Marcain Heavy 0.5% solution for injection
bupivacaine hydrochloride
Read all of this leaflet carefully before Marcain Heavy is given to you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- 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 nurse.
In this leaflet:
- 1. What Marcain Heavy is and what it is used for
- 2. Before Marcain Heavy is given to you
- 3. How Marcain Heavy is given to you
- 4. Possible side effects
- 5. How to store Marcain Heavy
- 6. Further information
What Marcain Heavy is and what it is used for
Marcain Heavy contains a medicine called bupivacaine hydrochloride. It belongs to a group of medicines called local anaesthetics.
Marcain Heavy is used to numb (anaesthetise) parts of the body. It stops pain happening during surgery (operations).
Before Marcain Heavy is given to you
You must not be given Marcain Heavy if:
- You are allergic (hypersensitive) to bupivacaine hydrochloride or any of the other ingredients of Marcain Heavy (see Section 6: Further information).
- You are allergic to any other local anaesthetics of the same class (such as lidocaine or ropivacaine).
- You have a skin infection near to where the injection will be given.
- You have blood poisoning (septicaemia).
- You have something called cardiogenic shock (a serious condition where the heart is unable to supply enough blood to the body).
- You have something called hypovolaemic shock (very low blood pressure leading to collapse).
- You have problems with clotting of your blood.
- You have diseases of the brain or spine such as meningitis, polio or spondylitis.
- You have a severe headache caused by bleeding inside the head (intracranial haemorrhage).
- You have problems with your spinal cord due to anaemia.
- You have had a recent trauma, tuberculosis or tumours of the spine.
You must not be given Marcain Heavy if any of the above apply to you. If you are not sure, talk to your doctor before you are given Marcain Heavy.
Take special care with Marcain Heavy
Check with your doctor before having Marcain Heavy if:
- You have heart, liver or kidney problems. This is because your doctor may need to adjust the dose of Marcain Heavy.
- You have been told that you have decreased volumes of blood (hypovolaemia).
- You have fluid in your lungs.
If you are not sure if any of the above apply to you, talk to your doctor before you are given Marcain Heavy.
Taking other medicines
Please tell your doctor if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines.
This is because Marcain Heavy can affect the way some medicines work and some medicines can have an effect on Marcain Heavy.
In particular, tell your doctor if you are taking any of the following medicines:
- Other local anaesthetics.
- Medicines used to treat an uneven heart beat (arrhythmia), such as amiodarone.
Your doctor needs to know about these medicines to be able to work out the correct dose of Marcain Heavy for you.
Pregnancy and breast-feeding
Before you are given Marcain Heavy, tell your doctor if you are pregnant, planning to get pregnant, or if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
Marcain Heavy may make you feel sleepy and affect the speed of your reactions. After you have been given Marcain Heavy, you should not drive or use tools or machines until the next day.
How Marcain Heavy is given to you
Marcain Heavy will be given to you by a doctor, who will decide the correct dose. It will be given to you as an injection into the lower part of your spine.
When Marcain Heavy is injected, it stops the nerves from being able to pass pain messages to the brain.
If you have been given too much Marcain Heavy
Serious side effects from getting too much Marcain Heavy need special treatment and the doctor treating you is trained to deal with these situations. The first signs of being given too much Marcain Heavy 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 Marcain Heavy as soon as these signs appear. This means that if any of these happen to you, or you think you have received too much Marcain Heavy, tell your doctor immediately.
More serious side effects from being given too much Marcain Heavy include tremors, fits (seizures) and heart problems.
Possible side effects
Like all medicines, Marcain Heavy may cause side effects although not everybody gets them.
Severe allergic reactions (rare, affect less than 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).
- Very low blood pressure which can make you feel faint or collapse.
Other possible side effects:
Very common (affects more than 1 in 10 people)
- Low blood pressure. This might make you feel dizzy or light-headed.
- Feeling sick (nausea).
- Slow heart beat.
Common (affects less than 1 in 10 people)
- Headache.
- Being sick (vomiting).
- Difficulty in passing urine or being incontinent.
Uncommon (affects less than 1 in 100 people)
- Itching, numbness, burning or tingling of the skin.
- Back pain.
- Muscle weakness for a short time.
Rare (affects less than 1 in 1,000 people)
- Heart attack.
- Difficulty breathing.
- Weakness or loss of feeling or loss of movement in your lower body.
- Long-lasting pain in your back or legs.
- Reduced or strange sensation or feeling in the skin.
Some symptoms can happen if the injection was given in the wrong way by mistake, or if you have been given it with other local anaesthetics. These include fits (seizures), feeling dizzy or light-headed, trembling and numbness of the tongue.
Possible side effects seen with other local anaesthetics which might also be caused by Marcain Heavy include:
- Damaged nerves. Rarely (affecting less than 1 in 1,000 people), this may cause permanent problems.
- If too much Marcain Heavy is given into the spinal fluid, the whole body may become numbed (anaesthetised).
Do not be concerned by this list of possible side effects. You may not get any of them. 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 nurse.
How to store Marcain Heavy
- Keep out of the reach and sight of children.
- Do not use after the expiry date which is stated on the container after EXP. The expiry date refers to the last day of that month.
- Do not store above 25°C.
- Your doctor or the hospital will normally store Marcain Heavy 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 Marcain Heavy correctly.
Further information
What Marcain Heavy contains
The active ingredient is bupivacaine hydrochloride anhydrous. Each millilitre (ml) of solution contains 5 mg of bupivacaine hydrochloride anyhydrous.
The other ingredients are glucose anhydrous, sodium hydroxide and water for injections.
This medicinal product contains less than 1 mmol sodium (23 mg) per ampoule. This is considered essentially sodium free.
What Marcain Heavy looks like and contents of the pack
Marcain Heavy is a clear, colourless solution for injection. It comes in glass ampoules containing 4 ml of solution.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Marcain Heavy is held by
Marcain Heavy is manufactured by
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name: Marcain Heavy 0.5%solution for injection
Reference number 17901/0142
This is a service provided by the Royal National Institute of Blind People.
Leaflet prepared: November 2007.
© AstraZeneca 2007.
Marcain is a trade mark of the AstraZeneca group of companies.
PAI 07 0127a
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