Tazocin

Package leaflet: Information for the patient

Tazocin 2 g/0,25 g powder for solution for infusion, 4 g/0,5 g powder for solution for infusion

piperacillin/tazobactam
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Tazocin is and what it is used for

Piperacillin belongs to a class of medicines known as "broad-spectrum penicillin antibiotics"
and is capable of killing many types of bacteria. Tazobactam can prevent some resistant
bacteria from surviving the effects of piperacillin. This means that when piperacillin and tazobactam
are administered together, they can kill a wider range of bacterial types.
Tazocin is used in adults and adolescents for the treatment of bacterial infections, such as those
affecting the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin, or
bloodstream. Tazocin may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections).
Tazocin is used in children aged between 2 and 12 years for the treatment of abdominal infections,
such as appendicitis, peritonitis (infection of the fluid and lining tissue of abdominal organs), and
gallbladder (biliary) infections. Tazocin may be used to treat bacterial infections in
patients with low white blood cell counts (reduced resistance to infections).
In certain severe infections, the physician may consider using Tazocin in combination with other antibiotics.

2. What you need to know before using Tazocin

Do not use Tazocin

• 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 Tazocin.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Tazocin:

• if you suffer from allergies. If you have multiple allergies, make sure to inform your doctor or another healthcare professional before taking this medicine;
• if you have diarrhoea before starting treatment, or if you develop diarrhoea during or after treatment. In this case, inform your doctor or another healthcare professional immediately. Do not take any other medicines for diarrhoea without first consulting your doctor;
• if you have low levels of potassium in your blood. Your doctor may want to check your kidney function before you take this medicine and may carry out regular blood tests during treatment;
• if you have kidney or liver problems or are undergoing haemodialysis. Your doctor may want to check your kidney function before you take this medicine and may carry out regular blood tests during treatment;
• if you are taking another antibiotic called vancomycin. Taking Tazocin together with vancomycin may increase the risk of kidney damage (see also section "Other medicines and Tazocin" in this leaflet);
• if you are taking certain medicines (called anticoagulants) to prevent excessive blood clotting (see also section "Other medicines and Tazocin"), or if you experience unexpected bleeding during treatment. In this case, you must inform your doctor or another healthcare professional immediately;
• if you develop seizures during treatment. In this case, you must inform your doctor or another healthcare professional immediately;
• if you suspect you have developed a new infection or if your infection worsens. In this case, you must inform your doctor or another healthcare professional immediately.

Haemophagocytic lymphohistiocytosis
Cases of a disease in which the immune system produces higher than normal numbers of white blood cells called histiocytes and lymphocytes, leading to inflammation (haemophagocytic lymphohistiocytosis), have been reported. This condition can be life-threatening if not diagnosed and treated early. If you develop several symptoms such as fever, swollen lymph nodes, feeling weak, mental confusion, shortness of breath, bruising, or rash, contact your doctor immediately.
If you notice signs or symptoms of an allergic reaction together with chest pain, inform your doctor immediately. These could be signs of a condition called Kounis syndrome.
If you experience unexplained muscle pain, tenderness, or weakness and/or dark-coloured urine, inform your doctor immediately. These could be signs of muscle damage (called rhabdomyolysis), which can lead to kidney problems.

Children
The use of piperacillin/tazobactam is not recommended in children under 2 years of age due to insufficient data on safety and efficacy.

Other medicines and Tazocin
Inform your doctor or another healthcare professional 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 and tazobactam.
These include:

• medicines for gout (probenecid), which may increase the time required for elimination of piperacillin and tazobactam from the body;
• medicines used to thin the blood or treat blood clots (e.g. heparin, warfarin, or aspirin);
• medicines used to relax muscles during surgery. Inform your doctor if you are scheduled to undergo general anaesthesia;
• methotrexate (a medicine used to treat cancer, arthritis, or psoriasis). Piperacillin and tazobactam may increase the time required for elimination of methotrexate from the body;
• medicines that may reduce potassium levels in the blood (e.g. tablets that increase urine production or certain anticancer medicines);
• medicines containing other antibiotics such as tobramycin, gentamicin, or vancomycin. Inform your doctor if you have kidney problems. Taking Tazocin and vancomycin at the same time may increase the risk of kidney damage, even if you do not have existing kidney problems.

Effect on laboratory test results
Inform your doctor or laboratory staff that you are taking Tazocin if you are required to provide a blood or urine sample.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or another healthcare professional before taking this medicine.
Your doctor will decide whether Tazocin is appropriate for you.
Piperacillin and tazobactam may pass to the unborn baby through the placenta or into breast milk. If you are breastfeeding, your doctor will decide whether Tazocin is appropriate for you.

Driving and using machines
Tazocin is not expected to affect your ability to drive or use machinery.

Tazocin contains sodium
Tazocin 2 g/0.25 g
This medicine contains 130 mg of sodium (the main component in food seasoning/table salt) per vial. This is equivalent to 6.5% of the maximum daily recommended dietary intake for an adult.
Tazocin 4 g/0.5 g
This medicine contains 261 mg of sodium (the main component in food seasoning/table salt) per vial. This is equivalent to 13% of the maximum daily recommended dietary intake for an adult.
This should be taken into account if you are on a controlled sodium diet.

3. How to use Tazocin

Your doctor or another healthcare professional will administer this medicine to you by infusion (a 30-minute intravenous infusion) into a vein.
Dosage
The dose of medicine you will receive depends on the condition being treated, 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 piperacillin/tazobactam administered every 6 to 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).
The doctor will calculate the dose based on the child's body weight, but no single dose will exceed 4 g/0.5 g of Tazocin.
Tazocin will be administered until all signs of infection have completely disappeared (from 5 to 14 days).
Patients with kidney problems
Your doctor may need to reduce the dose of Tazocin or the frequency of administration. Your doctor may also order blood tests to ensure the treatment dose is appropriate, especially if you need to receive this medicine for a prolonged period.
If you receive more Tazocin than you should
Since Tazocin is administered by a doctor or another healthcare professional, it is unlikely that you will receive an incorrect dose. However, if you experience any adverse effects such as seizures, or if you think you have been given too high a dose, inform your doctor immediately.
If you miss a dose of Tazocin
If you think a dose of Tazocin has not been administered, inform your doctor or another healthcare professional immediately.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Contact a doctor immediately if you experience any of the following potentially serious side effects:
The serious side effects (with frequency stated in parentheses) are:

• severe skin rashes initially appearing as reddish spots in the shape of a target or circular patches, often with central blisters, on the trunk. Other signs include mouth, throat, nose, extremities, genital or eye ulcers, and red, swollen eyes (conjunctivitis). The rash may progress to widespread blisters or extensive skin peeling and may be potentially life-threatening. These could be signs of Stevens-Johnson syndrome (frequency not known), bullous dermatitis (frequency not known), exfoliative dermatitis (frequency not known), or toxic epidermal necrolysis (rare);
• a skin condition accompanied by fever, characterized by numerous small fluid-filled blisters appearing within large areas of swollen, red skin, known as generalized acute exanthematous pustulosis (frequency not known);
• a severe, potentially fatal allergic condition (drug reaction with eosinophilia and systemic symptoms) that may affect the skin and, particularly, other organs beneath the skin, such as the kidneys and liver (frequency not known);
• swelling of the face, lips, tongue, or other parts of the body, breathlessness, wheezing, or difficulty breathing (allergic reactions including anaphylactic shock, frequency not known);
• sudden chest pain, which may be caused by an allergic reaction known as Kounis syndrome (frequency not known);
• severe skin rash or hives (uncommon), itching or skin rash (common);
• inflammation of the liver (hepatitis, frequency not known), yellowing of the skin or whites of the eyes (jaundice, frequency not known);
• low levels of red blood cells (anaemia, common), excessive destruction of red blood cells leading to unexplained breathlessness, red or brown urine (haemolytic anaemia, frequency not known);
• low platelet levels, which may lead to bleeding and bruising (thrombocytopenia, common);
• low levels of white blood cells, blood cells that fight infections (leucopenia, uncommon or neutropenia, frequency not known);
• very low levels of a type of white blood cells called granulocytes (agranulocytosis, rare);
• high levels of platelets (thrombocytosis, frequency not known);
• high levels of a type of white blood cells called eosinophils (eosinophilia, frequency not known);
• low levels of all types of blood cells, including platelets (pancytopenia, frequency not known);
• severe or persistent diarrhoea associated with fever or weakness (pseudomembranous colitis, rare);
• decreased potassium levels in the blood (uncommon);
• seizures (convulsions), observed in patients treated with high doses or with kidney problems (uncommon);
• severe muscle pain, tenderness, or weakness (rhabdomyolysis, frequency not known).

If any of the following side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or another healthcare professional.
Very common side effects (may affect more than 1 in 10 people):

• diarrhoea.

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

• yeast infection;
• formation of antibodies in the blood that attack red blood cells (positive direct Coombs test), prolonged blood clotting time (prolonged activated partial thromboplastin time);
• reduction of proteins in the blood;
• headache, insomnia;
• abdominal pain, vomiting, nausea, constipation, stomach discomfort;
• increased liver enzymes in the blood;
• abnormal results in blood tests for kidney function;
• fever, reaction at the injection site.

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

• prolonged blood clotting time (prolonged prothrombin time), reduced blood sugar levels;
• low blood pressure, inflammation of the veins (felt as tenderness or redness in the affected area), red skin;
• increased levels in the blood of a pigment produced during breakdown (bilirubin);
• skin reactions with redness, formation of skin lesions; joint and muscle pain;
• chills.

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

• nosebleeds;
• inflammation of the mucous membranes lining the mouth.

Frequency not known (cannot be estimated from the available data):

• appearance of bruises with small spots, prolonged bleeding time;
• blistering skin disease characterized by blisters on the skin and mucous membranes (linear IgA disease);
• reduced kidney function and kidney problems;
• a form of lung disease in which eosinophils (a type of white blood cells) appear in increased numbers in the lung;
• acute disorientation and confusion (delirium).

Treatment with piperacillin has been associated with an increased incidence of fever and skin rashes in patients with cystic fibrosis.
Beta-lactam antibiotics, including piperacillin/tazobactam, may lead to manifestations of signs of impaired brain function (encephalopathy) and seizures.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tazocin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after
Exp. The expiry date refers to the last day of that month.
Intact vials: do not store above 25°C.
For single use only. Any residual solution must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tazocin contains

• The active substances are piperacillin and tazobactam. Each vial contains 2 g of piperacillin (as the sodium salt) and 0.25 g of tazobactam (as the sodium salt). Each vial contains 4 g of piperacillin (as the sodium salt) and 0.5 g of tazobactam (as the sodium salt).
• The other components are monohydrate citric acid and disodium edetate (EDTA).

Description of the appearance of Tazocin and contents of the pack
Tazocin 2 g/0.25 g is a white to off-white powder supplied in a vial.
Packs contain 1, 5, 10, 12, 25 or 50 vials.
Tazocin 4 g/0.5 g is a white to off-white powder supplied in a vial.
Packs contain 1, 5, 10, 12, 25 or 50 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Italia S.r.l. – Via Isonzo, 71 – 04100 Latina
Manufacturer
Wyeth Lederle S.r.l
Via Franco Gorgone
Zona Industriale
95100 Catania
Pfizer Service Company BV,
Hoge Wei 10, Zaventem, 1930
Belgium

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Tazocin 2 g + 0.25 g powder for solution for infusion – 12 vials of powder
Tazocin 4 g + 0.5 g powder for solution for infusion – 1 vial of powder
Tazocin 4 g + 0.5 g powder for solution for infusion – 12 vials of powder

The following information is intended exclusively for healthcare professionals.

Note: Use for bacteremia due to ceftriaxone non-susceptible E. coli and K. pneumoniae producing extended-spectrum beta-lactamases (ESBL) is not recommended in adult patients.
Instructions for use
Tazocin must be administered by intravenous infusion (a 30-minute infusion).
Intravenous use
Reconstitute each vial with the volume of diluent indicated in the table below, using one of the compatible diluents listed. Shake by rotating until dissolved. With consistent rotation, reconstitution generally takes between 5 and 10 minutes (for further information on handling, see below).

*Compatible solvents for reconstitution:

• 0.9% sodium chloride injection solution (9 mg/ml)
• sterile water for injection
• 5% glucose

The maximum recommended volume of sterile water for injection per dose is 50 ml.
The reconstituted solution must be withdrawn from the vial using a syringe. Once reconstituted according to
instructions, the content withdrawn from the vial with the provided syringe will deliver the amount of piperacillin and
tazobactam indicated on the label.
Reconstituted solutions may be further diluted to the desired volume (e.g., from 50 ml to 150
ml) with one of the following compatible solvents:

• 0.9% sodium chloride injection solution (9 mg/ml)
• 5% glucose
• 6% dextran in 0.9% sodium chloride (9 mg/ml)
• Ringer's lactate injection solution
• Hartmann's solution
• Ringer's acetate
• Ringer's acetate/malate

Incompatibilities
When Tazocin is used concomitantly with another antibiotic (e.g., aminoglycosides), the
substances must be administered separately. Mixing beta-lactam antibiotics with
aminoglycosides in vitro may cause substantial inactivation of the aminoglycoside. However,
it has been established that amikacin and gentamicin are compatible with Tazocin in vitro when using certain diluents at specific concentrations (see below Co-administration of Tazocin with aminoglycosides).
Tazocin must not be mixed with other substances in the same syringe or infusion vial, as compatibility has not been established.
Due to chemical instability, Tazocin must not be used with solutions containing only sodium bicarbonate.
Tazocin is compatible with Ringer's lactate solution for co-administration via Y-site infusion.
Tazocin must not be added to blood products or albumin hydrolysates.

Co-administration of Tazocin with aminoglycosides
Due to in vitro inactivation of aminoglycosides by beta-lactam antibiotics, it is recommended that Tazocin and aminoglycosides be administered separately. When concomitant therapy with aminoglycosides is indicated, Tazocin and the aminoglycoside must be reconstituted and diluted separately.
Under circumstances where co-administration is recommended, Tazocin is compatible for simultaneous co-administration via Y-site infusion only with the following aminoglycosides and under the following conditions:

* The aminoglycoside dose must be based on the patient's body weight, the severity of the infection (serious or potentially life-threatening), and renal function (creatinine clearance).
The compatibility of Tazocin with other aminoglycosides has not been established. Compatibility for co-administration by infusion using a Y-site connector has been confirmed only for the concentrations and diluents of amikacin and gentamicin together with the Tazocin dose, as reported in the previous table. Simultaneous co-administration via a Y-site connector using conditions different from those described above may result in inactivation of the aminoglycoside by Tazocin.

Package leaflet: Information for the user

Tazocin

2 g + 0.25 g/4 ml powder and solvent for injectable solution for intramuscular use
Piperacillin/Tazobactam
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Tazocin is and what it is used for

Piperacillin belongs to a group of medicines known as "broad-spectrum penicillin antibiotics"
and is capable of killing many types of bacteria. Tazobactam can prevent some resistant bacteria
from surviving the effects of piperacillin. This means that when piperacillin and tazobactam
are administered together, they can kill a greater number of bacterial types.
Tazocin is used in adults, children (from 2 years of age upwards), and adolescents for the treatment of
bacterial infections, such as those affecting the lower respiratory tract (lungs) or the urinary tract
(kidneys and bladder).
In certain severe infections, the doctor may consider using Tazocin in combination with other antibiotics.

2. What you should know before using Tazocin

Do not use Tazocin

• if you are allergic to piperacillin, tazobactam, lidocaine, or 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 Tazocin.

Warnings and precautions
Talk to your doctor or pharmacist before using Tazocin.

• If you have allergies. If you have multiple allergies, inform your doctor or pharmacist before taking this medicine.
• If you have diarrhoea before treatment, or if you develop diarrhoea during or after treatment. In this case, you must inform your doctor or pharmacist immediately. Do not take medicines for diarrhoea without first consulting your doctor.
• If you have low levels of potassium in your blood. Your doctor may decide to check your kidney function before administering this medicine and may prescribe periodic blood tests during treatment.
• If you have kidney or liver problems or are undergoing haemodialysis. Your doctor may decide to check your kidney function before administering this medicine and may prescribe periodic blood tests during treatment.
• If you are taking another antibiotic called vancomycin. Taking Tazocin and vancomycin together may increase the risk of kidney damage (see also section “Other medicines and Tazocin” in this leaflet).
• If you are taking certain medicines (called anticoagulants) to prevent excessive blood clotting (see also section “Other medicines and Tazocin” in this leaflet), or if unexpected bleeding occurs during treatment. In this case, you must inform your doctor or pharmacist immediately.
• If you develop seizures during treatment. In this case, you must inform your doctor or pharmacist.
• If you suspect you have developed a new infection or if your infection worsens. In this case, you must inform your doctor or pharmacist.

Haemophagocytic lymphohistiocytosis
Cases of a disease in which the immune system produces higher than normal levels of white blood cells called histiocytes and lymphocytes, leading to inflammation (haemophagocytic lymphohistiocytosis), have been reported. This condition can be life-threatening if not diagnosed and treated early. If you develop several symptoms such as fever, swollen lymph nodes, feeling of weakness, mental confusion, shortness of breath, bruising, or skin rash, contact your doctor immediately.
If you experience muscle pain, tenderness or weakness and/or dark-coloured urine, inform your doctor immediately, as treatment will be stopped. These symptoms could be signs of muscle breakdown (rhabdomyolysis), which may lead to kidney problems.

Children
The use of Tazocin is not recommended in children under 2 years of age due to insufficient data on safety and efficacy.

Other medicines and Tazocin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take or need to take any other medicines, including those without a prescription.

Some medicines may interact with piperacillin and tazobactam. These include:

• Medicines for gout (probenecid). These may increase the time required for elimination of piperacillin and tazobactam from the body.
• Medicines to thin the blood or treat blood clots (e.g. heparin, warfarin, or aspirin).
• Medicines used to relax muscles during surgery. Inform your doctor if you are undergoing general anaesthesia.
• Methotrexate (a medicine used to treat cancer, arthritis, or psoriasis). Piperacillin and tazobactam may increase the time required for elimination of methotrexate from the body.
• Medicines that may reduce potassium levels in the blood (e.g. diuretic tablets or certain cancer medicines).
• Medicines containing the other antibiotics tobramycin, gentamicin, or vancomycin. Inform your doctor if you have kidney problems. Taking Tazocin and vancomycin together may cause acute kidney damage even if you do not have kidney problems.

Effect on laboratory tests
Inform your doctor or laboratory staff that you are taking Tazocin if you are required to provide a blood or urine sample.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether Tazocin is suitable for you.
Piperacillin and tazobactam may pass to the unborn baby through the placenta or to the infant through breast milk. If you are breastfeeding, your doctor will decide whether Tazocin is suitable for you.

Driving and using machines
Tazocin is not expected to affect your ability to drive or use machinery.

Tazocin contains sodium
This medicine contains 130 mg of sodium (the main component of table salt) per vial. This is equivalent to 6.5% of the maximum daily recommended dietary intake of sodium for an adult.

3. How to use Tazocin

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Tazocin 2 g + 0.25 g / 4 ml must be administered by intramuscular injection.
The solvent vial contains lidocaine; each package of Tazocin 2 g + 0.25 g / 4 ml must be used exclusively for intramuscular use.
The maximum dose of 2 g piperacillin/0.25 g tazobactam per injection site must not be exceeded.

Adult patients
The usual recommended daily dose is 12 g piperacillin/1.5 g tazobactam, given in divided doses every 6 or 8 hours. Higher daily doses of 18 g piperacillin/2.25 g tazobactam may be administered in divided doses in cases of severe infections.

The dosage and frequency of Tazocin 2 g + 0.25 g / 4 ml depend on the severity and location of the infection, as well as the type of suspected pathogens.
The usual dose for adults ranges from 2 g/0.25 g every 12 hours to 2 g/0.25 g every 6 hours, administered by intramuscular injection.

Tazocin should be used until all signs of infection have completely disappeared (5–14 days). The duration of treatment should be determined according to your doctor's instructions. If you have any doubts about how to use this medicine, consult your doctor.

Patients with kidney problems
Your doctor may need to reduce the dose of Tazocin or the frequency of administration. Your doctor may also perform blood tests to ensure that the prescribed dose is appropriate, especially if you are to receive this medicine for a prolonged period.

Instructions for use

1. Shake the vial to loosen the powder from the bottom.
2. Remove the flip-off plastic cap from the vial to expose the central portion of the rubber stopper and keep the cap. Avoid touching the central portion of the rubber stopper with your hands.

3. Using a syringe, withdraw the solvent from the ampoule and transfer it into the vial containing the powder.
4. Place the plastic cap back onto the rubber stopper to prevent touching the central portion with fingers. Shake vigorously until the powder is completely dissolved. Under continuous agitation, complete dissolution should occur within approximately 10 minutes.

5. Allow the resulting solution to stand until foam disappears. Ensure that the solution is clear and free from undissolved particles.
6. Remove the plastic cap and withdraw the solution using a 5 ml syringe.
7. Inject the reconstituted solution deeply into a muscle.

If you use more Tazocin than you should
If you think you have used too much medicine or if you experience adverse effects such as seizures, inform your doctor immediately.

If you forget to use Tazocin
If you think you have missed a dose of Tazocin, inform your doctor or pharmacist immediately.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects of Tazocin are:

• severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) which initially appear as reddish spots or circular wheals, often with central blisters on the trunk. Further symptoms include ulcers in the mouth, throat, nose, extremities, genitals, and conjunctivitis (red and swollen eyes). The rash may progress to widespread blistering or skin peeling, which can potentially be life-threatening; severe skin inflammation causing extensive skin peeling (exfoliative dermatitis)
• a severe, potentially fatal allergic condition (drug reaction with eosinophilia and systemic symptoms) that may involve the skin and particularly other internal organs such as the kidneys and liver
• a skin condition (acute generalized exanthematous pustulosis) accompanied by fever, consisting of numerous small fluid-filled pustules within large areas of swollen and reddened skin
• swelling of the face, lips, tongue, or other parts of the body
• shortness of breath, wheezing, or difficulty breathing
• sudden chest pain that may occur with an allergic reaction known as Kounis syndrome
• severe rash, itching, or hives on the skin
• yellowing of the eyes or skin
• damage to blood cells (signs include: unexpected breathlessness, red or brown urine, nosebleeds, and appearance of bruises)
• severe or persistent diarrhoea accompanied by fever or weakness
• muscle pain, tenderness, or weakness and/or dark-coloured urine (rhabdomyolysis, frequency not known)

If you experience any of the above side effects, consult your doctor immediately.
Other side effects:
Very common side effects (may affect more than 1 in 10 people):

• diarrhoea

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

• fungal infections
• reduction in platelets, reduction in red blood cells or blood pigment/haemoglobin, abnormal laboratory test (positive direct Coombs test), prolonged bleeding time (prolonged activated partial thromboplastin time)
• reduction in albumin protein in the blood, reduction in total blood proteins
• headache, insomnia
• abdominal pain, vomiting, nausea, indigestion, stomach discomfort
• increase in certain liver enzymes in the blood (increased alanine aminotransferase, increased aspartate aminotransferase)
• skin rash, itching
• increase in muscle metabolism product in the blood (increased blood creatinine)
• fever, injection site reaction

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

• reduction in white blood cells (leucopenia), prolonged blood clotting time (prolonged prothrombin time)
• low potassium levels in the blood (hypokalaemia), low blood sugar (glucose)
• seizures (convulsions), reported in patients receiving high doses or with kidney problems
• low blood pressure, inflammation of veins (felt as tenderness or redness in the affected area)
• flushed skin with hot flushes
• increase in breakdown product of blood pigments (bilirubin)
• skin reactions with redness and lesion formation (rash, erythema multiforme), hives
• joint and muscle pain
• chills

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

• severe reduction in granular white blood cells (agranulocytosis), nosebleeds
• serious colon infection
• inflammation of the mouth mucosa
• detachment of the upper layer of skin over the entire body (toxic epidermal necrolysis)

Frequency not known (cannot be estimated from available data):

• severe reduction in red blood cells, white blood cells, and platelets (pancytopenia), reduction in white blood cells (neutropenia), reduction in red blood cells due to premature breakdown (haemolytic anaemia), appearance of bruises with small spots (purpura), prolonged bleeding time
• increased platelets, increase in a specific type of white blood cells (eosinophilia)
• severe allergic reaction
• jaundice (yellowing of the skin or whites of the eyes)
• severe, widespread allergic reaction affecting the whole body with skin and mucosal rash and various skin eruptions (Stevens-Johnson syndrome), severe allergic condition involving the skin and other internal organs such as kidneys and liver (drug reaction with eosinophilia and systemic symptoms), numerous small fluid-filled pustules within large areas of swollen and reddened skin accompanied by fever (acute generalized exanthematous pustulosis)
• skin reactions with blister formation (bullous dermatitis), blistering skin disease characterized by blisters on the skin and mucous membranes (linear IgA disease), reduced kidney function and kidney problems
• accumulation of eosinophils, a type of white blood cell, in the lungs (eosinophilic pneumonia)
• acute disorientation and confusion (delirium)

Treatment with piperacillin has been associated with a higher incidence of fever and rash in patients with cystic fibrosis.
Beta-lactam antibiotics, including piperacillin/tazobactam, may lead to manifestations of signs of impaired brain function (encephalopathy) and seizures.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/en/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tazocin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, vial, and bottle after "Exp.". The expiry date refers to the last day of that month.
Intact vials: do not store above 25°C.
For single use only.
Reconstituted solution: after reconstitution, the solution should be administered immediately.
Discard any unused solution.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tazocin contains

• The active substances are piperacillin (as the sodium salt) and tazobactam (as the sodium salt). Each vial contains 2 g of piperacillin (as the sodium salt) and 0.25 g of tazobactam (as the sodium salt).
• The other components are disodium edetate (EDTA) and citric acid monohydrate.
• The solvent vial contains lidocaine hydrochloride and water for injections.

Description of the appearance of Tazocin and contents of the pack
Tazocin 2 g + 0.25 g/4 ml is a white to off-white powder supplied in a vial.
The packs contain 1 glass vial containing the powder + 1 glass solvent vial of 4 ml.
Marketing Authorisation Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Manufacturer
Wyeth Lederle S.r.l.,
Via Franco Gorgone – Zona Industriale
95100 Catania