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BUPIVACAINE HYDROCHLORIDE 2.5 MG/ML SOLUTION FOR INJECTION

Active substance(s): BUPIVACAINE HYDROCHLORIDE / BUPIVACAINE HYDROCHLORIDE / BUPIVACAINE HYDROCHLORIDE

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Bupivacaine Hydrochloride 2.5 mg/ml
Solution for Injection
Bupivacaine Hydrochloride 5 mg/ml
Solution for Injection
Bupivacaine hydrochloride

P15XXXXX

Bupivacaine Hydrochloride
2.5mg/ml 5 mg/ml

P15XXXXX

Bupivacaine Hydrochloride
2.5mg/ml 5 mg/ml

Package leaflet: Information for the user

Warnings and precautions
Talk to your doctor or, pharmacist or nurse before using Bupivacaine
Hydrochloride :
• If you are elderly and are in a generally impaired condition
• if you have any heart, liver or kidney problems. This is because
your doctor may need to adjust the dose of Bupivacaine
Hydrochloride.
• 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.

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist
or nurse.
- This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
- 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. See section 4.

Children
In children < 12 years as some injections of Bupivacaine Hydrochloride
in order to numb parts of the body during surgery are not established
in younger children Bupivacaine Hydrochloride is not established in
children < 1 year.

What is in this leaflet
1. What Bupivacaine Hydrochloride is and what it is used for
2. What you need to know before you use Bupivacaine
Hydrochloride
3. How to use Bupivacaine Hydrochloride
4. Possible side effects
5. How to store Bupivacaine Hydrochloride
6. Contents of the pack and other information

Taking some medicines together can be harmful. Remember that
the doctor at the hospital may not have been informed if you have
recently begun a course of treatment for another illness. In particular
tell your doctor if you are taking

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

If you are not sure if any of the above apply to you, talk to your doctor
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.

• medicines to control your heartbeat (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.

Bupivacaine Hydrochloride contains the active substance bupivacaine
hydrochloride. It belongs to a group of medicines called amide-type
local anaesthetics. It produces a loss of feeling or sensation that is
confined to one part of the body.

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.

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
• surgical operations, including obstetric operations such as
caesarean section
• relief of acute pain including labour pain or pain after an operation

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

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

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.

Do not use Bupivacaine Hydrochloride :

3. How to use Bupivacaine Hydrochloride

• if you are allergic to bupivacaine hydrochloride or to 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).
• adrenaline containing bupivacaine for special techniques (e.g.
penile block, Oberst block) to numb parts of the body where
areas with end arteries are affected

Bupivacaine Hydrochloride will be given to you by your doctor who
will have the necessary knowledge and experience in the technique
of epidural anaesthesia.

You must not be given Bupivacaine Hydrochloride if any of the above
apply to you. If you are not sure, talk to your doctor before you are
given Bupivacaine solution for injection.

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

The following information is intended for healthcare professionals only:

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.

You must talk to a doctor if you do not feel better or if you feel worse
after {number of} days

Any unused solution should be adequately disposed of, in accordance
with local requirements.
1. Administration
Solution for injection.

Black

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.

If you take more Bupivacaine Hydrochloride than you should
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).
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.

• 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
Adverse drug reactions in children are similar to those in adults.
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 Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard. 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.

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

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.

If you forget to take Bupivacaine Hydrochloride
If you think you have missed a dose, please tell your doctor or nurse.
Do not take a double dose to make up for a forgotten dose.

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

If you have any further questions on the use of this medicine, ask your
doctor, or pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

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.

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:

What Bupivacaine Hydrochloride contains

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).

− 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.

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).

Bupivacaine Hydrochloride 5 mg/ml:
Each ml contains 5 mg of bupivacaine hydrochloride
Each ampoule with 10ml solution contains 50 mg of bupivacaine
hydrochloride.

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.

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

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.
2. Handling Instructions
For single use only.
Only clear solutions practically free from particles should be used.
Any unused solution should be discarded.
Do not use this medicine after the expiry date, which is stated on the
ampoule, vial and carton. The expiry date refers to the last day of
that month.

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
Milpharm Limited
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
Or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 11/2016.

Storage information
This medicinal product does not require any special storage
conditions

P15XXXXX

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.

6. Contents of the pack and other information

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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