Ropimol

Ropimol, 7.5 mg/ml, solution for injection
Ropimol, 10 mg/ml, solution for injection
Ropivacaine hydrochloride
Please read the entire leaflet before using the 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 should not be passed on to others, as it may harm them even if their symptoms are the same.
• If any of the side effects worsen, or if any side effects not listed in this leaflet occur, inform your doctor immediately.

Leaflet contents:

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 7.5 mg/ml and 10 mg/ml, solution for injection:
It is used in adults and adolescents aged 12 years and older to numb (anaesthetize) a part of the body.
It is used to prevent or relieve pain:

• by numbing part of the body during medical procedures, including caesarean section delivery,
• during childbirth, after surgery, or following an injury.

2. Important information before using Ropimol

When not to use Ropimol:

• if the patient has a known allergy (hypersensitivity) to ropivacaine or to 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 (hypovolemia),
• if the patient is currently receiving another injectable or infused anaesthetic medicine. Ropivacaine should 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 arterial hardening (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
The safety and efficacy of Ropimol at concentrations of 7.5 mg and 10 mg/ml in injection solution have not been established in children up to and including 12 years of age. Ropimol at concentrations of 2 mg/ml and 5 mg/ml may be more appropriate.
If the patient is unsure whether the above warnings apply, medical advice should be sought before using the medicine.

Use of the medicine with other medicines
Inform the doctor about all medicines the patient is currently taking, including those obtained without a prescription.
In particular, inform the doctor if the patient is taking any of 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
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

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

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

3. How to use Ropimol

Ropimol must always be used as directed by the physician. The medicine is administered by injection.
What dose of Ropimol will the patient receive:

• The physician will decide the dose of the medicine to be administered.
• 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 aged 12 years and older ranges from 2 mg to 300 mg of ropivacaine hydrochloride.

Administration 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, the patient should immediately consult the physician.
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 feeling faint due to low blood pressure,
• muscle stiffness,
• irregular heartbeat. The patient should immediately contact the physician if any of the above symptoms occur. For any other questions concerning the use of this medicine, the patient should 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, inform 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, feeling faint, rash, itching (rare),
• irregular heartbeat, which may lead to a heart attack (rare),
• fast or slow heartbeat (common).

Contact your doctor immediately if any of the above symptoms occur.
Very common

• low blood pressure,
• nausea.

Common

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

Uncommon

• decrease in 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 skin sensation or sensitivity,
• stiffness or muscle spasms,
• feeling faint,
• difficulty speaking,
• feeling anxious (nervousness),
• 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 in fewer than 1 in 10 children), and vomiting, which is more common in children (occurs in more than 1 in 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 responsible entity.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

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.

6. Other information

What Ropimol contains
The active substance in Ropimol is ropivacaine hydrochloride.

• 7.5 mg/ml solution for injection: each millilitre of solution contains 7.5 mg of ropivacaine hydrochloride. A 10 ml or 20 ml ampoule contains 75 mg or 150 mg of ropivacaine hydrochloride, respectively.
• 10 mg/ml solution for injection: each millilitre of solution contains 10 mg of ropivacaine hydrochloride. A 10 ml or 20 ml ampoule contains 100 mg or 200 mg of ropivacaine hydrochloride, respectively.
  Other ingredients: sodium chloride, hydrochloric acid 1N, sodium hydroxide 1N, and water for injections.

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

• 7.5 mg/ml solution for injection in 10 ml or 20 ml transparent polypropylene or glass ampoules, with 5 ampoules in a pack.
• 10 mg/ml solution for injection in 10 ml or 20 ml transparent polypropylene or glass ampoules, with 5 ampoules in a 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 for sale in the European Economic Area countries under the following names:
Italy: Ropivacaina Molteni
Poland: Ropimol
Netherlands: Ropivacaine Hydrochloride Molteni