Afixora 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Afixora 400 mg film-coated tablets EFG

cefixime

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, pharmacist or nurse.
• 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 may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Afixora is and what it is used for

The active substance in Afixora is cefixime, an antibiotic belonging to the third generation of cephalosporins. Cefixime works by eliminating the bacteria causing the infection.

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

It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

It is indicated for the following infections when the causative bacteria are considered to be susceptible:

• Acute otitis media (severe infection of the middle ear).
• 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).
• Uncomplicated gonococcal urethritis and cervicitis (inflammation of the urethra and the lower end of the uterus caused by gonorrhoea).

2. What you need to know before taking Cefixima Codal

Do not take Cefixima Codal

• If you are allergic to cefixime or to any of the ingredients of this medicine (listed in section 6)
• If you have previously had a severe allergic reaction to beta-lactam antibiotics (such as penicillins). There is a rare possibility of experiencing a severe and sudden allergic reaction (anaphylactic reaction/anaphylactic shock), even with the first dose of this type of antibiotic. Symptoms may include chest tightness, dizziness, general malaise, fainting or difficulty breathing, erythema (redness of the skin). If you experience any of these symptoms, seek immediate medical attention and stop taking this medicine.

Warnings and precautions

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

Take special care:

• If you have renal impairment (it may be necessary to reduce the dose of Cefixima Codal).
• If you are taking other medicines known to potentially damage the kidneys. Also inform your doctor if you have any kidney problems. Your doctor may carry out certain tests periodically to monitor your kidney function during treatment with cefixime.
• If you are pregnant or breastfeeding.

A type of anemia (hemolytic anemia) has been observed during treatment with this medicine, which in rare cases may be fatal. If you have previously experienced this type of anemia during treatment with this medicine, it may recur.

Children

This medicine is intended for children over 12 years of age.

Other medicines and Cefixima Codal

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

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

Inform your doctor or pharmacist if you are taking medicines known to potentially harm the kidneys, such as certain antibiotics including aminoglycosides, colistin, polymyxin, and viomycin, or medicines that increase urine production (diuretics), such as ethacrynic acid or furosemide.

Also inform your doctor or pharmacist if you are taking nifedipine, a medicine used to treat high blood pressure or heart problems.

Pregnancy and breastfeeding

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

Driving and using machines

There are no known cases of cefixime interfering with the ability to drive vehicles or operate machinery.

3. How to take Cefixima Codal

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, 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 medicine may be taken with or without food.

The tablet may be divided into equal doses. The score line may also be used to assist breaking the tablet, thus facilitating swallowing.

Adults or children over 12 years of age:

The recommended dose of cefixime is 400 mg of cefixime (1 tablet) per day, administered either as a single oral dose or divided into two equal oral doses of 200 mg of cefixime (1/2 tablet) every 12 hours.

In elderly patients, the same dose as for adults may be used, unless severe renal impairment is present (in this case, consult your doctor).

The duration of treatment varies depending on the type of infection being treated, generally ranging between 3 and 7 days, and must be fully completed.

If you take more Cefixima Codal than you should

If you have taken an excessive amount of Cefixima Codal, consult your doctor as soon as possible. Take the packaging and this 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 for a whole day, take the next dose at the usual time the following day. Do not take a double dose to make up for the missed dose.

If you stop treatment with Cefixima Codal

Continue taking Cefixima Codal for the full duration 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 medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

The most common adverse effect of cefixime is diarrhoea. You should stop taking Cefixima Codal and consult your doctor if diarrhoea is very severe, persists or worsens, or if stools contain blood or mucus.

Frequent (may affect up to 1 in 10 people)

• Diarrhoea

Uncommon (may affect up to 1 in 100 people)

• Headache
• Abdominal pain, nausea (feeling unwell) and vomiting (being sick)
• Red skin rash (skin eruption)
• Abnormalities in blood tests assessing liver function (elevated transaminases and alkaline phosphatase)

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

• Bacterial superinfection
• Fungal superinfection (fungal infection)
• Eosinophilia (increase in a type of white blood cells called eosinophils)
• Hypersensitivity (allergic reactions)
• Loss of appetite (anorexia)
• Dizziness
• Flatulence (gas)
• Inflammation of the liver (hepatitis)
• Jaundice (yellowing of the skin and whites of the eyes)
• Skin rash (red spots on the skin) with eosinophilia and general symptoms (fever and enlarged lymph nodes) (DRESS syndrome)
• Inflammation of moist body surfaces (mucous membranes), such as the lining of the mouth and nose
• Fever
• Abnormalities in blood tests assessing kidney function (e.g., increased urea)
• Dizziness
• Eating disorder characterized by refusal to eat; lack of appetite

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

• Antibiotic-associated colitis (inflammation of the large intestine)
• Haemolytic anaemia (excessive destruction of red blood cells causing fatigue and pale skin)
• Anaphylactic shock (sudden and severe allergic reaction with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating and loss of consciousness)
• Rheumatoid arthritis (disease with painful inflammation and damage in the joints)
• Restlessness (psychomotor hyperactivity)
• Raised red areas on the skin that may appear all over the body (erythema multiforme)
• Itching (pruritus)
• Potentially life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)
• Potentially life-threatening reaction with flu-like symptoms and blistering of the skin, mouth, eyes and genitals (toxic epidermal necrolysis)
• Itchy rash (urticaria)
• Kidney inflammation (interstitial nephritis)
• Abnormalities in blood tests assessing kidney function (increased creatinine)

Reporting of adverse effects

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

5. Storage of Afixora

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

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

Store below 25°C.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the container and other information

Composition of Cefixima Codal

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

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

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

Appearance of the product and contents of the pack

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

The tablets are supplied in PVC-aluminum blisters.

Pack sizes of 5, 6, 7, 8, 10, 12 and 100 film-coated tablets.

Only some pack 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 most recent review of this leaflet:
July 2025