CEFTAZIDIME NORMON 500 mg POWDER AND SOLVENT FOR INJECTION

Introduction

Package Leaflet: Information for the User

Ceftazidime Normon 500 mg powder and solvent for solution for injection EFG

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 given
4. Possible side effects
5. Storage of Ceftazidime Normon
6. Contents of the pack and other 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 with 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

Ceftazidime Normon should not be given to you:

• if you are allergic(hypersensitive) to ceftazidime,to other cephalosporinsor to any of the other ingredientsof 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 Ceftazidime Normon.

• Tell your doctor beforestarting treatment with Ceftazidime Normon if you think this applies to you. You should not be given Ceftazidime Normon.

Warnings and precautions

While you are being given Ceftazidime Normon, 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 possible problems. (See Symptoms to be aware ofin section 4). If you have ever had an allergic reaction to other antibiotics, you may also be allergic to Ceftazidime Normon.

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:

• Tell the person taking the samplethat you have been given ceftazidime.

Using Ceftazidime Normon with other medicines

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

Do not use Ceftazidime Normon without talking to your doctor if you are also taking:

• a type of antibiotic called chloramphenicol
• a type of antibiotics called aminoglycosides, such as gentamicin, tobramycin
• a "water pill" (a diuretic called furosemide)

• Tell your doctorif this applies to you.

Pregnancy and breastfeeding

Tell your doctor before you are given Ceftazidime Normon:

• 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 Ceftazidime Normon 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 or use machines.

Do not drive or use machines unless you are sure that you are not affected.

Ceftazidime Normon contains sodium.

This medicine contains 26.04 mg (1.13 mmol) of sodium (a major component of table salt/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 Ceftazidime Normon is given

Ceftazidime Normon is usually given by a doctor or nurse.

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

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

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

Babies (over 2 months) and childrenweighing less than 40 kg

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

Adults and adolescentsweighing 40 kg or more

1 to 2 g of Ceftazidime Normon, 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 given a different dose than usual. Your doctor will decide how much Ceftazidime Normon you need, depending on the severity of your kidney disease. Your doctor will closely monitor you and perform kidney tests more frequently.

If you are given too much Ceftazidime Normon

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 Ceftazidime Normon 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, 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 be aware of

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, raised rash, swelling,sometimes in the face or mouth, causing 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 syndrome or toxic epidermal necrolysis).
• nervous system disorders:tremors, seizures, and, in some cases, coma. These have occurred in patients who received a very high dose, especially in patients with kidney disease.
• There have been rare reports of severe hypersensitivity reactions with severe skin rash, which may 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 immediately if you experience any of these symptoms.

Common side effects

May affect 1 in 10people:

• diarrhea
• swelling and redness around a vein
• red, itchy rash
• pain, burning, swelling, or inflammation at the injection site.

• Tell 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 with blood
• fungal infections in the mouth or vagina
• headache
• dizziness
• stomach pain
• nausea or vomiting
• fever and chills.

• Tell your doctorif you experience any of these.

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:

• inflammation or kidney failure

Other side effects

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

• inflammation or kidney failure
• tingling
• 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
• an increase in a certain type of white blood cell
• a 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 side effects directly through the Spanish Medicines and Health Products Agency's 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°C.

Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

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°C and 24 hours at a temperature between 2°C-8°C.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ceftazidime Normon

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

As an excipient, it contains anhydrous sodium carbonate.

Each ampoule of solvent contains 5 ml of water for injections.

Appearance of the product and contents of the pack

The pack of Ceftazidime Normon 500 mg powder and solvent for solution for injection contains a 8 ml capacity vial with 500 mg of ceftazidime in powder and an ampoule of solvent with 5 ml of water for injections. It is also available in packs of 50 vials and 50 ampoules (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 Health Products (AEMPS)

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