Document: leaflet MAH GENERIC_PL 02848-0117 change

• leaflet MAH GENERIC_PL 02848-0117
• leaflet MAH GENERIC_PL 02848-0179

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MercuryPharma

PATIENT INFORMATION LEAFLET

Bupivacaine Hydrochloride 0.25% w/v Solution for Injection and Bupivacaine Hydrochloride 0.5% w/v Solution for 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 are to be injected in a vein of the hands or legs. (Bier's block).

•    Adrenaline containing bupivacaine should not be given for special techniques (like penile block, Oberst block) to numb the part of the body where areas with end arteries are affected.

You should not be given this Injection as an epidural 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 have problems with the clotting of your blood or are taking any anticoagulant drugs that thin the blood

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

•    you have bleeding inside the head (intracranial haemorrhage)

•    you have increased pressure within the brain.

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 or midwife 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 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

•    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).

Taking other medicines:

Tell your doctor or midwife 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 Bupivacaine Hydrochloride Injection which can significantly alter their effects. These drugs include:

•    lidocaine, amiodarone, mexiletine (or any other medicine with local anaesthetic effect) for controlling the heart's rhythm.

Some drugs may increase the risk of side effects with Bupivacaine Hydrochloride Injection in certain situations. These drugs include:

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

•    medicines to lower your blood pressure including betablockers, e.g. atenolol, bisoprolol.

If you are already taking one of these medicines, speak to you doctor or midwife before you receive Bupivacaine Hydrochloride Injection.

Pregnancy and breastfeeding:

Tell your doctor/midwife before you are given this medicine if you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding. There is no evidence of harmful effects in pregnancy or breastfeeding. However as with all drugs, Bupivacaine Hydrochloride Injection should only be given in early pregnancy if absolutely necessary.

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

Driving and using machines:

Certain areas of your body will be numb for about 2-4 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.

continued overleaf

Bupivacaine Hydrochloride 0.25% w/v Solution for Injection and

Bupivacaine Hydrochloride 0.5% w/v Solution for Injection

MercuryPharma

3. HOW BUPIVACAINE HYDROCHLORIDE INJECTION IS GIVEN TO YOU

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

Before administrating an epidural Injection, your doctor may inject a test dose of 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.

Use in children and adolescents

Depending on the type of required analgesia 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.

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

5. HOW TO STORE BUPIVACAINE HYDROCHLORIDE INJECTION

Keep this medicine out of the sight and reach of children.

The solution should not be used after the expiry date printed 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 an ampoule is used, the remaining solution should be discarded.

The solution should not be used if it is discoloured in any way.

6. FURTHER INFORMATION

The active substance is bupivacaine hydrochloride.

The other ingredients are sodium chloride and sodium hydroxide and water for Injection.

What Bupivacaine Hydrochloride Injection looks like and contents of pack

Bupivacaine Hydrochloride Injection is a colourless or almost colourless, aqueous, sterile solution for injection and is available in two strengths:

Bupivacaine Hydrochloride Injection 0.25%w/v. Each 1ml contains 2.5mg of anhydrous bupivacaine hydrochloride.

Bupivacaine Hydrochloride Injection 0.5%w/v. Each 1ml contains 5mg of anhydrous bupivacaine hydrochloride.

Both product strengths are available as either:

•    10ml and 20ml clear glass ampoules in packs of 10 or

•    10ml and 20ml individual sterile wrapped clear glass ampoules in packs of 10.

Marketing authorisation holder

Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park,

Co Dublin, Ireland.

Manufacturer

B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.

Alternative site

Mercury Pharmaceuticals Limited,

Capital House, 85 King William Street, London EC4N 7BL, United Kingdom This leaflet was last revised in April 2015.

100407/LF/021/04, 100409/LF/021 /04