Ropimol

Ropimol
2 mg/ml, solution for infusion
Ropivacaine hydrochloride
Read the entire leaflet carefully before using this medicine.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you need advice or further information.
• This medicine has been prescribed for a specific individual and must not be passed on to others, as it may harm them, even if their symptoms are similar.
• If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform your doctor immediately.

Contents of the leaflet:

1. What Ropimol is and what it is 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 Ropimol is and what it is used for

Ropimol is a local anaesthetic medicine.
Ropimol 2 mg/ml, solution for infusion:
It is used for the management of acute pain in adults and children of all ages. It is used for anaesthesia (numbing) of a specific part of the body, for example, after surgery.

2. Important information before using Ropimol

When not to use Ropimol:

• if the patient has a known allergy (hypersensitivity) to ropivacaine or any of the other ingredients of the medicine (see 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 circulating blood volume (hypovolaemia),
• if the patient is currently receiving another anaesthetic medicine by injection or infusion (intravenous drip). Ropivacaine must not be used if any of the above warnings apply to the patient. If in doubt, consult a doctor before administering ropivacaine.

When to exercise special caution 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 disorders,
• if the patient is on a low-sodium diet,
• if the patient or a family member suffers from porphyria – a rare blood pigment disorder. Inform the doctor, as another anaesthetic medicine may need to be used.

Children

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

If the patient is unsure whether any of the above warnings apply, consult a doctor before using the medicine.

Use of Ropimol with other medicines
Inform the doctor about all medicines the patient has 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),
• antidepressant medicines (e.g. fluvoxamine),
• painkillers (opioids),
• antibiotics (e.g. enoxacin). If the patient is unsure whether any of the above warnings apply, consult a doctor before using the medicine.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Driving and operating machinery
Consult a doctor before driving or operating machinery, as Ropimol may cause drowsiness and slow reaction times. Ask the doctor whether the patient may drive or operate tools and machinery.

Important information about certain ingredients in Ropimol
Ropimol contains 3 mg of sodium per 1 ml. This should be taken into account if the patient is monitoring sodium intake in the diet.

3. How to use Ropimol

Ropimol should always be used as directed by the physician. The medicine is administered by infusion (intravenous drip).
What dose of Ropimol will the patient receive:

• The physician will decide the dose of the medicine the patient will receive.
• The dose depends on the intended purpose and other 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 from 12 years of age is from 2 mg to 300 mg of ropivacaine hydrochloride.
• The usual dose for newborns, infants, and children up to 12 years of age is from 1 mg to 2 mg of ropivacaine hydrochloride per kilogram of body weight.

Use of a higher than recommended dose of Ropimol:
It is unlikely that the patient will receive too much medicine if it is administered by a physician.
If the effect of the medicine seems too strong, contact the physician immediately.
Symptoms of overdose may include:

• paresthesia (burning, tingling, or numbness of the skin),
• involuntary movements,
• numbness around the mouth,
• visual or hearing disturbances,
• dizziness and a feeling of emptiness due to low blood pressure,
• muscle stiffness,
• irregular heartbeat.
  Contact the physician immediately if the patient experiences any of the above symptoms. For any other questions concerning the use of this medicine, contact the physician.

4. Possible adverse reactions

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

• very common: affects more than 1 in 10 people,
• common: affects 1 to 10 in 100 people,
• uncommon: affects 1 to 10 in 1,000 people,
• rare: affects 1 to 10 in 10,000 people,
• very rare: affects 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 symptoms listed below occur, contact your 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 heart attack (rare),
• fast or slow heartbeat (common).

Seek immediate medical attention if any of the above symptoms occur.
Very common

• low blood pressure,
• nausea.

Common

• paraesthesia (burning, prickling, or numbness sensation in 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,
• breathing difficulties or shallow breathing,
• disturbances in vision and hearing,
• loss of skin sensation or sensitivity,
• muscle stiffness or spasms,
• feeling faint (sensation of emptiness in the head),
• difficulty speaking,
• feeling of nervousness (anxiety),
• seizures (convulsions),
• loss of consciousness.

Children
In children, adverse reactions are the same as in adults, except for low blood pressure, which is less common in children (occurs less frequently than in 1 out of 10 children), and vomiting, which is more common in children (occurs in more than 1 out of 10 children).
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your 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.
Reporting adverse reactions helps provide more information on the safety of this medicinal product.

5. How to store the medicine Ropimol

• Keep out of the reach and sight 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.
• From a microbiological point of view, the medicine should be used immediately after opening. If not used immediately, the user is responsible for the storage period and conditions after first opening prior to use. However, the storage period of the medicine should not exceed 24 hours at a temperature of 2°C - 8°C.

6. Other information

What Ropimol contains
The active substance is ropivacaine hydrochloride.

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

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

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

Not all pack sizes may be marketed.

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 in the European Economic Area countries under the following names:
Italy Ropivacaina Molteni
Poland Ropimol
Netherlands Ropivacaine Hydrochloride Molteni