Ropivacaine hydrochloride Altan

Patient Information Leaflet

Ropivacaine Hydrochloride Altan 7.5 mg/ml Solution for Injection

ropivacaine hydrochloride
Generic medicine
Please read all of this leaflet carefully before you use this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Ropivacaine Hydrochloride Altan contains ropivacaine hydrochloride, which belongs to a group of medicines called amide-type local anaesthetics.
Ropivacaine Hydrochloride Altan is used in adults and children over 12 years of age to numb (anaesthetize) parts of the body. It is used to block pain or to provide relief from pain. It can be used for:
anaesthetizing parts of the body during surgical procedures, including childbirth or caesarean section;
providing pain relief during childbirth, after surgery, or following an injury.

2. What you need to know before using Ropivacaine Hydrochloride Altan

Do not use Ropivacaine Hydrochloride Altan
if you are allergic to ropivacaine, to other local anaesthetics of the amide type (such as lidocaine or
bupivacaine), or to any of the other ingredients of this medicine (listed in section 6).
In case of intravenous regional anaesthesia (injection into a blood vessel to anaesthetize a specific
area of your body), or paracervical obstetric anaesthesia (injection into the cervix to relieve pain
during childbirth).
If you have been diagnosed with reduced blood volume (hypovolemia), as you may develop low
blood pressure.
If you are unsure whether any of the above conditions apply to you, consult your doctor before
receiving Ropivacaine Hydrochloride Altan.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Ropivacaine Hydrochloride Altan:

• if you have heart, liver, or kidney problems. Your doctor may need to adjust the dose of Ropivacaine.
• if you or any member of your family has ever been diagnosed with a rare blood pigment disorder called "porphyria". Your doctor may need to administer a different anaesthetic medicine.
• about any medical conditions or diseases you currently have.

Children and adolescents
The use of Ropivacaine Hydrochloride Altan has not been studied in premature newborns.
Special caution is required with Ropivacaine Hydrochloride Altan:
in children aged 12 years and younger, as certain injections may numb parts of the body and therefore should not be administered to younger children. Other concentrations (2 mg/ml) may be more appropriate.
Other medicines and Ropivacaine Hydrochloride Altan
Inform your doctor if you are taking, have recently taken, or might take any other medicines. This includes over-the-counter medicines and herbal remedies. This is because Ropivacaine Hydrochloride Altan may affect how some medicines work, and some medicines may affect Ropivacaine Hydrochloride Altan.
In particular, inform your doctor if you are taking any of the following medicines:
other local anaesthetics
strong painkillers, such as morphine or codeine.
Medicines used to treat irregular heartbeat (arrhythmia), such as lidocaine and
mexiletine.
Your doctor needs to know about these medicines in order to determine the correct dose of
Ropivacaine Hydrochloride Altan for you.
Also inform your doctor if you are taking any of the following medicines:
Medicines for depression (such as fluvoxamine)
Antibiotics used to treat bacterial infections (such as enoxacin).
This is because your body takes longer to eliminate Ropivacaine Hydrochloride Altan if you are
taking these medicines. If you are taking any of these medicines, prolonged use of Ropivacaine
Hydrochloride Altan should be avoided.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your
doctor, pharmacist, or nurse before receiving this medicine.
Ropivacaine Hydrochloride Altan must not be used during pregnancy or breastfeeding unless clearly
necessary, as determined by your doctor.
It is not known whether ropivacaine hydrochloride affects pregnancy or passes into breast milk.
Driving and using machines
Ropivacaine Hydrochloride Altan may cause drowsiness and affect reaction speed. After receiving
Ropivacaine Hydrochloride Altan, you must not drive or operate tools or machinery until the next day.
Ropivacaine Hydrochloride Altan contains sodium
This medicine contains 3.15 mg of sodium (a main component of table salt) per ml. This corresponds to 0.16% of the maximum daily recommended dietary intake of sodium for an adult.

3. How to use Ropivacaine hydrochloride Altan

Method of administration
Ropivacaine hydrochloride Altan will be administered to you by a doctor or, occasionally, by a nurse under medical supervision.
Dosage
The dose your doctor administers will depend on the type of pain relief you require.
It will also depend on your body size, age, and physical condition.
Ropivacaine hydrochloride Altan will be administered as an injection. The site of administration will depend on the reason for which Ropivacaine hydrochloride Altan is being given.
Your doctor will administer Ropivacaine hydrochloride Altan at one of the following sites:

• The part of the body that needs to be anesthetized.
• The area near the part of the body that needs to be anesthetized.
• An area distant from the part of the body that needs to be anesthetized. This occurs when an epidural or infusion administration (into an area around the spinal cord) is performed.
  When Ropivacaine hydrochloride Altan is used in one of the ways described above, it prevents nerves from transmitting pain signals to the brain. You will not feel pain, heat, or cold sensations, but you may still perceive other sensations such as pressure or touch.
  Your doctor will know the correct method of administering this medicine.
  If you receive more Ropivacaine hydrochloride Altan than you should
  Serious adverse effects resulting from an overdose of Ropivacaine hydrochloride Altan require special treatment, and your doctor is able to manage these situations. The first signs of an overdose of Ropivacaine hydrochloride Altan are usually the following:
• Dizziness or mental confusion.
• Numbness of the lips and around the mouth.
• Numbness of the tongue.
• Hearing problems.
• Vision problems (visual disturbances).
  To reduce the risk of serious adverse effects, your doctor will stop administering Ropivacaine hydrochloride Altan as soon as any of these signs appear. This means that if any of the above situations occur, or if you think you have received too much Ropivacaine hydrochloride Altan, you must inform your doctor immediately.
  The most serious adverse effects from an overdose of Ropivacaine hydrochloride Altan include speech difficulties, muscle spasms, tremulousness, tremor, epileptic seizures (fits), and loss of consciousness.
  If any of these symptoms occur or if you think you have received too much Ropivacaine hydrochloride Altan, inform your doctor or healthcare personnel immediately.
  In case of acute toxicity, healthcare personnel will immediately take appropriate corrective measures.
  If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important side effects to be aware of:
Sudden, life-threatening allergic reactions (such as anaphylaxis, including anaphylactic shock) are rare, affecting between 1 and 10 patients in 10,000. Possible symptoms include sudden onset of rash, 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; feeling of fainting. If you think Ropivacaine hydrochloride Altan is causing an allergic reaction, inform your doctor immediately.
Other possible side effects:
Very common • Low blood pressure (hypotension). This may cause dizziness or
(more than 1 mental confusion.
patient in 10) • Feeling unwell (nausea).
Common: • Headache.
(affects from 1 to 10 • Tingling or abnormal sensation (paraesthesia).
patients in 100) • Feeling dizzy.

• Slow or fast heartbeat (bradycardia, tachycardia).
• High blood pressure (hypertension).
• Nausea (vomiting).
• Difficulty urinating (urinary retention).
• High temperature (fever) or tremors (chills).
• Back pain.

Uncommon • Anxiety.
(affects from 1 to 10 • Some symptoms may occur if the injection was accidentally administered
patients in 1,000) into a blood vessel or if an excessive dose of Ropivacaine hydrochloride
Altan was given (see also section 3 ‘If you receive more Ropivacaine
hydrochloride Altan than you should’, above). These include epileptic
seizures (convulsions), dizziness or mental confusion, numbness of the
lips and around the mouth, numbness of the tongue, hearing problems,
vision problems, speech problems, muscle stiffness and tremor).

• Reduced sense of touch (hypoesthesia).
• Fainting (syncope).
• Difficulty breathing (dyspnoea).
• Low body temperature (hypothermia).

Rare • Heart attack.
(affects from 1 to 10 • Irregular heartbeat (arrhythmia).
patients in 10,000)
Not known • Horner’s syndrome
(frequency cannot be (the frequency cannot be determined from the available data)
defined from the data
available)
Other possible side effects include:
Numbness due to nerve irritation caused by the needle or the injection. This usually does not last long.
Involuntary muscle movements (dyskinesia).
Possible side effects observed with other local anaesthetics, which could also be caused by
Ropivacaine hydrochloride Altan include:
Nerve damage. Rarely (affects from 1 to 10 patients in 10,000), this may cause permanent problems.
If an excessive dose of Ropivacaine hydrochloride Altan is administered into the spinal fluid, the entire body may become numb (anaesthetised).
Receiving an epidural injection (an injection into the space around the spinal nerves) may interrupt the nerve pathway 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 characterised by reduced pupil size,
Children
In children, side effects are the same as in adults, except that low blood pressure occurs less frequently in children (affects from 1 to 10 children in 100) and feeling unwell occurs more frequently in children (affects more than 1 child in 10).
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ropivacaine Hydrochloride Altan

Keep this medicine out of sight and reach of children.
Do not freeze.
Do not use this medicine after the expiry date stated on the carton or label,
after EXP. The expiry date refers to the last day of that month.
From a microbiological standpoint, the product should be used immediately unless the method of opening prevents the risk of microbial contamination. If not used immediately, the conditions and duration of storage are the responsibility of the user.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ropivacaine Hydrochloride Altan contains

• The active substance is ropivacaine hydrochloride. Each 10 ml vial contains 75 mg of ropivacaine hydrochloride.
• The excipients are: sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

Description of the appearance of Ropivacaine Hydrochloride Altan and package contents
Ropivacaine Hydrochloride Altan is a clear, colourless injectable solution.
Each pack contains 5 vials of 10 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Altan Pharmaceuticals S.A.
C/ Cólquide Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma
Las Rozas, 28230 Madrid, Spain

Manufacturer
Altan Pharmaceuticals S.A.
Polígono 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

The following information is intended exclusively for physicians or healthcare professionals

Ropivacaine Hydrochloride Altan is used in different ways:

• Injection of the solution into the tissue where surgery is to be performed.
• Injection around a nerve or group of nerves leading to the part of the body where surgery will be performed, e.g., injection under the armpits before surgery on the hand or forearm.
• Injection into the lower part 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 following table provides guidance on recommended dosages for the most common types of block. The dose used should be the lowest required to achieve effective block. The administered dose should be selected based on the physician's experience and knowledge of the patient's clinical condition.

| Conc. | Volume | Dose | Onset | Duration | |-----------|------------|----------|-----------|--------------| | mg/ml | ml | mg | minutes | hours |

SURGICAL ANESTHESIA
Lumbar epidural administration
Surgical procedure 7.5 15–25 113–188 10–20 3–5
Caesarean section 7.5 15–20 113–150 10–20 3–5

Thoracic epidural administration
For establishing a block for postoperative pain relief (dependent on the level of injection) 7.5 5–15 38–113 10–20 n/a

Major nerve block *
Brachial plexus block 7.5 30–40 225–300 10–25 6–10

Surgical field block (e.g., minor nerve blocks and infiltration) 7.5 1–30 7.5–225 1–15 2–6

The doses listed in the table are those considered necessary to produce an adequate block and should be regarded as a guide for use in adults. Individual variations in onset time and duration may occur. The "Dose" column lists the average dose ranges required. Reference texts should be consulted regarding factors influencing specific block techniques and individual patient requirements.

* Regarding major nerve blocks, recommendations can only be made for brachial plexus block. Lower doses may be needed for other major nerve blocks. However, there is currently no experience regarding specific dose recommendations for other blocks.

(1) Incremental dosing should be applied; the initial dose of approximately 100 mg (97.5 mg = 13 ml; 105 mg = 14 ml) should be administered over 3–5 minutes. If necessary, two additional doses totaling up to 50 mg may be given.
(2) n/a = not applicable.
(3) The dose for a major nerve block must be adjusted according to the site of administration and the patient's condition. Interscalene and supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used (see section “Warnings and precautions”).

In general, surgical anesthesia (e.g., epidural administration) requires higher concentrations and dosages. The 10 mg/ml formulation is recommended for epidural anesthesia when complete motor block is essential for surgery. For analgesia (e.g., epidural administration for acute pain treatment), lower concentrations and dosages are recommended.

Route of administration
Perineural and epidural use.

To avoid intravascular injection, careful aspiration before and during injection is recommended. When a large dose is to be administered, a test dose of 3–5 ml of lidocaine with adrenaline (epinephrine) is recommended. Accidental intravascular injection may be recognized by a transient increase in heart rate, while accidental intrathecal injection may be identified by signs of spinal block.

Aspiration must be performed before and during administration of the main dose, which should be injected slowly or in fractions at a rate of 25–50 mg/minute, with close monitoring of vital signs and maintenance of verbal contact. If symptoms of toxicity occur, administration must be immediately discontinued.

In surgical epidural block, single doses up to 250 mg of ropivacaine have been used and 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 performing prolonged blocks, either by continuous infusion or repeated bolus administration, the potential risk of achieving toxic plasma concentrations or inducing local neurotoxicity must be considered. Cumulative doses up to 675 mg of ropivacaine administered over 24 hours for surgical anesthesia and postoperative analgesia have been well tolerated in adults, as have continuous postoperative epidural infusions at rates up to 28 mg/hour for 72 hours. In a limited number of patients, higher doses up to 800 mg/day have been administered with a relatively low incidence of adverse reactions.

For postoperative pain management, the following technique may be recommended: unless already established preoperatively, an epidural block is induced via an epidural catheter using a 7.5 mg/ml concentration. Analgesia is maintained with infusion of Ropivacaine Hydrochloride Altan 2 mg/ml.

Infusion rates of 6–14 ml (12–28 mg) per hour provide adequate analgesia with mild and non-progressive motor block in most cases of moderate to severe postoperative pain. The maximum duration of epidural block is 3 days. However, careful monitoring of analgesic effect is required, and the catheter should be removed as soon as pain conditions allow. With this technique, a significant reduction in opioid requirements has been observed.

When performing prolonged peripheral nerve blocks, either by continuous infusion or repeated injections, risks of achieving toxic plasma concentrations or causing local neural damage must be considered. In clinical studies, femoral nerve block was established with 300 mg of ropivacaine 7.5 mg/ml and interscalene block with 225 mg of ropivacaine 7.5 mg/ml, respectively, before surgery. Analgesia was maintained with ropivacaine 2 mg/ml. Infusion rates and intermittent injections of 10–20 mg per hour for 48 hours provided adequate analgesia and were well tolerated.

Concentrations higher than 7.5 mg/ml of ropivacaine have not been documented for caesarean section.

Pediatric patients from 0 to 12 years inclusive
The use of ropivacaine 7.5 and 10 mg/ml may be associated with systemic and central toxic events in children. Lower dosages (2 mg/ml) are more appropriate for administration in this population.

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

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

Ropivacaine Hydrochloride Altan is preservative-free and for single use only. Any residual solution must be discarded.

Before administration, the solution should be visually inspected: do not use unless the solution is clear, colorless, and the container is undamaged.

The intact primary container must not be resterilized.

Other pack sizes:
Ropivacaine Hydrochloride Altan 2 mg/ml injectable solution: 10 ml vials
Ropivacaine Hydrochloride Altan 10 mg/ml injectable solution: 10 ml vials
Ropivacaine Hydrochloride Altan Pharma 2 mg/ml infusion solution: 100 ml bags covered by a removable overwrap
Ropivacaine Hydrochloride Altan Pharma 2 mg/ml infusion solution: 200 ml bags covered by a removable overwrap