Cefixime Sandoz 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Cefixime Sandoz 400 mg film-coated tablets 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, consult your doctor or pharmacist.
• 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Cefixima Sandoz contains the active substance cefixime, an antibiotic that belongs to a group called "cephalosporins".

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, administration, 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.

This medicine is used to treat the following bacterial infections in adults and adolescents over 12 years of age:

• acute ear infection,
• acute infection of the nasal cavity and paranasal sinuses,
• infection causing sudden worsening of chronic bronchitis,
• community-acquired pneumonia,
• uncomplicated acute urinary tract infections,
• uncomplicated gonorrhoea.

Consult your doctor if you worsen or do not improve.

2. What you need to know before taking Cefixima Sandoz

Do not take Cefixima Sandoz if:

• you are allergic to cefixime or to any of the other ingredients of this medicine (listed in section 6),
• you are allergic to any other type of antibiotic in the cephalosporin family.

Warnings and precautions

Talk to your doctor or pharmacist before taking cefixime:

• if you have ever had an allergic reaction to treatment with antibiotics. You may also be allergic to this treatment,
• if you have renal impairment. Your doctor will adjust your daily dose,
• if you have ever experienced antibiotic-induced hemolytic anemia due to treatment with cephalosporin antibiotics, including cefixime (reduction in red blood cells in the blood, which may cause paleness, weakness, or difficulty breathing).

During or after treatment, inform your doctor immediately:

• if you have diarrhoea. Do not take any medicine for diarrhoea without consulting your doctor first,

• if you develop skin rash or itching.

• As with all medicines in this class of antibiotics (beta-lactam antibiotics), administration of this medicine may carry a risk of encephalopathy, which may lead to seizures, confusion, altered consciousness, or abnormal movements, especially in cases of overdose or impaired renal function. If you experience these symptoms, consult your doctor or pharmacist immediately (see sections 3 and 4).

• Serious skin reactions such as toxic epidermal necrolysis (TEN, also known as Lyell's syndrome), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with Cefixima Sandoz (see section 4).

Your doctor may decide to discontinue treatment with this medicine and/or prescribe appropriate treatment (see section 4. Possible side effects).

If you develop serious skin reactions or any of the reactions listed in section 4, stop treatment immediately and contact your doctor or healthcare professional.

Children

Cefixima Sandoz is not recommended for children under 12 years of age.

Other medicines and Cefixima Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Inform your doctor if you are taking the following medicines, as they may interact with cefixime:

• anticoagulants (medicines that prevent blood clotting),
• caution when taking calcium channel blockers.

Interference with laboratory tests

If you are due to have any blood or urine tests, inform your doctor that you are taking cefixime, as cefixime may alter the results of some of these tests.

Pregnancy, breast-feeding and fertility

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

Pregnancy

Other substances in the group of medicines to which cefixime belongs are generally well tolerated during pregnancy.

Your doctor will decide whether the benefit of treatment outweighs the potential risk to your baby.

Breast-feeding

Since cefixime is excreted in small amounts in breast milk, you should ask your doctor whether you can take this medicine while breastfeeding. Your doctor will decide whether to interrupt breastfeeding or to discontinue/abstain from treatment with cefixime, taking into account the benefit of breastfeeding for your child and the benefit of treatment for you.

Driving and using machines

Cefixime may cause dizziness. If affected, you should not drive or operate machinery.

Cefixima Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Cefixima Sandoz

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Dosage

Your doctor will decide the correct dose of Cefixima Sandoz and will tell you how long you should take the medicine. The number of tablets you need to take depends on your condition. Follow your doctor's instructions precisely and never change the dose yourself. Ask your doctor or pharmacist if you are unsure about how much medicine to take or when to take it.

Adults and adolescents over 12 years of age

The recommended dose is 400 mg of cefixime: 400 mg (1 tablet of Cefixima Sandoz) once daily.

If your doctor has prescribed a once-daily dose, you should take it every 24 hours. The medicine should always be taken at the same time each day.

Duration of treatment

Most infections can be treated within 7 days. However, in severe cases cefixime may be used for 14 days.

Children under 12 years of age

Please note that Cefixima Sandoz tablets are not suitable for children. Instead, an oral suspension may be used, or you should consult your doctor for further information.

Elderly patients

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

Patients with renal impairment
If you have severe renal problems or are undergoing dialysis, your doctor may reduce your dose. There is insufficient data on the use of cefixime in children with renal impairment. Therefore, the use of cefixime is not recommended in these patients.

For creatinine clearance values below 20 ml/min, or in ambulatory peritoneal dialysis or hemodialysis, the recommended dosage is 200 mg once daily.

Patients with hepatic impairment
Dose adjustment is not necessary in patients with liver problems.

Method of administration

Oral use

The tablet should be taken with a sufficient amount of water and must be swallowed whole. The score line is intended solely for dividing the tablet if you find it difficult to swallow it whole. The halves should be taken one immediately after the other.

Cefixima Sandoz may be taken with or without food.

If you take more Cefixima Sandoz than you should

If you accidentally take or ingest more tablets of Cefixima Sandoz, or if a child ingests any of the cefixime tablets, inform your doctor or contact the nearest Emergency Department immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone: 91 562 04 20), stating the medicine and the amount ingested.

If you forget to take Cefixima Sandoz

If you forget to take a dose, take it as soon as you remember. However, if there are less than 6 hours until your next dose, do not take the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed dose.

If you stop taking Cefixima Sandoz prematurely

Do not stop treatment early, as it is important that you take this medicine for the full duration prescribed. If you stop taking it too soon, the infection may recur.

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 experiences them.

You should contact your doctor immediately if you experience any of the following serious side effects:

Allergic reactions

All medicines can cause allergic reactions, although serious allergic reactions are rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), or frequency not known (frequency cannot be estimated from available data). They may include the following allergic reactions of unknown frequency:

• Serum sickness-like reaction (an allergic reaction that may include symptoms such as skin rash, joint pain, muscle pain, fever),
• Sudden wheezing and tightness in the chest,
• Swelling of the eyelids, face, or lips.

Diarrhea (may affect up to 1 in 10 people):

• If you have diarrhea while taking this medicine or after taking it, do not try to treat it yourself. You should contact your doctor immediately. Your doctor may decide to stop treatment and prescribe appropriate therapy.
• There is a frequent risk of diarrhea. Blood may be present in the diarrhea. In very rare cases, this may be a severe form of colitis (pseudomembranous colitis or enterocolitis), which requires immediate discontinuation of treatment.

Severe skin reactions

• Flu-like symptoms with skin rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells [eosinophilia] and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]). (Frequency not known)
• Blisters or bleeding of the skin around the lips, eyes, mouth, nose, and genitals. Also flu-like symptoms and fever (Stevens-Johnson syndrome). (May affect up to 1 in 10,000 people)
• Severe blistering rash in which layers of skin may peel off, leaving large areas of exposed, raw skin all over the body. Also general malaise, fever, chills, and muscle pain (toxic epidermal necrolysis). (May affect up to 1 in 10,000 people)
• Symptoms of AGEP may include widespread red, scaly rash with bumps under the skin (including skin folds, chest, abdomen [including stomach], back, and arms) and blisters accompanied by fever. (May affect up to 1 in 10,000 people)

All of these allergic reactions require urgent medical attention. If you think you are experiencing any of these reactions, stop taking this medicine and contact your doctor or the nearest hospital emergency department immediately.

The following adverse effects have been reported:

Uncommon (may affect up to 1 in 100 people):

• Headache,
• Nausea,
• Vomiting,
• Abdominal pain,
• Skin rash,
• Changes in blood tests measuring liver function.

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

• Severe allergic reaction causing swelling of the face or throat (angioedema),
• Hypersensitivity reactions (these are skin rashes that are less severe allergic reactions than those mentioned above, lumpy rash [urticaria], itching),
• Dizziness/vertigo,
• Loss of appetite (anorexia),
• Flatulence (gas),
• Dyspepsia,
• Itching,
• Fever,
• Abnormal increase in the number of cells (eosinophils) in the blood, characteristic of allergic states,
• Increased blood urea (a measure of kidney function),
• Mucosal inflammation,
• Recurrent bacterial infections,
• Recurrent fungal infections.

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

• Severe allergic reaction causing difficulty breathing or shock (anaphylactic shock),
• Intestinal inflammation sometimes occurring after antibiotic treatment (antibiotic-associated colitis),
• Severe reduction in the number of white blood cells, increasing the likelihood of infections (agranulocytosis),
• Severe reduction in blood cells that may cause weakness, bruising, or increased risk of infections (pancytopenia),
• Decrease in small cells necessary for blood clotting, increasing the risk of bleeding or bruising (thrombocytopenia) (if you have a blood test for any reason, inform the person taking the sample that you are taking this medicine, as it may affect the result),
• Reduction in red blood cells that may cause the skin to turn pale yellow and cause weakness or shortness of breath (hemolytic anemia),
• Low white blood cell count (leukopenia),
• Restlessness associated with increased activity (psychomotor hyperactivity),
• Reversible kidney inflammation affecting its structure and function,
• Liver inflammation (hepatitis),
• Biliary disorder (cholestatic jaundice),
• Changes in special blood tests showing kidney function (increased blood creatinine).

Frequency not known (cannot be estimated from available data):

• Acute kidney failure, including kidney inflammation affecting its structure and function (acute kidney failure, including tubulointerstitial nephritis),
• A brain condition with symptoms such as seizures (convulsions), confusion, reduced alertness or awareness, unusual muscle movements or stiffness. This may be called encephalopathy. This side effect is more likely if you have taken an overdose or already have kidney problems,
• Genital or vaginal itching,
• Thrombocytosis,
• Decrease in the number of neutrophils in the blood (neutropenia).

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefixime Sandoz

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

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

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Cefixima Sandoz:

The active substance is cefixime.

Each film-coated tablet contains 400 mg of cefixime (as cefixime trihydrate).

The other components are:

• Core: calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.
• Coating: grafted poly(ethylene glycol) copolymer, talc, mono-/diglycerides, titanium dioxide (E171), poly(vinyl alcohol).

Appearance of the product and contents of the container

Film-coated tablets,

White to off-white, oblong, biconvex, approximately 8.4 x 19.8 mm in size.

This medicine is available in Al/Al blisters packed in cardboard cartons.

Pack sizes: 5, 7, 10 and 14 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble,

C/Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Sandoz GmbH

Biochemiestrasse 10

Kundl Triol 6250

Austria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Cefixim HEXAL 400 mg Filmtabletten

Bulgaria: ???????? 400 mg ????????? ????????s

Italy: Cefixima Sandoz

Romania: Axtrifia 400 mg, comprimate filmate

Slovenia: Cefixim Sandoz 400 mg

Date of the most recent revision of this leaflet: 03/2025

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

Medical advice/information

Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.

Sometimes, bacterial infections do not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being used. This means they can survive and even multiply despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. The rational use of antibiotics can help reduce the likelihood of bacteria becoming resistant.

When your doctor prescribes an antibiotic, it is intended solely to treat your current illness. Please follow the advice below to help prevent the emergence of resistant bacteria that could render antibiotics ineffective.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the correct number of days. Read the instructions on the label carefully, and if you do not understand something, ask your doctor or pharmacist to explain it.
2. You should not take an antibiotic unless it has been specifically prescribed for you, and you should use it only to treat the infection for which it was prescribed.
3. You should not take antibiotics prescribed for other people, even if their infection was similar to yours.
4. You should not give antibiotics prescribed for you to other people.
5. If you have leftover antibiotics after completing your prescribed treatment, you should return the remaining tablets to a pharmacy for proper disposal.