Bupivacaine hydrochloride 0.1 %w/v Solution for infusion

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

The name of your medicine is Bupivacaine Hydrochloride 0.1% w/v Solution for Infusion or Bupivacaine Hydrochloride 0.125% w/v Solution for Infusion. It will be referred to as Bupivacaine Infusion Solution for ease hereafter.

1. What Bupivacaine Infusion Solution is and what it is used for
2. What you need to know before Bupivacaine Infusion Solution is given to you
3. How Bupivacaine Infusion Solution is given to you
4. Possible side effects
5. How to store Bupivacaine Infusion Solution
6. Contents of the pack and other information

• know you are allergic to bupivacaine or to any of the other ingredients (see section 6 of this leaflet)
• are allergic to any other local anaesthetics of the same class (such as lidocaine or ropivacaine).
• are to be injected in a vein of the hands or legs (Bier's block).

• have an infection of the skin with pus at or near the site to be injected
• have inadequate circulation of blood to the heart, sudden loss of blood or weakness of the heart that causes low blood pressure, a weak rapid pulse, sweating and confusion
• have problems with the clotting of your blood or are taking any anticoagulant drugs that thin the blood
• are suffering from any infection, disease or tumour of the brain or spinal cord
• have bleeding inside the head (intracranial haemorrhage)
• have incomplete development of spine (Spina bifida)
• have an abnormal connection between veins and arteries (AV malformation)
• have increased pressure within the brain.

Talk to your doctor or nurse if one of these applies to you before you are given this medicine.

Talk to your doctor or pharmacist or nurse before you are given this medicine, if you:

• suffer from any liver, kidney problems
• suffer from any heart problem, particularly if it affects the heart rate
• suffer from severe shock or low blood pressure
• have breathlessness or restriction to breathing from fluid or a large tumour in the abdomen
• have accumulation of fluid around the lungs
• have a decrease in the amount of fluid circulating in your body causing symptoms such as sweating, mental confusion, dizziness or fainting (for example, due to dehydration or severe blood loss)
• are elderly (senile) or in poor health
• have high blood pressure during pregnancy
• have problems with the circulation of blood to the brain
• have excess fluid in the womb during pregnancy (hydramnios)
• have a tumour of the ovary or the womb
• have accumulation of excess fat in your body
• are in the late stages of pregnancy
• suffer from blood poisoning (septicaemia).

The use of Bupivacaine Infusion Solution in children less than 1 year of age is not established. If your child is aged over 1 and up to 12 years old your doctor will explain how the medicine can be given since some use of this medicine in this age group have not been established in certain procedures.

Tell your doctor or nurse before you are given this medicine if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

This is because Bupivacaine Infusion Solution can affect how some medicines work and different medicines can affect how Bupivacaine Infusion Solution works. In particular, tell your doctor if you are taking any of the following:

• medicines used to regulate the heartbeat such as lidocaine, amiodarone, mexiletine.
• medicines used to reduce the clotting power of the blood (anticoagulants) e.g. aspirin
• medicines to lower your blood pressure including betablockers, e.g. atenolol, bisoprolol.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine However, as with all drugs Bupivacaine Infusion Solution should only be given in early pregnancy if absolutely necessary.

Certain areas of your body will be numb for about 2-4 hours after having this medicine.

If this is likely to affect your ability to drive or use machinery you should wait for the effect to wear off. In general, it is wise to ask your doctor whether it is safe to drive.

• Bupivacaine 0.1% w/w Solution for Infusion contains 347 mg sodium (main component of cooking/table salt) in each 100 ml.
• Bupivacaine 0.125% w/w Solution for Infusion contains 346 mg sodium (main component of cooking/table salt) in each 100 ml.

This quantity of sodium is equivalent to 17% of the recommend maximum daily dietary intake of sodium for an adult.

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
• drooping of the upper eyelid, sunk in eye, flushing of the face (Horner's syndrome) are more commonly experienced in pregnant women.

Uncommon (may affect up to 1 in 100 people):

• feeling light-headed
• fits (seizures)
• ringing in the ears or being sensitive to sound
• difficulty in speaking
• numbness of the tongue or around the mouth
• blurred sight (vision)
• loss of consciousness
• shaking (tremors)
• twitching of your muscles.

Rare (may affect up to 1 in 1000 people):

• double vision
• nerve damage that may cause changes in sensation or muscle weakness (neuropathy). This may include peripheral nerve damage
• 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 legs
• weak or paralysed legs
• partial loss of movement (paresis)
• uneven heartbeat (arrhythmias). This could be life threatening
• slowed or stopped breathing or stopped heartbeat which could be life threatening.

• problems with your liver enzymes. This may happen if you have long-term treatment with this medicine
• damaged nerves. Rarely this may cause permanent problems
• blindness which is not permanent or problems with the muscles of 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Bupivacaine Infusion Solution is a colourless or almost colourless, aqueous, sterile solution for infusion and is available in two strengths. Both strengths are available in 100 ml or 250 ml plastic (polypropylene) bags for infusion in packs of 10 and 5 respectively.

Not all pack sizes may be marketed.