CEFTAZIDIME NORMON 500 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ceftazidime Normon 500 mg powder and solvent for injectable solution EFG

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Ceftazidime Normon is and what it is used for
2. What you need to know before being administered Ceftazidime Normon
3. How to administer Ceftazidime Normon
4. Possible adverse effects
5. How to store Ceftazidime Normon
6. Contents of the pack and other information

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

Ceftazidima Normon is an antibiotic used in adults and children (including newborns). It works by eliminating 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 may also be used:

• to prevent infections during prostate surgery in men
• to treat patients with low white blood cell count (neutropenia) and fever due to a bacterial infection.

2. What you need to know before Ceftazidime Normon is administered to you

Do not use Ceftazidime Normon:

• if you are allergic (hypersensitive) to ceftazidime, to other cephalosporins, or to any of the other ingredients of this medicine (listed in section 6).

• if you have ever had a severe allergic reaction to any other antibiotic (penicillins, monobactams, or carbapenems), as you may also be allergic to Ceftazidime Normon.

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

Warnings and precautions

While receiving Ceftazidime Normon, you should be alert for 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 watch for in section 4). If you have ever had an allergic reaction to other antibiotics, you may also be allergic to Ceftazidime Normon.

Severe skin reactions have been reported with ceftazidime treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

If you need blood or urine tests

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

• Inform the person taking the sample that you have been administered ceftazidime.

Use of Ceftazidime Normon with other medicines

Tell your doctor if you are using or have recently used, or might need to use, any other medicines, including those obtained without a prescription.

You must not be given Ceftazidime Normon without first talking to your doctor if you are also taking:

• an antibiotic called chloramphenicol

• a type of antibiotics called aminoglycosides, for example: gentamicin, tobramycin

• a "water pill" (a diuretic called furosemide)

• Inform your doctor if any of the above applies to you.

Pregnancy and breastfeeding

Tell your doctor before Ceftazidime Normon is administered to you:

• if you are pregnant, think you might be pregnant, or plan to become pregnant
• if you are breastfeeding

Your doctor will assess the benefit of treating you with Ceftazidime Normon against the potential risk to the baby.

Driving and using machines

Ceftazidime Normon may cause adverse effects such as dizziness, which may affect your ability to drive.

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

Ceftazidime Normon contains sodium.

This medicine contains 26.04 mg (1.13 mmol) of sodium (the main component of table/cooking salt) per vial, equivalent to 1.3% of the maximum daily intake of 2 g of sodium recommended by the WHO for an adult.

3. How to administer Ceftazidime Normon

Ceftazidime Normon is normally administered by a doctor or a nurse.

It can be given directly as an injection into a vein or into a muscle.

Ceftazidime Normon is reconstituted by the doctor, pharmacist, or nurse using water for injectable preparations.

Normal dose

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

Newborn babies (0–2 months)

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

Infants (over 2 months) and children weighing less than 40 kg

For each 1 kg of the infant's or child's weight, 100 to 150 mg of Ceftazidime Normon per day will be administered, divided into three doses. Maximum 6 g per day.

Adults and adolescents weighing 40 kg or more

1 g to 2 g of Ceftazidime Normon, three times a day. Maximum 9 g per day.

Patients over 65 years of age

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

Patients with kidney problems

You may be given a different dose than usual. The doctor will decide how much Ceftazidime Normon you need, depending on the severity of the kidney disease. Your doctor will monitor you closely and kidney function tests will be performed more frequently.

If you are given more Ceftazidime Normon than you should

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

You may also call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medication and the amount administered.

If you forget to use Ceftazidime Normon

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

If you stop treatment with Ceftazidime Normon

Do not stop receiving Ceftazidime Normon unless your doctor tells you to do so.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• Red, target-shaped or circular skin patches on the trunk, often with blisters in the center, peeling skin, or ulcers in the mouth, throat, nose, genitals, or eyes. These serious 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 (drug reaction with eosinophilia and systemic symptoms, DRESS syndrome).

• Widespread red rash with peeling, lumps under the skin, and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Symptoms to watch for

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

• Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes in the face or mouth, causing difficulty breathing.

• Skin rash, which may form blisters, and appears as small target-like lesions (a dark central spot surrounded by a paler area, with a dark ring around the edge).

• Widespread rash with blisters and peeling skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis.)

• Nervous system disorders: tremors, seizures, and in some cases coma. These have occurred in patients receiving very high doses, especially in patients with kidney disease.

• Rare cases of severe hypersensitivity reactions with serious skin rash have been reported, which may be accompanied by fever, fatigue, facial swelling or swollen lymph nodes, increased eosinophils (a type of white blood cell), and involvement of the liver, kidneys, or lungs (a reaction known as DRESS syndrome).

• Contact your doctor immediately if you experience any of these symptoms.

Common adverse effects

May affect 1 in 10 people:

• Diarrhea

• Swelling and redness around a vein

• Red, raised rash, which may be itchy

• Pain, burning, swelling, or inflammation at the injection site.

• Tell your doctor if any of these adverse effects concern you.

Common adverse effects that may appear in blood tests:

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

Uncommon adverse effects

May affect 1 in 100 people:

• Inflammation of the intestine, which may 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.

• Tell your doctor if you experience any of these.

Uncommon adverse effects that may appear in blood tests:

• Decrease in the number of white blood cells
• Decrease in the number of platelets (cells that help blood to clot)
• Increase in blood levels of urea, blood urea nitrogen, or serum creatinine.

Very rare adverse effects

May affect 1 in 10,000 people:

• Inflammation or failure of the kidneys

Other adverse effects

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

• Inflammation or failure of the kidneys
• Tingling
• Bad taste in the mouth
• Yellowing of the skin or whites of the eyes.

Other adverse effects that may appear in blood tests:

• Rapid destruction of red blood cells
• Increase in a certain type of white blood cells
• Severe decrease in the number of white blood cells.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 °C.

Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the maximum shelf life after reconstitution with the indicated volume of diluent is 8 hours at 25 °C and 24 hours at a temperature between 2 °C and 8 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ceftazidima Normon

The active substance is ceftazidime. Each vial contains 500 mg of ceftazidime (as pentahydrate).

It contains anhydrous sodium carbonate as excipient.

Each solvent ampoule contains 5 ml of water for injections.

Appearance of the product and contents of the pack

The pack of Ceftazidima Normon 500 mg powder and solvent for injectable solution contains an 8 ml vial with 500 mg of ceftazidime as powder and one solvent ampoule containing 5 ml of water for injections. It is also available in packs of 50 vials and 50 ampoules (Hospital pack).

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the most recent revision of this leaflet: October 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS):

http://www.aemps.gob.es.