CEFIXIME CODAL 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cefixima Codal400 mg film-coated tablets EFG

cefixima

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Cefixima Codal and what is it used for
2. What you need to know before taking Cefixima Codal
3. How to take Cefixima Codal
4. Possible side effects
5. Storage of Cefixima Codal
6. Package contents and additional information

1. What is Cefixima Codal and what is it used for

The active ingredient of Cefixima Codal is cefixime, a third-generation cephalosporin antibiotic. Cefixime works by eliminating the bacteria that cause the infection.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or common cold.

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

It is indicated in the following infections, when it is believed that the causative bacteria are sensitive:

• Acute otitis media (severe middle ear infection).
• Upper respiratory tract infections (pharyngitis, tonsillitis, acute sinusitis).
• Lower respiratory tract infections (acute exacerbations of chronic bronchitis, community-acquired pneumonia).
• Urinary tract infections (acute cystitis, uncomplicated acute pyelonephritis).
• Urethritis and cervicitis (inflammation of the urethra and cervix) due to gonorrhea, uncomplicated.

2. What you need to know before taking Cefixima Codal

Do not take Cefixima Codal

• If you are allergic to cefixime or to antibiotics of the penicillin class (beta-lactams). There is a rare possibility of a sudden and severe allergic reaction (anaphylactic reaction/anaphylactic shock) even with the first dose of antibiotics. Symptoms can include chest tightness, dizziness, discomfort (general feeling of discomfort, illness), fainting, or difficulty breathing, erythema (rash). If you experience any of these symptoms, seek medical help immediately and stop taking Cefixima Codal.
• If you are allergic to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Cefixima Codal.

Be particularly careful:

• If you have renal insufficiency (it may be necessary to reduce the dose of Cefixima Codal).
• If you are pregnant or breastfeeding.

Children

This medication is intended for children over 12 years old (or over 30 kg in weight).

Other medications and Cefixima Codal

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

If you are taking anticoagulants (medicines that prevent blood clotting) in tablet form, your doctor may consider it necessary to perform more frequent checks.

Pregnancy and breastfeeding

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

Driving and using machines

No cases of interference with cefixime and the ability to drive vehicles or use machines have been reported.

3. How to take Cefixima Codal

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Cefixima Codal is for oral use.

The tablets should be swallowed with a glass of water. It is recommended to take Cefixima Codal at approximately the same time each day.

This medication can be taken with or without food.

The tablet can be divided into equal doses.

The recommended dose is:

Adults or children over 12 years old (or over 30 kg in weight): 400 mg per day (1 tablet), taken once a day.

In elderly patients, the same dose as in adults can be used, unless there is severe renal insufficiency (in which case the doctor should be consulted).

The duration of treatment varies depending on the type of infection being treated, generally ranging from 3 to 7 days, and should be completed in its entirety.

If you take more Cefixima Codal than you should

If you have taken more Cefixima Codal than you should, consult your doctor as soon as possible. Bring the package and this package leaflet with you to show your doctor.

If you forget to take Cefixima Codal

If you forget to take a dose, take it as soon as you remember on the same day. If you forget to take it one day, take the normal dose the next day. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Cefixima Codal

Continue taking Cefixima Codal until the end of the treatment, even if you feel better. All prescribed doses are required to combat the infection. If some bacteria survive, the infection may return or worsen again.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The most common side effect of cefixime is diarrhea. You should stop taking Cefixima Codal and consult your doctor if the diarrhea is too frequent, persists, or worsens, or if the stools contain blood or mucus.

Common(may affect up to 1 in 10 people)

• Diarrhea

Uncommon(may affect up to 1 in 100 people)

• Headache
• Abdominal pain, nausea (feeling of discomfort), and vomiting (being sick)
• Red spots on the skin (rash)
• Abnormal liver tests (increased transaminases and alkaline phosphatase)

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

• Eosinophilia (increased number of a type of blood cell, eosinophils)
• Decreased platelet count or other blood cells
• Increased bilirubin in the blood
• Increased urea in the blood
• Dizziness
• Anorexia (potentially life-threatening eating disorder)
• Heartburn
• Jaundice (yellowing of the skin and sclera)
• Itching of the skin
• Rash (red spots on the skin) with eosinophilia and general symptoms (fever and swollen lymph nodes)
• Erythema multiforme (red spots on the skin and mucous membranes with fever, discomfort, muscle pain, and weakness, and possibly vomiting)
• Facial edema
• Breathing difficulties

Very rare(may affect up to 1 in 10,000 people)

• Antibiotic-associated colitis (swelling of the large intestine)
• Severe allergic reaction
• Urticaria
• Stevens-Johnson syndrome (severe form of erythema multiforme)
• Toxic epidermal necrolysis (most severe form of Stevens-Johnson syndrome, in which the top layer of the skin may peel off)
• Renal failure
• Increased serum creatinine

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Cefixima Codal

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the carton, after "EXP". The expiration date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Cefixima Codal

• The active ingredient is cefixime. Each film-coated tablet contains 447.68 mg of cefixime as trihydrate, equivalent to 400 mg of cefixime.
• The other ingredients are

Core: microcrystalline cellulose (E460), calcium hydrogen phosphate dihydrate (E341), pregelatinized starch, magnesium stearate (E470b);

Coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), macrogol 4000 (E1521), talc (E553b), red iron oxide (E172), yellow iron oxide (E172).

Appearance of the product and package contents

Cefixima Codal 400 mg are film-coated tablets of light brown color, oval, biconvex, scored on both sides, and measuring 18.2 ± 0.3 mm x 9.2 ± 0.3 mm.

The tablets are supplied in PVC-aluminum blisters.

Packaging sizes: 5, 6, 7, 8, 10, 12, and 100 film-coated tablets.

Not all packaging sizes may be marketed.

Marketing authorization holder

Codal-Synto Limited

Konstantinoupoleos 21

Limassol

3011

Cyprus

Manufacturer

Medochemie Ltd

1-10 Constantinoupoleos Street

Limassol

3011

Cyprus

Date of the last revision of this package leaflet:

July 2025