Leaflet: information for the user

Piperacilina/Tazobactam Accordpharma 4 g/0.5 g powder for solution for

infusion EFG

Read this leaflet carefully before you start using the medicine because 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 or pharmacist.

-This medicine has been prescribed for you. Do not give it to others even if they have the same symptoms, as it may harm them.

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

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

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

3.How to use Piperacilina/Tazobactam Accordpharma

4.Possible side effects

5.Storage of Piperacilina/Tazobactam Accordpharma

6.Contents of the pack 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/tazobactammay be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).

Piperacilina/tazobactam is used in children between2 and 12 years of age to treat abdominal infections, such as appendicitis, peritonitis (infection of the abdominal fluid and lining), and gallbladder infections.Piperacilina/tazobactammay 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 Accordpharma

-if you are allergic to piperacillin or tazobactam or any of the other ingredients of this medicine (listed in section 6).

-if you are allergic to antibiotics called penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to Piperacilina/Tazobactam Accordpharma.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Piperacilina/Tazobactam Accordpharma if:

• You have allergies. If you have multiple allergies, make sure to tell your doctor or another healthcare professional before receiving this product.
• You had diarrhea before treatment or if you start having diarrhea 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.
• You have low potassium levels in your blood. Your doctor may want to examine your kidneys before receiving this medicine and may perform blood tests periodically during treatment.
• You have kidney or liver problems, or if you are receiving hemodialysis. Your doctor may want to examine your kidneys before receiving this medicine and may perform blood tests periodically during treatment.
• You are using certain medications (called anticoagulants) to prevent excessive blood clotting (see alsoother medicines and Piperacilina/Tazobactam Accordpharmain this leaflet) or if you experience unexpected bleeding during treatment. In this case, you must inform your doctor or another healthcare professional immediately.
• You experience seizures during treatment. In this case, you must inform your doctor or another healthcare professional immediately.
• 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.
• You have severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute exanthematous pustulosis (AGEP). Stop using Piperacilina / Tazobactam Fresenius Accordhpharma and seek medical attention immediately if you notice any of the symptoms described in section 4.
• Lymphohistiocytosis

Cases of a disease in which the immune system produces too many otherwise normal white blood cells called histiocytes and lymphocytes, leading to inflammation (lymphohistiocytosis), 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 use in children under 2 years of age due to a lack of data on safety and efficacy.

Other medicines and Piperacilina/Tazobactam Accordpharma

Inform your doctor or nurse that you are using, have used recently or may need to use any other medicine, 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 to treat blood clots (e.g. heparin, warfarin or aspirin).

-medicines used to relax muscles during surgery. Inform your doctor if you are to undergo 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 decrease the level of potassium in the blood (e.g. diuretics or some cancer medicines).

-medicines that contain other antibiotics such as tobramycin, gentamicin or vancomycin. Inform your doctor if you have kidney problems.Using piperacillin/tazobactam and vancomycin 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, inform your doctor or laboratory staff that you are using piperacilina/tazobactam.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before receiving this medicine. Your doctor will decide if piperacilina/tazobactam is suitable for you.

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

Driving and operating machines

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

Piperacilina/Tazobactam Accordpharma 4g/0.5g contains sodium.

This medicine contains 216 mg of sodium (main component of table salt/for cooking). This is equivalent to 10.8% of the recommended daily maximum sodium intake for an adult.

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Your doctor or other healthcare professional will administer this medication through intravenous infusion (in a vein with a drip for 30 minutes). The dose of medication administered will depend on the disease for which you are being treated, your age, and whether you have kidney problems.

Adults and adolescents 12 years of age or older

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

Children 2 to 12 years of age

The recommended dose for children with abdominal infections is 100 mg/12.5 mg/kg of body weight of piperacillin/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 piperacillin/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 Accordpharma.

You will be administered Piperacilina/Tazobactam Accordpharma until the signs of infection have completely disappeared (for 5 to 14 days).

Patients with kidney problems

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

If you use more Piperacilina/Tazobactam Accordpharma than you should:

Since a doctor or other healthcare professional will be administering Piperacilina/Tazobactam Accordpharma, 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 forgot to use Piperacilina/Tazobactam Accordpharma

If you think you have not received a dose of Piperacilina/Tazobactam Accordpharma, tell your doctor or other healthcare professional immediately.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

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

Consult your doctor immediately if you experience any of these potentially serious side effects of Piperacilina/Tazobactam.

The serious side effects (frequency in parentheses) of Piperacilina/Tazobactam Accordpharma are:

• Severe skin eruptions [Stevens-Johnson syndrome, bullous dermatitis (unknown), exfoliative dermatitis (unknown), toxic epidermal necrolysis (rare)] that initially appear as red spots or circular patches with central blisters on the trunk. Other signs include mouth ulcers, throat, nose, limbs, genital, and conjunctivitis (red and swollen eyes). The eruption can progress to blistering or generalized peeling of the skin and may be potentially fatal
• Potentially serious 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)
• Lack of air, whistling, or difficulty breathing (unknown)
• Severe rash, urticaria (infrequent), itching, or skin eruption (frequent)
• Yellow discoloration of the eyes and skin(unknown)
• Blood cell damage [symptoms include: shortness of breath when not expected, urine of red or brown color (unknown), nasal bleeding (rare), bruises (unknown), severe decrease in white blood cells in the blood (rare)]
• Persistent or severe diarrhea accompanied by fever or weakness (rare)

If any of the following serious side effects occur, or if you experience any side effect not mentioned in this leaflet, inform your doctor or another healthcare professional.

Very frequent side effects (can affect more than 1 in 10 people):

-Diarrhea

Frequent side effects (can affect up to 1 in 10 people):

• Fungal 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
• Increased liver enzymes in the blood
• Skin eruptions, itching
• Abnormal kidney function tests
• Fever, reaction at the injection site

Rare side effects (can affect up to 1 in 100 people):

• Decrease in white blood cells in the blood (leucopenia), prolonged blood clotting time (prothrombin time prolonged)
• Seizures (convulsions), observed in patients receiving high doses or with renal problems
• Decrease in potassium in the blood, decrease in blood sugar
• Low blood pressure, inflammation of the veins (pain or redness of the affected area), skin redness
• Increased bilirubin, a breakdown product of blood pigment

• Redness, skin lesions, and urticaria
• Muscle and joint pain

• Chills

Rare side effects (can 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), decrease in white blood cells (neutropenia), decrease in red blood cells due to premature rupture or degradation, small hematoma, 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, yellow discoloration of the skin or white of the eyes
• Severe allergic reaction throughout the body with skin exanthems 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 skinaccompanying fever (acute generalized exanthematous pustulosis), skin eruptions with blisters (bullous dermatitis)
• Impaired renal function 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 manifestations of 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 Pharmacovigilance 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 this medication out of the sight and reach of children.

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

Unopened vials: No special storage conditions are required.

For single use only. Dispose of any unused solution.

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

Composition of Piperacilina/Tazobactam Accordpharma

·The active principles are piperacilina and tazobactam.

Each vial contains4 g of piperacilina (as sodium salt) and 0.5 g of tazobactam (as sodium salt).

Aspect of the product and contents of the package

Piperacilina/Tazobactam Accordpharma 4 g/0.5 g is a white or off-white powder that is supplied in a vial.

The packages contain 1 vial and 1sterile set of fluid transfer..

The clinical packages contain50vials and 50sterile sets of fluid transfer.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Accord Healthcare S.L.U.

World Trade Center. Moll de Barcelona, s/n, Edifici Est, 6th floor.

08039, Barcelona (Spain)

Responsible for manufacturing:

LABORATORIO REIG JOFRÉ, S.A.

C/ Jarama s/n Pol. Ind.

45007 – Toledo

Spain

or

MITIM, S.R.L.

Via Cacciamali, 34-38

Brescia

25125 – Italy

or

ACCORD HEALTHCARE POLSKA SP.Z O.O.

Magazyn Importera, ul.

Lutomierska, 50,

Pabianice, 95-200

Poland

Review date of this leaflet:December 2021

The detailed and updated information of 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 doctors or healthcare professionals:

Instructions for use

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

Intravenous route

To facilitate the reconstitution of the vial, invert it and shake it to release the powder adhering to the walls. Add the solvent and shake until complete dissolution.

It must be reconstituted each vial with the volume of solvent shown in the following table, using one of the compatible solvents for its reconstitution. Shake with rotary movements until it dissolves. If shaken constantly, it usually dissolves in a time of 5 to 10 minutes (see details of manipulation below).

* Compatible solvents for reconstitution:

·