Package leaflet: Information for the user

Piperacillin/Tazobactam Eberth 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 Eberth is and what it is used for

2. What you need to know before you use Piperacillin/Tazobactam Eberth

3. How to use Piperacillin/Tazobactam Eberth

4. Possible side effects

5. How to store Piperacillin/Tazobactam Eberth

6. Contents of the pack and other information

1. What Piperacillin/Tazobactam Eberth is and what is it 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 Eberth 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 Eberth may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).

Piperacillin/Tazobactam Eberth 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 Eberth 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 Eberth in combination with other antibiotics.

2. What you need to know before usingPiperacillin/Tazobactam Eberth

Do not use Piperacillin/Tazobactam Eberth

• if you are allergic to piperacillin or tazobactamPiperacillin/Tazobactam Eberth .

• if you are allergic to antibiotics known as penicillins, cephalosporins, or other beta-lactamase inhibitors, as you may be allergic to Piperacillin/Tazobactam Eberth .

Warnings and precautions

Talk to your doctor or pharmacist before using Piperacillin/Tazobactam Eberth :

• if you have allergies. If you have several allergies, make sure you tell your doctor or other healthcare professional before receiving this medicine.

• 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 are given 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 Eberth ’ in this leaflet) or any unexpected bleeding occurs during the treatment. In this case, talk to 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 younger than 2 years

Piperacillin/Tazobactam Eberth is not recommended for use in children younger than 2 years due to insufficient data on safety and effectiveness.

Other medicines and Piperacillin/Tazobactam Eberth

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.

In particular, tell your doctor or healthcare professional if you are taking any of the following medicines:

• medicines 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 (for example 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 (for example 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 your doctor or laboratory staff that you are taking Piperacillin/Tazobactam Eberth if you have to provide a blood or urine sample.

Pregnancy and breast-feeding

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 before receiving this medicine. Your doctor will decide if Piperacillin/Tazobactam Eberth 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 Eberth is right for you.

Driving and using machines

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

Piperacillin/Tazobactam Eberth contains sodium

Piperacillin/Tazobactam Eberth This medicine contains contains 9.4 mmol (216 mg) of sodium.

This should be taken into consideration, if you are on a controlled sodium (salt) diet.

3. How to use Piperacillin/Tazobactam Eberth

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.

Use in adults and adolescents aged 12 years or older

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).

Use in 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 child’s 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 child’s 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 Eberth .

You will be given Piperacillin/Tazobactam Eberth 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 Eberth 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 Eberth than you should

As you will receive Piperacillin/Tazobactam Eberth 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 Eberth

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

If you have any further questions on the use of this medicine, 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 Eberth 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 is, 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)

mucous lining of the mouth, constipation, indigestion, stomach upset

aminotransferase increased)

• itching, nettle rash

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

• fever, injection site reaction

• yeast infection (candida 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)

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.

If you get any side effects, talk to your doctor or healthcare professional. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in <to be completed in National Phase>.By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Piperacillin/Tazobactam Eberth

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 the vial after “EXP“. The expiry date refers to the last day of that month.

Unopened vials: Store in the original package in order to protect from light.

For single use only.

Discard any unused solution.

Reconstituted and/or diluted Piperacillin/Tazobactam Eberth should be used immediately.

From a microbiological point of view, the product should be used immediately.

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. Content of the pack and other information

What Piperacillin/Tazobactam Eberth contains

Each vial contains piperacillin sodium equivalent to 4 g piperacillin and 0.5 g tazobactam sodium equivalent to 0.5 g tazobactam.

What Piperacillin/Tazobactam Eberth looks like and contents of the pack

Powder for solution for infusion

Piperacillin/Tazobactam Eberth 4 g/ 0,5 g is a white to off-white powder supplied in packs of 1 or 10 vials enclosed in a carton with a package leaflet.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Dr. Friedrich Eberth Arzneimittel GmbH

Am Bahnhof 2

D-92289 Ursensollen

Germany

This leaflet was last revised in:

3 March 2016

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

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The following information is intended for medical or healthcare professionals only:

Piperacillin/Tazobactam Eberth 4 g/ 0.5 g

Instructions for use

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

The solution should be prepared under aseptic conditions. The solution is inspected visually to check for the presence of particles or discoloration. The solution may be used only when it is clear and free of particles.

Intravenous use

Reconstitute each vial with the volume of solvent shown in the table below, using one of the compatible solvents for reconstitution. Swirl until dissolved (for details on handling, please see below).

Content of vial	Volume of solvent* to be added to vial
4 g/ 0.50 g (4 g piperacillin and 0.5 g tazobactam)	20 ml

*Compatible solvents for reconstitution:

• 0.9% (9 mg/ml) sodium chloride solution for injection

• Sterile water for injection. The maximum recommended volume of sterile water for injection per dose is 50 ml.

• Glucose 5% (50 mg/ml) in water

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 reconstituted solutions may be further diluted to the desired volume (for example 50 ml to 100 ml) with one of the following compatible solvents:

• 0.9% (9 mg/ml) sodium chloride solution for injection

• Glucose 5% (50 mg/ml) in water

• Dextran 6% (60 mg/ml) in 0.9% (9 mg/ml) sodium chloride solution.

Incompatibilities

Whenever Piperacillin/Tazobactam Eberth is used concurrently with another antibiotic (for example aminoglycosides), the substances must be administered separately. The mixing of beta-lactam antibiotics with aminoglycosides, in vitro, can result in substantial inactivation of the aminoglycosides.

Piperacillin/Tazobactam Eberth 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 Eberth should not be used with solutions containing only sodium bicarbonate.

Lactated Ringer’s (Hartmann´s) solution is not compatible with piperacillin/tazobactam.

Piperacillin/Tazobactam Eberth should not be added to blood products or albumin hydrolysates.

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