ROPIVACAINE 10 MG / ML SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

Ropivacaine 10 mg/ml solution for injection

The following information is intended for medical or healthcare professionals only:

Handling

Ropivacaine should only be used by, or under the supervision of, clinicians experienced in regional anaesthesia (see section 3).

The intact container must not be re-autoclaved.

Posology

Adultsand children above 12 years of age

The following table is a guide to dosage for the more commonly used blocks in adults. The smallest dose required to produce an effective block should be used. The clinician‘s ex­perience and knowledge of the patient‘s physical status are of importance when deciding the dose.

The doses in the table are those considered to be necessary to produce a successful block and should be regarded as guidelines for use in adults. Individual variations in onset and duration occur. The figures in the column ,Dose‘ reflect the expected average dose range needed. Standard textbooks should be consulted for both factors affecting specific block techniques and individual patient requirements.

* With regard to major nerve block, only for brachial plexus block a dose recommendation can be given. For other major nerve blocks lower doses may be required. However, there is presently no experience of specific dose recommendations for other blocks.

• 1) Incremental dosing should be applied, the starting dose about 100 mg (97.5 mg = 13 ml; 105 mg = 14 ml) to be given over 3–5 minutes. Two extra doses, in total an additional 50mg, may be administered as needed.

• 2) The dose for a major nerve block must be adjusted according to site of administration and patient status. Interscalene and supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anaesthetic used. In general, surgical anaesthesia (e.g. epidural administration) requires the use of the higher concentrations and doses. The Ropivacaine 10 mg/ml formulation is recommended for epidural anaesthesia in which a complete motor block is essential for the surgery. For analgesia (e.g. epidural administration for acute pain management) the lower concentrations and doses are recommended.

Method of administration

Perineural and epidural administration by injection.

PACKAGE LEAFLET: INFORMATION FOR THE USER Ropivacaine 10 mg/ml solution for injection ropivacaine hydrochloride

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

• 1.What Ropivacaine is and what it is used for

• 2.What you need before you use Ropivacaine

• 3.How to use Ropivacaine

• 4.Possible side effects

• 5.How to store Ropivacaine

• 6.Contents of the pack and other information

This product will be referred to as Ropivacaine from here on.

1.WHAT ROPIVACAINE IS AND WHAT IT IS USED FOR

Ropivacaine 10 mg/ml solution for injection is used in adults and children above 12 years to numb (anaesthetise) parts of the body. It is used to stop pain happening or to provide pain relief. It can be used to:

• Numb parts of the body during surgery, including having a baby by Caesarean section.
• Relieve pain during childbirth, after surgery, or after an accident.

2.WHAT YOU NEED TO KNOW BEFORE YOU USE ROPIVACAINE

Do not use Ropivacaine

• if you are allergic (hypersensitive) to ropivacaine hydrochloride, other so called local anaesthetics of the amide type or any of the other ingredients of Ropivacaine (listed in section 6).
• if you have a decrease in blood volume (hypovolaemia). This is measured by healthcare personnel.
• for injection into a blood vessel to numb a specific area

of your body,

• for injection into the neck of the womb to relieve pain during childbirth.

Warning and precautions

Talk to your doctor or pharmacist before using Ropivacaine In children up to and including 12 years. Other strengths (2mg/ml, 5 mg/ml) may be more appropriate.

Special care should be taken to avoid any injection of Ropivacaine directly into a blood vessel to prevent any immediate toxic effects. Injection should not be performed in inflamed areas.

Please tell your doctor:

• if you are in a poor general conditon due to your age or other factors.
• if you have heart problems (partial or complete heart conduction block)
• if you have advanced liver problems
• if you have severe kidney problems.

Tell your doctor if you have any of these problems because your doctor may need to adjust the dose of Ropivacaine.

Please tell your doctor:

• if you suffer from acute porphyria (problems with building up red blood pigment, sometimes resulting in neurological symptoms).

Tell your doctor if you or somebody in your family have porphyria because your doctor may need to use another anaesthetic.

Other medicines and Ropivacaine

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Caution should be exercised if you are receiving:

• Other local anaesthetics (e.g. lidocaine) or agents structurally related to amide-type local anaesthetics, e.g. certain medicines used to treat an irregular heart beat (arrhythmia), such as mexiletine or amiodarone
• General anaesthetics or opioids, such as morphine or codeine
• Medicines used to treat depression (e.g. fluvoxamine)
• Certain antibiotics (e.g. enoxacin)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is not known if ropivacaine hydrochloride affects pregnancy or passes into breast milk.

Driving and using machines

Ropivacaine may make you feel sleepy and affect the speed of your reactions. After you have been given Ropivacaine, you should not drive or use any tools or machines until the next day.

Discuss with your doctor or pharmacist if you are unsure about anything.

Important information about some of the ingredients of Ropivacaine

This medicine contains 2.8 mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.14% of the recommended maximum daily dietary intake of sodium for an adult.

3.HOW TO USE ROPIVACAINE

Method of administration

Your doctor will administer Ropivacaine to you. It is administered by injection.

Dosage

The recommended dose will depend on what it is being used for and also on your health, age and weight. The smallest dose that can produce effective numbing (anaesthesia) of the required area should be used.

The usual dose

• for adults and adolescents older than 12 years of age is between 2 mg and 300 mg of ropivacaine hydrochloride.
• in infants and children (0 up to and including 12 years of age) is 1–3 mg for each kilogram of body weight.

Duration of treatment

Administration of ropivacaine hydrochloride usually takes between 2 to 10 hours in case of anaesthesia prior to certain surgeries and can take up to 72 hours in case of pain relief during or after surgery.

• If you are given more Ropivacaine than you should be The first symptoms of being given too much ropivacaine hydrochloride are usually problems with hearing and sight,
• numbness around the mouth,
• dizziness or light-headedness,
• tingling,
• speech disorder characterised by poor articulation (dysarthria),
• muscular stiffness, muscular twitching, fits (convulsions),
• low blood pressure,
• slow or irregular heart beat.

These symptoms may precede to cardiac arrest, breathing arrest or severe fits.

If you experience any of these symptoms or think you may have received too much Ropivacaine, tell your doctor or healthcare personnel immediately.

In case of acute toxicity, appropriate corrective actions will be taken immediately by the healthcare personnel.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.possible side effects

Like all medicines, Ropivacaine can cause side effects, although not everybody gets them.

Important side effects to look out for:

• Sudden life-threatening allergic reactions (such as anaphylaxis, angioneurotic oedema and urticaria) are rare. Possible symptoms include sudden onset of rash, itching or lumpy rash (hives),
• swelling of the face, lips, tongue or other parts of the body,
• and shortness of breath, wheezing or difficulty breathing. If you think that Ropivacaine is causing an allergic reaction, tell your doctor or healthcare personnel immediately.

Other possible side effects:

Very common may affect more than 1 in 10 people

• Low blood pressure (hypotension). This might make you feel dizzy or light-headed.
• Feeling sick (nausea)

Common may affect up to 1 in 10 people

• Headache, pins and needles (paraesthesia), feeling dizzy
• Slow or fast heart beat (bradycardia, tachycardia)
• High blood pressure (hypertension)
• Being sick (vomiting)
• Difficulty in passing urine (urinary retension)
• Back pain, increased temperature, muscular stiffness (rigor)

Uncommon may affect up to 1 in 100 people

• Anxiety
• Some symptoms can happen if the injection was given into a blood vessel by mistake, or if you have been given too much Ropivacaine (see also section 3 “If you are given more Ropivacaine than you should be” above).

These include fits (convulsions, seizures), feeling dizzy or light-headed, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, problems with your sight (vision), problems with your speech (dysarthria), muscular twitching and trembling, reduced sense of touch (hypoaesthesia)

• Fainting (syncope)
• Difficulty breathing (dyspnoea)
• Low body temperature

Rare may affect up to 1 in 1000 people

• Cardiac arrest, irregular heart beat (cardiac arrhythmias)

Possible side effects seen with other local anaesthetics which might also be caused by Ropivacaine include:

• Numbness, due to nerve irritation caused by the needle or the injection. This does not usually last for long.
• Damaged nerves. Rarely, this may cause permanent problems.
• If too much Ropivacaine is given into the spinal fluid, the whole body may become numbed (anaesthetised).

Additional side effects in children

In children, the side effects are the same as in adults except for low blood pressure which happens less often in children (affecting less than 1 in 10 children) and being sick which happens more often in children (affecting more than 1 in 10 children).

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk your doctoror pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website:. By reporting side effects you can help provide more information on the safety of this medicine.

5.how to store ropivacaine

Keep this medicine out of the sight and reach of children. Do not use Ropivacaine after the expiry date which is stated on the ampoule or carton box. The expiry date refers to the last day of that month.

Do not freeze.

Do not use Ropivacaine if you notice any precipitation in the solution for injection.

Your doctor or the hospital will normally store Ropivacaine and they are responsible for the quality of the product when it has been opened if it is not used immediately. They are also responsible for disposing of any unused Ropivacaine correctly.

Medicines should not be disposed of via wastewater or household waste. Your doctor, nurse or pharmacist will dispose of medicines no longer required. These measures will help to protect the environment.

6.contents of the pack and other information

What Ropivacaine contains

• The active substance is ropivacaine hydrochloride 10 mg/ ml. Each 10 ml polypropylene ampoule contains 100 mg ropivacaine(as hydrochloride).

Each 20 ml polypropylene ampoule contains 200 mg ropivacaine, (as hydrochloride).

• The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment) and water for injections.

What Ropivacaine looks like and contents of the pack

Pack sizes:

• 10 sterile ampoules in plastic blister.