CEFTAZIDIME SALA 1000 mg POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Ceftazidime Reig Jofre 1,000 mg powder 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.
• If you experience 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 Reig Jofre and what is it used for.
2. What you need to know before you are given Ceftazidime Reig Jofre
3. How Ceftazidime Reig Jofre is administered
4. Possible side effects.
5. Storage of Ceftazidime Reig Jofre
6. Contents of the pack and further information

1. What is Ceftazidime Reig Jofre and what is it used for

Ceftazidime 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 Reig Jofre 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.

Ceftazidime Reig Jofre 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 Reig Jofre

Do not use Ceftazidime Reig Jofre

• if you are allergicto ceftazidimeor 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 reactionto any other antibiotic(penicillins, monobactams, and carbapenems) as you may also be allergic to Ceftazidime Reig Jofre

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse beforestarting to use Ceftazidime Reig Jofre.

While you are being given Ceftazidime Reig Jofre, you should be aware of certain symptoms, such as allergic reactions, nervous system disorders, and gastrointestinal disorders like diarrhea. This will reduce the risk of possible problems. See (“Symptoms to be aware of”) in section 4. If you have ever had an allergic reaction to other antibiotics, you may also be allergic to Ceftazidime Reig Jofre.

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 testCeftazidime 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 Reig Jofre.

Other medicines and Ceftazidime Reig Jofre

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

Ceftazidime Reig Jofre should not be administered without talking to your doctor if you are also taking:

• a type of antibiotic called chloramphenicol
• a type of antibiotics called aminoglycosides, for example: gentamicin, tobramycin
• a “water pill” (a diuretic called furosemide).

• Tell your doctorif this applies to you

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Your doctor will weigh the benefits of treating you with Ceftazidime Reig Jofre against the risks to the baby.

Driving and using machines

Ceftazidime 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 Ceftazidime Reig Jofre does not affect you.

Ceftazidime Reig Jofre contains sodium

Patients on low-sodium diets should note that this medicine contains 55 mg (2.3 mmol) of sodium per vial.

3. How Ceftazidime Reig Jofre is administered

Ceftazidime is usually administered by a doctor or nurse. It can be administered as a drip (intravenous infusion) or directly as an injection into a vein or muscle.

Ceftazidime Reig Jofre is reconstituted by the doctor, pharmacist, or nurse using water for injections or a suitable infusion fluid.

Usual dose

The correct dose of Ceftazidime Reig Jofre 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.

Infants (0-2 months)

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

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

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

Adults and adolescents weighing 40 kg or more

1 g to 2 g of ceftazidime three times a day. Maximum 9 g per day.

Patient over 65 years

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

Patient with kidney problems

You may be given a different dose than usual. Your doctor will decide how much ceftazidime you need based on the severity of your kidney disease. Your doctor will closely monitor you and perform kidney function tests more frequently.

If you are given more Ceftazidime Reig Jofre 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 on 91 562 04 20, stating the medicine and the amount administered.

If you miss a dose of Ceftazidime Reig Jofre

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.

If you stop treatment with Ceftazidime Reig Jofre

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

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

4. Possible side effects

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

Symptoms to be aware of

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

• Severe allergic reaction. The signs include itchy, lumpy rash, swelling, sometimes on the face or mouth, causing difficulty breathing.

• Skin rash, which can form blistering, and appears as small targets(a dark center surrounded by a lighter area, with a dark ring around the edge).

• Widespread skin rashwith blistering and 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 given very high doses, especially in patients with kidney disease.

Rare cases 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) have been reported

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

• Red, circular, or target-shaped skin patches on the trunk, 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 syndrome or drug hypersensitivity reaction).

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

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

Common side effects

May affect up to 1 in 10patients:

• diarrhea
• swelling and redness around a vein
• red, itchy, lumpy 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 up to 1 in 100patients:

• 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 blood urea, urea nitrogen, or serum creatinine levels.

Other side effects

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

• 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. This includes any possible side effects not listed in this leaflet.You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (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 Reig Jofre

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

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

Do not store above 25°C. Store in the original package to protect from light.

The shelf life after reconstitution is 8 hours at 25°C or 24 hours in the refrigerator (2-8°C).

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

6. Contents of the pack and further information

Composition of Ceftazidime Reig Jofre

• The active substance is Ceftazidime

Each vial contains 1000 mg of ceftazidime (as pentahydrate)

• The other ingredients are: anhydrous sodium carbonate (sodium)

Appearance and packaging of the product

Ceftazidime Reig Jofre 1,000 mg powder for solution for injection (hospital use), is presented as a powder for solution for injection. Each pack contains 1 vial of ceftazidime powder. It is available in packs of 50 vials (clinical packaging).

Marketing authorization holder and manufacturer

Marketing authorization holder

LABORATORIO REIG JOFRE, S.A

Gran Capitan 10, 08970 Sant Joan Despi (Barcelona), Spain

Manufacturer

LABORATORIO REIG JOFRE, S.A

Jarama 111, Toledo - 45007, Spain

LDP LABORATORIOS TORLAN, S.A.

Ctra. de Barcelona, 135-B, Cerdanyola del Valles (Barcelona), 08290, Spain

Date of last revision of this leaflet: October 2024

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