Leaflet: Information for the User

Ropivacaína Altan 10 mg/ml Injectable Solution EFG

ropivacaína, hydrochloride

Read this leaflet carefully before you start using 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, pharmacist or nurse.

- 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, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Ropivacaína Altan and what it is used for

2. What you need to know before using Ropivacaína Altan

3. How to use Ropivacaína Altan

4. Possible side effects

5. Storage of Ropivacaína Altan

6. Contents of the pack and additional information

RopivacaínaAltancontains hydrochloride ropivacaína which belongs to a group of medications called amide local anesthetics.

Ropivacaína Altan is indicated in adults and children over 12 years old to anesthetize (insensitize) specific parts of the body. It is used to stop pain or provide pain relief. It can be used for:

• To anesthetize parts of the body during surgery.
• To relieve pain during childbirth, after surgery, or after an accident.

No use Ropivacaína Altan

- If you are allergic to ropivacaine, other local anesthetic amides (such as lidocaine or bupivacaine) or any of the other components of this medication (listed in section 6).

- In case of regional intravenous anesthesia (injection into a blood vessel to numb a specific area of your body) or paracervical obstetric anesthesia (injection into the cervix to relieve pain during childbirth).

- If you have a decreased blood volume (hypovolemia) as you may develop a decrease in blood pressure.

If you are unsure if any of the above applies to you, consult your doctor before Ropivacaína Altan is administered to you.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Ropivacaína Altan:

• if you have heart, liver or kidney problems. Your doctor may need to adjust the dose of Ropivacaína Altan.

• if you have ever been told that you or a family member has a rare blood pigment disorder called "porphyria". Your doctor may need to administer a different anesthetic medication.

• about any medical condition or problem you have.

Children and adolescents

Ropivacaína Altan has not been studied in premature children.

Be especially careful with Ropivacaína Altan:

• in children up to 12 years inclusive, as some injections to numb body parts are not established in young children.Other concentrations (2 mg/ml) may be more suitable.

Use of Ropivacaína Altan with other medications

Inform your doctor if you are using, have used recently or may need to use any other medication, including those purchased without a prescription and herbal medicines.This is because Ropivacaína Altan may affect how some medications work and some medications may have an effect on Ropivacaína Altan.

Inform your doctor in particular if you are taking any of the following medications:

• Other local anesthetics
• Strong pain medications, such as morphine or codeine.
• Medications used to treat irregular heartbeat (arrhythmia), such as lidocaine and mexiletine.

Your doctor needs to know if you are using these medications to calculate the correct dose of Ropivacaína Altan.

Inform your doctor also if you are taking any of the following medications:

-Medications used to treat depression (such as fluvoxamine)

-Antibiotics used to treat bacterial infections (such as enoxacina).

This is because your body takes longer to eliminate Ropivacaína Altan if you are taking these medications. If you are taking any of these medications, avoid prolonged use of Ropivacaína Altan.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor, pharmacist or nurse before this medication is administered to you.

Ropivacaína Altan should not be used during pregnancy and breastfeeding unless your doctor deems it clearly necessary.

The effect of hydrochloride ropivacaine on pregnancy or passage into breast milk is unknown.

Driving and operating machinery

Ropivacaína Altan may cause drowsiness and affect your reaction speed. Do not drive or use tools or machinery after Ropivacaína Altan is administered to you until the next day.

Ropivacaína Altan contains sodium

This medication contains 3.03 mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 0.15% of the recommended daily maximum sodium intake for an adult.

Administration Method

Ropivacaína Altan should be administered by a doctor or, occasionally, by a nurse under the supervision of a doctor.

Dose

The dose administered by your doctor will depend on the type of pain relief you need. It will also depend on your build, age, and physical condition.

Ropivacaína Altan will be administered to you in the form of an injection. The part of the body used will depend on the reason for administering Ropivacaína Altan. Your doctor will administer Ropivacaína Altan 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 an area away from the part of the body that needs to be numbed. This is the case if you are administered an epidural or infusion injection (in an area around the spinal cord).

When Ropivacaína Altan is administered in this way, it prevents nerves from 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.

Your doctor will decide the best way to administer this medication.

If you are administered more Ropivacaína Altan than you should

Severe side effects resulting from receiving too much Ropivacaína Altan require special treatment, and your doctor is trained to act in these situations. The first signs of having received too much Ropivacaína Altan are usually:

• Dizziness or vertigo.
• Numbness of the lips and around the mouth.
• Numbness of the tongue.
• Problems with hearing.
• Problems with vision.

Your doctor will stop administering Ropivacaína Altan as soon as these signs appear to reduce the risk of severe adverse effects. If you experience any of these symptoms, or think you have received too much Ropivacaína Altan,inform your doctor immediately

More severe side effects resulting from receiving too much Ropivacaína Altan include problems with speech, muscle spasms, tremors, seizures, attacks, and loss of consciousness.

If you experience any of these symptoms or think you may have received too much Ropivacaína Altan, inform your doctor or healthcare staff immediately.In case of overdose or accidental ingestion, contact the Toxicological Information Service at Teléfono 91 562 04 20.

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

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

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

Important side effects to be aware of:

Sudden and potentially life-threatening allergic reactions (such as anaphylaxis, including anaphylactic shock) are rare and affect 1 to 10 people out of every 10,000.

The possible symptoms include: sudden onset of 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 think Ropivacaina Altan is causing an allergic reaction, inform your doctor immediately.

Other possible side effects:

Other possible side effects include:

• Numbness, due to nerve irritation caused by the needle or injection. This usually does not last long.
• Uncontrolled muscle movements (dyskinesia).

Side effects observed with other local anesthetics that may also be produced by Ropivacaina Altan include:

• Nerve damage. Rarely (affects 1 to 10 users in 10,000), it may cause permanent problems.
• If too much Ropivacaina Altan is administered into the spinal fluid, it may numb the entire body (anesthetized).
• Receiving an epidural injection (injection into the space surrounding the spinal nerves) may cause a disruption of a nerve pathway from the brain to the head and neck, especially in pregnant women, which may sometimes lead to a condition called Horner's syndrome. It is characterized by a decrease in pupil size, drooping of the upper eyelid, and inability of sweat glands to produce sweat. It will resolve on its own when treatment is stopped.

Children

In children, side effects are the same as in adults except for low blood pressure, which occurs less frequently in children (affects 1 to 10 children in 100) and feeling unwell occurs more frequently in children (affects more than 1 child in 10).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 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 out of sight and reach of children.

Do not freeze.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

From a microbiological standpoint, unless the opening method excludes the risk of microbiological contamination, the product must be used immediately. If not used immediately, storage times for use and conditions are the responsibility of the user.

Medicines should not be disposed of through drains or in the trash. The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Ropivacaine Altan Composition

- The active ingredient is ropivacaine hydrochloride. Each 10 ml ampoule contains 100 mg of ropivacaine hydrochloride.

- The other components (excipients) are: sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injection preparations.

Product Appearance and Packaging Contents

Ropivacaine Altan is presented as a transparent and colorless injectable solution. Each package contains 5 ampoules of 10 ml.

Not all package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Altan Pharmaceuticals S.A.

C/ Cólquide 6, Portal 2, 1st Floor

Edificio Prisma.

28230 Las Rozas (Madrid) - Spain

Responsible Manufacturer

Altan Pharmaceuticals S.A.

Poligono Industrial de Bernedo s/n

01118 Bernedo (Álava), Spain

Or

Altan Pharmaceuticals, S.A.

Avda. de la Constitución, 198- 199, Industrial Park Monte Boyal,

Casarrubios del Monte, 45950 Toledo, Spain

Last Review Date of this Leaflet: 06/2024

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This information is intended solely for healthcare professionals:

Ropivacaine Altan is used in several ways:

- injection of the solution into the tissue where the surgery will be performed.

- injection around a nerve or group of nerves that conduct to the area of the body where the surgery will be performed; for example, an injection in the armpit before surgery on the forearm or hand.

- injection in the lower part of the spine when it is necessary to anesthetize the legs or lower parts of the body.

Dosage

Adults and adolescents over 12 years of age:

The table below shows some recommendations for the most commonly used dose in different types of blockage. The smallest dose required to produce an effective block should be used. 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 10 mg/ml formulation is recommended. For analgesia (e.g. epidural administration in acute pain treatment), lower concentrations and doses are recommended.

Administration Form

Epidural and perineural administration.

Before and during injection, careful aspiration is recommended to prevent intravascular injection. When a higher dose is to be injected, a test dose of 3-5 ml of lidocaine (lignocaine) with adrenaline (epinephrine) is recommended. Accidental intravascular injection may be recognized by a temporary increase in heart rate, and accidental subarachnoid injection by signs of spinal block with apnea or hypotension.

Aspiration is required before and during administration of the main dose, which will be injected slowly or in increasing 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.

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

Concentrations above 7.5 mg/ml of Ropivacaine Altan have not been studied in cesarean section interventions.

Pediatric patients 0 to 12 years of age inclusive

The use of Ropivacaine 7.5 and 10 mg/ml may be associated with systemic and central toxic events in children. Lower concentrations (2 mg/ml) are more appropriate for administration to this population.

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

Incompatibilities

In the absence of compatibility studies, this medication should not be mixed with others.

Ropivacaine Altan does not contain preservatives and is intended onlyfor a single use. Discard any unused solution.

The solution should be visually inspected before use, and not used unless the solution is transparent and colorless and the package is intact.

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

Other presentations:

Ropivacaine Altan 2 mg/ml injectable solution: 10 ml ampoules

Ropivacaine Altan 7.5 mg/ml injectable solution: 10 ml ampoules

Ropivacaine Altan 2 mg/ml infusion solution: 100 ml bags with a removable overwrap

Ropivacaine Altan 2 mg/ml infusion solution: 200 ml bags with a removable overwrap

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.