Tottizim

Package leaflet: Information for the patient

TOTTIZIM 500 mg/1.5 ml

powder and solvent for injectable solution for intramuscular use
TOTTIZIM 1 g/3 ml
powder and solvent for injectable solution for intramuscular use
TOTTIZIM 1 g/10 ml
powder and solvent for injectable solution for intravenous use
TOTTIZIM 1 g
powder for injectable solution for intravenous use
TOTTIZIM 2 g
powder for infusion solution
Ceftazidime
Please read carefully this leaflet before 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 they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What TOTTIZIM is and what it is used for

TOTTIZIM is an antibiotic used in adults and children (including newborn infants). It works by killing the bacteria that cause infections and belongs to a group of medicines called cephalosporins.
TOTTIZIM is used to treat serious bacterial infections of the lungs or chest, lungs and bronchi in patients suffering from a condition known as cystic fibrosis, brain (meningitis), ear, urinary tract, skin and soft tissues, abdomen and abdominal wall (peritonitis), bones and joints.
TOTTIZIM may also be used to prevent infections during surgical operations of the prostate in men and to treat patients with a low number of white blood cells (neutropenia) who have fever due to a bacterial infection.

2. What you need to know before taking TOTTIZIM

Do not take TOTTIZIM

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if you have previously experienced a severe allergic reaction to any other antibiotic (penicillins, monobactams, or carbapenems), as you may also be allergic to TOTTIZIM.

Tell your doctor before starting treatment with TOTTIZIM if you think any of the above applies to you.
TOTTIZIM must not be administered to you.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking TOTTIZIM
Be vigilant for certain symptoms such as allergic reactions, nervous system disorders, and gastrointestinal disturbances, such as diarrhoea, while being treated with TOTTIZIM. This will help reduce the risk of potential problems. See ( Conditions requiring caution ) in section 4. If you have had an allergic reaction to other antibiotics, you may also be allergic to TOTTIZIM.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ceftazidime treatment. Seek immediate medical advice if you notice any symptoms related to these serious skin reactions described in section 4.

If you require blood or urine tests
TOTTIZIM may interfere with the results of urine sugar tests and with the blood test known as the Coombs test.
Inform the person collecting the sample that you are being treated with TOTTIZIM.

Other medicines and TOTTIZIM
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription.
TOTTIZIM must not be administered to you without first consulting your doctor if you are taking:

• an antibiotic called chloramphenicol
• a class of antibiotics called aminoglycosides, such as gentamicin, tobramycin
• diuretic tablets called furosemide
  Inform your doctor if any of the above applies to you.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will assess the benefits of treatment with TOTTIZIM against the potential risks to the unborn or nursing infant.

Driving and using machines
TOTTIZIM may cause side effects that can affect your ability to drive, such as dizziness.
Do not drive or operate machinery unless you are certain you will not be affected.

TOTTIZIM contains sodium
TOTTIZIM 1 g
This medicine contains 51 mg of sodium (the main component of table salt) per vial. This is equivalent to 2.5% of the maximum daily dietary intake recommended for an adult.
TOTTIZIM 2 g
This medicine contains 101 mg of sodium (the main component of table salt) per vial. This is equivalent to 5% of the maximum daily dietary intake recommended for an adult.
TOTTIZIM 500 mg/1.5 ml
This medicine contains 25 mg of sodium (the main component of table salt) per vial. This is equivalent to 1.25% of the maximum daily dietary intake recommended for an adult.
Talk to your doctor or pharmacist if you need to take one or more vials of TOTTIZIM daily for a prolonged period, especially if you have been advised to follow a low-sodium diet.

3. How to take TOTTIZIM

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
TOTTIZIM is generally administered by a doctor or nurse. It may be given as an intravenous infusion or as an injection directly into a vein or into a muscle.
TOTTIZIM is prepared by the doctor, pharmacist, or nurse using water for injections or appropriate infusion fluids.

Usual dose
The recommended dose of TOTTIZIM will be decided by your doctor and depends on: the severity and type of infection; whether you are being treated with other antibiotics; your body weight and age; and the condition of your kidneys.

Use in children
Newborns (0–2 months of age)
A daily dose of 25 to 60 mg of TOTTIZIM per kilogram of the child's body weight, divided into two doses, will be administered.

Children (over 2 months of age) and children weighing less than 40 kg
A daily dose of 100 to 150 mg of TOTTIZIM per kilogram of the infant’s or child’s body weight, divided into three doses, will be administered. The maximum dose is 6 g per day.

Use in adults and adolescents weighing 40 kg or more
1 to 2 g of TOTTIZIM three times daily. The maximum dose is 9 g per day.

Use in patients over 65 years of age
The daily dose should generally not exceed 3 g per day, especially if over 80 years of age.

Use in patients with kidney problems
You may be given a different dose than usual. Your doctor or nurse will determine the amount of TOTTIZIM you need based on the severity of your kidney disease. Your doctor will monitor you closely and may perform kidney function tests more regularly.

If you take more TOTTIZIM than you should
If you accidentally use a higher dose than prescribed, contact your doctor or the nearest hospital immediately.

If you forget to take TOTTIZIM
If you miss an injection, take it as soon as possible. However, if it is almost time for the next injection, skip the missed dose. Do not take a double dose (two injections at the same time) to make up for a forgotten dose.

If you stop treatment with TOTTIZIM
Do not stop treatment with TOTTIZIM unless your doctor tells you to.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions requiring immediate attention
The following serious side effects have occurred in a small number of people, but their exact frequency is unknown.
Contact your doctor immediately if you notice any of the following symptoms:

• Reddish patches on the trunk; the patches are target-like or circular macules, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Generalized, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes of the face or mouth, causing difficulty breathing.
• Nervous system disorders: tremors, seizures, and in some cases coma. These have occurred in people who were given too high a dose, especially in those with kidney disease.

Common side effects
These may affect up to 1 in 10 patients:

• Diarrhea
• Swelling and redness along the vein
• Raised, red rash which may be itchy
• Pain, burning, swelling, or inflammation at the injection site

Tell your doctor if any of these conditions concern you.

Common side effects that may be detected by blood tests include:

• Increase in a type of white blood cells (eosinophilia)
• Increase in the number of cells that help blood clot
• Increase in liver enzymes

Uncommon side effects
These may affect up to 1 in 100 patients:

• Inflammation of the intestine, which may cause pain or diarrhea, possibly containing blood
• Fungal infections (candidiasis) in the mouth or vagina
• Headache
• Dizziness
• Stomach pain
• Nausea or vomiting
• Fever and chills
  Tell your doctor if you experience any of these conditions.

Uncommon side effects that may be detected by blood tests include:

• Decrease in the number of white blood cells
• Decrease in the number of platelets (cells that help blood clotting)
• Increase in blood levels of urea, azotemia, or serum creatinine

Other side effects
Other side effects have occurred in a small number of people, but their exact frequency is unknown:

• Kidney inflammation or kidney failure
• Sensation of pins and needles
• Unpleasant taste in the mouth
• Yellowing of the whites of the eyes or skin

Other side effects that may be detected by blood tests include:

• Too rapid destruction of red blood cells
• Increase in certain types of white blood cells
• Severe decrease in the number of white blood cells

Rare cases of allergic reaction with severe skin rash have been reported, which may be accompanied by fever, fatigue, swelling of facial or lymphatic glands, increase in a type of white blood cells (eosinophils), and effects on the kidneys, liver, and lungs (a reaction called DRESS).

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor. 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 TOTTIZIM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp.". The expiry date refers to the
last day of that month.
Before reconstitution, store the vials protected from light and at a temperature not exceeding 25°C.
The product in solution, after reconstitution with water for injections or with compatible infusion liquids
(e.g. physiological saline, glucose or sodium lactate solutions), should normally be used within 18 hours if
stored at room temperature and within 7 days if stored at 4°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. OTHER INFORMATION

What TOTTIZIM contains
The active substance is ceftazidime pentahydrate.
TOTTIZIM 500 mg/1.5 ml - powder and solvent for injectable solution for intramuscular use
Each vial of powder contains 582 mg of ceftazidime pentahydrate, equivalent to 500 mg of ceftazidime.
The other excipients are: anhydrous sodium carbonate.
Each solvent vial contains water for injections.
TOTTIZIM 1 g/3 ml - powder and solvent for injectable solution for intramuscular use
Each vial of powder contains 1.164 g of ceftazidime pentahydrate, equivalent to 1 g of ceftazidime.
The other excipients are: anhydrous sodium carbonate.
Each solvent vial contains water for injections.
TOTTIZIM 1 g/10 ml - powder and solvent for injectable solution for intravenous use
Each vial of powder contains 1.164 g of ceftazidime pentahydrate, equivalent to 1 g of ceftazidime.
The other excipients are: anhydrous sodium carbonate.
Each solvent vial contains water for injections.
TOTTIZIM 1 g - powder for injectable solution for intravenous use
Each vial of powder contains 1.164 g of ceftazidime pentahydrate, equivalent to 1 g of ceftazidime.
The other excipients are: anhydrous sodium carbonate.
TOTTIZIM 2 g - powder for infusion solution
Each vial of powder contains 2.328 g of ceftazidime pentahydrate, equivalent to 2 g of ceftazidime.
The other excipients are: anhydrous sodium carbonate.

Description of the appearance of TOTTIZIM and contents of the pack
Powder and solvent for injectable solution for intramuscular use
Carton pack containing 1 vial of 500 mg powder and 1 solvent vial of 1.5 ml.
Carton pack containing 1 vial of 1 g powder and 1 solvent vial of 3 ml.

Powder and solvent for injectable solution for intravenous use
Carton pack containing 1 vial of 1 g powder and 1 solvent vial of 10 ml.

Powder for infusion solution
Carton pack containing 10 vials of 1 g powder.
Carton pack containing 1 vial of 2 g powder.

Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22 - 00071 Pomezia (Rome) - Italy

Manufacturer:
ESSETI Farmaceutici S.r.l.
Via Campobello, 15 - 00071 Pomezia (Rome) – Italy