Leaflet: information for the user

Piperacilina/Tazobactam Accord Healthcare 2 g/0.25 g powder for solution for infusion EFG

Piperacilina/Tazobactam Accord Healthcare 4 g/0.5 g powder for solution for infusion EFG

Read this leaflet carefully before you start taking 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, pharmacist or nurse.

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

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

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

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

3.How to use Piperacilina/Tazobactam Accord Healthcare

4.Possible side effects

5.Storage of Piperacilina/Tazobactam Accord Healthcare

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. 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 Accord Healthcare in combination with other antibiotics.

No use Piperacilina/Tazobactam Accord Healthcare

-si es alérgico a la piperacilina o al tazobactam.

-si es alérgico a los antibióticos llamados penicilinas, cefalosporinas u otros inhibidores de las betalactamasas, ya que podría ser alérgico a Piperacilina/Tazobactam Accord Healthcare.

Advertencias y precauciones

Consulte a su médico o farmacéutico antes de empezar a usar Piperacilina/Tazobactam Accord Healthcare

• Si tiene alergias. Si tiene varias alergias, asegúrese de decírselo a su médico u otro profesional sanitario antes de recibir este producto.
• Si padecía diarrea antes del tratamiento o si la empieza a tener durante o después del tratamiento. En este caso, asegúrese de decírselo inmediatamente a su médico u otro profesional sanitario. No tome ningún medicamento para la diarrea sin consultar antes con su médico.
• Si tiene los niveles de potasio en sangre bajos. Es posible que su médico quiera examinarle los riñones antes de recibir este medicamento y podría realizarle análisis de sangre periódicos durante el tratamiento.
• Si tiene problemas de riñón o de hígado, o si recibe hemodiálisis. Es posible que su médico quiera examinarle los riñones antes de recibir este medicamento y podría realizarle análisis de sangre periódicos durante el tratamiento.
• Si está tomando otro antibiótico llamado vancomicina al mismo tiempo que Piperacilina/Tazobactam. Esto puede aumentar el riesgo de daño renal (ver también “Otros medicamentos y Piperacilina/Tazobactam Accord Healthcare” en este prospecto)
• Si está utilizando determinados medicamentos (llamados anticoagulantes) para evitar el exceso de coagulación de la sangre (ver también “Otros medicamentos y Piperacilina/Tazobactam Accord Healthcare” en este prospecto) o si presenta una hemorragia inesperada durante el tratamiento. En este caso, debe informar inmediatamente a su médico u otro profesional sanitario.
• Si presenta convulsiones durante el tratamiento. En este caso, debe informar inmediatamente a su médico u otro profesional sanitario.
• Si piensa que le ha aparecido una infección nueva o le ha empeorado la infección. En este caso, debe informar inmediatamente a su médico u otro profesional sanitario.

Se han notificado casos de una enfermedad en la que el sistema inmunitario produce demasiados glóbulos blancos, por lo demás normales, denominados histiocitos y linfocitos, lo que provoca una inflamación (linfohistiocitosis hemofagocítica). Esta enfermedad puede ser potencialmente mortal si no se diagnostica y trata precozmente. Si experimenta síntomas múltiples como fiebre, hinchazón de los ganglios, sensación de debilidad, sensación de mareo, dificultad para respirar, hematomas o erupción cutánea, póngase en contacto con su médico inmediatamente.

Niños
No se recomienda utilizar piperacilina/tazobactam en niños menores de 2 años de edad, no hay suficientes datos disponibles sobre seguridad y eficacia en esta población.

Otros medicamentos y Piperacilina/Tazobactam Accord Healthcare

Comunique a su médico o profesional sanitario si está utilizando, ha utilizado recientemente o podría tener que utilizar cualquier otro medicamento, incluso los adquiridos sin receta. Algunos medicamentos pueden tener interacciones con la piperacilina o el tazobactam.

Estos incluyen:

-un medicamento para la gota (probenecid). Este producto puede aumentar el tiempo que tardan la piperacilina y el tazobactam en eliminarse del organismo.

-medicamentos que se utilizan para diluir la sangre o para tratar los coágulos de sangre (por ejemplo, heparina, warfarina o ácido acetilsalicílico).

-medicamentos que se utilizan para relajar los músculos durante la cirugía. Informe a su médico si se va a someter a una anestesia general.

-metotrexato (un medicamento que se utiliza para el tratamiento del cáncer, la artritis o la psoriasis). La piperacilina y el tazobactam pueden aumentar el tiempo que tarda el metotrexato en eliminarse del organismo.

-medicamentos que disminuyen el nivel de potasio en la sangre (por ejemplo, pastillas para orinar o algunos medicamentos para el cáncer).

-medicamentos que contengan otros antibióticos como tobramicina, gentamicina o vancomicina. Informe a su médico si tiene problemas renales. Tomar Piperacilina/Tazobactam Accord Healthcare y vancimicina al mismo tiempo puede aumentar el riesgo de lesión renal incluso si no tiene problemas de riñón.

Efectos sobre los análisis de laboratorio

Si tiene que proporcionar una muestra de sangre u orina, dígale al médico o al personal de laboratorio que está tomando Piperacilina/Tazobactam Accord Healthcare.

Embarazo y lactancia

Si está embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o profesional sanitario antes de utilizar este producto.

Su médico decidirá si Piperacilina/Tazobactam es adecuado para usted.

La piperacilina y el tazobactam pueden pasar al bebé en el útero o a través de la leche materna. Si está amamantando a un niño, su médico decidirá si Piperacilina/Tazobactam Accord Healthcare es adecuado para usted.

Conducción y uso de máquinas

No se prevé que el uso de Piperacilina/Tazobactam Accord Healthcare influya en la capacidad para conducir o utilizar máquinas.

Piperacilina/Tazobactam Accord Healthcare contiene sodio

Piperacilina/Tazobactam Accord Healthcare 2 g/0,25 g polvo para solución para perfusión EFG

Este medicamento contiene 108 mg de sodio (componente principal de la sal de mesa/para cocinar) en cada vial. Esto equivale al 5,4% de la ingesta diaria máxima de sodio recomendada para un adulto.

Piperacilina/Tazobactam Accord Healthcare 4 g/0,5 g polvo para solución para perfusión EFG

Este medicamento contiene 216 mg de sodio (componente principal de la sal de mesa/para cocinar) en cada vial. Esto equivale al 10,8% de la ingesta diaria máxima de sodio recomendada para un adulto.

Esto debe tenerse en cuenta si se sigue una dieta baja en sodio.

Your doctor or another healthcare professional will administer this medication through intravenous infusion (into a vein with a drip for 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 kidney problems.

Adults and adolescents 12 years 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 old

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 Accord Healthcare.

You will be given Piperacilina/Tazobactam Accord Healthcare 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 Accord Healthcare 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 Accord Healthcare than you should:

Since a doctor or another healthcare professional will be administering Piperacilina/Tazobactam Accord Healthcare, 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 more piperacillin/tazobactam than 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 Accord Healthcare

If you think you have not received a dose of Piperacilina/Tazobactam Accord Healthcare, 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 Accord Healthcare 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, throat, nose, limb, genital, and conjunctivitis (red and swollen eyes) ulcers. The eruption may progress to blistering or generalized skin peeling and, potentially, be 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
• 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
• swelling of the face, lips, tongue, or other parts of the body (unknown)
• shortness of breath, wheezing, or difficulty breathing (unknown)
• severe rash, urticaria (infrequent), itching, or skin eruption (frequent)
• yellowing of the eyes and skin(unknown)
• blood cell damage [symptoms include: shortness of breath when not expected, red or brown urine (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 ofthe followingside effects are severe or if you experience any side effect not mentioned in this patient information 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, 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 with high doses or kidney problems
• low blood pressure, inflammation of the veins (pain or redness in the affected area), skin redness
• increase in a breakdown product of hemoglobin (bilirubin)

• skin reactions with redness, skin lesions, and 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), 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 cell (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 exanthems and mucous membrane, 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 skinhinchada and accompanied by fever (acute generalized exanthematous pustulosis), skin reactions with blisters (bullous dermatitis)
• renal dysfunction 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.

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 that does not appear in this patient information 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” or ”EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Reconstituted and/or diluted solutions must be used immediately.

From a microbiological standpoint, the product must be used immediately. If not used immediately, storage times in use and pre-use conditions are the responsibility of the user.

For single use only. Dispose of any unused solution.

Medications should not be thrown down the drain 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 Accord Healthcare:

Piperacilina/Tazobactam Accord Healthcare 2 g/0.25 g powder for solution for infusion EFG

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

Piperacilina/Tazobactam Accord Healthcare 4 g/0.5 g powder for solution for infusion EFG

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

This medicinal product does not contain more ingredients.

Aspect of the product and content of the packaging

Piperacilina/Tazobactam Accord Healthcare is a white or off-white powder for solution for infusion supplied in a vial.

Packaging sizes: 1 vial, 10 vials or 50 vials.

Only some packaging sizes may be marketed.

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:

Mitim, S.R.L.

Via Cacciamali, 34-38

Brescia

25125 – Italy

This medicinal product is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet:02/2024

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

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This information is intended solely for healthcare professionals:

Nota: The use for extended-spectrum beta-lactamase (ESBL) producing E. coli and K. pneumoniae (ceftriaxone non-susceptible) bacteremia is not recommended in adults.

Instructions for use

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

Intravenous route

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 dissolved. If shaken constantly, it usually dissolves in less than 5 to 10 minutes (see manipulation details below).

* Compatible solvents for reconstitution:

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