Hyperbaric Bupivacaine Hydrochloride Injection 0.5% W/V

MercuryPharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Hyperbaric Bupivacaine Hydrochloride Injection

0.5%w/v

Bupivacaine Hydrochloride

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2. Before you are given Hyperbaric Bupivacaine Hydrochloride Injection

3. How Hyperbaric Bupivacaine Hydrochloride Injection is given to you

4. Possible side effects

5. How to store Hyperbaric Bupivacaine Hydrochloride Injection

6. Further information

1. WHAT HYPERBARIC BUPIVACAINE HYDROCHLORIDE INJECTION IS AND WHAT IT IS USED FOR

Bupivacaine belongs to a group of medicines called amide-type anaesthetics. Hyperbaric Bupivacaine Hydrochloride injection is used to numb (anaesthetise) parts of the body during surgery in adults and children of all ages.

Hyperbaric Bupivacaine Hydrochloride Injection may be used by injecting it around the spinal cord, e.g as an epidural, to prevent or relieve pain during a surgical operation. It is suitable for operations on the urinary tract or legs lasting 2-3 hours, and operations on the abdomen lasting 45-60 minutes.

2. BEFORE YOU ARE GIVEN HYPERBARIC BUPIVACAINE HYDROCHLORIDE INJECTION

You should not be given this medicine if:

• you know you are allergic to bupivacaine or to any other amide-type of local anaesthetic, or to any of the other ingredients (see Section 6 of this leaflet).

You should not be given this Injection in the spinal cord if:

• you have an infection of the skin with pus at or near the site to be injected

• you 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

• you are suffering from any infection, disease or tumour of the brain or spinal cord

• you are suffering from a disorder affecting the clotting of the blood or if you are taking anticoagulants to prevent blood clots

• You have bleeding inside the head (intracranial haemorrhage).

Speak to your doctor or midwife if one of these applies to you before you are given this medicine. Take special care and tell your doctor if:

• you suffer from any liver and kidney problems

• you suffer from any heart problem, particularly if it affects the heart rate

• you suffer from severe shock or low blood pressure

• you have breathlessness or restriction to breathing from fluid or a large tumour in the abdomen

• you have accumulation of fluid around the lungs

• you 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)

• you are elderly (senile) or in poor health

• you are in the late stages of pregnancy

• you suffer from blood poisoning (septicaemia)

• you have high blood pressure during pregnancy

• you have problems with the circulation of blood to the brain

• you have excess fluid in the womb during pregnancy (hydramnios)

• you have a tumour of the ovary or the womb

• you have accumulation of excess fat in your body.

Taking other medicines:

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

Some drugs can interact with Hyperbaric Bupivacaine Hydrochloride Injection which can significantly alter their effects. These drugs include:

• any medication used to regulate the heart beat such as lidocaine, amiodarone, mexiletine. Some drugs may increase the risk of side effects with Hyperbaric Bupivacaine Hydrochloride. These drugs include:

• an anticoagulant e.g. aspirin (to reduce the clotting power of the blood)

• medicines to raise or lower your blood pressure including betablockers, e.g. atenolol, bisoprolol. If you are already taking one of these medicines, speak to your doctor before you receive Hyperbaric Bupivacaine Hydrochloride Injection.

Pregnancy and breast-feeding:

Tell your doctor before you are given this medicine if you are pregnant, think you may be pregnant or are planning to become pregnant, or are breast-feeding. However, as with all drugs Hyperbaric Bupivacaine Hydrochloride Injection should only be given in early pregnancy if absolutely necessary.

Driving and using machines:

Certain areas of your body will be numb for about 24 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.

3. HOW HYPERBARIC BUPIVACAINE HYDROCHLORIDE INJECTION IS GIVEN TO YOU

Hyperbaric Bupivacaine Hydrochloride Injection should only be administered by a doctor who will, in the case of an injection given in the spinal cord, have the necessary knowledge and experience in the technique of spinal anaesthesia.

Before administrating an injection in to the spinal cord, your doctor may inject a test dose of Hyperbaric Bupivacaine Hydrochloride Injection to ensure that the solution is not directed into a blood vessel.

Your doctor will decide on the most suitable dosage for your particular case and may decide to reduce the dose if you are young, or elderly, or in a weak condition. If you are concerned about how much of this medicine you have received, speak to your doctor immediately.

If you are given more Hyperbaric Bupivacaine Hydrochloride Injection than you should As Hyperbaric Bupivacaine Hydrochloride Injection is administered by a healthcare professional it is unlikely that you will be given too much. If you are at all concerned, speak to your doctor.

In this event, you will be treated in the hospital and you will be given the necessary treatment.

If you miss a dose of Hyperbaric Bupivacaine Hydrochloride Injection

This is unlikely as the injection is given by a healthcare professional but if you are concerned

about missing a dose, speak to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Use in children and adolescents

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Hyperbaric Bupivacaine Hydrochloride Injection can sometimes cause side effects, although not everyone gets them.

All medicines can cause allergic reactions although serious allergic reactions are rare.

Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately. Other serious side effects are also rare, but may occur if too much Hyperbaric Bupivacaine Hydrochloride Injection is given or if the drug is unintentionally injected into a blood vessel.

If you notice any of the following effects inform your doctor immediately.

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).

Common (affects less than 1 in 10 people):

• Being sick (Vomiting)

• Feeling dizzy

• Pins and needles

• High blood pressure

• Slow heart beat

• Problems in 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 (affects less than 1 in 100 people)

• Feeling light-headed

• Fits

• Ringing in the ears or being sensitive to sound

• Difficulty in speaking

• Numbness of the tongue

• Blurred sight

• Loss of consciousness

• Shaking

• Twitching of your muscles.

Rare (affects less than 1 in 1000 people):

• Double vision

• Nerve damage that may cause changes in sensation or muscle weakness. 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 legs

• Spinal cord injury (paraplegia)

• Partial loss of movement (paresis)

• Uneven heart beat or stopped heart beat. This could be life threatening

• Slowed or stopped breathing.

Possible side effects seen with other local anaesthetics which might also be caused by Bupivacaine include:

• Problems with your liver enzymes. This may happen if you have long-term treatment with this medicine

• Damage nerves. Rarely this may cause permanent problems

• Blindness which is not permanent

• Problems with the muscles of 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.

Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effect get serious or you notice any side effects not listed in this leaflet, please tell your doctor or midwife.

Reporting of side effects

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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom Yellow Card Scheme

Freephone: 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays)

Website: www.mhra.gov.uk/yellowcard

5. HOW TO STORE HYPERBARIC BUPIVACAINE HYDROCHLORIDE INJECTION

Keep out of the reach and sight of children.

Do not use Hyperbaric Bupivacaine Hydrochloride Injection after the expiry date which is stated on the ampoule and carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

Keep the container in the outer carton in order to protect from light.

This medicine should not be mixed with any other drugs unless compatibility is known.

The solution must not be stored in contact with metals e.g. needles or metal parts of syringes, as dissolved metal ions may cause swelling at the site of the injection.

If only part of the solution is used, or if the contents of the ampoule are discoloured, the rest should be thrown away.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

The active substance is bupivacaine hydrochloride.

The other ingredients are dextrose monohydrate, sodium hydroxide and water for injections.

What Hyperbaric Bupivacaine Hydrochloride Injection looks like and contents of pack

Hyperbaric Bupivacaine Hydrochloride Injection is a colourless or almost colourless, aqueous, sterile solution for injection. Each ml contains bupivacaine Hydrochloride 5.28mg equivalent to anhydrous bupivacaine hydrochloride 5mg.

Hyperbaric Bupivacaine Hydrochloride Injection 0.5% w/v is available as 4ml clear glass ampoules in packs of 10.

Marketing authorization holder

Mercury Pharma International Ltd, Roscrea, Co. Tipperary, Ireland.

Manufacturer

B.Braun Melsungen AG, Mistelweg 2, Berlin, 12357, Germany This leaflet was last revised in: September 2013.

101620/LF/2