Ceftriaxone Normon 1000 mg powder and solvent for solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ceftriaxone Normon 1000 mg powder and solvent for injectable solution and for infusion EFG

Read the entire 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could 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.

Leaflet contents:

1. What Ceftriaxone Normon is and what it is used for
2. What you need to know before using Ceftriaxone Normon
3. How to use Ceftriaxone Normon
4. Possible side effects
5. How to store Ceftriaxone Normon
6. Contents of the pack and other information

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

Ceftriaxone is an antibiotic administered to adults and children (including newborns). It works by eliminating bacteria that cause infections. This medicine is an antibiotic belonging to a group called cephalosporins.

Ceftriaxone is indicated in the treatment of infections:

• of the brain (meningitis);
• of the lungs;
• of the middle ear;
• of the abdomen and abdominal wall (peritonitis);
• of the urinary tract and kidneys;
• of bones and joints;
• of the skin and soft tissues;
• of the blood;
• of the heart.

This medicine may be administered:

• to treat specific sexually transmitted infections (gonorrhea and syphilis);
• to treat patients with low white blood cell count (neutropenia) who have fever due to a bacterial infection;
• following acute exacerbations in adults with chronic bronchitis;
• to treat Lyme disease (infection caused by tick bite) in adults and children, including newborns from 15 days of age;
• to prevent infections during surgical procedures.

2. What you need to know before using Ceftriaxone Normon

Do not use Ceftriaxone Normon

• If you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously had a sudden or severe allergic reaction to penicillin or other similar antibiotics (such as cephalosporins, carbapenems, or monobactams). Signs of an allergic reaction include sudden swelling of the throat or face making it difficult to breathe or swallow, sudden swelling of hands, feet, and ankles, chest pain, or a rapid and severe skin rash.
• If you are allergic to lidocaine and you are to be given ceftriaxone by intramuscular injection.

Ceftriaxone Normon must not be administered to newborns in the following cases:

• Premature babies.
• Newborns (up to 28 days of age) with certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or if a calcium-containing product is to be injected intravenously.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given Ceftriaxone Normon if:

• You have recently received or are about to receive calcium-containing products.
• You have recently had diarrhoea after taking an antibiotic. If you have ever had intestinal problems, particularly colitis (inflammation of the intestine).
• You have liver or kidney problems (see section 4).
• You have gallstones or kidney stones.
• You suffer from other diseases, such as haemolytic anaemia (reduction in red blood cells, which may cause yellowing of the skin, weakness, or difficulty breathing).
• You are on a low-sodium diet.
• You are experiencing or have experienced a combination of the following symptoms: skin rash, redness of the skin, blisters on the lips, eyes, and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes seen in blood tests, an increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 "Possible side effects").

If you are to have blood or urine tests

If you are given ceftriaxone for prolonged periods, you may need periodic blood tests. Ceftriaxone may alter the results of urine glucose tests and of the blood test known as the Coombs test. If you are to undergo any testing, inform the person taking your sample that you have been given ceftriaxone.

If you are diabetic or need to monitor your blood glucose levels, do not use certain glucose monitoring systems, as they may give inaccurate results while you are receiving ceftriaxone. If you use such systems, consult the user instructions and inform your doctor or pharmacist. Alternative monitoring methods may be used if necessary.

Children

Talk to your doctor, pharmacist, or nurse before your child is given ceftriaxone if:

• They have recently received or are about to receive intravenously a product containing calcium.

Other medicines and Ceftriaxone Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• An antibiotic called aminoglycosides.
• An antibiotic called chloramphenicol (used to treat infections, particularly of the eye).

Pregnancy, breast-feeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Your doctor will assess the benefits of treatment with ceftriaxone against the potential risks to the fetus.

Driving and using machines

Ceftriaxone may cause dizziness. If you feel dizzy, do not drive or operate tools or machinery. Inform your doctor if you experience these symptoms.

Ceftriaxone Normon contains sodium

This medicine contains 83.24 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 4.16% of the maximum daily recommended sodium intake for an adult.

3. How to use Ceftriaxone Normon

Ceftriaxone is usually administered by a doctor or nurse. It may be given as an intravenous infusion or by direct injection into a vein or into a muscle. Ceftriaxone is prepared by a doctor, pharmacist, or nurse and must never be mixed with injections containing calcium, nor should it be administered simultaneously with such injections.

Recommended dose

Your doctor will decide the appropriate dose of ceftriaxone for you. The dose depends on the severity and type of infection, whether you are being treated with other antibiotics, your body weight and age, as well as on how well your kidneys and liver are functioning. The number of days or weeks during which you will receive ceftriaxone depends on the type of infection you have.

Adults, elderly patients, and children from 12 years of age with a body weight of 50 kilograms (kg) or more:

• 1 to 2 g once daily, depending on the severity and type of infection. In severe cases, your doctor may increase the dose (up to 4 g once daily). If the daily dose exceeds 2 g, it may be given as a single dose once daily or divided into two separate doses.

Neonates, infants, and children from 15 days to 12 years of age with a body weight below 50 kg:

• 50 to 80 mg of ceftriaxone per kilogram of body weight once daily, depending on the severity and type of infection. In case of severe infection, the doctor may increase the dose up to 100 mg per kilogram of body weight, with a maximum of 4 g per day. If the daily dose exceeds 2 g, it may be given as a single dose once daily or divided into two separate doses.
• Children weighing 50 kg or more should receive the usual adult dose.

Neonates (0–14 days):

• 20 to 50 mg of ceftriaxone per kilogram of body weight, administered once daily, depending on the severity and type of infection.
• The maximum daily dose must not exceed 50 mg per kg of the infant's body weight.

Patients with liver or kidney problems

You may receive a different dose than the usual recommended dose. Your doctor will determine the appropriate dose of ceftriaxone for you and will monitor your condition based on the severity of your liver or kidney disorder.

If you are given more Ceftriaxone Normon than you should

If you accidentally receive a higher dose than prescribed, contact your doctor or nearest hospital immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

If you forget to use Ceftriaxone Normon

If you have missed an injection, administer it as soon as possible. However, if the time for your next scheduled injection is approaching, do not administer the missed dose. Do not take a double dose (two injections at the same time) to make up for the missed dose.

If you stop using Ceftriaxone Normon

Do not discontinue treatment with ceftriaxone unless your doctor has instructed you to do so. If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, ceftriaxone can cause adverse effects, although not everyone experiences them.

The possible adverse effects associated with the use of this medicine are listed below:

Treatment with ceftriaxone, particularly in elderly patients with severe disorders of the kidney or nervous system, may in rare cases lead to decreased level of consciousness, abnormal movements, agitation, and seizures.

Severe allergic reactions (frequency not known, cannot be estimated from available data)

If you experience a severe allergic reaction, seek medical advice immediately.

Signs may include:

• Sudden swelling of the face, throat, lips, or mouth, which may cause difficulty breathing or swallowing.
• Sudden swelling of the hands, feet, and ankles.
• Chest pain occurring in the context of allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome).

Serious skin reactions (frequency not known, cannot be estimated from available data)

If you experience a severe allergic reaction, seek medical advice immediately. Signs may include:

• A severe rash that develops rapidly, with blisters or skin peeling, and sometimes blisters in the mouth (Stevens-Johnson syndrome [SJS] and toxic epidermal necrolysis [TEN]).
• A combination of any of the following symptoms: widespread rash, high body temperature, elevated liver enzyme levels, abnormalities in blood count (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or systemic drug hypersensitivity syndrome with eosinophilia).
• Jarisch-Herxheimer reaction causing fever, chills, headache, muscle pain, and skin rash, which usually resolve spontaneously. These effects occur shortly after starting ceftriaxone treatment for spirochetal infections, such as Lyme disease.

Other possible adverse effects:

Frequent (may affect up to 1 in 10 people)

• Abnormalities in white blood cells (such as decreased leukocytes and increased eosinophils) and platelets (decreased thrombocytes).
• Soft stools or diarrhea.
• Abnormal results in liver function blood tests.
• Skin rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infection (e.g., candida or genital fungal infections).
• Decreased number of white blood cells (granulocytopenia).
• Decreased number of red blood cells (anemia).
• Blood clotting disorders. Signs may include easy bruising, as well as joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Pruritus (itching).
• Pain or burning sensation at the site of ceftriaxone administration. Blisters, bruising, intense redness or rash, burning sensation, pain, irritation, itching, skin hardening, or inflammation at the injection site.
• Elevated temperature (fever).
• Abnormal liver function test results (increased creatinine in blood).

Rare (may affect up to 1 in 1,000 people)

• Inflammation of the large intestine (colon). Signs may include diarrhea, usually with blood and mucus, stomach pain, and fever.
• Difficulty breathing (bronchospasm).
• Rash (urticaria) that may affect large areas of the body, with itching and swelling.
• Blood or glucose in urine.
• Edema (fluid accumulation).
• Chills.
• Infections at the injection site.

Frequency not known (frequency cannot be estimated from available data)

• Secondary infection that may not respond to previously prescribed antibiotics.
• Type of anemia in which red blood cells are destroyed (hemolytic anemia).
• Marked decrease in white blood cells (agranulocytosis).
• Seizures.
• Dizziness (spinning sensation).
• Inflammation of the pancreas (pancreatitis). Signs may include severe stomach pain radiating to the back.
• Inflammation of the mucous lining of the mouth (stomatitis).
• Inflammation of the tongue (glossitis). Signs may include swelling, redness, and pain in the tongue.
• Disorders of the gallbladder and/or liver, which may cause pain, nausea, vomiting, yellowing of the skin (jaundice), itching, darkening of urine, and pale stools.
• Neurological disorder that may cause severe jaundice in neonates (nuclear jaundice).
• Kidney disorders due to deposits of calcium-ceftriaxone. These may cause pain during urination or reduced urine output.
• False positive Coombs test result (a test that detects certain blood disorders).
• False positive result for galactosemia (abnormal accumulation of the sugar galactose).
• Ceftriaxone may alter the results of certain types of blood glucose tests. Consult your doctor.

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 Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceftriaxone 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 Ceftriaxone Normon after the expiry date stated on the container after “EXP”. The expiry date refers to the last day of the month indicated.

Reconstituted solutions remain chemically and physically stable for 6 hours at 25°C and for 24 hours when refrigerated (2°C–8°C).

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage conditions and duration prior to use are the responsibility of the user and should not exceed 24 hours when stored between 2°C and 8°C, unless reconstitution has taken place under controlled and validated aseptic conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ceftriaxone Normon

The active substance is ceftriaxone.

Each vial contains 1,000 mg of ceftriaxone (as ceftriaxone sodium).

Once reconstituted with the 10 ml of solvent contained in the ampoule, the concentration of the solution is 100 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The powder vial contains no other components (excipients).

The solvent ampoule contains 10 ml of water for injections.

Appearance of the product and contents of the pack

Ceftriaxone Normon consists of a powder and solvent for injectable solution and for infusion.

The powder is almost white or slightly yellowish.

It is available in cardboard packs containing 1 vial of powder and 1 solvent ampoule, and packs containing 100 vials of powder and 100 solvent ampoules. Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6 – 28760
Tres Cantos – Madrid (Spain)

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Ceftriaxone Normon 1000 mg powder and solvent for injectable solution and for infusion EFG

Iceland: Ceftriaxone Normon 1000 mg powder for solution for infusion and concentrate for solution for infusion, solution

Date of the most recent revision of this leaflet: March 2026

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (https://www.aemps.gob.es)

This information is intended for healthcare professionals only

Please refer to the product's package leaflet or summary of product characteristics for complete prescribing information.

Solutions containing ceftriaxone must not be mixed or combined with other agents. In particular, diluents containing calcium (e.g., Ringer's solution, Hartmann's solution) must not be used to reconstitute ceftriaxone vials or to dilute reconstituted vials intended for intravenous administration, as precipitates may form. Ceftriaxone must not be mixed or administered simultaneously with calcium-containing solutions.

According to available information in medical literature, ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole, and aminoglycosides.

Instructions for use

For intravenous administration, dissolve the contents of the vial in 10 ml of solvent from the accompanying ampoule (10 ml of water for injections).

Once reconstituted with 10 ml of solvent, the concentration of the solution is 100 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The solution should be inspected before injection for the presence of particles or turbidity. If foreign particles are observed, the solution must be discarded.

The dose and administration regimen depend on the patient's age and weight, as well as the severity of the infection.

The solution must not be mixed with solutions containing other antibiotics or with any other solutions different from those mentioned above.