Leaflet: information for the user

Ceftazidima Normon 1 g powder and solvent for solution for injection EFG

ceftazidima

Read this leaflet carefully before you start using 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:

• Lungs or chest
• Lungs and bronchi in patients with cystic fibrosis
• Brain (meningitis)
• Ears
• Urinary tract
• Skin and soft tissues
• Abdomen and abdominal wall (peritonitis)
• 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 this medicine:

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

• Inform your doctor beforestarting treatment with this medicine if you think this affects you. Do not be given this medicine.

Warnings and precautions

While you are being given this medicine, 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 this medicine.

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

Ceftazidime 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 ceftazidime.

Use of Ceftazidime Normon with other medicines

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

You should not be given this medicine 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 this medicine is given to you:

• 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 this medicine against the risk to the baby.

Driving and operating machines

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

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

Ceftazidime Normon contains sodium.

This medicine contains 52.08 mg (2.26 mmol) of sodium(main component of table salt/for cooking)per vial. This is equivalent to 2.65% of the maximum daily intake for an adult."

This medication is usually administered by a doctor or a nurse.

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

Recommended Dose

The correct dose of this medication 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 Ceftazidima 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 this medication 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 medication, 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 you need of this medication, 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 administered more Ceftazidima 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 forgot to use Ceftazidima 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 Ceftazidima Normon

Do not stop receiving this medication 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 may cause side effects, although not everyone will experience them.

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

• Red patches on the skin in the shape of a bull's-eye or circles 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 includehives and itching, swelling,sometimes on the face or in the mouth that causesdifficulty breathing.
• Skin rash,which may formblisters,and appears assmall targets(a 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.

Rare cases of severe hypersensitivity reactions with severe skin rash have been reported, which may be accompanied by fever, fatigue, facial or lymph node swelling, 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 raised skin 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 effectsvery 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:

• Tickling
• 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 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.

Medications should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Ceftazidima Normon Composition

The active ingredient is ceftazidima. Each vial contains 1 g of ceftazidima (as pentahidrato).

As an excipient, it contains anhydrous sodium carbonate.

Each ampoule of solvent contains 10 ml of water for injectable preparations.

Product appearance and packaging content

The packaging of Ceftazidima Normon 1 g powder and solvent for injectable solution contains a 17 ml capacity vial with 1 g of ceftazidima powder and an ampoule of solvent with 10 ml of water for injectable preparations. It is also presented in packaging of 50 vials and 50 ampoules (clinical packaging).

Marketing authorization holder and responsible manufacturer

Laboratorios Normon, S.A.

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

Last review date of this leaflet:October 2024

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es.