Leaflet: information for the user

Ropsine2 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. How to useRopsine

4. Possible side effects

5. Storage ofRopsine

6. Contents of the pack and additional information

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

Ropsine2 mg/ml injectable solution is used in adults and children of all ages for the treatment of acute pain. It numbs (anesthetizes) a part of the body, for example, after surgery.

No useRopsine

• if you areallergic(hypersensitive)to ropivacaine 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 newborns, as they are more susceptible toRopsine.
• In children under 12 years, as the use ofRopsineinjections to numb a body part has not been established.

Special care must be taken toavoid any injectionofRopsinedirectly into a blood vesselto prevent any immediate toxic effects. 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 yourRopsinedosage.

Inform your doctor:

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

Inform your doctor if you or a family member suffers from 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.

Caution should be exercised 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. The effect of ropivacaine hydrochloride on pregnancy or passage into breast milk is unknown.

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 3.39 mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 0.2% 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 a sensory block (anesthesia) of the required area should be used.

Usual Dose

• foradultsand adolescents over 12 yearsis between2 mg and 300 mgof ropivacaine hydrochloride.
• ininfants and children(from 0 to 12 years, 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 ofpain reliefduring or after surgery.

If moreRopsineis administered than it should

The first symptoms of having received 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:

Sudden and potentially life-threatening allergic reactions (e.g., anaphylaxis, including anaphylactic shock) are rare and affect 1 to 10 people out of every 10,000. Possible symptoms include:

• Onset of sudden rash, itching, or hives (urticaria);
• Itching or rash with swelling(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(hypotension).This could make you feel dizzy or lightheaded.
• Feeling unwell(nausea).

Common(may affect up to 1 in 10 people)

• Headache, tingling (paresthesias), feeling of dizziness.
• Slow or fast heart rate(bradycardia, tachycardia).
• High blood pressure(hypertension).
• Feeling unwell(vomiting).
• Difficulty urinating (urinary retention).
• Back pain, high temperature, muscle stiffness.

Rare(may affect up to 1 in 100 people)

• Anxiety.
• Some symptoms may occur if the injection was administered by mistake into a blood vessel, or if you have been given too muchRopsine(see also section 3 “If you have been given too muchRopsine” earlier). These include seizures (convulsions, crises), feeling of dizziness or lightheadedness,numbness of the lips and around the mouth,numbness of thetongue,hearing problems, vision problems (vision), 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 into 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 feeling unwell, 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 Vigilance of Medicinal Products 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. This way, you will help protect the environment.

Composition ofRopsine

• The active principle is ropivacaine hydrochloride 2 mg/ml. Each 10 ml polypropylene ampoule contains 20 mg of ropivacaine (as hydrochloride).

Each 20 ml polypropylene ampoule contains 40 mg of ropivacaine (as hydrochloride).

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

Appearance of the product and contents of the pack

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

Ropsine 2 mg/ml injectable solution EFG is available in 10 ml and 20 ml transparent polypropylene ampoules.

Pack size:

10 sterile ampoules in a plastic blister.

Marketing authorisation holder and responsible person for manufacturing

Marketing authorisation holder:

Sintetica GmbH

Albersloher Weg 11

48155 Münster

Germany

Responsible person for manufacturing:

Sintetica GmbH

Albersloher Weg 11

48155 Münster

Germany

Last review date of this leaflet: September 2018

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 squeezing 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 medicines are products without preservatives and are intended for single use. Discard any unused solution.

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

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

Dosage

Adults and adolescents over 12 years of age

The following table is a guide to the most commonly used doses for different types of block.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.

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

Administration route

Perineural and epidural administration by injection.

Before and during injection, careful aspiration is recommended to prevent intravascular injection. When administering a higher dose, a 3-5 ml dose of 2% lidocaine (lignocaine) with adrenaline (epinephrine) 1:200,000 is recommended 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 injected slowly or in incremental doses at a rate of 25-50 mg/minute, while constantly monitoring the patient's vital functions and maintaining verbal contact with them. If toxic symptoms appear, administration of the drug should be stopped immediately.

Doses of up to 250 mg of ropivacaine hydrochloride have been used for epidural block in surgery and were well tolerated.

A single dose of 300 mg has been used for brachial plexus block 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 toxic plasma concentrations 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 infusions post-operatively at rates of up to 28 mg/hour for 72 hours. In a limited number of patients, doses up to 800 mg/day have been administered with relatively few adverse reactions.

For post-operative pain relief, the following technique is recommended: Unless the treatment with Ropivacaína is initiated before the intervention, a spinal block is induced with this product at a concentration of 7.5 mg/ml using an epidural catheter. Analgesia is maintained with a continuous infusion of Ropsine 2 mg/ml. Infusion rates of 6-14 ml (12-28 mg) per hour provide adequate analgesia with only slight and non-progressive motor block in most cases with post-operative pain of moderate to severe intensity. 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 has been administered for post-operative pain relief for up to 72 hours. This combination of ropivacaine hydrochloride and fentanyl provided better pain relief but caused opioid-type side effects; this combination has only been investigated for ropivacaine hydrochloride 2 mg/ml.

When applying prolonged peripheral nerve blocks, either through continuous infusion or repeated injections, the risks of achieving toxic plasma concentrations 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.

Children from 0 to 12 years of age

1. It is recommended to use the lower limit of the dose range for thoracic epidural blocks, while for lumbar or caudal epidural blocks, it is recommended to administer the upper limit of the dose.
2. Recommended for lumbar epidural block. It is appropriate to reduce the bolus dose for thoracic epidural analgesia.

Infants from 1 year and children up to 12 years:

The proposed doses of ropivacaine hydrochloride for peripheral block in infants and children provide guidelines for use in children without serious illness.Prior to administering the drug to children with serious illness, a more conservative dose and close monitoring are recommended.

Single injections for peripheral nerve block (e.g. ilioinguinal nerve block, brachial plexus block) should not exceed 2.5-3.0 mg/kg.

Continuous infusion for peripheral nerve block is recommended at 0.2-0.6 mg/kg/h (0.1-0.3 ml/kg/h) for up to 72 hours.

The use of ropivacaine hydrochloride in premature infants has not been documented.

Administration route

Epidural administration by injection.

Careful aspiration before and during injection is recommended 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 caudal epidural injection of 2 mg/ml ropivacaine hydrochloride produces adequate post-operative analgesia below T12 in most patients when a dose of 2 mg/kg is used in a volume of 1 ml/kg. The volume of the caudal epidural 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 concentration of ropivacaine hydrochloride have been studied in children over 4 years, but 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.

When recommending the infusion of ropivacaine hydrochloride, Ropsine injectable solution may be used.

Incompatibilities

There are no compatibility studies with other solutions, so this medicine should not be mixed with other medications.

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

Elimination

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