Marcain Heavy Steripack 0.5% w/v Solution for Injection
1. What Marcain Heavy is and what it is used for
2. What you need to know 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. Contents of the pack and other information
The name of your medicine is ‘Marcain Heavy Steripack 0.5% w/v Solution for Injection’. It is referred to as Marcain Heavy in the rest of this leaflet. Marcain Heavy contains the active substance called bupivacaine hydrochloride. It belongs to a group of medicines called local anaesthetics.
Marcain Heavy is used to numb (anaesthetise) parts of the body during surgery in adults and children of all ages. It stops pain happening during surgery (operations).
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.
Talk to your doctor or nurse before having Marcain Heavy:
If you are not sure if any of the above apply to you, talk to your doctor or nurse before using Marcain Heavy.
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 Marcain Heavy can affect the way some medicines work and some medicines can have an effect on Marcain Heavy.
You must not be given Marcain Heavy if you are having the following:
Also tell your doctor if you are taking any of the following medicines:
Your doctor needs to know about these medicines to be able to work out the correct dose of Marcain Heavy for you.
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 taking this medicine
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.
This medicinal product contains less than 1 mmol sodium (23 mg) per ampoule. This is considered essentially sodium free.
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.
Marcain Heavy is injected slowly into the spinal channel (part of the spine) 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.
When Marcain Heavy is injected, it stops the nerves from being able to pass pain messages to the brain.
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:
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.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
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.
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.
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
The active ingredient is bupivacaine hydrochloride anhydrous. Each millilitre (ml) of solution contains 5 mg of bupivacaine hydrochloride anhydrous.
The other ingredients are glucose anhydrous, sodium hydroxide and water for injections.
Marcain Heavy is a clear, colourless solution for injection. It comes in 5 ml type I (Ph. Eur) clear glass ampoules. Each ampoule contains 4 ml of solution for injection. The product comes in blisters of 5 ampoules.
The Marketing Authorisation for Marcain Heavy marketed in Ireland and Malta is held by
Marcain Heavy is manufactured by