Patient leaflet - Bupivacaine Hydrochloride 5 mg / ml solution for injection

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

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

Bupivacaine Hydrochloride 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 in adults, infants and children above 1 year of age

2. What you need to know before you use Bupivacaine Hydrochloride

Do not use Bupivacaine Hydrochloride:

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.
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 you have problems with your spinal cord due to anaemia.
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 Hydrochloride if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given Bupivacaine solution for injection.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before using Bupivacaine Hydrochloride:

if you have heart, liver or kidney problems. This is because your
doctor may need to adjust the dose of Bupivacaine Hydrochloride. Problems with your liver enzymes. This may happen if you have long-term treatment with this medicine.
if you have epilepsy.
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.

Children

In children aged less than 12 years as some injections of Bupivacaine Hydrochloride in order to numb parts of the body during surgery are not established in younger children. The use of Bupivacaine Hydrochloride is not established in children less than 1 year of age.

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

Other medicines and Bupivacaine Hydrochloride

Tell your doctor or pharmacist 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 Hydrochloride for you.

Pregnancy, breast-feeding and fertility

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.

Pregnancy

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

Breast-feeding

Bupivacaine may get into breast milk. If you are breast-feeding you should discuss options with your doctor.

Fertility

There are no data on the effect of Bupivacaine on human fertility.

Driving and using machines

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

Bupivacaine Hydrochloride contains Sodium

Each ml of Bupivacaine 2.5 mg/ml solution for injection contains approximately 3.38 mg (0.15 mmol) of sodium. Each ml of Bupivacaine 5 mg/ml solution for injection contains approximately 3.19 mg (0.14 mmol) of sodium. To be taken into consideration by patients on a controlled sodium diet.

3. How to use Bupivacaine Hydrochloride

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

The recommended 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 Hydrochloride will be given to you as an injection. The part of the body where you are injected will depend on why you are being given Bupivacaine Hydrochloride. Your doctor will give you Bupivacaine Hydrochloride 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 Hydrochloride 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.

Use in children and adolscents

Depending on the type of required analgesia, Bupivacaine Hydrochloride is injected into epidural space (part of spine) or other parts of the body by a doctor experienced in paediatric anaesthetic techniques. Dosage depends on the age and weight of the patient and will be determined by the doctor.

If you have been given too much Bupivacaine Hydrochloride solution for injection

Serious side effects from getting too much Bupivacaine Hydrochloride 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 Hydrochloride 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).

The following information is intended for healthcare professionals only:

Any unused solution should be adequately disposed of, in accordance with local requirements.

1. Administration

Solution for injection.

The medicinal product is for percutaneous infiltration, 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. For the paediatric patient’s lowest dose required for adequate analgesia should be used. Package leaflet: Information for the user

Bupivacaine Hydrochloride 2.5 mg/ml Solution for

Injection Bupivacaine Hydrochloride 5 mg/ml Solution for

Injection

To reduce the risk of serious side effects, your doctor will stop giving you Bupivacaine Hydrochloride 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 Hydrochloride, tell your doctor immediately.

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

Method of administration:

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

4. Possible side effects

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

The following side effects have also been reported.

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 Hydrochloride include:

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 the eyes that are long-lasting. This may happen with some injections given around the eyes.

Additional side effects in children and adolescents

Side effects in children are similar to those in adults. 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, pharmacist or nurse. This includes any possible side effects listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www. mhra.gov.uk/yellowcard 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.

5. How to store Bupivacaine Hydrochloride

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, vial 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.

Bupivacaine Hydrochloride is for single use only. Discard any unused solution.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Bupivacaine Hydrochloride contains

The active substance is bupivacaine hydrochloride. Bupivacaine Hydrochloride 2.5 mg/ml:

Each ml contains 2.5 mg of bupivacaine hydrochloride Each ampoule with 10ml solution contains 25 mg of bupivacaine hydrochloride.

Bupivacaine Hydrochloride 5 mg/ml:

Each ml contains 5 mg of bupivacaine hydrochloride Each ampoule with 10ml solution contains 50 mg of bupivacaine hydrochloride.

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

What Bupivacaine Hydrochloride looks like and contents of the pack

Solution for injection.

A clear, colourless, aqueous, sterile solution.

10 ml type I clear glass ampoules.

Each carton contains 1, 5, 10, 20 and 100 ampoules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Eugia (UK) Ltd

Ares Block, Odyssey Business Park

West End Road

Ruislip HA4 6QD

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited

Hf26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Milpharm Limited