Patient Information

Ropivacaína B.Braun 10 mg/ml Injectable Solution EFG

Ropivacaína, hydrochloride

Read this entire leaflet carefully before you start taking 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 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 for what it is used

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

3. How you will be given Ropivacaína B. Braun

4. Possible side effects

5. Storage of Ropivacaína B. Braun

6. Contents of the container and additional information

The active ingredient is ropivacaína hydrochloride.

Ropivacaína B. Braun belongs to a group of medicines called local anesthetics (pain insensitizers).

Ropivacaína B. Braun injectable solution and for infusion is used in adults and adolescents (over 12 years) to anesthetize (insensitize) parts of your body during surgery, including cesarean section. It is used to prevent the appearance of pain or relieve pain.It may be used for

• anesthetizing body parts during surgery, including cesarean section.
• relieving pain during childbirth, after surgery, or after an accident.

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 (including 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 cervix 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 unsure if anything of the above affects you, speak with your doctor before they administer Ropivacaína B. Braun to you..

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 to you.
• If you have a weak 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

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

Use of Ropivacaína B. Braun with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to take 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. Brauneven while on 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 if you think you may be pregnant, consult your doctorbefore they administer this medication to you.The safety of ropivacaína for use during pregnancy or breastfeeding has not been established.

Driving and operating machinery

Ropivacaína B. Braunmay cause drowsiness and alter your reaction time.After receiving this medication, do not drive, operate machinery or work in hazardous situations until the next day.

Ropivacaína B. Braun contains sodium

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

This medication will be administered by an expert doctor or under the supervision of one.

Ropivacaína B.Braun will be administered in the form of an injection. The part of the body where it will be applied will depend on the reason for which it is 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 zone away from the part of the body that needs to be numbed. This is the case if you are administered an injection or epidural infusion in the middle or lower back near the spinal column.

While Ropivacaína B. Braun is being administered, you will be closely monitored by healthcare professionals.

This medication makes the nerves stop transmitting pain messages to the brain. You will no longer feel 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 your build, age, and physical condition.

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

Since this medication will be administeredbya 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:

If you receive too much Ropivacaína B. Braun, informimmediatelyyour doctorifyou experienceany of the following adverse effects:

• You feel dizzy or have vertigo.
• You have numbness in your lips and around your mouth.
• You have numbness in your tongue.
• You have hearing problems.
• You have 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 them 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 are,among others,speech problems, muscle spasms, tremors, convulsions, seizures, and loss of consciousness.

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

If you have any other doubts about the use of thismedication, ask your doctor.

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

All medicines, including Ropivacaína B. Braun, can rarely cause allergic reactions such as anaphylaxis, including anaphylactic shock (can affect up to 1 person in every 1,000).. 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 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).

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

Rare (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 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 (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, the 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 theSpanish 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 10 mg of ropivacaine hydrochloride (in the form of ropivacaine hydrochloride monohydrate).

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

1 vial of 20 ml of injectable solution contains 200 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 forinjectable preparations.

Appearance of the product and contents of the package

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

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

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

B. Braun Melsungen AG

Carl-Braun-Strasse 1Postal address:

34212 Melsungen, Germany34209 Melsungen, Germany

Phone: +49/5661/71-0

Fax: +49/5661/71-4567

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Austria, Germany, Luxembourg:Ropivacain-HCl B.Braun10mg/ml Injektionslösung

Denmark:Ropivacain B.Braun 10 mg/ml

Finland:RopivacaineB.Braun10 mg/ml injektioneste, liuos

France:RopivacaineB. Braun10mg/ml, solution injectable enampoule

Italy:Ropivacaina B. Braun10mg/ml soluzione iniettabile

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

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

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

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

Last review date 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 Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Administration form

A careful aspiration before and during injection is recommended 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, administration should be stopped immediately.

Warnings

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

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

The responsible physician should take 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. Seizures 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

Disposal 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 visually inspected before use.

Only use if the solution is transparent and colorless and if the container and its closure are intact

Validity period after the 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 immediately.

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.