Leaflet: information for the user

Ropsine10 mg/ml injectable solution EFG

Ropivacaine hydrochloride

Read this leaflet carefully before you start using the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• 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 isRopsineand what it is used for

2. What you need to know before starting to useRopsine

3. Howto useRopsine

4. Possible side effects

5. Storage ofRopsine6. Contents of the pack and additional information

Ropsinecontains the active ingredient hydrochloride of ropivacaine, which belongs to a class of medications called local anesthetics.

Ropsine10 mg/ml injectable solution is used in adults and adolescents over 12 years old to numb (anesthetize) parts of the body. It is used to stop or relieve pain. It can be used for:

• To numb a part of the body during surgery, including having a caesarean section.
• To relieve pain during childbirth, after surgery, or after an accident.

No useRopsine

• if you areallergic(hypersensitive) toropivacaine hydrochloride, to any other amide-type anesthetic or to any of the other components ofRopsine(listed in section 6),
• if you have adecreased blood volume(hypovolemia). This will be measured by healthcare personnel,
• toinject it into a blood vesselto numb a specific area of your body,
• toinject it into the cervixto relieve pain during childbirth.

Warnings and precautions

Consult your doctor or pharmacist before starting to useRopsine

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

Special care should be taken toavoid any injectionofRopsinedirectly into a blood vesselto prevent any immediate toxic effect. The injection should not be made in an inflamed area.

Inform your doctor:

• if you have apoor general conditiondue to age or other factors,
• if you haveheart problems(partial or complete heart block),
• if you have anadvanced liver problem,
• if you havesevere kidney problems.

Inform your doctor if you have any of these problems as your doctor will need to adjust yourRopsinedose.

Inform your doctor:

• if you haveacute porphyria(problems with the generation of red blood cell pigments, sometimes resulting in neurological symptoms).

Inform your doctor if you or a family member has porphyrin as your doctor may need to use another anesthetic.

Use ofRopsinewith other medicines

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine.

Be cautious if you are receiving:

• Other local anesthetics(e.g., lidocaine) or structurally related agents, such as certain medications used to treat irregular heartbeats (arrhythmia), such as mexiletine or amiodarone,
• General anestheticsoropioids, such as morphine or codeine,
• Medications used to treatdepression(e.g., fluvoxamine),
• Certain antibiotics(e.g., enoxacina).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine. It is unknown whether ropivacaine hydrochloride affects pregnancy or passes into breast milk.

Driving and operating machinery

Ropsinemay cause drowsiness and affect your reaction time. Do not drive or use tools or machinery after takingRopsine, until the next day.

Consult your doctor or pharmacist if you have any doubts.

Important information about some of the components ofRopsine

This medicine contains 2.8 mg 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.

Administration Method

Ropsinewill be administered by your doctor. It will be administered via injection.

Dose

The recommended dose will depend on what it is being used for and also on your health, age, and weight.

The smallest dose that can produce an anesthetic effect in the required area should be used.

Usual Dose

• foradultsand adolescents over 12 years oldis between2 mg and 300 mgof ropivacaine hydrochloride.
• in infants and children(from 0 to 12 years old, inclusive)is between1-3 mg per kilogramof body weight.

Treatment Duration

The administration of ropivacaine hydrochlorideusuallylastsbetween2 and 10 hoursin the caseofanesthesiabefore certain surgeries and may takeup to 72 hoursin the case of pain relief during or after surgery.

If you are administered moreRopsinethan you should

The first symptoms of having been administered more ropivacaine hydrochloride than you should, are usually related to:

• hearing and vision,
• numbness around the mouth,
• dizziness or fainting,
• tingling,
• speech disorder characterized by poor articulation (dysarthria),
• muscle stiffness, muscle spasms, seizures,
• low blood pressure,
• slow or irregular heart rate.

These symptoms may precede a cardiac arrest, respiratory arrest, or severe seizures.

If you experience any of these symptoms or think you may have received too muchRopsine, inform your doctor or healthcare personnel immediately.

In the case of acute toxicity, the appropriate corrective measures will be taken immediately by healthcare personnel.

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

Like all medicines,Ropsinecan cause side effects, although not everyone will experience them.

Important side effects to be aware of:

Severe and potentially life-threatening allergic reactions (such as anaphylaxis, including anaphylactic shock) are rare and affect 1 to 10 people per 10,000. Possible symptoms include:

• Onset of sudden rash, itching, or hives (urticaria);
• Swelling of the face, lips, tongue, or other parts of the body;
• Shortness of breath, wheezing, or difficulty breathing;
• And a feeling of loss of consciousness.

If you thinkRopsineis causing an allergic reaction, inform your doctor or healthcare professional immediately.

Other possible side effects:

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

• Low blood pressure.This could make you feel dizzy or lightheaded.
• Sensation of discomfort (nausea).

Common(may affect up to 1 in 10 people)

• Headache, tingling (paresthesias), sensation of dizziness.
• Slow or rapid heartbeat (bradycardia, tachycardia).
• High blood pressure.
• Sensation of discomfort (vomiting).
• Difficulty urinating (urinary retention).
• Back pain, high temperature, muscle stiffness.

Rare(may affect up to 1 in 100 people)

• Anxiety.
• Some symptoms may appear if the injection was administered by mistake in a blood vessel, or if you have been given moreRopsinethan you should (see also section 3 “If you are given moreRopsinethan you should” previously). These include seizures (convulsions, crises), sensation of dizziness or lightheadedness,numbness of the lips and around the mouth,numbness of the tongue,hearing problems,vision problems,speech problems (dysarthria), muscle stiffness and tremor, decreased sense of touch (hypoesthesia).
• Fainting (syncope).

• Difficulty breathing (dyspnea).
• Low body temperature.

Very rare(may affect up to 1 in 1000 people)

• Heart attack, irregular heartbeat (arrhythmias).

Possible side effects observed with other local anesthetics that may also be produced byRopsineinclude:

• Numbness, due to nerve irritation caused by the needle or injection. This usually does not last long.

• Nerve damage. Rarely,it may cause permanent problems.
• If too muchRopsineis administered in the spinal fluid, it may numb the entire body (anesthetized).

Additional side effects in children

In children,side effects are the same as in adults except for low blood pressure, which is less common in children (affects fewer than 1 in 10 children) and sensation of discomfort, which are more common in children (affects more than 1 in 10 children).

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting 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 the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://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 useRopsineafter the expiration date that appears on the vial or box. The expiration date is the last day of the month indicated.

Do not freeze.

Do not useRopsineif you observe any precipitation in the injection solution.

Normally, your doctor or the hospital will storeRopsineand are responsible for the product quality if once opened it is not used immediately. They are also responsible for disposing of all unusedRopsinecorrectly.

Medicines should not be thrown down the drains, nor in the trash. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition ofRopsine

• The active principle is ropivacaine hydrochloride 10 mg/ml. Each 10 ml polypropylene ampoule contains 100 mg of ropivacaine (as hydrochloride).

Each 20 ml polypropylene ampoule contains 200 mg of ropivacaine (as hydrochloride).

• The other components are sodium chloride, sodium hydroxide (for pH adjustment) and water for injection.

Aspect of the product and contents of the package

Ropsine injectable solution is a transparent, colorless, sterile, isotonic, isobaric aqueous injectable solution.

Ropsine 10 mg/ml injectable solution EFG is available in 10 ml and 20 ml transparent polypropylene ampoules.

Package size:

10 sterile ampoules in a plastic blister.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder::

Sintetica GmbH

Albersloher Weg 11

48155 Münster

Germany

Responsible manufacturer:

Sintetica GmbH

Albersloher Weg 11

48155 Münster

Germany

Last review date of this leaflet:September 2023.

The detailed and updated information on this medicine 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 doctors or healthcare professionals:

Handling

Ropsine should be used by, or under the supervision of, experienced medical professionals in regional anesthesia (see section 3)

1. Hold the ampoule upright and rotate the neck to remove any remaining solution.

Twist the top of the ampoule sharply to open it.

1. The ampoule can be connected directly to the syringe as shown in fig.2.

The ampoules fit both Luerfit and LuerLock syringes.

1. Hold the syringe with the ampoule pointing upwards. Without pressing the ampoule, withdraw the solution. Maintain downward pressure on the syringe plunger once the solution has been withdrawn and until the empty ampoule is discarded.

Validity period prior to opening

3 years

Validity period after opening

From a microbiological point of view, the product should be used immediately. If not used immediately, storage during use and conditions before use are the responsibility of the user and generally should not exceed 24 hours at 2-8°C.

Ropsine products are preservative-free and are intended for single use. Discard any unused solution.

The product should be visually inspected before use. The solution should only be used if the solution is transparent, practically free of particles, and the packaging is intact.

The intact packaging should not be re-introduced into the autoclave.

Dosage

Adults and adolescents over 12 years of age

The table below is a guide to the most commonly used doses for different types of blockage.Use the smallest dose required to produce an effective block. Clinical experience and knowledge of the patient's clinical condition are important factors in deciding the dose.

* With regard to trunk nerve block, only a recommendation for brachial plexus block can be given. For other trunk nerve blocks, lower doses may be required. However, there is currently no experience for specific dose recommendations for other blocks.

1)Administer the dose in increments. The initial dose of 100 mg (97.5 mg = 13 ml; 105 mg = 14 ml) should be administered over 3-5 minutes, and additional doses of up to 50 mg may be administered if necessary.

2)The dose used for trunk nerve block should be adjusted according to the site of administration and the patient's condition. Interscalene and supraclavicular plexus blocks are associated with a higher frequency of severe adverse reactions, regardless of the local anesthetic used (see section 4.4).

Generally, surgery anesthesia (e.g. epidural administration) requires the use of higher concentrations and doses. For surgical procedures requiring deep motor block, epidural anesthesia using Ropsine 10 mg/ml formulation is recommended. For analgesia (e.g. epidural administration for acute pain treatment), lower concentrations and doses are advised.

Administration route

Perineural and epidural administration by injection.

Before and during injection, careful aspiration should be performed to prevent intravascular injection. When administering a higher dose, a 3-5 ml dose of lidocaine 2% (lignocaine) with adrenaline (epinephrine) 1:200,000 should be administered as a test dose. Accidental intravascular injection may be recognized by a temporary increase in heart rate, and accidental intrathecal injection by signs of spinal block.

Aspiration should be performed before and during administration of the main dose, which should be administered slowly or in increments at a rate of 25-50 mg/minute, while closely monitoring the patient's vital functions and maintaining verbal contact with them. If toxic symptoms appear, administration of the drug should be stopped immediately.

In epidural block for surgery, doses of up to 250 mg of ropivacaine hydrochloride have been used and were well tolerated.

In brachial plexus block, a single dose of 300 mg has been used in a limited number of patients and was well tolerated.

When prolonged peripheral nerve blocks are applied, either through continuous infusion or repeated injections, the risks of achieving a toxic plasma concentration or inducing local neural damage should be considered. Accumulated doses of up to 675 mg of ropivacaine hydrochloride for surgery and post-operative analgesia administered over 24 hours were well tolerated in adults, as well as continuous epidural post-operative infusions at rates of up to 28 mg/hour for 72 hours. In a limited number of patients, doses of up to 800 mg/day have been administered with relatively few adverse reactions.

For post-operative pain treatment, the following technique is recommended: Unless Ropivacaína is initiated before the intervention, an epidural block is induced with it at a concentration of 7.5 mg/ml using an epidural catheter. Analgesia is maintained with a Ropsine 2 mg/ml infusion. Infusion rates of 6-14 ml (12-28 mg) per hour provide adequate analgesia with only mild and non-progressive motor block in most cases with moderate to severe post-operative pain. The maximum duration of epidural block is 3 days. However, close monitoring of analgesic effect should be performed to remove the catheter as soon as possible. With this technique, a significant reduction in the need for opioid use has been observed.

In clinical studies, a continuous epidural infusion of 2 mg/ml ropivacaine hydrochloride alone or mixed with 1-4 μg/ml fentanyl for post-operative pain treatment over a period of up to 72 hours has been administered. This combination of ropivacaine hydrochloride and fentanyl provided better pain relief but caused opioid-type side effects; only ropivacaine hydrochloride 2 mg/ml has been investigated for this combination.

When applying prolonged peripheral nerve blocks, either through continuous infusion or repeated injections, the risks of achieving a toxic plasma concentration or inducing local neural damage should be considered. In clinical studies, a femoral nerve block was established with 300 mg of ropivacaine hydrochloride 7.5 mg/ml and an interscalene block with 225 mg of ropivacaine hydrochloride 7.5 mg/ml, respectively, before surgery; analgesia was then maintained with ropivacaine hydrochloride 2 mg/ml. Infusion rates or intermittent injections of 10-20 mg per hour for 48 hours resulted in adequate analgesia and were well tolerated.

Pediatric population from 0 to12 years of age inclusive

The use of Ropsine 10 mg/ml may be associated with systemic and central toxic events in children. Lower concentrations (2 mg/ml, 5 mg/ml) are more suitable for administration in this population.

The use of ropivacaine hydrochloride in premature neonates has not been studied in any form of administration.

Administration route

Epidural administration by injection.

Careful aspiration should be performed before and during injection to prevent intravascular injection. The patient's vital functions should be closely monitored during injection. If toxic symptoms appear, injection should be stopped immediately.

A single epidural caudal injection of 2 mg/ml ropivacaine hydrochloride provides adequate post-operative analgesia below T12 in most patients when a dose of 2 mg/kg is administered in a volume of 1 ml/kg. The volume of the epidural caudal injection can be adjusted to achieve a different distribution of sensory block, as recommended in the literature. Doses of up to 3 mg/kg of a 3 mg/ml ropivacaine hydrochloride concentration have been studied in children over 4 years old; however, this concentration is associated with a higher incidence of motor block.

It is recommended to fractionate the calculated dose of local anesthetic, regardless of the administration route.

In the event that the infusion of ropivacaine hydrochloride is recommended, Ropsine injectable solution may be used.

Incompatibilities

No compatibility studies have been conducted with other solutions, so this medication should not be mixed with other medications.

Precipitation may occur in alkaline solutions since ropivacaine hydrochloride has low solubility at pH > 6.0.

Elimination

The unused medication and all materials that have come into contact with it will be disposed of in accordance with local regulations.