Ceftriaxone Normon 500 mg powder and solution for intramuscular injection EFG

Ceftriaxone is used to treat infections of:

• the brain (meningitis)

• the lungs

• the middle ear

• the abdomen and abdominal wall (peritonitis)

• the urinary tract and kidneys

• the bones and joints

• the skin and soft tissues

• the blood

• the heart

Ceftriaxone can also be used:

• to treat specific sexually transmitted infections (gonorrhea and syphilis)
• to treat patients with low levels of white blood cells (neutropenia) who have fever due to a bacterial infection
• to treat chest infections in adults with chronic bronchitis
• to treat Lyme disease (transmitted by ticks) 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 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 rapidly spreading, intense skin rash.
• If you are allergic to lidocaine and need to receive ceftriaxone by intramuscular injection.
• If you have a cardiac conduction disorder causing low blood pressure or slowed heart rate (complete heart block).
• If you have reduced blood volume (hypovolemia).

Ceftriaxone Normon must not be used in newborns in the following cases:

• Premature infants.
• Newborns (up to 28 days) with jaundice (yellowing of the skin or whites of the eyes), or if a calcium-containing product is to be administered intravenously.

Warnings and precautions

Talk to your doctor or pharmacist before starting Ceftriaxone Normon:

• If you have recently used or are about to use calcium-containing products.
• If you have recently had diarrhea after taking an antibiotic. If you have any intestinal disorders, particularly colitis (inflammation of the intestine).
• If you have liver or kidney problems (see section 4).
• If you have gallstones or kidney stones.
• If you have other medical conditions, such as hemolytic anemia (a decrease in red blood cells, which may cause yellowing of the skin, weakness, and difficulty breathing).
• If you are on a low-sodium diet.
• If you have muscle function loss and muscle weakness (myasthenia).
• If you have seizures (epilepsy).
• If you have any heart disorders, particularly those affecting heart rate.
• If you have any respiratory disorders.
• If you have porphyria (a rare inherited disorder affecting the skin and nervous system).
• If you are experiencing or have experienced a combination of any of the following symptoms: rash, skin redness, blistering of the lips, eyes, and mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme levels 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 undergoing blood or urine tests

When using this medicine for prolonged periods, periodic blood tests may be necessary. Ceftriaxone may alter the results of urine glucose tests and of the blood test known as the Coombs test. If you are undergoing any test:

• Inform the person drawing your sample that you are taking this medicine.

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

Children

Talk to your doctor or pharmacist before administering ceftriaxone to your child if:

• They have taken or are about to receive a calcium-containing product intravenously.

Other medicines and Ceftriaxone Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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, as they may interact with ceftriaxone:

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

A large number of medicines may interact with lidocaine and alter its effects. These include:

• Medicines used to treat infections (clarithromycin, erythromycin).
• Medicines used to treat stomach ulcers (e.g., cimetidine).
• Strong painkillers such as codeine or meperidine (narcotics or opioid medicines).
• Medicines used to treat cardiac arrhythmias (e.g., mexiletine, tocainide).

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, inform your doctor before using this medicine. Your doctor will assess the benefits of ceftriaxone treatment against any potential risks to the fetus.

Driving and using machines

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

Ceftriaxone Normon contains sodium

This medicine contains 41.6 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 2.08% of the maximum daily sodium intake recommended for an adult.

It contains 0.904 mmol (20.8 mg) of sodium per ml of reconstituted solution.

3. How to use Ceftriaxone Normon

Follow exactly the instructions for the administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Ceftriaxone is usually administered by a doctor or nurse. It is given by intramuscular injection. Ceftriaxone is prepared for administration by a doctor, pharmacist, or nurse. It must not be mixed or simultaneously administered with other injectable products containing calcium.

For intramuscular administration, the contents of the vial should be dissolved in 2 ml of solvent from the accompanying ampoule.

Recommended dose

Your doctor will determine the correct dose of ceftriaxone. The dose will depend on the type and severity of the infection, whether you are already receiving other antibiotics, your weight and age, as well as the condition of your liver and kidneys. The number of days or weeks you will receive ceftriaxone will depend on the type of infection.

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

• 1 to 2 g daily, depending on the type and severity of the infection. If your infection is severe, your doctor may prescribe a higher dose (up to 4 g daily). If your daily dose exceeds 2 g, it may be administered as a single daily dose or as two separate doses.

Newborns, infants, and children from 15 days to 12 years of age with a body weight of less than 50 kg:

• 50 to 80 mg of ceftriaxone per kg of body weight once daily, depending on the type and severity of the infection. If the infection is severe, your doctor may prescribe a higher dose, up to 100 mg per kg of body weight, up to a maximum of 4 g once daily. If your daily dose exceeds 2 g, it may be administered as a single daily dose or as two separate doses.
• Children with a body weight of 50 kg or more should receive the standard adult dose.

Newborns (up to 14 days of age):

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

Patients with liver or kidney problems

If you have impaired kidney or liver function, you may require a different dose than usual. Your doctor will decide how much ceftriaxone you need and will carefully monitor you based on the severity of your kidney or liver disease.

If you use more Ceftriaxone Normon than you should

If you accidentally receive a higher dose than prescribed, contact your doctor or go to the nearest hospital as soon as possible.

If you forget to use Ceftriaxone 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 dose. Do not administer a double dose (two injections at once) to make up for a missed dose.

If you stop using Ceftriaxone Normon

Do not stop receiving ceftriaxone unless your doctor tells you to. If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

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

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 kidney or nervous system disorders, may in rare cases lead to decreased 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, contact your doctor immediately.

Signs may include:

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

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

If you experience a severe allergic reaction, contact your doctor immediately. Signs may include:

• A severe rash that develops rapidly, with blistering or peeling of the skin and sometimes blisters in the mouth (Stevens-Johnson syndrome [SJS] and toxic epidermal necrolysis [TEN]).
• A combination of any of the following symptoms: widespread skin rash, high body temperature, increased liver enzyme levels observed in blood tests, abnormalities in blood count (eosinophilia), enlarged 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 spirochete infections, such as Lyme disease.

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 liver function test results in blood tests.
• Skin rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infection (e.g., candidiasis 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/discomfort 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.
• High temperature (fever).
• Abnormal kidney test values in blood tests (increased serum creatinine).

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 the 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 certain 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 oral mucosa (stomatitis).
• Inflammation of the tongue (glossitis). Signs may include swelling, redness, and pain in the tongue.
• Gallbladder or liver disorders that may cause pain, nausea, vomiting, yellowing of the skin (jaundice), itching, darkening of the urine, and clay-colored stools.
• Neurological disease that may cause severe jaundice in neonates (nuclear jaundice).
• Kidney disorders due to deposition of calcium-ceftriaxone complexes, which may cause pain during urination or reduced urine output.
• False positive Coombs test result (a test detecting 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.

Accidental intravascular injection of lidocaine during intramuscular administration of ceftriaxone may lead to additional adverse effects. These may include:

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

• Changes in heart rate and rhythm.
• Low blood pressure.
• Slow heart rate (less than 60 beats per minute).
• Cessation of normal blood circulation due to cardiac arrest and reduced blood flow.
• Loss of balance, tingling around the mouth, numbness of the tongue, difficulty tolerating everyday sounds (hyperacusis), ringing in the ears (tinnitus), dizziness or vertigo, confusion, restlessness, involuntary rhythmic muscle contractions, seizures or epilepsy, deep unconsciousness (coma).
• Blurred vision, double vision, or temporary loss of vision.
• Malaise (nausea or vomiting).
• Breathing difficulties.
• Reduced respiratory rate or respiratory arrest.
• Drowsiness or abnormal daytime fatigue or fainting.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines at 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.

Before reconstitution: 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.

After reconstitution: 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 the time before use are the responsibility of the professional 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 containers and unused medicines at the SIGRE point at your pharmacy. If in doubt, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Ceftriaxone Normon

The active substance is ceftriaxone.

Each powder vial contains 500 mg of ceftriaxone (as ceftriaxone sodium).

The solvent ampoule contains 20 mg of lidocaine hydrochloride monohydrate.

After reconstitution with the 2 ml of solvent containing lidocaine hydrochloride monohydrate provided in the ampoule, the concentration of the solution is 250 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The other components (excipients) are:

Solvent ampoule: water for injections.

Presentation of the product and contents of the pack

Presented as a glass vial closed with a rubber stopper and sealed with a flip-off cap, and 1 solvent ampoule.

Pack size: 1 vial.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon S.A.

Ronda de Valdecarrizo, 6 – 28760

Tres Cantos – Madrid (Spain)

Date of latest revision of this summary: January 2026

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

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This information is intended for healthcare professionals only

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

This medicine must be reconstituted before use. The reconstituted solution is for single use only. Discard any unused solution.

The reconstituted solution is clear and yellow or slightly yellowish.

Instructions for use

For intramuscular use only.

For intramuscular administration, dissolve the contents of the vial in 2 ml of solvent from the accompanying ampoule (a solution of 20 mg/2 ml lidocaine hydrochloride monohydrate).

After reconstitution with 2 ml of solvent, the concentration of the solution is 250 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The solution should be inspected visually for particulate matter or discoloration prior to injection. If foreign particles are observed, the solution must be discarded. Then inject into a relatively large muscle. Do not administer more than 1 gram at a single injection site. For doses exceeding 2 g, intravenous administration should be used.

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

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