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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 and Tazobactam

Read all of this leaflet carefully before you start taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

The name of your medicine is one of the following:

-    Piperacillin/Tazobactam 2g/0.25g powder for solution for infusion

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

In the rest of this leaflet your medicine is called Piperacillin/Tazobactam.

In this leaflet:

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

2.    Before you are given Piperacillin/Tazobactam

3.    How Piperacillin/Tazobactam is given

4.    Possible side effects

5.    Storing Piperacillin/Tazobactam

6.    Further 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)

•    the urinary tract (kidneys and bladder)

•    the abdomen

•    the 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. BEFORE YOU ARE GIVEN PIPERACILLIN/TAZOBACTAM

Do not use Piperacillin/Tazobactam

•    If you are allergic (hypersensitive) to piperacillin or tazobactam, or any of the other ingredients of Piperacillin/Tazobactam.

•    If you are allergic (hypersensitive) to antibiotics known as penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to Piperacillin/Tazobactam.

Take special care with 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 Taking 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.

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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines may interact with piperacillin and tazobactam.

It is very important to tell your doctor:

•    If you are taking any of the following medicines:

-    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 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 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.

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

This medicinal product contains 4.7mmol (108.1mg) of sodium/vial of powder for solution for infusion.

This medicinal product contains 9.4mmol (216.2mg) of sodium/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 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 the daily 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

A doctor or a nurse will usually give you this medicine. If you miss one of your appointments, please let your doctor know immediately.

If you stop taking Piperacillin/Tazobactam

It is very important to finish the course of treatment your doctor has prescribed, even if you start to feel better. If you do not finish the course of treatment, your condition may get worse again.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Piperacillin/Tazobactam can cause side effects, although not everybody gets them.

Adverse reactions have been ranked as per the seriousness of the side effect and further under heading of frequency. The following conversions have been used for determining frequency:

-    common: affects 1 to 10 users in 100

-    uncommon: affects 1 to 10 users in 1,000

-    rare: affects 1 to 10 users in 10,000

-    very rare: affects less than 1 user in 10,000

The following side effects may occur:

Very serious side effects

If any of the following happen, stop taking Piperacillin/Tazobactam powder for solution for infusion and tell your doctor immediately or go to the casualty department at your nearest hospital

The following are rare side effects:

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

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

The following are very rare side effects:

-    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)

Serious side effects

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

The following are uncommon side effects:

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

-    allergic reaction

-    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)

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

-    yeast infection (candidal superinfection)

The following are rare side effects:

-    (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)

-    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)

-    poor kidney functions and kidney problems

The following are very rare side effects:

-    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

-    blood urea nitrogen increased

Other side effects:

Tell your doctor of you notice any of the following:

Common side effects:

-    diarrhoea, vomiting, nausea

-    skin rashes

The following are uncommon side effects:

-    thrush

-    headache, sleeplessness

-    itching, nettle rash

-    fever, injection site reaction

The following are rare side effects:

-    flushed red skin

-    joint and muscle pain

-    rigors chill / rigidity

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

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

5. STORING PIPERACILLIN/TAZOBACTAM

Keep out of the reach and sight of children.

Do not use Piperacillin/Tazobactam after the expiry date which is stated on the outer carton and the vials after abbreviation (EXP). The expiry date refers to the last day of that month.

Powder:

Store below 25° C. Keep the vials in the outer carton, in order to protect from light.

The reconstituted solution should be used immediately.

For single use only.

Discard any unused solution.

The reconstituted and further diluted solution should be used within 24 hours.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Piperacillin/Tazobactam contains

The active substances are Piperacillin Sodium and Tazobactam Sodium.

Each vial (30ml capacity) contains 2.085g of piperacillin sodium, equivalent to 2g of piperacillin and 0.268g tazobactam sodium equivalent to 0.25g of tazobactam.

Each vial (30ml capacity) contains 4.17g of piperacillin sodium, equivalent to 4g of piperacillin and 0.536g tazobactam sodium equivalent to 0.5g of tazobactam.

Sodium content: 4.7mmol (108.1mg) of sodium/vial of powder for solution for infusion.

Sodium content: 9.4mmol (216.2mg) of sodium/vial of powder for solution for infusion.

There are no other ingredients.

What Piperacillin/Tazobactam looks like and contents of the pack

Piperacillin/Tazobactam is a white to light yellow crystalline powder. Your doctor or nurse will mix it with another solution to give to you as a drip (infusion) into your veins.

Each vial of Piperacillin/Tazobactam contains 2.25g of your medicine.

Each vial of Piperacillin/Tazobactam contains 4.5g of your medicine.

Each pack contains 1, 5, 10 or 20 vials (glass containers) of Piperacillin/Tazobactam.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus.

Manufacturers: 1. DEMO S.A., 21^st km National Road Athens-Lamia, 14568 Krioneri, Athens, Greece, 2. BIOPHARMA S.R.L., Via delle Gerbere S.N.C., Santa Palomba, Pomezia (RM).

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom:	Piperacillin/Tazobactam 2g/0.25g powder for solution for infusion Piperacillin/Tazobactam 4g/0.5g powder for solution for infusion
Germany:	Piperacillin/Tazobactam Noridem 2g/0.25g