Prospecto:Information for the User

Piperacilina/Tazobactam Sandoz 2 g/0.25 g powder for solution for infusion EFG

Piperacilina/Tazobactam Sandoz 4 g/0.5 g powder for solution for infusion EFG

piperacilina/tazobactam

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What is Piperacilina/Tazobactam Sandoz and what is it used for

2.What you need to know before starting to use Piperacilina/Tazobactam Sandoz

3.How to use Piperacilina/Tazobactam Sandoz

4.Possible adverse effects

5.Storage of Piperacilina/Tazobactam Sandoz

6.Contents of the package and additional information

Piperacilina belongs to a group of medicines called "broad-spectrum penicillin antibiotics" and can destroy many types of bacteria. Tazobactam may prevent some resistant bacteria from surviving the effects of piperacilina. In this way, by administering piperacilina and tazobactam together, more types of bacteria are destroyed.

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

Piperacilina/Tazobactam is used in children between 2 and 12 years of age to treat abdominal infections, such as appendicitis, peritonitis (infection of the abdominal fluid and lining of abdominal organs), and gallbladder infections. Piperacilina/Tazobactam Sandoz may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).

In certain severe infections, your doctor may decide to use piperacilina/tazobactam in combination with other antibiotics.

No use Piperacilina/Tazobactam Sandoz

-if you are allergic to piperacilina or tazobactam or to any of the other components of this medication (listed in section 6),

-if you are allergic to antibiotics called penicilins, cefalosporins or other beta-lactamase inhibitors, as you may be allergic to piperacilina/tazobactam.

Advertencias y precauciones

Consult your doctor or pharmacist or nurse before starting to use piperacilina/tazobactam:

-if you have allergies. If you have multiple allergies, make sure to tell your doctor or another healthcare professional before receiving this product,

-if you have diarrhea before treatment or if it starts during or after treatment. In this case, make sure to tell your doctor or another healthcare professional immediately. Do not take any medication for diarrhea without consulting your doctor first,

-if you have low levels of potassium in your blood. Your doctor may want to examine your kidneys before receiving this medication and may perform blood tests periodically during treatment,

-if you are using another antibiotic called vancomicina at the same time as piperacilina/tazobactam, it may increase the risk of kidney damage (see also “Other medications and Piperacilina/Tazobactam Sandoz” in this prospecto),

-if you have kidney or liver problems, or if you receive hemodiálisis. Your doctor may want to examine your kidneys before receiving this medication and may perform blood tests periodically during treatment,

-if you are using certain medications (called anticoagulants) to prevent excessive blood clotting (see also “Other medications and Piperacilina/Tazobactam Sandoz” in this prospecto) or if you experience unexpected bleeding during treatment. In this case, you must inform your doctor or another healthcare professional immediately,

-if you experience convulsions during treatment. In this case, you must inform your doctor or another healthcare professional immediately,

-if you think you have developed a new infection or if your infection has worsened. In this case, you must inform your doctor or another healthcare professional immediately.

Linfohistiocitosis hemofagocítica

Cases of a disease in which the immune system produces too many normal white blood cells called histiocitos and linfocitos, causing inflammation (linfohistiocitosis hemofagocítica), have been reported. This disease can be potentially fatal if not diagnosed and treated promptly. If you experience multiple symptoms such as fever, swelling of lymph nodes, feeling of weakness, feeling of dizziness, difficulty breathing, bruises or skin rash, contact your doctor immediately.

Niños menores de 2 años

Piperacilina/tazobactam is not recommended for use in children under 2 years of age due to the scarcity of data on safety and efficacy.

Otros medicamentos y Piperacilina/Tazobactam Sandoz

Inform your doctor or another healthcare professional if you are using, have used recently or may need to use any other medication, including those acquired without a prescription. Some medications may interact with piperacilina or tazobactam.

These include:

-a medication for gout (probenecid). This product may increase the time it takes for piperacilina and tazobactam to be eliminated from the body,

-medications used to thin the blood or to treat blood clots (e.g. heparin, warfarin or acetylsalicylic acid),

-medications used to relax muscles during surgery. Inform your doctor if you are going to undergo general anesthesia,

-methotrexate (a medication used to treat cancer, arthritis or psoriasis). Piperacilina and tazobactam may increase the time it takes for methotrexate to be eliminated from the body,

-medications that decrease the level of potassium in the blood (e.g. diuretics or some medications for cancer),

-medications that contain other antibiotics such as tobramicina, gentamicina or vancomicina. Inform your doctor if you have kidney problems.The use of piperacilina/tazobactam and vancomicina at the same time may increase the risk of kidney damage, even if you do not have kidney problems.

Efectos sobre los análisis de laboratorio

If you need to provide a blood or urine sample, tell your doctor or laboratory personnel that you are using piperacilina/tazobactam.

Embarazo y lactancia

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or another healthcare professional before using this medication. Your doctor will decide if piperacilina/tazobactam is suitable for you.

Piperacilina and tazobactam may pass into the fetus or through breast milk. If you are breastfeeding a child, your doctor will decide if piperacilina/tazobactam is suitable for you.

Conducción y uso de máquinas

The use of Piperacilina/Tazobactam Sandoz is not expected to affect your ability to drive or use machines.

Piperacilina/Tazobactam Sandoz 2g /0,25 g contains sodium

This medication contains 109 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 6% of the maximum daily sodium intake recommended for an adult.

Piperacilina/Tazobactam Sandoz 4g /0,5 g contains sodium

This medication contains 217 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 11% of the maximum daily sodium intake recommended for an adult.

This should be taken into account in patients with low-sodium diets.

Your doctor or another healthcare professional will administer this medication through intravenous infusion (into a vein with a drip over 30 minutes).

Dose

The dose of medication you receive will depend on the illness you are being treated for, your age, and whether you have any kidney problems.

Adults and adolescents over 12 years of age

The usual dose is 4 g/0.5 g of piperacilina/tazobactam administered every 6-8 hours through a vein (directly into the bloodstream).

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 piperacilina/tazobactam administered every 8 hours through a vein (directly into the bloodstream). The usual dose for children with low white blood cell counts is 80 mg/10 mg/kg of body weight of piperacilina/tazobactam administered every 6 hours through a vein (directly into the bloodstream).

Your doctor will calculate the dose based on the child's weight, but each individual dose will not exceed 4 g/0.5 g of piperacilina/tazobactam.

You will be given piperacilina/tazobactam until the signs of infection have completely disappeared (5-14 days).

Patients with kidney problems

Your doctor may need to reduce the dose of piperacilina/tazobactam or the frequency of administration. Your doctor may also want to perform blood tests to ensure you receive the correct dose of treatment, especially if you need to use this medication for a long time.

If you use more Piperacilina/Tazobactam Sandoz than you should

Since a doctor or another healthcare professional will administer piperacilina/tazobactam, it is unlikely that you will receive an incorrect dose. However, if you experience side effects, such as seizures, or think you have been given too much medication, tell your doctor immediately.

If you have taken morepiperacilina/tazobactamthan you should, consult your doctor immediately, your pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Piperacilina/Tazobactam Sandoz

If you think you have not received a dose of piperacilina/tazobactam, tell your doctor or another healthcare professional immediately.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Consult your doctor immediatelyif you experience any of the potentially serious side effects of piperacilina/tazobactam.

The serious side effects (frequency in parentheses) of piperacilina/tazobactam are:

• severe skin eruptions [Stevens-Johnson syndrome, bullous dermatitis (unknown), exfoliative dermatitis (unknown), toxic epidermal necrolysis (rare)] that initially appear as red macules or circular patches with central blisters on the trunk. Other signs include mouth, throat, nose, limb, genital, and conjunctivitis (red and swollen eyes) ulcers. The rash may progress to blistering or generalized skin peeling and, potentially, be fatal,
• potentially severe allergic reaction (medication reaction with eosinophilia and systemic symptoms) that can affect the skin and other major organs such as the kidneys or liver (unknown),
• a skin disease (acute generalized exanthematous pustulosis) accompanied by fever, consisting of numerous small pustules filled with liquid that appear on large areas of swollen and red skin (unknown),

-swelling of the face, lips, tongue, or other parts of the body (unknown),

-shortness of breath, wheezing, or difficulty breathing (unknown),

-severe rash or hives (rare), itching or skin rash (unknown),

-yellowing of the eyes and skin (unknown),

-blood cell damage (symptoms include: shortness of breath when not expected, urine that is red or brown (unknown), nasal bleeding (rare), bruises (unknown), severe decrease in white blood cells in the blood (rare)]

-severe or persistent diarrhea accompanied by fever or weakness (rare).

If any ofthe followingside effects are severe or if you experience any side effect not mentioned in this leaflet, inform your doctor or another healthcare professional.

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

• diarrhea.

Common side effects(may affect up to 1 in 10 people)

• yeast infection,
• decrease in platelets, decrease in red blood cells or hemoglobin (blood pigment), abnormal laboratory tests (direct Coombs test positive), prolonged blood clotting time (activated partial thromboplastin time prolonged),
• decrease in blood proteins,
• headache, insomnia,
• abdominal pain, vomiting, nausea, constipation, stomach discomfort,
• increase in liver enzymes in the blood,
• skin eruptions, itching,
• abnormal kidney function tests,
• fever, reaction at the injection site.

Uncommon side effects(may affect up to 1 in 100 people)

• decrease in white blood cells in the blood (leucopenia), prolonged blood clotting time (prothrombin time prolonged),
• decrease in potassium in the blood, decrease in blood sugar,
• seizures (convulsions), observed in patients receiving high doses or with renal problems,
• low blood pressure, inflammation of the veins (pain or redness of the affected area), skin redness,
• increase in a breakdown product of blood pigment (bilirubin),
• skin reactions with redness, skin lesions, urticaria,
• muscle and joint pain,
• chills.

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

• severe decrease in white blood cells (agranulocytosis), nasal bleeding,
• severe colon infection, inflammation of the mucous membrane of the mouth,
• detachment of the top layer of the skin from the entire body (toxic epidermal necrolysis).

Side effects of unknown frequency(cannot be estimated from available data)

• severe decrease in red blood cells, white blood cells, and platelets (pancytopenia), severe decrease in white blood cells (neutropenia), premature or premature breakdown of red blood cells, small hematomas, prolonged bleeding time, increase in platelets, increase in a specific type of white blood cells (eosinophilia),
• allergic reaction and severe allergic reaction,
• inflammation of the liver, yellowing of the skin or white of the eyes,
• severe allergic reaction throughout the body with skin exanthema and mucosa, blisters, and multiple skin eruptions (Stevens-Johnson syndrome), severe allergic reactions affecting the skin and other organs such as the kidneys and liver (medication reaction with eosinophilia and systemic symptoms), numerous small pustules filled with liquid that appear on large areas of swollen and red skin accompanied by fever (acute generalized exanthematous pustulosis), skin reactions with blisters (bullous dermatitis),
• renal function deficiency and renal problems,
• a type of lung disease where eosinophils (a type of white blood cell) appear in the lung in greater numbers,
• acute disorientation and confusion (delirium).

In patients with cystic fibrosis, treatment with piperacilina has been associated with an increased incidence of fever and skin eruptions.

Betalactam antibiotics, including piperacilina/tazobactam, may lead to signs of altered brain function (encephalopathy) and seizures.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and label after “CAD/EXP”. The expiration date is the last day of the month indicated.

Unopened vials/bottles:

No special storage conditions are required.

For the storage conditions of the medicine once reconstituted and diluted, see the end of the leaflet "This information is intended solely for healthcare professionals”.

For single use only. Dispose of unused solution.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Piperacillin/Tazobactam Sandoz Composition

-The active ingredients are piperacillin and tazobactam.

Piperacillin/Tazobactam Sandoz 2 g/0.25 g

Each vial contains 2 g of piperacillin (as piperacillin sodium) and 0.25 g of tazobactam (as tazobactam sodium).

Piperacillin/Tazobactam Sandoz 4 g/0.5 g

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

-The other components are:

This medicine does not contain any ingredients other than the active ingredients.

Appearance of the product and contents of the package

Piperacillin/Tazobactam Sandoz 2 g/0.25 g is a white or off-white powder for solution for infusion supplied in glass vials.

The vials are packaged in cartons.

Package sizes: 1, 5, 10, 12, and 50 vials.

Piperacillin/Tazobactam Sandoz 4 g/0.5 g is a white or off-white powder for solution for infusion supplied in glass vials or bottles.

The vials or bottles are packaged in cartons.

Package sizes: 1, 5, 10, 12, and 50 vials or bottles.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer:

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Slovakia:Piperacilin comp. Sandoz 4 g/0.5 g prášok na infúzny roztok

France:PIPERACILLINE/TAZOBACTAM SANDOZ 4 g/0.5 g, poudre poursolution pour perfusion

HungaryPiperacillin/Tazobactam Sandoz 4 g/0.5 g por oldatos infúzióhoz Ireland:Piperin 2 g/0.25 g Powder for Solution for Infusion

Piperin 4 g /0.5 g Powder for Solution for Infusion

Netherlands:Piperacilline/Tazobactam Sandoz 2 g/0.25 g poeder vooroplossing infusie

Piperacilline/Tazobactam Sandoz 4 g/0.5 g poeder voor oplossing

infusie

Sweden:Piperazillin/Tazobactam Sandoz 2 g/0.25 g pulver till injektions-

/infusionsvätska, lösning

Piperazillin/Tazobactam Sandoz 4 g/0.5 g pulver till injektions-

/infusionsvätska, lösning

Spain:Piperacilina/Tazobactam Sandoz 2 g/0.25 g polvo para solución para

perfusión EFG

Piperacilina/Tazobactam Sandoz 4 g/0.5 g polvo para solución para

perfusión EFG

Last review date of this leaflet:January 2023.

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.

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This information is intended solely for healthcare professionals:

Nota: no se recomienda el uso para bacteriemia debida aE. coliyK. pneumoniae(no sensible a ceftriaxona) productoras de betalactamasa de espectro extendido (BLEE) en pacientes adultos.

After reconstitution (and dilution)

The stability in physical and chemical use has been demonstrated for 24 hours at a temperature of 20-25 °C and for 48 hours at 2-8 °C.

From a microbiological point of view, once opened, the product must be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not exceed 24 hours at a temperature of 2-8 °C, unless the reconstitution/dilution takes place in validated and controlled aseptic conditions.

Instructions for use

Piperacillin/Tazobactam will be administered by intravenous infusion (bottle over 30 minutes).

The reconstitution and dilution must be done in aseptic conditions.Before administration, the solution must be visually inspected for particles and color change. Only the solution should be used if it is transparent and free of particles.

Intravenous

Each vial/bottle must be reconstituted with the volume of solvent shown in the following table, using one of the compatible solvents for its reconstitution. Shake with rotary movements until dissolved. If shaken constantly, it usually dissolves in 3 minutes (see manipulation details below).

* Compatible solvents for reconstitution:

• sterile water for injection,
• solution of 9 mg/ml of sodium chloride (0.9%) in water for injection,
• solution of 50 mg/ml of glucose (5%) in water for injection,
• solution of 50 mg/ml of glucose (5%) in solution of 9 mg/ml of sodium chloride (0.9%).

The reconstituted solutions must be extracted from the vial with a syringe. After reconstitution in the manner indicated, the content of the vial extracted with a syringe will provide the nominal amount of piperacillin and tazobactam.

The reconstituted solutions can be diluted further to the desired volume (i.e., 50 ml to 150 ml) with one of the following compatible solvents:

• solution of 9 mg/ml of sodium chloride (0.9%) in water for injection,
• solution of 50 mg/ml of glucose (5%) in water for injection,
• solution of dextran (grade 40) 60 mg/ml (6%) in solution of 9 mg/ml of sodium chloride (0.9%).

Incompatibilities

Whenever piperacillin/tazobactam is used simultaneously with another antibiotic (e.g., aminoglycosides), these must be administered separately. The mixture of beta-lactam antibiotics with aminoglycosidesin vitromay result in a substantial inactivation of the aminoglycoside. However, it has been determined that amikacin and gentamicin are compatible with piperacillin/tazobactamin vitrowith certain diluents at specific concentrations (seeCo-administration with aminoglycosidesbelow).

Piperacillin/Tazobactam Sandoz should not be mixed with other substances in a syringe or infusion bottle, as its compatibility has not been established.

Piperacillin/Tazobactam must be administered through a separate infusion device from any other medication, unless its compatibility has been demonstrated.

Piperacillin/Tazobactam Sandoz should not be used with solutions that contain only sodium bicarbonate due to chemical instability.

Piperacillin/Tazobactam Sandoz is not compatible with Ringer Lactate solution (Hartmann).

Piperacillin/Tazobactam Sandoz should not be added to blood derivatives or albumin hydrolysates.

Co-administration of piperacillin/tazobactam with aminoglycosides

Due to the inactivationin vitroof the aminoglycoside by beta-lactam antibiotics, it is recommended to administer piperacillin/tazobactam and the aminoglycoside separately.

Piperacillin/tazobactam and the aminoglycoside should be reconstituted and diluted separately when concomitant treatment with aminoglycosides is indicated.

When co-administration is recommended, piperacillin/tazobactam is compatible for simultaneous administration by Y infusion with the following aminoglycosides under the following conditions:

* The aminoglycoside dose should be based on the patient's weight, the severity of the infection (severe or life-threatening), and renal function (creatinine clearance).

The compatibility of piperacillin/tazobactam with other aminoglycosides has not been established. Only the concentrations and diluents for amikacin and gentamicin with the piperacillin/tazobactam doses indicated in the above table have been established as compatible for co-administration by Y infusion.

Simultaneous administration by Y infusion of piperacillin/tazobactam with another aminoglycoside in any other way than indicated above may result in the inactivation of the aminoglycoside by piperacillin/tazobactam.