Leaflet: information for the user

Ropivacaína B. Braun 7.5 mg/ml injectable solution 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 doubts, consult your doctor or pharmacist.
• If you experience any adverse 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 to receive Ropivacaína B. Braun

3. How you will be administered Ropivacaína B. Braun

4. Possible adverse 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 insensitizing medicines). Ropivacaína B. Braun injectable solution is used

-in adults and adolescents (over 12 years)to anesthetize (insensitize) parts of your body.It is used to prevent the appearance of pain or relieve pain. It can be used for

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

You should not be administered Ropivacaína B. Braun

• Ifyouareallergictohydrochlorideofropivacaínaoranyoftheothercomponentsofthismedication(includingthoselistedinsection6).Ahypersensitivityreactionmayincludeskineruption,itching,difficultybreathingorswellingoftheface,lips,throatortongue.
• Ifyouareallergictoanyotherlocalanestheticofthesameclass(e.g.lidocaínaorbupivacaína).
• Forinjectionintoabloodvesseltoinsensitizeaspecificareaofyourbody,orinthecervicalostorelievepainduringchildbirth.
• Ifyouhavebeentoldthatyouhaveadecreaseinbloodvolume(hypovolemia).

Ifyouarenotsureifsomethingaboveaffectsyou,talktoyourdoctorbeforetheyadministerRopivacaínaB.Braun.

Warnings and precautions

ConsultyourdoctorbeforestartingtoreceiveRopivacaínaB.Braun,informyourdoctor:

• Ifyouhaveheart,liver,orkidneyproblems. YourdoctormayneedtoadjustthedoseofRopivacaínaB.Braun.
• Ifyouhaveeverbeentoldthatyouhavearareblooddisordercalled"porfiria"orifsomeoneinyourfamilyhasit. Yourdoctormayneedtoadministeradifferentanesthetic.
• Ifyouhaveaweakhealthduetoadvancedageorotherreasons.
• Aboutanymedicalconditionorproblemyouhaveorhavehadinthepast.

Children

Inchildrenupto12years,otherconcentrations(2mg/ml,5mg/ml)maybemoreappropriate.

Use of Ropivacaína B. Braun with other medications

Informyourdoctororpharmacistifyouareusing,haveusedrecentlyormayneedtotakeanyothermedication.

Thisisespeciallyimportantwiththefollowingmedications,whichmaymaketheeffectsofRopivacaínaB.Braunmorepotent:

• Otherlocalanesthetics(e.g.lidocaína),
• Strongpainrelievers(e.g.morfina),
• Medicationsusedtotreatirregularheartbeats(e.g.amiodarona,mexiletina).

Prolongeduseofropivacaínashouldbeavoidedifyouarereceiving:

• Medicationsusedtotreatdepression(e.g.fluvoxamina),
• Antibioticsusedtotreatbacterialinfections(e.g.enoxacina).

YourdoctormaydecidethatRopivacaínaB.Braunisstillappropriateforyouevenifyouarereceivingthesetreatments.

Pregnancy and breastfeeding

Ifyouarepregnant,breastfeeding,thinkyoumaybepregnant,orplantobecomepregnant,consultyourdoctorbeforereceivingthismedication.Theeffectsofropivacaínaonthefoetusorinfantareunknownandmaybeharmful.

Driving and operating machinery

RopivacaínaB.Braunmaycausedrowsinessandalteryourabilitytoreact. Afterreceivingthismedication,donotdrive,operatemachines,orworkinhazardoussituationsuntilthenextday.

Ropivacaína B. Braun contains sodium

Thismedicationcontains2.9mgofsodium(maincomponentofsaltortablesalt)ineachml. Thisisequivalentto0.15%ofthedailymaximumsodiumintakerecommendedforanadult.

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 why 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 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 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 dose 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 more Ropivacaína B. Braun is administered than it should

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

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 dizzy or have vertigo.
• You experience numbness of the lips and around the mouth.
• You experience numbness of the 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 include, among others, speech problems, muscle spasms, tremors, seizures, attacks, 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. Braunmay cause rare allergic reactionssuch as anaphylaxis, including anaphylactic shock(may affect up to 1person in every 1,000). You must inform your doctorimmediatelyif 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 (may affect more than 1 person in every 10)

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

Common (may 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 (may 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" above). These include, among others, 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 skinand tremors.

Rare (may 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 1child in every 10) and feeling sick occurs more frequently in children (affects more than 1child in every 10).

Reporting side effects

If you experienceanytype ofside effect, consultyour 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 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 7.5 mg of ropivacaine hydrochloride (in the form of ropivacaine hydrochloride monohydrate).

1 vial of 10 ml of injectable solution contains 75 mg of ropivacaine hydrochloride (in the form of ropivacaine hydrochloride monohydrate).

1 vial of 20 ml of injectable solution contains 150 mg of ropivacaine hydrochloride (in the form of 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 injectable preparations.

Appearance of the product and contents of the packaging

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

1. Ropivacaine B. Braun 7.5 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.Braun 7.5 mg/ml Injektionslösung

Bulgaria:RopivacainHCIB. Braun 7.5 mg/mlsolution forinjection

Denmark:Ropivacain B.Braun 7.5 mg/ml

Estonia:Ropivacaine B.Braun 7.5 mg/ml

1. Finland:Ropivacaine B.Braun 7.5 mg/mlinjektioneste, liuos
2. France:Ropivacaine B Braun 7.5 mg/ml, solution injectable enampoule
3. Greece:Ropivacain HCI B. Braun 7.5 mg/ml solution for injection
4. Italy:Ropivacaina B. Braun 7.5 mg/mlsoluzione iniettabile
5. Letonia:Ropivacaine B. Braun 7.5 mg/mlškidums injekcijam
6. Lithuania:Ropivacaine B. Braun 7.5 mg/ml injekcinis tirpalas
7. Netherlands:Ropivacaïne HCl B. Braun 7.5 mg/ml, oplossing voorinjectie
8. Norway:Ropivacain B. Braun 7.5 mg/ml injeksjonsvaeske,opplosning
9. Portugal:Ropivacaína B. Braun7,5mg/ml solução injetável
10. Spain:Ropivacaina B. Braun 7.5 mg/ml solución inyectable
11. Sweden:Ropivacaine B. Braun 7.5mg/ml injektionsvätska, lösning

Last review date 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

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 them. If symptoms of toxicity appear, administration should be stopped immediately.

Warnings

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

Patientsscheduled for a block 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 may 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 may 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 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 ampoules and their closure are intact.

Validity period after the first opening of 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 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.

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