Package leaflet: Information for the user

Ropimol
5 mg/ml, solution for injection
Ropivacaine hydrochloride
Read the entire leaflet carefully before use.

Keep this leaflet, as you may need to read it again.
Consult your doctor or pharmacist if you have any further questions.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If any side effects worsen or if you experience any side effects not listed in this leaflet, inform your doctor.

Contents of the leaflet:

What Ropimol is and what it is used for
Important information before using Ropimol
How to use Ropimol
Possible side effects
How to store Ropimol
Contents of the pack and other information

1. What Ropimol is and what it is used for

Ropimol is a local anaesthetic administered epidurally (into the epidural space).

It is used in adults for: anaesthesia (numbing) of a part of the body during surgical procedures. It is injected into the lower part of the patient's spine. It helps to rapidly block pain from the patient's waist downwards for a limited period (usually 1 to 2 hours). The medicine may be used in adults and adolescents aged over 12 years.
It is used in children aged 1 to 12 years for anaesthesia (numbing) of a part of the body. It is used to prevent or relieve pain.

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 this medicine (listed in section 6),
if the patient has previously experienced allergic reactions to other anaesthetic medicines (including local anaesthetics of the amide group),
if the patient has reduced blood volume (hypovolemia),
if the patient is simultaneously receiving another anaesthetic medicine by injection or infusion (intravenous drip). Ropivacaine should not be used if any of the above warnings apply to the patient. If in doubt, consult a doctor before administering ropivacaine.

Warnings and precautions for Ropimol

Special caution is required in children, as the safety and efficacy of epidural administration have not been established in this age group.

Consult a doctor before using the medicine if:

the patient has heart disease or hardening of the arteries (vascular disease),
the patient has acute liver disease or kidney disorders,
the patient is on a low-sodium diet,
the patient or a family member suffers from a rare blood pigment disorder – haemoglobin (porphyria). If this is the case, inform the doctor, as another anaesthetic medicine may need to be used. If the patient is unsure whether the above warnings apply, consult a doctor before using the medicine.

Other medicines and Ropimol

Inform the doctor about all medicines currently used or recently taken, including those obtained without a prescription. In particular, inform the doctor if the patient is taking the following medicines:

medicines used for heart rhythm disorders (antiarrhythmics),
antidepressants (e.g. fluvoxamine),
painkillers (opioids),
antibiotics (e.g. enoxacin).
If the patient is unsure whether the above warnings apply, consult a doctor before using the medicine.

Pregnancy, breastfeeding and fertility

During pregnancy and breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.

Driving and operating machinery

Consult a doctor before driving, using tools or operating machinery, as Ropimol may cause drowsiness and slowed reaction times. Ask the doctor whether the patient is allowed to drive, use tools or operate machinery.

Important information about certain ingredients of Ropimol

Ropimol contains sodium. The medicine contains 3 mg of sodium per 1 ml. This should be taken into account if the patient is monitoring sodium intake in their diet.

3. How to use Ropimol

Ropimol is administered by injection. This procedure is performed by a doctor.
What dose of Ropimol the patient will receive

The doctor will decide what dose of the medicine the patient should receive.
The dose depends on the intended use of the medicine and factors such as the patient's health status, age, and body weight.
The lowest effective dose should be used.
The usual dose of the medicine for adults and adolescents aged 12 years and older ranges from 15 mg to 25 mg. Administration of a higher than recommended dose of Ropimol It is unlikely that the patient will receive too much of the medicine if it is administered by a doctor. If the effect of the medicine seems too strong, the patient should immediately consult a doctor. Symptoms of overdose may include:
paresthesia (burning, prickling, or numbness sensations in the skin),
sudden involuntary movements,
numbness around the mouth,
disturbances in vision or hearing,
dizziness and a feeling of emptiness in the head due to low blood pressure,
muscle stiffness,
irregular heartbeat. The patient should contact a doctor immediately if any of the above symptoms occur. If there are any further doubts regarding the use of this medicine, the patient should consult a doctor.

4. Possible adverse reactions

Like any medicine, Ropimol can cause adverse reactions, although not everyone experiences them.
The following terminology has been used to describe the frequency of occurrence of adverse reactions:

very common: occurs in more than 1 in 10 people,
common: occurs in 1 to 10 in 100 people,
uncommon: occurs in 1 to 10 in 1,000 people,
rare: occurs in 1 to 10 in 10,000 people,
very rare: occurs in fewer than 1 in 10,000 people,
not known: frequency cannot be estimated from the available data.

The following adverse reactions may occur:
If any of the following symptoms occur, contact a doctor immediately:

allergic reactions, including anaphylactic shock – symptoms may include: swelling of the face, lips, mouth or throat, dizziness or feeling faint due to low blood pressure, rash, itching (rare),
irregular heartbeat which may lead to a heart attack (rare),
fast or slow heartbeat (common). Contact a doctor immediately if any of the above symptoms occur. Very common
low blood pressure,
nausea.

Common

paraesthesia (burning, prickling or numbness of the skin),
difficulty passing urine,
high blood pressure,
dizziness,
headache,
vomiting,
back pain,
high temperature and chills.

Uncommon

decreased body temperature (hypothermia): symptoms include chills and confusion,
numbness or loss of sensation around the mouth and tongue,
difficulty breathing or shallow breathing,
disturbances in vision and hearing,
loss of sensation or sensitivity of the skin,
stiffness or muscle spasms,
feeling faint,
difficulty speaking,
feeling anxious (restlessness),
seizures (convulsions),
loss of consciousness.

Children
In children, adverse reactions are the same as in adults, except for low blood pressure, which occurs less frequently in children (occurs in fewer than 1 in 10 children), and vomiting, which occurs more frequently in children (occurs in more than 1 in 10 children).
If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform a doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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.
Adverse reactions can also be reported to the marketing authorization holder. By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Ropimol

Keep this medicine out of 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 specified month.
Do not store above 25°C. Do not store in the refrigerator or freeze.
Do not use Ropimol if any contamination is visible in the solution or if the solution is not clear.

6. Contents of the pack and other information

What Ropimol contains
The active substance is ropivacaine hydrochloride.

5 mg/ml solution for injection: each millilitre of solution contains 5 mg of ropivacaine hydrochloride. A 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 injections.

What Ropimol looks like and contents of the pack
Ropimol is a clear, colourless solution for injection.
The medicine is available in the following pack sizes:

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

Marketing Authorisation 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
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Italy Ropivacaina Molteni
Poland Ropimol
Netherlands Ropivacaine Hydrochloride Molteni