Piperacillin/tazobactam 4 g/0.5 g powder for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Piperacillin/tazobactam is and what it is used for
2. What you need to know before you use Piperacillin/tazobactam
3. How to use Piperacillin/tazobactam
4. Possible side effects
5. How to store Piperacillin/tazobactam
6. Contents of the pack and other information

• if you are allergic to piperacillin or tazobactam or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to antibiotics known as penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to piperacillin/tazobactam.

Talk to your doctor, pharmacist or nurse before using Piperacillin/tazobactam.

• if you have allergies. If you have several allergies, make sure you tell your doctor or other healthcare professional before receiving this product.
• if you are suffering from diarrhoea before, or if you develop diarrhoea during or after your treatment. In this case, make sure you tell your doctor or other healthcare professional immediately. Do not take any medicine for the diarrhoea without first checking with your doctor.
• if you have low levels of potassium in your blood. Your doctor may want to check your kidneys before you take this medicine and may perform regular blood tests during treatment.
• if you have kidney or liver problems, or are receiving haemodialysis. Your doctor may want to check your kidneys before you take this medicine, and may perform regular blood tests during treatment.
• if you are taking certain medicines (called anticoagulants) to avoid an excess of blood clotting (see also Other medicines and Piperacillin/tazobactam in this leaflet) or any unexpected bleeding occurs during the treatment. In this case, you should inform your doctor or other healthcare professional immediately.
• if you develop fits (convulsions) during the treatment. In this case, you should inform your doctor or other healthcare professional.
• if you think you developed a new or worsening infection. In this case, you should inform your doctor or other healthcare professional.

The use of piperacillin / tazobactam is not recommended for use in children below the age of 2 years due to insufficient data on safety and effectiveness.

Tell your doctor or other healthcare professional if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. Some medicines may interact with piperacillin and tazobactam.

These include:

• medicine for gout (probenecid). This can increase the time it takes for piperacillin and tazobactam to leave your body.
• medicines to thin your blood or to treat blood clots (e.g. heparin, warfarin or aspirin).
• medicines used to relax your muscles during surgery. Tell your doctor if you are going to have a general anaesthetic.
• methotrexate (medicine used to treat cancer, arthritis or psoriasis). Piperacillin and tazobactam can increase the time it takes for methotrexate to leave your body.
• medicines that reduce the level of potassium in your blood (e.g. tablets enhancing urination or some medicines for cancer).
• medicines containing the other antibiotics tobramycin, gentamicin or vancomycin. Tell your doctor if you have kidney problems.

Effect on laboratory tests

Tell the doctor or laboratory staff that you are taking piperacillin/tazobactam if you have to provide a blood or urine sample.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or other healthcare professional for advice before receiving this medicine. Your doctor will decide if piperacillin/tazobactam is right for you.

Piperacillin and tazobactam can pass to a baby in the womb or through breast milk. If you are breast-feeding, your doctor will decide if piperacillin/tazobactam is right for you.

The use of piperacillin/tazobactam is not expected to affect the ability to drive or use machines.

Piperacillin/tazobactam 2 g / 0.25 g

This medicine contains 103.25 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 5.13% of the recommended maximum daily dietary intake of sodium for an adult.

Piperacillin/tazobactam 4 g / 0.5 g

This medicine contains 206.48 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 10.32% of the recommended maximum daily dietary intake of sodium for an adult.

This should be taken into consideration if you are on a controlled-sodium diet.

The dose of medicine given to you depends on what you are being treated for, your age, and whether or not you have kidney problems.

Adults and adolescents above 12 years of age

The usual dose is 4 g / 0.5 g of piperacillin / tazobactam given every 6-8 hours, which is given into one of your veins (directly into the blood stream).

Children aged 2 to 12 years

The usual dose for children with abdominal infections is 100 mg / 12.5 mg / kg of body weight of piperacillin / tazobactam given every 8 hours into one of your veins (directly into the blood stream).

The usual dose for children with low white blood cell counts is 80 mg / 10 mg / kg of body weight of piperacillin / tazobactam given every 6 hours into one of your veins (directly into the blood stream).

Your doctor will calculate the dose depending on your child’s weight but each individual dose will not exceed 4 g / 0.5 g of piperacillin/tazobactam.

You will be given piperacillin/tazobactam until the sign of infection has gone completely (5 to 14 days).

Your doctor may need to reduce the dose of Piperacillin/tazobactam or how often you are given it.

Your doctor may also want to test your blood to make sure that your treatment is at the right dose, especially if you have to take this medicine for a long time.

As you will receive Piperacillin/tazobactam from a doctor or other healthcare professional, you are unlikely to be given the wrong dose. However, if you experience side effects, such as convulsions, or think you have been given too much, tell your doctor immediately.

If you think you have not been given a dose of Piperacillin/tazobactam, tell your doctor or other healthcare professional immediately.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

Piperacillin/tazobactam 2 g / 0.25 g

• The active substances are piperacillin (as sodium salt) equivalent to 2 g and tazobactam (as sodium salt) equivalent to 0.25 g.
• There are no other ingredients.

Piperacillin/tazobactam 4 g / 0.5 g

• The active substances are piperacillin (as sodium salt) equivalent to 4 g and tazobactam (as sodium salt) equivalent to 0.5 g.
• There are no other ingredients.

Piperacillin/tazobactam 2 g/0.25 g is off-white to white cake or powder for solution for infusion

Available in 30ml Type I glass Vial, butyl rubber stoppers and aluminium plastic combined cap.

Pack sizes: 1, 5, 10, 12, 25 or 50 vials per carton.

Piperacillin/tazobactam 4 g/0.5 g is off-white to white cake or powder for solution for infusion

Available in 50ml Type I glass Vial, butyl rubber stoppers and aluminium plastic combined cap.

Pack sizes: 1, 5, 10, 12, 25 or 50 vials per carton.

Not all pack sizes may be marketed.

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