Piperacillin/tazobactam Sala 4 g/0.5 g powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Piperacillin/Tazobactam Sandoz is and what it is used for
2. What you need to know before using Piperacillin/Tazobactam Sandoz
3. How to use Piperacillin/Tazobactam Sandoz
4. Possible side effects
5. How to store Piperacillin/Tazobactam Sandoz
6. Contents of the pack and other information

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

Piperacillin belongs to a group of medicines called "broad-spectrum penicillin antibiotics" and can destroy many types of bacteria. Tazobactam can prevent some resistant bacteria from surviving the effects of piperacillin. Thus, when piperacillin and tazobactam are administered together, a wider range of bacteria are destroyed.

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 between 2 and 12 years of age to treat abdominal infections such as appendicitis, peritonitis (infection of the fluid and lining of the abdominal organs), and biliary tract infections. Piperacillin/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 decide to use Piperacillin/Tazobactam in combination with other antibiotics.

2. What you need to know before using Piperacilina/Tazobactam Sala

Do not use Piperacilina/Tazobactam Sala

• if you are allergic to piperacillin or tazobactam, or to 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 also be allergic to Piperacilina/Tazobactam.

Warnings and precautions

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

• if you have allergies. If you have multiple allergies, make sure to inform your doctor or healthcare professional before receiving this medicine.
• if you had diarrhea before treatment or if you develop diarrhea during or after treatment. In this case, inform your doctor or healthcare professional immediately. Do not take any medication for diarrhea without first consulting your doctor or healthcare professional.
• if you have low levels of potassium in the blood. Your doctor may want to examine your kidney function before you receive this medicine and may perform periodic blood tests during treatment.
• if you have kidney or liver problems, or if you are undergoing hemodialysis. Your doctor may want to assess your kidney function before treatment and may perform periodic blood tests during treatment.
• if you are taking another antibiotic called vancomycin at the same time as piperacillin/tazobactam, as this may increase the risk of kidney damage (see also Other medicines and Piperacilina/Tazobactam Sala in this leaflet).
• if you are taking certain medicines (called anticoagulants) to prevent excessive blood clotting (see also "Other medicines and Piperacilina/Tazobactam Sala" in this leaflet) or if you experience unexpected bleeding during treatment. In such case, inform your doctor or healthcare professional immediately.
• if you experience seizures during treatment. In this case, inform your doctor or healthcare professional immediately.
• if you suspect you have developed a new infection or if your existing infection worsens. In this case, inform your doctor or healthcare professional immediately.
• Hemophagocytic lymphohistiocytosis

Cases of a condition in which the immune system produces excessive numbers of otherwise normal white blood cells called histiocytes and lymphocytes, leading to inflammation (hemophagocytic lymphohistiocytosis), have been reported. This condition can be potentially fatal if not diagnosed and treated early. If you experience multiple symptoms such as fever, swollen lymph nodes, feeling of weakness, dizziness, difficulty breathing, bruising, or skin rash, contact your doctor immediately.

Children under 2 years of age

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

Other medicines and Piperacilina/Tazobactam Sala

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Some medicines may interact with piperacillin or tazobactam.

These include:

• a medicine for gout (probenecid). This product may increase the time it takes for piperacillin and tazobactam to be eliminated from the body.
• medicines used to thin the blood or treat blood clots (e.g., heparin, warfarin, or acetylsalicylic acid).
• medicines used to relax muscles during surgery. Inform your doctor if you are undergoing general anesthesia.
• methotrexate (a medicine used to treat cancer, arthritis, or psoriasis). Piperacillin and tazobactam may increase the time it takes for methotrexate to be eliminated from the body.
• medicines that reduce potassium levels in the blood (e.g., diuretics or certain cancer medicines).
• medicines containing other antibiotics such as tobramycin, gentamicin, or vancomycin. Inform your doctor if you have kidney problems, even if you do not have a history of kidney issues. Using piperacillin/tazobactam and vancomycin together may increase the risk of kidney damage, even in patients without pre-existing kidney problems.

Effects on laboratory tests

If you need to provide a blood or urine sample, inform your doctor or laboratory staff that you are taking Piperacilina/Tazobactam.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether Piperacilina/Tazobactam is appropriate for you.

Piperacillin and tazobactam may pass to the unborn child through the placenta or to the infant through breast milk. If you are breastfeeding, your doctor will decide whether Piperacilina/Tazobactam is suitable for you.

Driving and using machines

Piperacilina/Tazobactam Sala is not expected to affect your ability to drive or operate machinery.

Piperacilina/Tazobactam Sala contains sodium

This medicine contains 216 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 10.8% of the maximum daily recommended sodium intake for an adult. This should be taken into account for patients on low-sodium diets.

3. How to use Piperacillin/Tazobactam Sandoz

Your doctor or another healthcare professional will administer this medicine by intravenous infusion (into a vein via an infusion set over 30 minutes).

Dosage

The dose of medicine you will be given depends on the illness being treated, your age, and whether or not you have kidney problems.

Adults and adolescents aged 12 years and older

The usual dose is 4 g/0.5 g of piperacillin/tazobactam administered every 6–8 hours intravenously (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 body weight of piperacillin/tazobactam administered every 8 hours intravenously (directly into the bloodstream). The usual dose for children with low white blood cell counts is 80 mg/10 mg/kg body weight of piperacillin/tazobactam administered every 6 hours intravenously (directly into the bloodstream).

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

You will be administered Piperacillin/Tazobactam until all signs of infection have completely disappeared (from 5 to 14 days).

Patients with kidney problems

Your doctor may need to reduce your dose of Piperacillin/Tazobactam or adjust the frequency of administration. Your doctor may also wish to perform blood tests to ensure you are receiving the appropriate dose, especially if you need to take this medicine for a prolonged period.

If you use more Piperacillin/Tazobactam Sandoz than you should

Since a doctor or healthcare professional will be administering Piperacillin/Tazobactam, it is unlikely that you will receive an incorrect dose. However, if you experience adverse effects such as seizures, or if you are concerned that you may have received too much Piperacillin/Tazobactam, contact your doctor or pharmacist immediately.

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

If you forget to use Piperacillin/Tazobactam

If you think a dose of Piperacillin/Tazobactam has not been administered to you, inform your doctor or healthcare professional immediately.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

Contact your doctor immediately if you experience any of these potentially serious adverse effects of piperacillin/tazobactam.

Serious adverse effects (with frequency in parentheses) of Piperacillin/Tazobactam are:

• severe skin rashes [(Stevens-Johnson syndrome, bullous dermatitis (frequency not known), exfoliative dermatitis (frequency not known), toxic epidermal necrolysis (rare)] which initially appear on the trunk as reddish spots resembling targets or circular spots with central blisters. Other signs include mouth, throat, nose, limb, genital, or conjunctivitis (red and swollen eyes) ulcers. The rash may progress to blistering or widespread skin peeling and, potentially, may be fatal.
• severe, potentially life-threatening allergic reaction (drug reaction with eosinophilia and systemic symptoms) that may affect the skin and other vital organs such as the kidneys or liver.
• a skin disease (acute generalized exanthematous pustulosis) accompanied by fever, consisting of numerous small fluid-filled pustules appearing on large areas of swollen and reddened skin.
• swelling of the face, lips, tongue, or other parts of the body (frequency not known),
• shortness of breath, wheezing, or difficulty breathing (frequency not known),
• severe skin rash or hives (uncommon), itching or skin rash (common),
• yellowing of the eyes and skin (frequency not known),
• damage to blood cells [symptoms include: unexpected shortness of breath, red or brown urine (frequency not known), nosebleeds (rare), small bruises (frequency not known), severe decrease in white blood cells in the blood (rare)],
• severe or persistent diarrhoea accompanied by fever or weakness (rare).

If any of the following adverse effects are severe, or if you experience any adverse effect not listed in this leaflet, inform your doctor or another healthcare professional promptly.

Very common adverse effects (may affect up to 1 in 10 people):

• diarrhoea

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

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

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

• decrease in white blood cells in blood (leucopenia), prolonged blood clotting time (prolonged prothrombin time)
• low blood potassium levels, low blood sugar levels
• seizures, observed in patients receiving high doses or with kidney problems
• low blood pressure, inflammation of veins (pain on touching or redness in the affected area), skin redness
• increase in a breakdown product of blood pigment (bilirubin)
• skin reactions with redness, skin lesion formation, hives
• muscle and joint pain
• chills

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

• severe decrease in white blood cells (agranulocytosis), nosebleeds
• severe colon infection, inflammation of the mucous membrane of the mouth
• detachment of the upper layer of skin over the entire body (toxic epidermal necrolysis)

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

• severe decrease in red blood cells, white blood cells, and platelets (pancytopenia), decrease in white blood cells (neutropenia), decrease in red blood cells due to premature rupture or degradation, small bruises, prolonged bleeding time, increased platelets, increase in a specific type of white blood cells (eosinophilia).
• • allergic reaction and severe allergic reaction.
• • liver inflammation, yellowing of the skin or whites of the eyes.
• • severe systemic allergic reaction with skin and mucosal rashes, blisters, and various skin eruptions (Stevens-Johnson syndrome), severe allergic reactions affecting the skin and other organs such as the kidney and liver (drug reaction with eosinophilia and systemic symptoms), numerous small fluid-filled pustules appearing on large areas of swollen and reddened skin accompanied by fever (acute generalized exanthematous pustulosis), blistering skin reactions (bullous dermatitis).
• • impaired kidney function and kidney problems.
• • a type of lung disease where eosinophils (a type of white blood cells) appear in increased numbers in the lungs.
• • acute disorientation and confusion (delirium).

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

Beta-lactam antibiotics, including piperacillin/tazobactam, may cause signs of brain function disturbances (encephalopathy) and seizures.

Reporting of adverse effects:

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

5. Storage of Piperacillin/Tazobactam Sandoz

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 on the label of the vial after “EXP”. The expiry date refers to the last day of the month indicated.

Unopened vials: No special storage conditions are required.

For single use only. Any unused solution should be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information / Additional information

Composition of Piperacillin/Tazobactam Sala

The active substances are piperacillin and tazobactam.

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

Appearance of the product and contents of the container

Piperacillin/Tazobactam Sala 4 g/0.5 g is a white or almost white powder supplied in a vial.

Packaging with 1 vial.

Clinical pack with 50 vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Laboratorio Reig Jofre, S.A.

C/ Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer:

Laboratorio Reig Jofré, S.A.

Jarama, 111

Toledo 45007

Spain

Date of the most recent review of this leaflet: March 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.

This information is intended for healthcare professionals only:

Instructions for use

Piperacillin/Tazobactam shall be administered by intravenous infusion (drip over 30 minutes).

Intravenous route

Each vial must be reconstituted with the volume of solvent shown in the following table, using one of the compatible solvents for reconstitution. To facilitate reconstitution, invert the vial and shake gently to loosen any powder adhering to the walls. Mix by rotating movements until dissolved. With continuous shaking, reconstitution is usually achieved within 5 to 10 minutes (see handling details below).

• Compatible solvents for reconstitution:
  • 0.9% (9 mg/ml) sodium chloride injection solution
  • Sterile water for injections (1)
  • 5% glucose

(1) The maximum recommended volume of sterile water for injections per dose is 50 ml.

Reconstituted solutions must be withdrawn from the vial using a syringe. After reconstitution as indicated, the amount withdrawn from the vial with a syringe will provide the nominal quantity of piperacillin and tazobactam.

Reconstituted solutions may subsequently be further diluted to the desired volume (e.g., from 50 ml to 150 ml) with one of the following compatible diluents:

• 0.9% (9 mg/ml) sodium chloride injection solution
• 5% glucose
• 6% dextran in 0.9% sodium chloride

Incompatibilities

Whenever Piperacillin/Tazobactam is used simultaneously with another antibiotic (e.g., aminoglycosides), they must be administered separately. Mixing beta-lactam antibiotics with aminoglycosides in vitro may result in substantial inactivation of the aminoglycoside.

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

Due to chemical instability, Piperacillin/Tazobactam Sala must not be used with solutions containing only sodium bicarbonate.

Piperacillin/Tazobactam Sala is not compatible with Ringer's lactate solution (compound sodium chloride solution).

Piperacillin/Tazobactam Sala must not be added to blood products or albumin hydrolysates.