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 4 g/0.5 g powder for solution for infusion is and what it is used for
2. What you need to know before you use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
3. How to use Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
4. Possible side effects
5. How to store Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
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 4 g/0.5 g powder for solution for infusion

Talk to your doctor, pharmacist or nurse before using Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion

• 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 another antibiotic called vancomycin at the same time as Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion, this may increase the risk of kidney injury (see also Other medicines and Piperacillin/Tazobactam 4 g/ 0.5 g powder for solution for infusion in this leaflet).
• if you are taking certain medicines (called anticoagulants) to avoid an excess of blood clotting (see also Other medicines and Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion 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 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.
• Haemophagocytic lymphohistiocytosis
  There have been reports about a disease in which the immune system makes too many of otherwise normal white blood cells called histiocytes and lymphocytes, resulting in inflammation (haemophagocytic lymphohistiocytosis). This condition may be life-threatening if not diagnosed and treated early. If you experience multiple symptoms such as fever, swollen glands, feeling weak, feeling lightheaded, shortness of breath, bruising, or skin rash, contact your doctor immediately.

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

Please tell your doctor or pharmacist 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.
• methotrextate (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. Taking Piperacillin/tazobactam and vancomycin at the same time may increase the risk of kidney injury even if you have no kidney problems.

Tell the doctor or laboratory staff that you are taking Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion 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 4 g/0.5 g powder for solution for infusion 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 4 g/0.5 g powder for solution for infusion is right for you.

The use of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion is not expected to affect the ability to drive or use machines.

This medicinal product contains 217 mg (9.44 mmol) sodium per vial, equivalent to 10.8% of the WHO recommended maximum daily intake of 2g sodium for an adult.

• 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 old

The usual dose is 4 g/0.5 g 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 4 g/0.5 g powder for solution for infusion.

You will be given Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion until the sign of infection has gone completely (5 to 14 days).

Patients with kidney problems

Your doctor may need to reduce the dose of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion 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 4 g/0.5 g powder for solution for infusion 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 4 g/0.5 g powder for solution for infusion, tell your doctor or other healthcare professional immediately.

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 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.

• The active substances are piperacillin and tazobactam.
  Each vial contains 4 g piperacillin (as piperacillin sodium) and 0.5 g tazobactam (as tazobactam sodium).
• This medicine does not include any other ingredient.

Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion comes in packs containing one small bottle of powder which must be dissolved into a solution before it is given to you by infusion (a slow ‘drip’) into your vein.

Packs containing 1 vial; 10 vials (clinical package); 50 vials (clinical package); 100 vials (clinical package).

Not all pack sizes may be marketed.

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