Cefixime Normon 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Cefixime Normon 200 mg hard capsules EFG

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

Contents of the leaflet

1. What Cefixime Normon 200 mg is and what it is used for
2. What you need to know before taking Cefixime Normon 200 mg
3. How to take Cefixime Normon 200 mg
4. Possible adverse effects
5. How to store Cefixime Normon 200 mg
6. Contents of the pack and other information

1. What Cefixima Normon 200 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:

• Upper respiratory tract infections: pharyngitis and tonsillitis.
• Lower respiratory tract infections: acute bronchitis, exacerbations of chronic bronchitis, and pneumonia.
• ENT infections: otitis media.
• Uncomplicated urinary tract infections.

2. What you need to know before taking Cefixima Normon 200 mg

Do not take Cefixima Normon

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

Warnings and precautions

Consult 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 with 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 discontinuation of treatment.

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

• if your treatment with cefixime is prolonged, it 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. If this occurs, inform your doctor.

• if you have serious 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 a test to monitor kidney function during treatment.

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

• if you develop acute renal 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 ethacrynic 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)

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

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 drinks

Cefixime 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.

Due to insufficient information on the potential adverse effects of Cefixima Normon during pregnancy, Cefixima Normon is recommended during pregnancy only if prescribed by your doctor after evaluating the benefit-risk ratio.

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

The use of Cefixima Normon during breastfeeding is not recommended unless prescribed by your doctor after evaluation of the benefit-risk ratio. 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 use machines. However, some adverse effects may affect concentration and reaction ability; therefore, this should be taken into account in situations where concentration and reaction ability are important, such as when driving or operating machinery.

3. How to take Cefixima Normon 200 mg

Follow exactly the instructions for use of this medicine as given 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 200 mg every 12 hours or 2 capsules (400 mg) once daily.

For women with uncomplicated acute cystitis, a dose of 400 mg daily (2 capsules as a single dose) for 3 days is recommended.

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

Patients with renal problems

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

Patients with hepatic problems

In patients with hepatic impairment, since cefixima is not metabolized in the liver, the medicine can be administered without the need for dose adjustment.

Elderly patients

It is not necessary to change the dose in elderly patients, provided 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 result in intoxication. If it occurs, gastric lavage and symptomatic treatment are recommended. In case of severe allergic manifestations, treatment should be symptomatic: 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 missed doses. Wait until the next scheduled dose and continue your treatment as usual.

If you stop taking Cefixima Normon

Your doctor will indicate the duration of your treatment with Cefixima Normon. Do not discontinue 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 the blood.

Rare (may affect up to 1 in 1,000 people):
Loss of appetite, flatulence, itching, mucosal inflammation, 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 reactions (Stevens-Johnson syndrome, erythema multiforme), blood disorders (leukopenia, agranulocytosis, pancytopenia, thrombocytopenia, coagulation disorders, anemia and other changes in blood count), transient hyperactivity, anaphylactic 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 may 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 200 mg

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton 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. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Cefixima Normon

• The active substance is cefixime. One capsule contains 200 mg of cefixime (as trihydrate).
• The other components (excipients) are: Anhydrous colloidal silica, macrogol stearate 40 and magnesium stearate. Components of the capsule shell: gelatin, yellow iron oxide (E-172) and titanium dioxide (E-171).

Appearance of the product and contents of the container

Cefixima Normon 200 mg are opaque yellow hard capsules, packaged in PVC/aluminum blisters and available in pack sizes of 14 and 21 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 on this medicinal product 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 may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66398/P_66398.html