Cefixime Normon 400 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Cefixime Normon 400 mg hard capsules EFG

Read the entire leaflet carefully before you start taking 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Cefixime Normon 400 mg is and what it is used for
2. What you need to know before taking Cefixime Normon 400 mg
3. How to take Cefixime Normon 400 mg
4. Possible adverse effects
5. How to store Cefixime Normon 400 mg
6. Contents of the pack and other information

1. What Cefixima Normon 400 mg is and what it is used for

Cefixima Normon contains a substance called cefixime, which belongs to the group of antibiotics known as "cephalosporins", used to treat infections caused by bacteria.

Cefixima Normon is used to treat

• Otolaryngological infections: acute sinusitis.
• Lower respiratory tract infections: acute bronchitis and acute exacerbations of chronic bronchitis.
• Urinary tract infections: uncomplicated acute pyelonephritis.

2. What you need to know before taking Cefixima Normon 400 mg

Do not take Cefixima Normon

• if you are allergic to cefixime, to other cephalosporins or cephem antibiotics, or to any of the other ingredients of this medicine (listed in section 6),

Warnings and precautions

Talk to your doctor or pharmacist before taking Cefixima Normon:

• if you have previously experienced any type of allergic reaction to cephalosporins, penicillins, or any other medicine.

If you are allergic to other beta-lactam antibiotics (e.g. penicillin), a possible cross-allergic reaction to cefixime should be considered. Special caution is required in patients who have experienced an anaphylactic reaction to penicillins. The appearance of any allergic manifestation requires immediate discontinuation of treatment.

• if you have asthma or a predisposition to allergic reactions.

• if you develop severe skin reactions while taking this medicine, such as toxic epidermal necrolysis, Stevens-Johnson syndrome, or DRESS syndrome (drug reaction with eosinophilia and systemic symptoms). If this occurs, stop taking this medicine and contact your doctor immediately.

• if you experience drug-induced hemolytic anemia or have a history of hemolytic anemias associated with this type of medicine.

• if your treatment with cefixime is prolonged, as this may increase the risk of superinfections caused by fungi or resistant bacteria. If this occurs, your doctor will assess whether treatment interruption is necessary.

• if you develop severe diarrhea, or notice blood, mucus, or pus in your stools. Inform your doctor if this happens.

• if you have severe gastrointestinal problems with nausea and vomiting.

• if you are taking diuretic medicines and/or medicines that may be harmful to the kidneys. Your doctor may perform tests to monitor kidney function during treatment.

• if you have severe renal impairment. Your doctor will adjust the dose and monitor you closely.

• if you experience acute kidney failure. If this occurs, stop taking this medicine and contact your doctor immediately.

Treatment with cefixime may increase the risk of developing drug-resistant bacteria.

Some antibiotics in the cephalosporin family may cause seizures, especially in patients with renal impairment when the dose has not been reduced. If seizures occur, stop taking this medicine and contact your doctor immediately.

Children

Administration is not recommended in premature infants, newborns, and infants up to 6 months of age.

Other medicines and Cefixima Normon

Taking cefixime together with any of the following medicines may alter the effect of both cefixime and the other medicine:

• diuretic medicines (such as etacrynic acid or furosemide) or medicines that may be harmful to the kidneys (certain antibiotics, colistin, polymyxin, chloramphenicol)

• medicines acting on blood vessels (such as nifedipine)

• medicines used to control blood clotting (coumarins)

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Interference with laboratory tests

Cefixima Normon may cause false positive results in urine tests for ketones and glucose, and false positive results in the direct Coombs test (a diagnostic test for certain types of anemia).

Taking Cefixima Normon with food and drink

Cefixima Normon may be taken with food.

Pregnancy and breastfeeding

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

Because there is insufficient information on the potential adverse effects of cefixime during pregnancy, Cefixima Normon is recommended during pregnancy only if prescribed by your doctor after evaluating the benefit-risk balance.

It has not been detected that cefixime passes into breast milk.

Treatment with Cefixima Normon during breastfeeding is not recommended unless prescribed by your doctor after evaluating the benefit-risk balance. Your doctor will decide whether to continue breastfeeding and cefixime treatment.

Driving and using machines

Based on current experience, Cefixima Normon has no effect on the ability to drive or operate machinery. However, some adverse effects may affect concentration and reaction time; therefore, this should be taken into account in situations where concentration and reaction capacity are important, such as when driving or operating machinery.

3. How to take Cefixima Normon 400 mg

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

Unless your doctor has given you different instructions, follow these guidelines:

The recommended daily dose for adults and children over 12 years of age is 1 capsule of 400 mg/24 hours, for 10 days.

Cefixima Normon is administered orally. The capsules must be swallowed whole, without chewing, and taken with some liquid.

Patients with renal problems

In case of renal insufficiency with a creatinine clearance ≥20 ml/min, dose adjustment is not necessary; if clearance is lower, the dose should be reduced by half. In hemodialyzed patients, the dosage of cefixime should not exceed 200 mg/day.

Patients with hepatic problems

In patients with hepatic insufficiency, the fact that cefixime is not metabolized in the liver allows administration of the drug without the need to modify the dose.

Elderly patients

Dose adjustment is not necessary for elderly patients if kidney function is normal.

If you think that the effect of Cefixima Normon is too strong or too weak, inform your doctor or pharmacist.

If you take more Cefixima Normon than you should

Contact your doctor or pharmacist immediately.

Due to the low toxicity of cefixime, accidental massive ingestion is not expected to cause intoxication. If it occurs, gastric lavage and symptomatic treatment are recommended. In case of severe allergic reactions, symptomatic treatment should be administered: adrenaline, corticosteroids, antihistamines.

In case of overdose or accidental ingestion, call the Toxicology Information Service (Tel. 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Cefixima Normon

Do not take a double dose to make up for forgotten doses. Wait for the next dose and continue your treatment as usual.

If you stop treatment with Cefixima Normon

Your doctor will indicate the duration of your treatment with Cefixima Normon. Do not stop treatment early, as your symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If they occur, the following may be observed:

Common (may affect up to 1 in 10 people):
Diarrhea, soft stools.

Uncommon (may affect up to 1 in 100 people):
Nausea, vomiting, indigestion, abdominal pain, urticaria, skin redness, rash, exanthema, headache, reversible increases in liver enzymes in blood.

Rare (may affect up to 1 in 1,000 people):
Loss of appetite, flatulence, itching, inflammation of the mucous membranes, dizziness, fever, hypersensitivity reactions such as flushing, palpitations, difficulty breathing, decreased blood pressure, facial swelling, transient increase in blood urea concentration, pathogen resistance, predisposition to superinfections by fungi and resistant bacteria in case of prolonged administration, blood disorders (eosinophilia, increase in a type of blood cell).

Very rare (may affect up to 1 in 10,000 people):
Inflammation of the large intestine, toxic skin disorders (Stevens-Johnson syndrome, erythema multiforme), blood disorders (leucopenia, agranulocytosis, pancytopenia, thrombocytopenia, coagulation disorders, anemia and other changes in blood count), transient hyperactivity, allergic shock, serum-sickness-like reactions (e.g. joint pain and swelling, muscle pain, urticaria, etc.), hepatitis, yellowing of the skin, renal disorders.

Frequency not known (cannot be estimated from available data):
DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms), granulocytopenia (reduction in granulocyte white blood cells), increased bilirubin in blood (which may cause yellowing of the skin), acute renal failure including tubulointerstitial nephritis (a type of kidney inflammation).

An increased predisposition to seizures cannot be excluded.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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: https://www.notificaRAM.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefixime Normon 400 mg

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Store in the original packaging.

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

6. Contents of the pack and other information

Composition of Cefixime Normon

• The active substance is cefixime. One capsule contains 400 mg of cefixime (as trihydrate).
• The other components (excipients) are: anhydrous colloidal silica, macrogol stearate 40 and magnesium stearate. Capsule components: gelatin, yellow iron oxide (E-172) and titanium dioxide (E-171).

Appearance of the product and pack contents

Cefixime Normon 400 mg are opaque yellow hard capsules, packed in PVC/aluminum blisters and available in packs of 1 and 10 hard capsules.

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: December 2025

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

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66397/P_66397.html