Ceftriaxone Normon 1000 mg powder and solution for intramuscular injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ceftriaxone Normon 1,000 mg powder and solution for injectable solution for intramuscular injection 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, consult 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 reactions, consult your doctor, pharmacist, or nurse, even if these are adverse reactions 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 Normon is an antibiotic for adults and children (including newborn infants). Ceftriaxone exerts its effect by eliminating bacteria responsible for infections. It belongs to a group of medicines called cephalosporins.

Ceftriaxone Normon is administered by intramuscular injection as a solution containing lidocaine, which helps reduce the pain associated with the injection.

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 be used:

• to treat specific sexually transmitted infections (gonorrhoea 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 rapid and severe 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 a 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 injected 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 diarrhoea 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 suffer from other diseases, such as haemolytic anaemia (reduction 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 affecting heart rate.

• If you have any respiratory disorders.

• If you have porphyria (a rare inherited disease affecting the skin and nervous system).

• If you experience or have experienced a combination of any of the following symptoms: rash, redness of the skin, blisters on the lips, eyes, and mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme levels seen in blood tests, an increase in a type of white blood cell (eosinophilia), and enlarged lymph nodes (signs of serious skin reactions; see also section 4 “Possible side effects”).

If you are to have 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 to have any tests:

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

If you are diabetic or need to monitor your blood glucose levels, do not use certain glucose monitoring systems, as the 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, if you are taking any of the following medicines, inform your doctor or pharmacist, as they may interact with ceftriaxone:

• An antibiotic known as an aminoglycoside.
• An antibiotic called chloramphenicol (used to treat infections, particularly of the eye).

A large number of medicines may interact with lidocaine and cause changes in their effects. These medicines 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 treatment with ceftriaxone 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 83.24 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 4.14% of the maximum daily recommended sodium intake for an adult.

It contains 1.03 mmol (23.78 mg) of sodium per ml of reconstituted solution.

3. How to use Ceftriaxone Normon

Follow exactly the instructions for administration of this medicine 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 must be dissolved in 2 ml of solvent from the accompanying ampoule.

Recommended dose

Your doctor will decide 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 from 12 years of age with a body weight of 50 kilograms (kg) or more:

• 1 to 2 g per day, 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 per day). If your daily dose exceeds 2 g, it may be administered either 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 either 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):

• 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 must not exceed 50 mg per kg of the infant's body weight.

Patients with hepatic or renal impairment

If you have impaired kidney or liver function, you may require a different dose than usual. Your doctor will determine how much ceftriaxone you need and will closely 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, it should be given 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 do so. 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 may cause adverse effects, although not everyone will experience them.

The possible adverse effects associated with the use of this medicine are as follows:

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

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

If you experience a severe allergic reaction, consult your doctor immediately. Symptoms 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 in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome).

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

If you experience a severe allergic reaction, consult your doctor immediately. Symptoms may include:

• A severe rash that develops rapidly, with blisters 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.

Common (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., 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/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, hardening of the skin, or inflammation at the injection site.
• Elevated 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). Symptoms 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 unknown (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). Symptoms may include severe abdominal pain radiating to the back.
• Inflammation of the oral mucosa (stomatitis).
• Inflammation of the tongue (glossitis). Symptoms may include swelling, redness, and pain in the tongue.
• Disorders of the gallbladder or liver that may cause pain, nausea, vomiting, yellowing of the skin (jaundice), itching, darkening of urine, and clay-colored stools.
• Neurological disease that may cause severe jaundice in neonates (nuclear jaundice).
• Kidney disorders due to deposition of calcium-ceftriaxone, which may cause pain during urination or reduced urine output.
• False positive Coombs test result (a test detecting certain blood disorders).
• False positive test 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 adverse effects may include:

Frequency unknown (frequency cannot be estimated from available data)

• Changes in heart rate and rhythm.
• Low blood pressure.
• Slow heart rate (less than 60 beats/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), vertigo or dizziness, confusion, nervousness, involuntary rhythmic muscle contractions, seizures or epilepsy, deep unconsciousness (coma).
• Blurred vision, double vision, or temporary loss of vision.
• Malaise (nausea or vomiting).
• Difficulty breathing.
• Decreased respiratory rate or respiratory arrest.
• Drowsiness or abnormal daytime fatigue or fainting.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may 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.

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 under refrigeration (2°C–8°C).

From a microbiological standpoint, the product should be used immediately. If not used immediately, storage conditions and the time before use are the responsibility of the user and must not exceed 24 hours when stored between 2°C and 8°C, unless reconstitution has taken place under controlled, 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 have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ceftriaxone Normon

The active substance is ceftriaxone.

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

The solvent ampoule contains 35 mg of lidocaine hydrochloride monohydrate.

After reconstitution with the 3.5 ml of solvent containing lidocaine hydrochloride monohydrate contained in the ampoule, the concentration of the solution is 285.71 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The other components (excipients) are:

Solvent ampoule: water for injections.

Appearance of the product and contents of the pack

It is presented in a glass vial, closed with a rubber stopper and sealed with a flip-off cap, and 1 solvent ampoule.

Pack sizes of 1 and 100 vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon S.A.

Ronda de Valdecarrizo, 6 – 28760

Tres Cantos – Madrid (Spain)

Date of the most recent review of this leaflet: January 2026

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

This information is intended for healthcare professionals only

Please consult the package insert or summary of product characteristics 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 3.5 ml of solvent from the accompanying ampoule (a solution of lidocaine hydrochloride monohydrate 35 mg/3.5 ml). In the case of administering 2 g of ceftriaxone per day by intramuscular route, two 1-g vials of ceftriaxone should be reconstituted with two ampoules of lidocaine hydrochloride monohydrate solution (35 mg/3.5 ml).

After reconstitution with 3.5 ml of solvent, the concentration of the solution is 285.71 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The solution should be inspected before injection for the presence of particles or cloudiness. 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 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 specified above.