Leaflet: information for the user

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

Read this leaflet carefully before you start taking this medicine, because 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Ceftazidima Normon is an antibiotic used in adults and children (including newborns). It acts by eliminating the bacteria that cause infections. It belongs to a group of medications known ascephalosporins.

Ceftazidima Normon is used to treat severe 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.

Ceftazidima 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.

You should not be given Ceftazidima Normon:

• if you are allergic(hypersensitive) toceftazidima,to other cephalosporins or to any of the other components of this medication (listed in section 6).
• if you have ever had asevere allergic reactionto anyother antibiotic(penicillins, monobactams and carbapenems) as you may also be allergic to Ceftazidima Normon.

• Inform your doctor beforestarting treatment with Ceftazidima Normon if you think this affects you. You should not be given Ceftazidima Normon.

Warnings and precautions

While you are being given Ceftazidima 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. (SeeSymptoms to be aware ofin section 4). If you have ever had an allergic reaction to other antibiotics you may also be allergic to Ceftazidima Normon.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and generalized acute pustular psoriasis (GAPP) have been reported in association with ceftazidima 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 blood or urine tests

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

• Inform the person taking the samplethat you have been given ceftazidima.

Use of Ceftazidima Normon with other medications

Inform your doctor if you are using or have recently used or may need to use any other medication, including those purchased without a prescription.

You should not be given Ceftazidima Normon without talking to your doctor if you are also taking:

• an antibiotic calledchloramphenicol
• a type of antibiotic calledaminoglycosides, for example:gentamicin, tobramycin.
• a “urine tablet” (a diuretic calledfurosemide)

• Inform your doctorif this affects you.

Pregnancy and breastfeeding

Inform your doctor before you are givenCeftazidima Normon:

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

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

Driving and operating machinery

Ceftazidima 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.

Ceftazidima Normon contains sodium.

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

Ceftazidime Normon is usually administered by a doctor or nurse.

It can be administered directly as aninjectionin a vein or muscle.

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

Usual dose

The correct dose of Ceftazidime Normon 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 renal function.

Newborn babies (0-2 months)

For every 1 kg of the baby's weight, 25 to 60 mg of Ceftazidime Normon 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 Ceftazidime Normon 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 Ceftazidime Normon, three times a day. Maximum 9 g per day.

Patients over 65 years old

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

Patients with kidney problems

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

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 can also call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount administered.

If you forget to use 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 once) to compensate for the missed dose,receive the next dose at the usual time.

If you interrupt the treatment with Ceftazidime Normon

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

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

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

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

• Rash of red patches with a target or circular shape on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, or eyes. These severe skin eruptions may be preceded by fever and pseudogripal symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Widespread rash, elevated body temperature, and enlarged lymph nodes (RFESS syndrome or drug hypersensitivity syndrome).

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

Symptoms to be aware of

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

• Severe allergic reaction.The signs includeswollen and itchy rash, swelling,sometimes on the face or in the mouth that causesdifficulty breathing.
• Skin rash,which may formblisters,and appears assmall targets(central dark spot surrounded by a lighter area, with a dark ring around the edge).
• Generalized rashwithblistersandskin peeling.(These may be signs ofStevens-Johnson syndrome or toxic epidermal necrolysis).
• Nervous system disorders:shaking, seizures, and, in some cases, coma. These have occurred in patients receiving a very high dose, especially in patients with kidney disease.
• There have been reports of rare severe hypersensitivity reactions with severe skin rash, which may be accompanied by fever, fatigue, facial swelling or lymph node enlargement, increased eosinophils (a type of white blood cell), liver, kidney, or lung damage (a reaction known as DRESS syndrome)

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

Frequent side effects

May affect1 in 10people:

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

• Inform your doctorif any of these side effects concern you.

Frequent 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 to clot
• An increase in liver enzymes.

Rare side effects

May affect1 in 100people:

• Intestinal inflammation that may cause pain or diarrhea that may have 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.

Rare 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 to clot)
• An increase in urea, ureic nitrogen, or serum creatinine levels in the blood.

Side effectsextremely rare

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:

• Kidney inflammation or failure
• Tickling sensation
• Bad taste in the mouth
• The skin or the whites of the eyes turn yellow.

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 type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store below 25 °C.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Ceftazidima Normon

The active ingredient is ceftazidima. Each vial contains 500 mg of ceftazidima (as pentahidrato).

As an excipient, it contains anhydrous sodium carbonate.

Each ampoule of solvent contains 5 ml of water for injectable preparations.

Appearance of the product and content of the packaging

The packaging of Ceftazidima Normon 500 mg powder and solvent for injectable solution contains a vial of 8 ml capacity with 500 mg of ceftazidima powder and an ampoule of solvent with 5 ml of water for injectable preparations. It is also presented in packaging of 50 vials and 50 ampoules (Clinical packaging).

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

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

Date of the last review of this leaflet:October 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

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