Ropimol

PATIENT INFORMATION LEAFLET: USER INFORMATION

Ropimol

2 mg/ml, solution for infusion

Ropivacaine hydrochloride

Read the leaflet carefully before using the medicine.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you need advice or more information.
• This medicine has been prescribed for you only. Do not give it to others, as it may harm them, even if their symptoms are the same.
• If any of the side effects get worse or if you notice any side effects not listed in this leaflet, tell your doctor.

Table of contents of the leaflet:

• 1. What is Ropimol and what is it used for
• 2. Important information before using Ropimol
• 3. How to use Ropimol
• 4. Possible side effects
• 5. How to store Ropimol
• 6. Other information

1. What is Ropimol and what is it used for

Ropimol is a local anesthetic.

Ropimol 2 mg/ml, solution for infusion:

It is used to treat acute pain in adults and children of all ages. It is used for anesthesia (anesthesia) of a part of the body, e.g. after surgery.

2. Important information before using Ropimol

When not to use Ropimol:

• if the patient is allergic (hypersensitive) to ropivacaine or any of the other ingredients of the medicine (see section 6),
• if the patient has had allergic reactions to other anesthetics in the past (including local anesthetics of the amide group),
• if the patient has decreased blood volume (hypovolemia),
• if the patient is taking another anesthetic by injection or infusion (drip) at the same time. Ropivacaine should not be used if any of the above warnings apply to the patient. If in doubt before using ropivacaine, consult a doctor.

When to be careful when using Ropimol

Consult a doctor before using the medicine:

• if the patient has heart disease or hardening of the arteries (vascular disease),
• if the patient has acute liver disease or kidney problems,
• if the patient is on a low-sodium diet,
• if the patient or a family member has porphyria - a rare blood pigment disease. Tell your doctor about this, as you may need to use a different anesthetic.

Children

• Newborns are more sensitive to Ropimol.
• In children up to 12 years of age, especially in infants under 1 year of age, the safety and efficacy of Ropimol have not been established for certain types of anesthesia. The use of ropivacaine in premature infants has not been documented.
• In children up to 12 years of age, the safety and efficacy of Ropimol 7.5 mg and 10 mg/ml in solution for injection have not been established. Ropimol 2 mg/ml and 5 mg/ml may be more suitable.

If the patient is not sure if the above warnings apply to them, consult a doctor before using the medicine.

Using the medicine with other medicines

Tell your doctor about all the medicines you have taken recently, including those that are available without a prescription.
In particular, inform your doctor if you are taking any of the following medicines:

• medicines used to treat heart rhythm disorders (anti-arrhythmic medicines),
• antidepressants (e.g. fluvoxamine),
• painkillers (opioids),
• antibiotics (e.g. enoxacine). If the patient is not sure if the above warnings apply to them, consult a doctor before using the medicine.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before using this medicine.

Driving and using machines

Consult a doctor before driving or using machines, as Ropimol may cause drowsiness and slow down reactions. Ask your doctor if you can drive or use tools and machines.

Important information about some ingredients of Ropimol

Ropimol contains 3 mg of sodium in 1 ml. This should be taken into account if the patient is controlling their sodium intake.

3. How to use Ropimol

Ropimol should always be used as directed by a doctor. The medicine is given by infusion (drip).

What dose of Ropimol will the patient receive:

• The doctor will decide what dose of the medicine the patient will receive.
• The dose depends on the purpose for which it is intended and other factors such as the patient's health, age, and weight.
• The smallest effective dose should be used.
• The usual dose of the medicine for adults and adolescents from 12 years of age is 2 mg to 300 mg of ropivacaine hydrochloride.
• The usual dose for newborns, infants, and children up to 12 years of age is 1 mg to 2 mg per kilogram of body weight.

Using a higher dose of Ropimol than recommended:

It is unlikely that the patient will receive too much medicine if it is administered by a doctor.
If the patient feels that the effect of the medicine is too strong, they should immediately consult a doctor.
Symptoms of overdose may include:

• paresthesia (tingling, stabbing, or numbness of the skin),
• involuntary movements,
• numbness around the mouth,
• vision or hearing disturbances,
• dizziness and a feeling of emptiness due to low blood pressure,
• muscle stiffness,
• irregular heartbeat. The patient should immediately contact a doctor if they notice any of the above symptoms. If the patient has any other questions about using this medicine, they should contact a doctor.

4. Possible side effects

Like all medicines, Ropimol can cause side effects, although not everybody gets them.
The following terminology has been used to describe the frequency of side effects.

• very common: symptoms occur in more than 1 in 10 patients,
• common: symptoms occur in 1 to 10 patients in 100,
• uncommon: symptoms occur in 1 to 10 patients in 1,000,
• rare: symptoms occur in 1 to 10 patients in 10,000,
• very rare: symptoms occur in less than 1 in 10,000 patients,
• unknown: frequency cannot be estimated from the available data.

The following side effects may occur:

If any of the following symptoms occur, the patient should immediately inform their doctor:

• allergic reactions, including anaphylactic shock - symptoms may include: swelling of the face, lips, mouth, or throat, dizziness or a feeling of emptiness in the head due to low blood pressure, feeling of loss of consciousness, rash, itching (rare),
• irregular heartbeat, which can lead to a heart attack (rare),
• fast or slow heartbeat (common).

The patient should contact their doctor immediately if they experience any of the above symptoms.

Very common

• low blood pressure,
• nausea.

Common

• paresthesia (tingling, stabbing, or numbness of the skin),
• difficulty urinating,
• high blood pressure,
• dizziness,
• headache,
• vomiting,
• back pain,
• high temperature and chills.

Uncommon

• drop in body temperature (hypothermia); symptoms include shivering and confusion,
• numbness or loss of sensation around the mouth and tongue,
• difficulty breathing or shallow breathing,
• vision and hearing disturbances,
• loss of skin sensation or sensitivity,
• stiffness or muscle cramps,
• feeling of emptiness in the head,
• difficulty speaking,
• feeling of anxiety (restlessness),
• seizures (convulsions),
• loss of consciousness.

Children

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

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309.
Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ropimol

• Keep out of the sight and reach of children.
• Do not use Ropimol after the expiry date stated on the label and carton. The expiry date refers to the last day of the month.
• Do not store above 25°C. Do not store in the refrigerator or freeze.
• Do not use Ropimol if there are any visible impurities in the solution or if the solution is not clear.
• For microbiological reasons, the medicine should be used immediately after opening. If it is not used immediately, the user is responsible for the storage conditions and duration of storage after first opening, prior to administration. The storage duration should not exceed 24 hours at a temperature of 2°C - 8°C.

6. Other information

What Ropimol contains

The active substance of the medicine is ropivacaine hydrochloride.

• 2 mg/ml solution for infusion: each milliliter of solution contains 2 mg of ropivacaine hydrochloride. 200 mg or 400 mg of ropivacaine hydrochloride, respectively, in 100 ml or 200 ml of solution, in a bag. The other ingredients of the medicine are: sodium chloride, hydrochloric acid 1N, sodium hydroxide 1N, and water for injections.

What Ropimol looks like and what the pack contains

Solution for infusion.
Ropimol is a clear, colorless solution for infusion.
The medicine is available in the following packs:

• 2 mg/ml solution for infusion in transparent polypropylene bags of 100 ml or 250 ml, 5 bags in a pack.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

• L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67, Frazione Granatieri 50018 Scandicci (FI), Italy

Date of last revision of the leaflet:09/2023
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy
Ropivacaine Molteni
Poland
Ropimol
Netherlands
Ropivacaine Hydrochloride Molteni