Package leaflet: Information for the user

PIPERTEX 1 g Powder and solvent for injectable solution, 2 g Powder and solvent for injectable solution, 4 g Powder for injectable solution

piperacillin sodium
Generic medicine
Please read all of this leaflet carefully before you start 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, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What PIPERTEX is and what it is used for
What you need to know before using PIPERTEX
How to use PIPERTEX
Possible side effects
How to store PIPERTEX
Package contents and other information

1. What PIPERTEX is and what it is used for

PIPERTEX contains the active substance sodium piperacillin, which belongs to a group of medicines called penicillins that slow down or stop the growth of bacteria.
PIPERTEX is indicated for the treatment of infections caused by bacteria sensitive to piperacillin, such as:

simple and complicated infections of the kidneys, genital tract, and urinary tract. In this case, PIPERTEX can be administered intramuscularly or intravenously;
acute and chronic respiratory tract infections;
severe bloodstream infections affecting the whole body (severe systemic infections and septicemia);
skin and soft tissue infections;
lung infections (empyema, pneumonia, and lung abscess);
abdominal infections (peritonitis and abscess);
female genital tract infections (endometritis, pelvic inflammatory disease, pelvic abscess, and salpingitis).

PIPERTEX is also indicated for the prevention of infections before and after surgical procedures (perioperative prophylaxis).

2. What you need to know before using PIPERTEX

Do not use PIPERTEX

if you are allergic to piperacillin or to similar medicines (penicillins, cephalosporins) or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic to medicines used to induce anaesthesia (lidocaine or other amide-type anaesthetics);
if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
if this medicine is to be administered to a child during early infancy (see section “Use in children”).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using PIPERTEX.
Haemophagocytic lymphohistiocytosis
Cases of a disease in which the immune system produces an abnormally high number 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.
Before prescribing this medicine, your doctor must carefully examine you (take a thorough medical history) to ensure that you have not previously experienced allergic reactions to penicillins, cephalosporins and/or other allergens.
This product can be taken safely by patients with coeliac disease.
During prolonged treatment with this medicine and at high doses, your doctor should periodically monitor your health status by performing blood tests and adjusting the dosage as appropriate.
Use in children
The use of this medicine is contraindicated in early infancy (see section “Do not use PIPERTEX”).
PIPERTX and laboratory tests
Inform your doctor that you are using this medicine before undergoing certain laboratory tests, as PIPERTEX may interfere with a laboratory test (Coombs test).
Other medicines and PIPERTEX
Inform your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
If you have infections caused by specific types of bacteria (Pseudomonas, Serratia, Klebsiella, Proteus indole-positive, Providencia, Staphylococcus), this medicine may be used in combination with aminoglycoside antibiotics. However, these antibiotics must not be mixed together with PIPERTEX, but administered separately.
Use PIPERTEX with great caution and inform your doctor if you are taking:

medicines used to treat bacterial infections such as oxacillin or flucloxacillin;
probenecid, a medicine used to treat gout.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor, pharmacist or nurse before using this medicine.
If you are pregnant, do not use this medicine except when strictly necessary and under the direct supervision of a doctor.
Do not use this medicine if you are breastfeeding.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
PIPERTX contains sodium
PIPERTX 1 g contains 44.3 mg of sodium (the main component of table salt) per vial.
This corresponds to 2.2% of the maximum recommended daily dietary intake for an adult.
PIPERTX 2 g contains 88.6 mg of sodium (the main component of table salt) per vial.
This corresponds to 4.4% of the maximum recommended daily dietary intake for an adult.
PIPERTX 4 g contains 177.3 mg of sodium (the main component of table salt) per vial.
This corresponds to 8.9% of the maximum recommended daily dietary intake for an adult.

3. How to use PIPERTEX

Use this medicine exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
PIPERTX can be administered intramuscularly (IM), directly into a vein (intravenous bolus), or by slow intravenous infusion (intravenous drip).

Intramuscular administration (IM)
The lidocaine vial included in the package must be used only for intramuscular administration.
The recommended dose for adults is 1 vial of 2 g, twice daily.

Intravenous administration (IV)
For direct intravenous administration lasting 3-5 minutes, the contents of the vial must be dissolved in water for injections (4 ml for the 1 g vial; 8 ml for the 2 g vial).
The vial must be shaken vigorously for 2-3 minutes until the contents are completely dissolved.
The dose will be determined by the doctor according to the severity of the infection being treated and will be divided into multiple daily administrations:

generally in adults 150 - 300 mg/kg/day (up to a maximum of 24 g in 24 hours), divided into several doses.

Piperacillin must not be mixed with 5-fluorouracil or aminoglycosides due to inactivation processes affecting these substances.
For infusion, commonly used intravenous infusion solutions may be used, except those containing only sodium bicarbonate or solutions with a pH higher than 8.5 or lower than 4.5.

Use in children

Intramuscular administration (IM)
In children, the dose should be reduced according to age as follows:

children over 6 years of age: 1 vial of 1 g, twice daily.
children under 6 years of age: half a vial of 1 g (0.5 g), twice daily.

Intravenous administration (IV)
The dose will be determined by the doctor according to the type and severity of the infection being treated and will be divided into multiple daily administrations: generally 100 - 300 mg/kg/day.

Use in patients with renal problems
If you have kidney problems (renal insufficiency), your doctor will determine the appropriate dose based on your kidney function (creatinine clearance values).

If you use more PIPERTEX than you should
Cases of overdose are not known.
In case of accidental ingestion/overuse of an excessive dose of PIPERTEX, contact your doctor immediately or go to the nearest hospital.

If you forget to use PIPERTEX
Do not use a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
With this medicine, you may experience the following side effects:

severe allergic reactions (anaphylactic/anaphylactoid reactions) to piperacillin and other serious allergic phenomena as with other penicillins. Urticaria and skin rash (generally transient) have been reported more frequently.
nausea, diarrhoea
altered transaminase levels in the blood (a parameter used to assess liver function)
reduced number of certain blood cells (eosinophilia, leucopenia, anaemia, agranulocytosis, thrombocytopenia) and purpura, generally reversible
positive Coombs test
dizziness, headache, fatigue, hallucinations and muscle spasms (myoclonus)
pain, redness and hardening at the intramuscular injection site
occasionally, inflammation of the veins (phlebitis and thrombophlebitis) after intravenous administration.

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
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 PIPERTEX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Solutions for intramuscular injection, once prepared, must be used immediately.
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 PIPERTEX contains
PIPERTEX 1 g Powder and solvent for injectable solution
Vial

The active substance is sodium piperacillin. Each vial contains 1.04 g of sodium piperacillin equivalent to 1 g of piperacillin.

Solvent ampoule (for intramuscular use only): lidocaine hydrochloride, water for injectable preparations (2 ml).
PIPERTEX 2 g Powder and solvent for injectable solution
Vial

The active substance is sodium piperacillin. Each vial contains 2.08 g of sodium piperacillin equivalent to 2 g of piperacillin.

Solvent ampoule (for intramuscular use only):
lidocaine hydrochloride, water for injectable preparations (4 ml).
PIPERTEX 4 g Powder for injectable solution

The active substance is sodium piperacillin. Each vial contains 4.16 g of sodium piperacillin equivalent to 4 g of piperacillin.

Description of the appearance of PIPERTEX and contents of the pack
PIPERTEX 1 g Powder and solvent for injectable solution
The pack contains 1 vial of 1 g powder + 1 solvent ampoule
PIPERTEX 2 g Powder and solvent for injectable solution
The pack contains 1 vial of 2 g powder + 1 solvent ampoule
PIPERTEX 4 g Powder for injectable solution
The pack contains 10 vials of 4 g.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmatex Italia srl, Via San Paolo, 1-20121 - Milano (Italy)
Manufacturers
Vial + Solvent ampoule:
Mitim S.r.l. - Via Cacciamali 34-38 - 25125 Brescia - Italy
Solvent ampoule:
Fisiopharma Srl - Industrial area - 84020 Palomonte (SA) - Italy