Ropimol

PATIENT INFORMATION LEAFLET: USER INFORMATION

Ropimol

2 mg/ml, solution for injection

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 pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If any of the side effects get worse, or if you notice any 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. Other information

1. What is Ropimol and what is it used for

Ropimol is a local anesthetic.

Ropimol 2 mg/ml, solution for injection:

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:

When to be extra careful when using Ropimol

You should consult your doctor before using the medicine:

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 you are not sure if the above warnings apply to you, consult your doctor before using the medicine.

Using Ropimol with other medicines

Tell your doctor about all the medicines you have taken recently, including those that are available without a prescription.
In particular, tell 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. enoxacin). If you are not sure if the above warnings apply to you, consult your doctor before using the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before using this medicine.

Driving and using machines

Ask your doctor for advice before driving or using machines, as Ropimol may cause drowsiness and slowed reactions. Ask your doctor if you can drive or operate tools and machines.

Important information about some ingredients of Ropimol

Ropimol contains 3 mg of sodium per 1 ml. This should be taken into account if you are controlling your sodium intake.

3. How to use Ropimol

Ropimol should always be used as directed by your doctor. The medicine is given by injection.

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 for which it is intended and other factors such as your health, age, and weight.
• Use the smallest effective dose.
• The usual dose of the medicine for adults and adolescents over 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 you will receive too much medicine if it is given by a doctor.
If you feel that the effect of the medicine is too strong, contact your doctor immediately.
Symptoms of overdose may include:

• paresthesia (tingling, stinging, or numbness of the skin),
• involuntary movements,
• numbness around the mouth,
• vision or hearing disturbances,
• dizziness and feeling of emptiness in the head due to low blood pressure,
• muscle stiffness,
• irregular heartbeat. Contact your doctor immediately if you notice any of the above symptoms. If you have any other questions about using this medicine, contact 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: 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 you experience any of the following symptoms, contact your doctor immediately:

• allergic reactions, including anaphylactic shock - symptoms may include: swelling of the face, lips, mouth, or throat, dizziness or 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).

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 chills 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 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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 that month.
• Do not store above 25°C. Do not store in the refrigerator or freeze.
• Do not use Ropimol if you notice any contamination in the solution or if the solution is not clear.

6. Other information

What Ropimol contains

The active substance of the medicine is ropivacaine hydrochloride.

• 2 mg/ml solution for injection: each milliliter of solution contains 2 mg of ropivacaine hydrochloride. One ampoule of 10 ml or 20 ml solution contains 20 mg or 40 mg of ropivacaine hydrochloride. The other ingredients are: sodium chloride, hydrochloric acid 1N, sodium hydroxide 1N, and water for injections.

What Ropimol looks like and what the pack contains

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

• 2 mg/ml solution for injection in 10 ml or 20 ml transparent polypropylene or glass ampoules, 5 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