CEFTAZIDIME NORMON 2 g POWDER FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Ceftazidime Normon 2 g powder for solution for infusion EFG

ceftazidime

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Ceftazidime Normon and what is it used for
2. What you need to know before you are given Ceftazidime Normon
3. How Ceftazidime Normon is administered
4. Possible side effects
5. Storage of Ceftazidime Normon
6. Contents of the pack and further information

1. What is Ceftazidime Normon and what is it used for

Ceftazidime Normon is an antibiotic used in adults and children (including newborns). It works by killing the bacteria that cause infections. It belongs to a group of medicines known as cephalosporins.

Ceftazidime Normon is used to treat serious bacterial infections of:

• The lungs or chest
• The lungs and bronchi in patients with cystic fibrosis
• The brain (meningitis)
• The ear
• The urinary tract
• The skin and soft tissues
• The abdomen and abdominal wall (peritonitis)
• The bones and joints.

Ceftazidime Normon can also be used:

• To prevent infections during prostate surgery in men

to treat patients who have a low white blood cell count (neutropenia) and fever due to a bacterial infection.

2. What you need to know before you are given Ceftazidime Normon

This medicine must not be administered to you:

• if you are allergic(hypersensitive) to ceftazidime, to other cephalosporinsor to any of the other components of this medicine (listed in section 6).
• if you have ever had a severe allergic reactionto any other antibiotic(penicillins, monobactams, and carbapenems) as you may also be allergic to this medicine.

♦ Inform your doctorbefore starting treatment with Ceftazidime Normon if you think this applies to you. This medicine must not be administered to you.

Warnings and precautions

While you are being administered this medicine, you should be aware of certain symptoms such as allergic reactions, nervous system disorders, and gastrointestinal disorders, such as diarrhea. This will reduce the risk of potential problems. See (Symptoms to which you should pay attention) in section 4. If you have ever had an allergic reaction to other antibiotics, you may also be allergic to this medicine.

Severe 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 relation to ceftazidime treatment. Seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

If you need a blood or urine test

Ceftazidime Normon may affect the results of urine glucose tests and a blood test known as the Coombs test. If you are having tests:

♦ Inform the person taking the samplethat you have been administered ceftazidime.

Use of Ceftazidime Normon with other medicines

Tell your doctor if you are using, have recently used, or might use any other medicines.

This medicine must not be administered to you without talking to your doctor if you are also taking:

• an antibiotic called chloramphenicol
• a type of antibiotic called aminoglycosides, for example: gentamicin, tobramycin
• a "water pill" (a diuretic called furosemide)

♦ Inform your doctorif this applies to you.

Pregnancy and breastfeeding

Tell your doctor before you are administered this medicine:

• If you are pregnant, think you may be pregnant, or plan to become pregnant
• If you are breastfeeding

Your doctor will weigh the benefits of treating you with this medicine against the risks to the baby.

Driving and using machines

Ceftazidime Normon may cause side effects such as dizziness that affect your ability to drive.

Do not drive or operate machinery unless you are sure it does not affect you.

Ceftazidime Normon contains sodium.

This medicine contains 104.15 mg (4.53 mmol) of sodium (the main component of table salt/cooking salt) per vial. This is equivalent to 5.2% of the maximum daily intake for an adult.

3. How Ceftazidime Normon is administered

This medicine is usually administered by a doctor or nurse.It is administered as a drip(intravenous infusion).

This medicine is reconstituted by the doctor, pharmacist, or nurse using a suitable infusion fluid.

Recommended dose

The correct dose of this medicine for you will be decided by your doctor and depends on: the severity and type of infection, if you are being treated with other antibiotics, your weight and age, and your kidney function.

Newborn babies (0-2 months)

For every 1 kg of the baby's weight, 25 to 60 mg of this medicine will be administered per day, divided into two doses.

Babies (over 2 months) and childrenwho weigh less than 40 kg

For every 1 kg of the baby's or child's weight,100 to 150 mg of this medicine will be administered per day, divided into three doses. Maximum 6 g per day.

Adults and adolescentswho weigh 40 kg or more

1 g to 2 g of this medicine, three times a day. Maximum 9 g per day.

Patients over 65 years of age

The daily dose should not normally exceed 3 g per day, especially if you are over 80 years old.

Patients with kidney problems

You may be administered a different dose than usual. The doctor will decide how much of this medicine you need, depending on the severity of the kidney disease. Your doctor will closely monitor you and perform kidney tests more frequently.

If you are administered more Ceftazidime Normon than you should

If you accidentally receive more than the prescribed dose, contact your doctor or the nearest hospital.

You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount administered.

If you miss a dose of Ceftazidime Normon

If you miss an injection, you should receive it as soon as possible. However, if it is almost time for the next injection, skip the missed injection. Do not use a double dose (two injections at the same time) to make up for the missed dose. Receive the next dose at the usual time.

If you stop treatment with Ceftazidime Normon

Do not stop receiving this medicine unless your doctor tells you to.

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

4. Possible side effects

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

Seek medical attention immediately if you notice any of the following symptoms:

• Red skin patches with a target-like shape or circular shape on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, or eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

• Widespread and red rash with peeling, bumps under the skin, and blisters accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Symptoms to which you should pay attention

The following serious side effects have occurred in a small number of patients, but their exact frequency is unknown:

• Severe allergic reaction. The signs include itchy and swollen rash, swelling, sometimes in the face or mouth that causes difficulty breathing.
• Skin rash, which can form blisters, and appears as small targets(a dark central spot surrounded by a lighter area, with a dark ring around the edge).
• Widespread rashwith blistersand skin peeling. (These can be signs of Stevens-Johnson syndromeor toxic epidermal necrolysis).
• Nervous system disorders: tremors, seizures, and, in some cases, coma. These have occurred in patients who are administered a very high dose, especially in patients with kidney disease.

There have been reports of rare cases of severe hypersensitivity reactions with severe skin rash, which can be accompanied by fever, fatigue, swelling of the face or lymph nodes, increased eosinophils (a type of white blood cell), liver, kidney, or lung involvement (a reaction known as DRESS syndrome)

♦ Contact your doctor or nurse immediately if you experience any of these symptoms.

Common side effects

May affect 1 in 10people:

• Diarrhea
• Swelling and redness around a vein
• Red and swollen skin rash, which can cause itching
• Pain, burning, swelling, or inflammation at the injection site.

♦ Inform your doctorif any of these side effects worry you.

Common side effects that may appear in blood tests:

• An increase in a type of white blood cell (eosinophilia)
• An increase in the number of cells that help blood clot
• An increase in liver enzymes.

Uncommon side effects

May affect 1 in 100people:

• Inflammation of the intestine that can cause pain or diarrhea that may contain blood
• Fungal infections in the mouth or vagina
• Headache
• Dizziness
• Stomach pain
• Nausea or vomiting
• Fever and chills.

♦ Inform your doctorif you experience any of them.

Uncommon side effects that may appear in blood tests:

• A decrease in the number of white blood cells
• A decrease in the number of platelets (cells that help blood clot)
• An increase in urea, ureic nitrogen, or serum creatinine levels in the blood.

Rare side effects

May affect 1 in 10,000 people:

• Kidney inflammation or failure

Other side effects

Other side effects that have occurred in a small number of patients, but whose exact frequency is unknown:

• Numbness
• Bad taste in the mouth
• Yellowing of the skin or the whites of the eyes.

Other side effects that may appear in blood tests:

• Rapid destruction of red blood cells
• Increased levels of a certain type of white blood cell
• Significant decrease in the number of white blood cells.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website: https//www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceftazidime Normon

Keep this medicine out of the sight and reach of children.

Store below 25 ºC.

Store in the original package to protect from light.

Do not use this medicine after the expiry date stated on the package after EXP. The expiry date is the last day of the month indicated.

From a microbiological point of view, the product should be used immediately. If not used immediately, the maximum validity period once the injectable is reconstituted with the indicated volume of diluent is 8 hours at a temperature of 25 ºC and 24 hours at a temperature between 2 ºC-8 ºC.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ceftazidime Normon

The active substance is ceftazidime. Each vial contains 2 g of ceftazidime (as pentahydrate).

As an excipient, it contains anhydrous sodium carbonate.

Appearance of the product and pack contents

The Ceftazidime Normon 2 g powder for solution for infusion pack contains a 20 ml capacity vial with 2 g of ceftazidime in powder form. It is presented in packs of 1 vial or 50 vials (clinical pack).

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of last revision of this leaflet:October 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es.