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Piperacillin/Tazobactam 4g/0.5g Powder for Solution for Infusion

Active Ingredient:
piperacillin sodium , tazobactam sodium
Company:  
Wockhardt UK Ltd See contact details
ATC code: 
J01CR05
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 18 Jul 2023
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 29831/0341.

{printer} Print patient leaflet as text only

Piperacillin-Tazobactam 2g/0.25g & 4g/0.5g Powder for Solution for Infusion

Package leaflet: Information for the user

Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Infusion

Piperacillin/Tazobactam 4g/0.5g Powder for Solution for Infusion

Piperacillin (as Sodium) with Tazobactam (as Sodium)

Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine is 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.

The name of your medicine is Piperacillin/Tazobactam 2g/0.25g and 4g/0.5g Powder for Solution for Infusion.

In the rest of this leaflet Piperacillin/Tazobactam 2g/0.25g and 4g/0.5g Powder for Solution for Infusion is called Piperacillin with Tazobactam.

What is in this leaflet:

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

1. What Piperacillin with Tazobactam is and what it is used for

Piperacillin belongs to the group of medicines called broad-spectrum penicillin antibiotics. It can kill many kinds of bacteria. Tazobactam can prevent some resistant bacteria from surviving the effects of piperacillin. This means that when piperacillin and tazobactam are given together, more types of bacteria are killed.

Piperacillin with Tazobactam is used in adults and adolescents to treat bacterial infections, such as those affecting the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin or blood. Piperacillin with Tazobactam may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).

Piperacillin with Tazobactam is used in children aged 2-12 years to treat infections of the abdomen such as appendicitis, peritonitis (infection of the fluid and lining of the abdominal organs), and gallbladder (biliary) infections.

Piperacillin with Tazobactam may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).

In certain serious infections, your doctor may consider using Piperacillin with Tazobactam in combination with other antibiotics.

2. What you need to know before you are given Piperacillin with Tazobactam
Do not use Piperacillin with Tazobactam:
  • if you are allergic to piperacillin or tazobactam or any of the other ingredients of this medicine
  • if you are allergic to antibiotics known as penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to Piperacillin with Tazobactam.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before being given Piperacillin with 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 liver or kidney 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 Using other medicines 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.

Children below 2 years

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

Other medicines and Piperacillin with Tazobactam

Please tell your doctor or other healthcare professional if you are taking, 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 tor 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 to tobramycin or gentamycin. Tell your doctor if you have kidney problems.

Effect on laboratory tests

Tell the doctor or laboratory staff that you are taking Piperacillin with Tazobactam if you have to provide a blood or urine sample.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are trying to become pregnant, tell your doctor or other healthcare professional before receiving this product. Your doctor will decide if this medicine 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 whether this medicine is right for you.

Your doctor will advise you if you should have this medicine.

Driving and using machines

The use of Piperacillin with Tazobactam is not expected to affect the ability to drive or use machines.

Piperacillin with Tazobactam contains sodium

Piperacillin/Tazobactam 2g/0.25g contains 4.72mmol (109mg) of sodium per vial of powder for solution for infusion.

Piperacillin/Tazobactam 4g/0.5g contains 9.44mmol (217mg) of sodium per vial of powder for solution for infusion.

To be taken into consideration by patients on a controlled sodium diet.

3. How Piperacillin with Tazobactam is given

Your doctor or other healthcare professional will give you this medicine through an infusion (a drip for 30 minutes) into one of your veins. 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.

This product must not be mixed or Co-administered with any aminoglycoside and must not be reconstituted or diluted with Lactated Ringer’s (Hartmann’s) solution.

Adults and adolescents aged 12 years or older

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

Children aged 2 to 12 years

The recommended dose for children with abdominal infections is 100mg/12.5mg/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 80mg/10mg/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 the daily dose will not exceed 4g/0.5g.

You will be given Piperacillin with Tazobactam 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 with 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.

If you are given more Piperacillin with Tazobactam than you should

As you will be given Piperacillin with Tazobactam by 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 miss a dose of Piperacillin with Tazobactam

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

If you have any further questions on the use of this medicine, ask your doctor or other health care professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

See a doctor immediately if you experience any of these potentially serious side effects with this medicine:

The serious side effects (with frequency in brackets) of this medicine are:

  • serious skin rashes [Stevens-Johnson syndrome, dermatitis bullous (Not known), dermatitis exfoliative (Not known) toxic epidermal necrolysis (Rare)] appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs include ulcers in the mouth, throat, nose, extremities, genitals and conjunctivitis (red and swollen eyes). The rash may progress to widespread blistering or peeling of the skin and potentially may be life-threatening
  • severe potentially fatal allergic condition (drug reaction with eosinophilia and systemic symptoms) that can involve the skin and most importantly other organs under the skin such as the kidney and the liver
  • a skin condition (acute generalised exanthematous pustulosis) accompanied by fever, which consists of numerous tiny fluid filled blisters contained within large areas of swollen and reddened skin
  • swelling of the face, lips, tongue or other parts of the body (not known)
  • shortness of breath, wheezing or trouble breathing (not known)
  • severe rash or hives (uncommon), itching or rash on the skin (common)
  • yellowing of the eyes or skin (not known)
  • damage to blood cells [the signs include: being breathless when you do not expect it, red or brown urine (not known), nosebleeds (rare) and small spot bruising (not known)], severe decrease in white blood cells (Rare)
  • severe or persistent diarrhoea accompanied by a fever or weakness (rare).

If any of the following side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or other healthcare professional.

Very common side effects: may affect more than 1 in 10 people

  • diarrhoea.

Common side effects: may affect up to 1 in 10 people

  • yeast infection
  • decrease in platelets, decrease of red blood cells or blood pigment / haemoglobin, abnormal lab test (positive direct Coombs), prolonged blood clotting time (activated partial thromboplastin time prolonged)
  • decrease in blood protein
  • headache, sleeplessness
  • abdominal pain, vomiting, nausea, constipation, upset stomach
  • increase in blood liver enzymes
  • skin rash, itching
  • abnormal kidney blood tests
  • fever, injection site reaction.

Uncommon side effects: may affect up to 1 in 100 people

  • decrease in white blood cells (leukopenia), prolonged blood clotting time (prothrombin time prolonged)
  • decreased blood potassium, decreased blood sugar
  • fits (convulsions), seen in patients on high doses or with kidney problems
  • low blood pressure, inflammation of the veins (felt as tenderness or redness in the affected area), reddening of skin
  • increase of a blood pigment breakdown product (bilirubin)
  • skin reactions with redness, formation of skin lesions, nettle rash
  • joint and muscle pain
  • chills.

Rare side effects: may affect up to 1 in 1,000 people

  • severe decrease in white blood cells (agranulocytosis), bleeding of the nose
  • serious infection of the colon, inflammation of the mucous lining of the mouth
  • detachment of the top layer of the skin all over the body (toxic epidermal necrolysis).

Not known: frequency cannot be estimated from the available data

  • severe decrease of red blood cells, white blood cells and platelets (pancytopenia), decrease in white blood cells (neutropenia), decrease of red blood cells due to premature breakdown or degradation, small spot bruising, bleeding time prolonged, increase of platelets, increase of a specific type of white blood cells (eosinophilia)
  • allergic reaction and severe allergic reaction
  • inflammation of the liver, yellow staining of the skin or whites of the eyes
  • serious body wide allergic reaction with skin and mucous lining rashes, blistering and various skin eruptions (Stevens-Johnson Syndrome), severe allergic condition involving skin and other organs such as the kidney and the liver (drug reaction with eosinophilia and systemic symptoms), numerous tiny fluid filled blisters contained within large areas of swollen and reddened skin accompanied by fever (acute generalised exanthematous pustulosis), skin reactions with blistering (dermatitis bullous)
  • poor kidney functions and kidney problems
  • a form of lung disease where eosinophils (a form of white blood cell) appear in the lung in increased numbers
  • acute disorientation and confusion (delirium).

Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.

Beta-lactam antibiotics, including piperacillin tazobactam, may lead to signs of altered brain function (encephalopathy) and convulsions.

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, website: www.mhra.gov.uk/yellowcard or search for the 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.

5. How to store Piperacillin with Tazobactam

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

Do not use your medicine after the expiry date which is stated on the carton and the label on the small glass container (vial).

The expiry date refers to the last day of that month.

Do not store above 25°C.

Made-up solutions may be stored for up to 24 hours in a refrigerator (2°C - 8°C). For single use only. Discard any unused solution.

Do not throw away any medicines via wastewater or household waste.Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information
What Piperacillin with Tazobactam contains

The active substances are piperacillin as the sodium salt and tazobactam as the sodium salt. There are no other ingredients.

Piperacillin with Tazobactam2g/0.25g contains 2g of piperacillin (as sodium salt) and 0.25g of tazobactam (as sodium salt).

Piperacillin with Tazobactam4g/0.5g contains 4g of piperacillin (as sodium salt) and 0.5g of tazobactam (as sodium salt).

What Piperacillin with Tazobactam looks like

Piperacillin with Tazobactam is a powder for solution for intravenous infusion.

Contents of the pack

The powder comes in a glass vial with a rubber cap and metal/plastic seal. 1, 2, 5, or 10 vials come in a box. Not all pack sizes may be marketed.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only) Please be ready to give the following information:

Product Name Reference Number

Piperacillin/Tazobactam 2g/0.25g Powder for Solution for Infusion. 29831/0329

Piperacillin/Tazobactam 4g/0.5g Powder for Solution for Infusion. 29831/0341

This is a service provided by the Royal National Institute of Blind People.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Wockhardt UK Limited
Ash Road North
Wrexham
LL13 9UF
UK

Manufacturer:

Laboratory Reig Jofre S.A.
C/Jarama s/n Pol Ind
45007
Toledo
Spain

This leaflet was last revised in 05/2023

103276/8

Wockhardt UK Ltd
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Address
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
Telephone
+44 (0)1978 661 261
Fax
+44 (0)1978 661 702
WWW
www.wockhardt.co.uk
Medical Information e-mail
[email protected]