Pharma – Q Bupivacaine 50 mg/10 ml Injection

PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml is a medicine which is used as a local anaesthetic. It produces loss of feeling or sensation that is confined to one part of the body. PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml belongs to a group of medicines called amide-type anaesthetics. PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml is used for certain medical or surgical procedures e.g., Caesarean section, and for the relief of pain, e.g., labour pain or pain after an operation.

PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml should not be administered to you:

• If you are hypersensitive (allergic) to bupivacaine hydrochloride or to any of the other ingredients of PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml (listed in section 6).
• If you are hypersensitive (allergic) to any other local anaesthetic medicine of the same class (such as lidocaine [lignocaine]) or ropivacaine.
• If you have diseases of the brain or spine such as meningitis or polio.
• 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 brain or spine tumours.
• If you have tuberculosis of the spine.
• 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) or hypovolaemic shock (very low blood pressure leading to collapse).
• If you have problems with clotting of your blood or are on ongoing anticoagulation treatment.

Warnings and precautions

Special care should be taken with PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml: Your doctor will always keep resuscitation (lifesaving) equipment, oxygen, and medication at hand when any local anaesthetic is used. This injection may affect your heart more adversely than other local anaesthetic. It may also affect your central nervous system. These adverse effects may be increased if you have a shortage in the amount of oxygen reaching your tissues or if your body fluids and tissues contain increased levels of acid. You may experience a decrease in blood pressure after you receive anaesthesia into your spine or into the epidural spaces of your spine. You may experience a drop in blood pressure while you are in labour and if your body is not in an appropriate position. Your foetus may be affected following the use of local anaesthetics in labour. Tell your doctor or health care provider before being given the injection:

• If you are old or weak.
• If you have a muscle disorder causing weakness.
• If you have fits, heart, kidney, and/or liver problems. This is because your doctor may need to adjust the dose of PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml.
• 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.
• If you have blood poisoning (septicaemia).

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml. PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml will be given to you by a person who is qualified to do so in a hospital setting. You will receive PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml through an injection. Your doctor will choose the dose that is right for you. Your dose will be calculated individually according to certain criteria which your doctor will take into consideration, depending on the type of surgery and the duration of anaesthesia required. PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml will not be given to children younger than 12 years of age. If you have the impression that the effect of PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml is too strong or too weak, talk to your doctor or pharmacist.

PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml can have side effects. Not all side effects reported for PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following serious side effects occur, stop receiving PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are serious side effects, and you may have had an allergic reaction to PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml. You may need urgent medical care or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Dysfunction of the heart, drop in blood pressure and heart rate,
• Abnormal heart rhythms and heart attacks may occur,
• Failure to breathe and coma.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

• Frequent Pins and needles
• Dizziness
• Slow heartbeat
• Changes in blood pressure (usually low blood pressure). This might make you feel dizzy or lightheaded
• High blood pressure
• Feeling sick (nausea) or being sick (vomiting)

Less frequent:

• Excitation, depression and nervousness
• Fits (seizures)
• Numbness of the tongue or around the mouth
• Ringing in the ears or being sensitive to sound
• Loss of consciousness
• Blurred vision, double vision
• Shaking (tremors)
• Light headedness
• Difficulty speaking
• Twitching of your muscles
• Chill or fever
• Drowsiness
• 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
• Partial loss of movement (paresis)
• Spinal cord injury (paraplegia)
• Slowed or stopped breathing
• Problems with your liver enzymes (this may happen if you have long-term treatment with this medicine)
• Skin rash or itching
• Skin reaction at the injection site

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of PHARMA - Q BUPIVACAINE INJECTION 50 mg/10 ml.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light.