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Document: leaflet MAH GENERIC_PL 04569-0979 change

• leaflet MAH GENERIC_PL 04569-0979
• leaflet MAH GENERIC_PL 16363-0221
• leaflet MAH GENERIC_PL 24598-0019

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Package leaflet: Information for the user

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

(piperacillin/tazobactam)

Read all of this leaflet carefully before you start using 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 or pharmacist.

•    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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

2.    What you need to know before you are given Piperacillin/Tazobactam

3.    How Piperacillin/Tazobactam is given

4.    Possible side effects

5.    How to store Piperacillin/Tazobactam

6.    Contents of the pack and other information

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

Piperacillin belongs to the group of medicines known as '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/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/Tazobactam may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).

Piperacillin/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/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/Tazobactam in combination with other antibiotics.

2.    What you need to know before you are given Piperacillin/Tazobactam

Do not use Piperacillin/Tazobactam

• 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.

Warnings and precautions

Talk to your doctor or pharmacist before receiving 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 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.

Children below 2 years

Piperacillin/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/Tazobactam

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 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 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/Tazobactam if you have to provide a blood or urine sample.

Pregnancy, breast-feeding and fertility

If you are pregnant, 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 breastfeeding, your doctor will decide if Piperacillin/Tazobactam is right for you.

Driving and using machines

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

Important information about some of the ingredients of Piperacillin/Tazobactam

Piperacillin/Tazobactam 4 g/0.5 g contains 9.4 mmol (216 mg) of sodium per vial of powder for solution for infusion.

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

3.    How Piperacillin/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.

Adults and adolescents aged 12 years or older

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 following information is intended for medical or healthcare professionals only:

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

Instructions for use

Piperacillin/Tazobactam will be given by intravenous infusion (a drip for 30 minutes).

Intravenous use

Each injection vial of Piperacillin/Tazobactam needs to be reconstituted by adding 50 ml of one of the following solutions:

•    Sterile water for injection

•    0,9% (9 mg/ml) sodium chloride solution for injection

•    Glucose 5%

In a first step, add the volume of solution indicated in the table below to each injection vial:

Content of the vial	Volume of solution to be added to the vial
2 g/0.25 g (2 g piperacillin and 0.25 g tazobactam)	10 ml
4 g/0.50 g (4 g piperacillin and 0.5 g tazobactam)	20 ml

Shake strongly the medicinal product during 1 to 2 minutes and following this step, add the same solution to make total volume to 50 ml.

Shake strongly the medicinal product again until it is completely dissolved.

The reconstituted solutions should be withdrawn from the vial by syringe. When reconstituted as directed, the vial contents withdrawn by syringe will provide the labelled amount of piperacillin and tazobactam.

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). Patients with kidney problems

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.

If you receive more Piperacillin/Tazobactam than you should

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 miss a dose of Piperacillin/Tazobactam

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

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

4.    Possible side effects

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

The serious side effects of Piperacillin/Tazobactam are:

•    swelling of the face, lips, tongue or other parts of the body

•    shortness of breath, wheezing or trouble breathing

•    severe rash, itching or hives on the skin

•    yellowing of the eyes or skin

•    damage to blood cells (the signs include: being breathless when you do not expect it, red or brown urine, nosebleeds and bruising)

If you notice any of the above, see a doctor straight away. For frequency of these reactions, refer to the information below.

Common (may affect up to 1 in 10 people)

•    diarrhoea, vomiting, nausea

•    skin rashes

Uncommon (may affect up to 1 in 100 people)

•    thrush

•    (abnormal) decrease in white blood cells (leukopenia, neutropenia) and platelets (thrombocytopenia)

•    allergic reaction

•    headache, sleeplessness

•    low blood pressure, inflammation of the veins (felt as tenderness or redness in the affected area)

•    jaundice (yellow staining of the skin or whites of the eyes), inflammation of the mucous lining of the mouth, constipation, indigestion, stomach upset

•    increase of certain enzymes in the blood (alanine aminotransferase increased, aspartate aminotransferase increased)

•    itching, nettle rash

•    increase of muscle metabolism product in the blood (blood creatinine increased)

•    fever, injection site reaction

•    yeast infection (candidal superinfection)

Rare (may affect up to 1 in 1,000 people)

•    (abnormal) decrease of red blood cells or blood pigment / haemoglobin, (abnormal) decrease of red blood cells due to premature breakdown (degradation) (haemolytic anaemia), small spot bruising (purpura), bleeding of the nose (epistaxis) and bleeding time prolonged, (abnormal) increase of a specific type of white blood cells (eosinophilia)

•    severe allergic reaction (anaphylactic/anaphylactoid reaction, including shock)

•    flushed red skin

•    a certain form of infection of the colon (pseudomembranous colitis), abdominal pain

•    inflammation of the liver (hepatitis), increase of a blood pigments breakdown product (bilirubin), increase of certain enzymes in the blood (blood alkaline phosphatase increased, gamma-glutamyltransferase increased)

•    skin reactions with redness and formation of skin lesions (exanthema, erythema multiforme), skin reactions with blistering (bullous dermatitis)

•    joint and muscle pain

•    poor kidney functions and kidney problems

•    rigors chill / rigidity

Very rare (may affect up to 1 in 10,000 people)

•    severe decrease of granular white blood cells (agranulocytosis), severe decrease of red blood cells, white blood cells and platelets (pancytopenia)

•    prolonged time for blood clot formation (prolonged partial thromboplastin time, prothrombin time prolonged), abnormal lab test (positive direct Coombs), increase of platelets (thrombocythaemia)

•    decrease of potassium in the blood (hypokalaemia), decrease of blood sugar (glucose), decrease of the blood protein albumin, decrease of blood total protein

•    detachment of the top layer of the skin all over the body (toxic epidermal necrolysis), serious bodywide allergic reaction with skin and mucous lining rashes and various skin eruptions (Stevens-Johnson Syndrome)

•    blood urea nitrogen increased

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

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 at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Piperacillin/Tazobactam

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

Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP” The expiry date refers to the last day of that month.

Unopened vials: Do not store above 25°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 throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Piperacillin/Tazobactam contains

The active substances are piperacillin and tazobactam.

Each vial contains 4 g piperacillin (as sodium salt) and 0.5 g tazobactam (as sodium salt).

There are no other ingredients.

What Piperacillin/Tazobactam looks like and contents of the pack

Piperacillin/Tazobactam is a white to off-white powder supplied in a vial.

Packs containing 1, 5, 10, 12 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer:

Laboratorio Pharmaceutico C.T.S.r.l. - Via Dante Alighieri, 71 - 18038 SANREMO - IM - Italy.

Mitim S.r.l. Via Rodi n^o 27, 25126 Brescia, Italy.

Detailed information on this medicine is available on the web site of MHRA: http://www.mhra.gov.uk/index.htm

This leaflet was revised in: January 2016.

PR791520 / 791520

Incompatibilities

Whenever Piperacillin/Tazobactam is used concurrently with another antibiotic (e.g. aminoglycosides), the substances must be administered separately. The mixing of beta-lactam antibiotics with aminoglycosides, in vitro, can result in substantial inactivation of the aminoglycoside). Piperacillin/Tazobactam should not be mixed with other substances in a syringe or infusion bottle since compatibility has not been established.

Because of chemical instability, Piperacillin/Tazobactam should not be used with solutions containing sodium bicarbonate.

Lactated Ringer's (Hartmann's) solution is not compatible with Piperacillin/Tazobactam. Piperacillin/Tazobactam should not be added to blood products or albumin hydrolysates. Co-administration of Piperacillin/Tazobactam with aminoglycosides

Due to the in vitro inactivation of the aminoglycoside by beta-lactam antibiotics, Piperacillin/Tazobactam and the aminoglycoside are recommended for separate administration. Piperacillin/Tazobactam and the aminoglycoside should be reconstituted and diluted separately when concomitant therapy with aminoglycosides is indicated.

Piperacillin/Tazobactam should be administered through an infusion set separately from any other drugs unless compatibility is proven.

Special precautions for storage Before first opening:

Do not store above 25°C.

After reconstitution/dilution:

To reduce the risk of microbial contamination, reconstituted/diluted solutions should be used immediately. If not used immediately, in use storage times and conditions prior to administration are the responsibility of the user.

v1/May 2015