Ropivacaine Altan 10 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ropivacaine Altan 10 mg/ml solution for injection EFG

ropivacaine hydrochloride

Read the entire 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Ropivacaine Altan is and what it is used for
2. What you need to know before using Ropivacaine Altan
3. How to use Ropivacaine Altan
4. Possible side effects
5. How to store Ropivacaine Altan
6. Contents of the pack and other information

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

Ropivacaine Altan contains ropivacaine hydrochloride, which belongs to a group of medicines called amide-type local anesthetics.

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

• Numbing parts of the body during surgery.
• Relieving pain during childbirth, after surgery, or following an injury.

2. What you need to know before using Ropivacaine Altan

Do not use Ropivacaine Altan

• If you are allergic to ropivacaine, to other amide-type local anesthetics (such as lidocaine or bupivacaine), or to any of the other ingredients of this medicine (listed in section 6).
• For intravenous regional anesthesia (injection into a blood vessel to numb a specific area of your body) or obstetric paracervical anesthesia (injection into the cervix to relieve pain during childbirth).
• If you have reduced blood volume (hypovolemia), as you may develop low blood pressure.

If you are unsure whether any of the above apply to you, consult your doctor before being administered Ropivacaine Altan.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Ropivacaine Altan:

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

• If you or a family member has ever been diagnosed with a rare blood pigment disorder called "porphyria." Your doctor may need to administer a different anesthetic.

• About any medical conditions or health problems you may have.

Children and adolescents

The use of Ropivacaine Altan has not been studied in premature infants.

Use extra caution with Ropivacaine Altan:

• In children up to and including 12 years of age, as certain types of injections to numb body parts have not been established in young children. Other concentrations (2 mg/ml) might be more appropriate.

Use of Ropivacaine Altan with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription and herbal remedies. This is because Ropivacaine Altan may affect how some medicines work, and some medicines may affect Ropivacaine Altan.

In particular, inform your doctor if you are taking any of the following medicines:

• Other local anesthetics
• Strong painkillers such as morphine or codeine
• Medicines used to treat irregular heartbeat (arrhythmia), such as lidocaine and mexiletine

Your doctor needs to know if you are taking these medicines in order to calculate the correct dose of Ropivacaine Altan.

Also inform your doctor if you are taking any of the following medicines:

• Medicines used to treat depression (e.g., fluvoxamine)
• Antibiotics used to treat bacterial infections (e.g., enoxacin)

This is because your body takes longer to eliminate ropivacaine if you are taking these medicines. If you are taking any of these medicines, prolonged use of Ropivacaine Altan should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor, pharmacist, or nurse before being administered this medicine.

Ropivacaine Altan should not be used during pregnancy or breastfeeding unless clearly necessary, as determined by your doctor.

It is unknown whether ropivacaine hydrochloride affects pregnancy or passes into breast milk.

Driving and using machines

Ropivacaine Altan may cause drowsiness and affect your reaction speed. Do not drive or operate tools or machinery after receiving Ropivacaine Altan until the following day.

Ropivacaine Altan contains sodium

This medicine contains 3.03 mg of sodium (main component of table/cooking salt) per ml. This corresponds to 0.15% of the maximum daily recommended sodium intake for an adult.

3. How to use Ropivacaine Altan

Method of administration

Ropivacaine Altan must be administered by a physician or, occasionally, by a nurse under the supervision of a physician.

Dosage

The dose your doctor administers will depend on the type of pain relief you require. It will also depend on your physical build, age, and general health condition.

Ropivacaine Altan will be given to you as an injection. The part of the body where it will be administered depends on the reason for which Ropivacaine Altan is being given. Your doctor will administer Ropivacaine 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 distant from the part of the body that needs to be numbed. This is the case when you receive an epidural injection or infusion (into the area surrounding the spinal cord).

When Ropivacaine Altan is administered in one of these ways, it prevents nerves from transmitting pain signals to the brain. You will no longer feel pain, heat, or cold in the treated area, but you may still perceive other sensations such as pressure or touch.

Your doctor will decide the most appropriate method for administering this medicine.

If you are given more Ropivacaine Altan than you should

Serious side effects resulting from receiving too much Ropivacaine Altan require special treatment, and your doctor is trained to manage such situations. The first signs that too much Ropivacaine Altan has been administered are usually:

• Dizziness or lightheadedness.
• Numbness of the lips and around the mouth.
• Numbness of the tongue.
• Hearing problems.
• Vision problems.

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

More severe adverse effects from receiving excessive amounts of Ropivacaine Altan include speech difficulties, muscle spasms, tremors, convulsions, seizures, and loss of consciousness.

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

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Important adverse effects to be aware of:

Sudden and potentially life-threatening allergic reactions (e.g. anaphylaxis, including anaphylactic shock) are rare and affect between 1 and 10 people in 10,000.

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 fainting. If you think Ropivacaine Altan is causing you an allergic reaction, inform your doctor immediately.

Other possible adverse effects:

Other possible side effects include:

• Numbness, due to nerve irritation caused by the needle or injection. This is usually not long-lasting.
• Involuntary muscle movements (dyskinesia).

Possible adverse reactions observed with other local anaesthetics that could also be caused by Ropivacaine Altan include:

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

Children

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

Reporting of adverse reactions

If you experience any adverse reaction, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Ropivacaine Altan

Keep out of the sight and reach of children.

Do not freeze.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. The disposal of unused medicine and of all materials that have been in contact with it must be carried out in accordance with local regulations.

6. Contents of the pack and other information

Composition of Ropivacaine Altan

• The active substance is ropivacaine hydrochloride. Each 10-mL vial 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 injections.

Appearance of the medicinal product and contents of the pack

Ropivacaine Altan is presented as a clear, colourless injectable solution. Each pack contains 5 vials of 10 mL.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Altan Pharmaceuticals S.A.

C/ Cólquide 6, Portal 2, 1st Floor, Office F, Edificio Prisma

28231 Las Rozas (Madrid), Spain

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, Polígono Industrial Monte Boyal,

Casarrubios del Monte, 45950 Toledo, Spain

Date of the most recent review of this leaflet: 06/2024

This information is intended for healthcare professionals only:

Ropivacaine Altan is used in several ways:

• Injection of the solution into the tissue where surgery will be performed.
• Injection around a nerve or group of nerves leading to the part of the body where surgery will be performed; for example, an injection in the armpit before forearm or hand surgery.
• Injection in the lower region of the spine when anesthesia of the legs or lower parts of the body is required.

Dosage

Adults and adolescents over 12 years of age:

The table below provides recommendations on the most commonly used dose for different types of block. The smallest dose required to achieve effective block should be used. Clinical experience and knowledge of the patient's clinical condition are important factors in determining the dose.

Generally, anesthesia for surgery (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 the treatment of acute pain), lower concentrations and doses are recommended.

Route of administration

Epidural and perineural administration.

Careful aspiration is recommended before and during injection 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 advised. Accidental intravascular injection may be recognized by a transient increase in heart rate, and accidental subarachnoid injection by signs of spinal block with apnea or hypotension.

Aspiration must 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 continuously monitoring the patient's vital functions and maintaining verbal contact. If toxic symptoms occur, administration of the drug must be immediately discontinued.

Single doses of up to 250 mg of ropivacaine have been used in epidural blockade for surgery and were well tolerated.

Concentrations exceeding 7.5 mg/ml of Ropivacaína Altan have not been studied in cesarean section procedures.

Pediatric patients from 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 in this population.

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

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Ropivacaína Altan contains no preservatives and is intended for single use only. Any unused solution must be discarded.

The solution should be inspected visually before use; do not use unless the solution is clear, colorless, and the container is intact.

An intact container must not be re-sterilized in an autoclave.

Other presentations:

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

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

Ropivacaína Altan 2 mg/ml solution for infusion: 100 ml bags coated with a removable overwrap

Ropivacaína Altan 2 mg/ml solution for infusion: 200 ml bags coated with a removable overwrap

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.