BUPIVACAINE 2.5 MG / ML SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

What is in this leaflet

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

• 2. What you need to know before Bupivacaine is given to you

• 3. How Bupivacaine is given

• 4. Possible side effects

• 5. How to store Bupivacaine

• 6. Contents of the pack and other information

1. what bupivacaine is and what it is used for

Bupivacaine contains the active substance bupivacaine hydrochloride. It belongs to a group of medicines called amide-type local anaesthetics.

• This medicine is used 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 in adults and children above 12 years.
• Relieve pain during childbirth.
• Relieve pain in adults, infants and children above 1 year of age.

2. what you need to know before bupivacaine is given to you

You must not be given Bupivacaine

• if you are allergic to bupivacaine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to any other local anaesthetics of the same class (such as lidocaine or ropivacaine).
• if you have a skin infection near to where the injection will be given.
• if you have something called cardiogenic shock (a condition where the heart is unable to supply enough blood to the body).
• if you have something called hypovolaemic shock (very low blood pressure leading to collapse).
• if you have problems with clotting of your blood (coagulation disorder) or ongoing anticoagulation treatment.
• if you have diseases of the brain or spine such as meningitis, polio or spondylitis.
• if you have a severe headache caused by bleeding inside the head (intracranial haemorrhage).
• if your spine is damaged from tuberculosis, a tumour or recent injury.
• if you have blood poisoning (septicaemia).
• if you have had a recent trauma, tuberculosis or tumours of the spine.
• if you are having obstetrical paracervical block (a type of anaesthesia given during labour).

You must not be given Bupivacaine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given this medicine.

Warnings and precautions

Talk to your doctor or nurse before you are given Bupivacaine:

• if you have heart, kidney or liver problems. This is because your doctor may need to adjust the dose of Bupivacaine.
• if you have a swollen stomach due to more fluid than normal.
• if you have a stomach tumour.
• if you have been told that you have decreased volume of blood (hypovolaemia).
• if you have fluid in your lungs.
• if you have epilepsy.
• injection of adrenaline containing

bupivacaine in areas with arteries with no collateral circulation.

If you are not sure if any of the above applies to you, talk to your doctor or nurse before you are given Bupivacaine.

Children

• The use of Bupivacaine in order to numb parts of the body during surgery is not established in children 1 to 12 years.
• The safety and efficacy of Bupivacaine are not established in children less than

1 year of age.

• Other medicines and Bupivacaine Tell your doctor if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Bupivacaine can affect the way some medicines work and some medicines can have an effect on Bupivacaine. In particular, tell your doctor if you are taking any of the following medicines: Medicines used to treat an uneven heart beat (arrhythmia) such as lidocaine, mexiletine or amiodarone.
• Medicines used to stop blood clots (anti-coagulants).

Your doctor needs to know about these medicines to be able to work out the correct dose of Bupivacaine for you.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before this medicine is administered to you.

Pregnancy

There are no or limited amount of data from the use of bupivacaine in pregnant women.

Breast-feeding

Bupivacaine enters the mother’s milk, if you are breast-feeding you should discuss options with your doctor.

Fertility

There are no data on the effect of bupivacaine hydrochloride on human fertility.

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

Bupivacaine contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per ampoule, that is to say essentially ‘sodium-free’.

10 mL and 20 mL ampoules:

This medicine contains 3.31 mg sodium (main component of cooking/table salt) per 1 mL. This is equivalent to 0.17% of the recommended maximum daily dietary intake of sodium for an adult.

3. How Bupivacaine is given

This medicine will be given to you by a doctor. Your doctor will know the correct way to give you this medicine.

The dose that your doctor gives you will depend on the type of pain relief that you need and the part of your body that the medicine will be injected into. It will also depend on your body size, age, and physical condition. Usually one dose will last long enough but more doses may be given if the surgery takes a long time. Bupivacaine will be given to you as an injection or infusion. The part of the body where you are injected will depend on why you are being given Bupivacaine. Your doctor will give you this medicine in one of the following places:

• Near to the part of the body that needs to be numbed.
• In an area away from the part of the body that needs to be numbed. This is the case if you are given an epidural injection (an injection around the spinal cord).

When Bupivacaine is injected into the body in one of these ways, it stops the nerves from being able to pass pain messages to the brain. It will slowly wear off when the medical procedure is over.

If you have been given more Bupivacaine than you should Serious side effects from getting too much Bupivacaine are unlikely. They need special treatment and the doctor treating you is trained to deal with these situations. The first signs of being given too much Bupivacaine are usually as follows:

• Feeling dizzy or light-headed.
• Numbness of the lips and around the mouth.
• Numbness of the tongue.
• Hearing problems.
• Problems with your sight (vision). To reduce the risk of serious side effects, your doctor will stop giving you Bupivacaine as soon as these signs appear. This means that if any of these happen to you, or you think you have received too much Bupivacaine, tell your doctor immediately.

More serious side effects from being given too much Bupivacaine include twitching of your muscles, fits (seizures), and loss of consciousness.

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

The following information is intended for healthcare professionals only:

Bupivacaine 2.5 mg / mL Solution for injection

Bupivacaine 5 mg / mL Solution for injection

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Administration

Solution for injection.

The medicinal product is for percutaneous infiltration, intra-articular block, peripheral nerve block(s) and central neural block (caudal or epidural) use only.

The clinician’s ex­perience and knowledge of the patient’s physical status is important in calculating the required dose. The lowest dose required for adequate anaesthesia should be used. An overall dose limit of 150 mg should not be exceeded. A dose of 400 mg administered over 24 hours is well tolerated in the average adult, which does not include the initial bolus dose, can be used routinely. For the paediatric patient’s lowest dose required for adequate analgesia should be used.

Handling Instructions

For single use only.

Only clear solutions practically free from particles should be used. Any unused solution should be discarded.

Bupivacaine should not be stored in contact with metals such as needles and syringes with details of metals that can come into contact with the solution. Metal ions might precipitate and cause swelling at the injection area. Do not use this medicine after the expiry date, which is stated on the ampoule and carton. The expiry date refers to the last day of that month.

Method for preparation of 1.25 mg / mL concentration:

Bupivacaine 2.5 mg / mL Solution for injection:

• Withdraw 250 mL of diluent from

500 mL non-pvc diluent bag/bottle and inject

250 mL of Bupivacaine 2.5 mg / mL Solution for injection into 500 mL non-pvc diluent bag/bottle to get final concentration 1.25 mg / mL.

• The diluent bag/bottle should be gently shaken for the drug uniformity.

4. possible side effects

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

Severe allergic reactions (rare: may affect up to 1 in 1,000 people) If you have a severe allergic reaction, tell your doctor immediately. The signs may include sudden onset of:

• Swelling of your face, lips, tongue or throat. This may make it difficult to swallow.
• Severe or sudden swelling of your hands, feet and ankles.
• Difficulty breathing.
• Severe itching of the skin (with raised lumps).

Other possible side effects:

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• Being sick (vomiting).
• Feeling dizzy.
• Pins and needles.
• High blood pressure (hypertension).
• Slow heartbeat.
• Problems passing water.

Uncommon: may affect up to 1 in 100 people

• Feeling light-headed.
• Fits (seizures).
• Numbness of the tongue or around the mouth.
• Ringing in the ears or being sensitive to sound.
• Difficulty speaking.
• Blurred sight (vision).
• Loss of consciousness.
• Shaking (tremors).
• Twitching of your muscles.

Rare: may affect up to 1 in 1,000 people

• Double vision.
• Nerve damage that may cause changes in sensation or muscle weakness (neuropathy). This may include peripheral nerve damage.
• A condition called arachnoiditis (inflammation of the membrane that surrounds the spinal cord). The signs include a stinging or burning pain in the lower back or legs and tingling, numbness or weakness in the legs.
• Weak or paralysed legs.
• Uneven heart beat (arrhythmias).

This could be life-threatening.

• Slowed or stopped breathing or stopped heartbeat. This could be life-threatening.

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

• Problems with your liver enzymes. This may happen if you have longterm treatment with this medicine.
• Damaged nerves. Rarely this may cause permanent problems.
• Blindness which is not permanent or problems with the muscles of the eyes that are long-lasting. This may happen with some injections given around the eyes.

Do not be concerned by this list of possible side effects. You may not get any of them.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via

For UK: Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

For IE: HPRA Pharmacovigilance, Website:.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store bupivacaine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the ampoule and carton after “EXP”. The expiry date refers to the last day of that month.

Do not use this medicine if you notice the contents are discoloured in any way or if particles are present.

Do not refrigerate or freeze. After first opening, the product should be used immediately.

After dilution: Chemical and physical in-use stability has been demonstrated for 7 days at 25 ± 2°C and for 24 hours at 2 – 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2 to 8°C, unless opening / dilution has taken place in controlled and validated aseptic conditions.

Your doctor or the hospital will normally store Bupivacaine 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 Bupivacaine correctly.

6. contents of the pack and other information

What Bupivacaine contains

• The active substance is bupivacaine hydrochloride anhydrous.

Bupivacaine 2.5 mg / mL Solution for injection:

Each mL contains 2.5 mg bupivacaine hydrochloride anhydrous.

Bupivacaine 5 mg / mL Solution for injection:

Each mL contains 5 mg bupivacaine hydrochloride anhydrous.

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

What Bupivacaine looks like and contents of the pack

Bupivacaine Solution for injection is a clear, colourless, sterile solution for injection. It is available in polypropylene ampoules.

Polypropylene ampoules of 5 mL, 10 mL or 20 mL. Ampoules are placed in cartons.

Pack sizes of 5, 10 and 50 ampoules.

Polypropylene ampoules of 5 mL, 10 mL or 20 mL. Each ampoule is placed individually in a plastic polypropylene blister. Blisters are placed in cartons.

Pack sizes of 5, 10 and 50 ampoules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: Noridem Enterprises Limited, Evagorou & Makariou, Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus Manufacturer:

DEMO S.A. PHARMACEUTICAL INDUSTRY, 21st Km National Road Athens-Lamia, 145 68 Krioneri, Attiki, Greece, T: +30 210 8161802, F: +30 2108161587

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Cyprus AMIBUSIN 2.5 mg / mL Solution for injection AMIBUSIN 5 mg / mL Solution for injection

Czech

Republic Bupivacaine Noridem Bupivacaine Noridem Denmark Bupivacaine Noridem Bupivacaine Noridem Greece AMIBUSIN 2,5 mg / mL Evcaipo SiaAupa AMIBUSIN 5 mg / mL Evcaipo SiaAupa

France BUPIVACAINE NORIDEM 2,5 mg/mL, solution injectable BUPIVACAINE NORIDEM 5 mg/mL, solution injectable

Ireland Bupivacaine 2.5 mg / mL Solution for injection Bupivacaine 5 mg / mL Solution for injection

Norway Bupivacaine Noridem

Bupivacaine Noridem

Poland Bupivacaini Noridem

Bupivacaini Noridem Sweden Bupivacaine Noridem Bupivacaine Noridem

Slovak

Republic Bupivacaine Noridem Bupivacaine Noridem

United

Kingdom (Northern Ireland) Bupivacaine 2.5 mg / mL Solution for injection Bupivacaine 5 mg / mL Solution for injection

This leaflet was last revised in 01/2022

Bupivacaine 5 mg / mL Solution for injection:

• Withdraw 125 mL of diluent from

500 mL non-pvc diluent bag/bottle and inject

125 mL of Bupivacaine 5 mg / mL Solution for injection into 500 mL non-pvc diluent bag/bottle to get final concentration 1.25 mg / mL.

• The diluent bag/bottle should be gently shaken for the drug uniformity.

Method for preparation of 2.5 mg / mL concentration:

Bupivacaine 5 mg / mL Solution for injection:

• Withdraw 250 mL of diluent from 500 mL non-pvc diluent bag/bottle and inject 250 mL of Bupivacaine 5 mg / mL Solution for injection into 500 mL non-pvc diluent bag/bottle to get final concentration 2.5 mg / mL.
• The diluent bag/bottle should be gently shaken for the drug uniformity.