Prospecto: Information for the User

Piperacilina/Tazobactam Aurovitas 4 g/0.5 g Powder for Solution for Infusion EFG

Read this prospectus carefully before starting to take 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, pharmacist, or nurse.

-This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.

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

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

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

3.How to use Piperacilina/Tazobactam Aurovitas

4.Possible adverse effects

5.Storage of Piperacilina/Tazobactam Aurovitas

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 concurrently, 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 old to treat infections in the abdomen, such as appendicitis, peritonitis (infection of the fluid and lining of the abdominal organs), and gallbladder infections. Piperacilina/tazobactam 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 consider using piperacilina/tazobactam in combination with otherantibiotics.

No use Piperacilina/TazobactamAurovitas

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

-If you are allergic to antibiotics called penicilinas, cefalosporinas, or other beta-lactamase inhibitors, as you may be allergic to piperacilina/tazobactam.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Piperacilina/Tazobactam Aurovitas:

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

-If you had diarrhea before treatment or if you start having it 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 potassium levels 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 have kidney or liver problems, or are receiving hemodialysis. Your doctor may want to check 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 alsoOther Medications and Piperacilina/Tazobactam Aurovitasin this prospecto).

-If you are using certain medications (called anticoagulants) to prevent excessive blood clotting (see alsoOther Medications and Piperacilina/Tazobactam Aurovitasin 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 seizures 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 that your infection has worsened. In this case, you must inform your doctor or another healthcare professional immediately.

Lymphohistiocytosis Hemophagocytic

Cases of a disease in which the immune system produces too many normal white blood cells called histiocitos and linfocitos, causing inflammation (lymphohistiocytosis hemophagocytic) 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 weak, feeling dizzy, difficulty breathing, bruises, or skin rash, contact your doctor immediately.

Children under 2 years

Piperacilina/tazobactam is not recommended for children under 2 years due to a lack of data on safety and efficacy.

Other Medications and Piperacilina/Tazobactam Aurovitas

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Some medications may interact with piperacilina or tazobactam. These include:

-A medication for gout (probenecid). This medication 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 aspirin).

-Medications used to relax muscles during surgery. Inform your doctor if you are 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 potassium levels in the blood (e.g., diuretics or some cancer medications).

-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.

Laboratory Test Effects

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

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist 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, your doctor will decide if piperacilina/tazobactam is suitable for you.

Driving and Operating Machines

The use of piperacilina/tazobactam is not expected to affect your ability to drive or operate machines.

Piperacilina/Tazobactam Aurovitas contains sodium

This medication contains 216 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 10.8% of the recommended daily maximum sodium intake 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).

Dosage

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

Adults and adolescents 12 years of age or older

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 2 to 12 years of age

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 to 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 Aurovitas 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount administered.

If you forgot to use Piperacilina/Tazobactam Aurovitas

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 nurse.

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

Consult your doctor immediatelyif you experience any of these 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 frequency), exfoliative dermatitis (unknown frequency), toxic epidermal necrolysis (rare)] that initially appear on the trunk as red spots with a bull's-eye shape or circular spots with central blisters. Other signs include mouth ulcers, throat, nose, limbs, genital, and conjunctivitis (red and swollen eyes). The rash may progress to blistering or generalized skin peeling and, potentially, be fatal.

-potentially fatal severe allergic reaction (medication reaction with eosinophilia and systemic symptoms) that can affect the skin and other major organs of the body such as the kidneys or liver.

-a skin disease (acute generalized pustular psoriasis) accompanied by fever, consisting of numerous small pustules filled with liquid that appear on large areas of swollen and red skin.

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

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

-severe skin eruption or urticaria on the skin (rare), itching, or skin eruption (frequent).

-yellowing of the eyes and skin (unknown frequency).

-blood cell damage [symptoms include: shortness of breath when not expected, urine that is red or brown (unknown frequency), nasal bleeding (rare), small hematomas (unknown frequency), 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 in 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.

-peeling of the top layer of the skin on 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), decrease in red blood cells due to premature rupture or degradation, small hematomas, prolonged bleeding time, increase in platelets, increase in a specific type of white blood cells (eosinophilia).

-severe 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 pustular psoriasis), skin reactions with blisters (bullous dermatitis).

-renal function deficiency and kidney 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.

The beta-lactam antibiotics, including piperacilina/tazobactam, may lead tosigns of alteredbrain 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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the vial label after CAD. The expiration date is the last day of the month indicated.

Powder:

Unopened vials: Store below 25°C.

For single use only. Discard unused solution.

The reconstituted/diluted medication solutions are physically compatible and chemically stable for 24 hours at controlled room temperature (25°C) and 48 hours at 2-8°C.

From a microbiological standpoint, reconstituted and diluted solutions should be used immediately. If not used immediately, storage times and conditions before use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of empty containers and unused medications. This will help protect the environment.

Composition ofPiperacilina/Tazobactam Aurovitas

-The active ingredients are piperacilinaand tazobactam. Each vial contains 4 g of piperacilina (in the form ofsodium salt) and 0.5 g oftazobactam (in the form ofsodium salt).

-There are no morecomponents.

Appearance of the product and contents of the package

White to off-white powder for solution for infusion.

Piperacilina/Tazobactam Aurovitas is available in vials of 1, 10 or 12 vials packaged in cardboard boxes with a leaflet.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

For more information about this medication, please contact the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Last review date of this leaflet:December 2022

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

This information is intended only for medical professionals or healthcare professionals:

Nota: do not use for bacteremia due toE. coliandK. pneumoniae(not susceptible to ceftriaxone) producing extended-spectrum beta-lactamase (ESBL) in adult patients.

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

The following text is an extract from the Technical Dossier that serves as a guide for the administration of Piperacilina/Tazobactam Aurovitas. The prescribing physician must be familiar with the Technical Dossier to determine the suitability of use in a specific patient.

For intravenous infusion.

Incompatibilities with diluents and other medications

•Ringer Lactate solution (Hartmann) is not compatible with piperacilina/tazobactam.

•When used concomitantly with other antibiotics (e.g. aminoglycosides), piperacilina/tazobactam should be administered separately. The mixture of piperacilina/tazobactam with an aminoglycosidein vitromay cause inactivation of the aminoglycoside.

•Piperacilina/tazobactam should not be mixed with other medications in a syringe or glass vial for infusion, as compatibility has not been established.

•Due to chemical instability, piperacilina/tazobactam should not be used in solutions containing sodium bicarbonate.

•Piperacilina/tazobactam should not be added to products containing blood or hydrolyzed albumin.

Instructions for use, handling and disposal

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

Instructions for inserting the needle into the rubber stopper

To prevent the rubber stopper from being dislodged when inserting the needle into the rubber stopper, it is recommended to use a needle with an outer diameter of 0.8 mm or less for reconstituting the medication.

The needle should only be inserted in the center of the rubber stopper, vertically.

For single use only. Discard unused solution.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Sterile diluents for preparing the reconstituted solution

•Sterile water forparenteral preparations.

•Injectable solution of sodium chloride 9 mg/ml (0.9%).

•Glucose 50 mg/ml (5%) in sterile water forparenteral preparations.

•Glucose 50 mg/ml (5%) in injectable solution of sodium chloride 9 mg/ml (0.9%).

Instructions for dilution (for intravenous infusion)

Each vial of piperacilina/tazobactam 4 g/0.5 g should be reconstituted with 20 ml of the above diluents.

Shake until complete dissolution.

The reconstituted solutions can be diluted further to the concentration range of 13.33/1.67 mg/ml to 80/10 mg/ml with the following diluents:

•Sterile water forparenteral preparations.

•Injectable solution of sodium chloride 9 mg/ml (0.9%).

•Glucose 50 mg/ml (5%) in sterile water forparenteral preparations.

•Glucose 5% in injectable solution of sodium chloride 0.9%.

Special storage conditions

Vials not opened:Store below 25°C.

The reconstituted/diluted solutions of the medication are physically compatible and chemically stable for 24 hours at controlled room temperature (25°C) and 48 hours at 2-8°C.

From a microbiological point of view, the reconstituted and diluted solutions should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not normally exceed 24 hours at 2‑8°C,unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.