading to high plasma concentrations.

Patients with hypovolaemia due to any cause may develop sudden, severe hypotension during epidural anaesthesia, regardless of the local anaesthetic used.

Handling

Disposal of unused medicinal product and all materials that have been in contact with it must be carried out in accordance with local regulations.

For single use only.

The medicinal product should be visually inspected before use.

The solution should only be used if it is clear and colourless and if the container and closure are intact.

Stability after first opening of the container

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

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

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