Ropimol

Leaflet attached to the packaging: information for the user

Ropimol

5 mg/ml, solution for injection

Ropivacaine hydrochloride

You should read all of the leaflet before using the medicine.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please 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. Contents of the pack and other information

1. What is Ropimol and what is it used for

Ropimol is a local anesthetic, administered epidurally (under the outer membrane covering the spinal cord).

• It is used in adults for: anesthesia (anesthesia) of a part of the body during surgical procedures. It is injected into the lower parts of the patient's spine. It helps to quickly stop pain from the patient's waist down for a limited time (usually from 1 to 2 hours). The medicine may be used in adults and adolescents over 12 years of age.
• It is used in children from 1 to 12 years of age for anesthesia (anesthesia) of a part of the body. It is used to stop or alleviate pain.

2. Important information before using Ropimol

When not to use Ropimol:

Warnings and precautions for Ropimol

• Particular caution should be exercised in children, as the safety and efficacy of epidural administration have not been established in them.

You should consult a doctor before using the medicine if:

• you have heart disease or hardening of the arteries (vascular disease),
• you have acute liver disease or kidney problems,
• you are on a low-sodium diet,
• you or a family member has a rare blood disorder - porphyria. If so, you should tell your doctor, as you may need to use a different anesthetic. If you are not sure if the above warnings apply to you, you should consult your doctor before using the medicine.

Other medicines and Ropimol

You should tell your doctor about all the medicines you are taking now or have taken recently, including those that are available without a prescription.
In particular, you should inform your doctor if you are taking the following medicines:

• medicines used for heart rhythm disorders (anti-arrhythmic medicines),
• antidepressant medicines (e.g. fluvoxamine),
• pain-relieving medicines (opioids),
• antibiotics (e.g. enoxacine). If you are not sure if the above warnings apply to you, you should consult your doctor before using the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to become pregnant, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

You should consult your doctor before driving, using tools, or operating machinery, as Ropimol may cause drowsiness and slowed reactions. You should ask your doctor if you can drive, use tools, or operate machinery.

Important information about some of the ingredients of Ropimol

Ropimol contains sodium. The medicine contains 3 mg of sodium per 1 ml. You should take this into account if you are controlling your sodium intake.

3. How to use Ropimol

Ropimol is administered by injection. The procedure is performed by a doctor.

What dose of Ropimol will you receive

• Your doctor will decide what dose of the medicine you will receive.
• The dose depends on the purpose of using the medicine and factors such as the patient's health, age, and weight.
• You should use the smallest effective dose.
• The usual dose of the medicine for adults and adolescents over 12 years of age is from 15 mg to 25 mg.

Using a higher dose of Ropimol than recommended

It is unlikely that you will receive too much medicine if it is administered by a doctor.
If you feel that the effect of the medicine is too strong, you should contact your doctor immediately.
Symptoms of overdose may include:

• paresthesia (tingling, stinging, or numbness of the skin),
• sudden involuntary movements,
• numbness around the mouth,
• vision or hearing disturbances,
• dizziness and a feeling of emptiness in the head due to low blood pressure,
• muscle stiffness,
• irregular heartbeat. You should contact your doctor immediately if you notice any of the above symptoms. If you have any further doubts about using this medicine, you should consult your 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: side effects occur in more than 1 in 10 people,
• common: side effects occur in 1 to 10 people in 100,
• uncommon: side effects occur in 1 to 10 people in 1,000,
• rare: side effects occur in 1 to 10 people in 10,000,
• very rare: side effects occur in less than 1 in 10,000 people,
• not known: frequency cannot be estimated from the available data. The following side effects may occur:

If you experience any of the following symptoms, you should contact your doctor immediately:

• 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 (occurring rarely),
• irregular heartbeat, which may lead to a heart attack (occurring rarely),
• fast or slow heartbeat (occurring commonly). You should contact your doctor immediately if you experience any of the above symptoms.

Very common

• low blood pressure,
• nausea.

Common

• paresthesia (tingling, stinging, 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 or hearing disturbances,
• loss of sensation or sensitivity of the skin,
• stiffness or muscle cramps,
• feeling of emptiness in the head,
• difficulty speaking,
• feeling of agitation (anxiety),
• seizures (convulsions),
• loss of consciousness.

Children

In children, 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).
If any of the side effects get worse, or if you notice any side effects not listed in this leaflet, you should tell your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your 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

• The medicine should be stored out of sight and out of 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 that month.
• Do not store above 25°C. Do not store in the refrigerator or freeze.
• Do not use Ropimol if you can see any contamination in the solution or if the solution is not clear.

6. Contents of the pack and other information

What Ropimol contains

The active substance of the medicine is ropivacaine hydrochloride.

• 5 mg/ml solution for injection: each milliliter of solution contains 5 mg of ropivacaine hydrochloride. One 10 ml ampoule contains 50 mg of ropivacaine hydrochloride. The other ingredients are: hydrochloric acid 3.6% w/v, sodium chloride, sodium hydroxide, and water for injection.

What Ropimol looks like and what the pack contains

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

• 5 mg/ml solution for injection in 10 ml transparent polypropylene or glass ampoules, 5 ampoules in a pack.

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