CEFIXIME REIWA HEALTHCARE 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cefixima Reiwa Healthcare 200 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Cefixima Reiwa Healthcare and what is it used for
2. What you need to know before you take Cefixima Reiwa Healthcare
3. How to take Cefixima Reiwa Healthcare
4. Possible side effects
5. Storage of Cefixima Reiwa Healthcare
6. Pack contents and further information

1. What is Cefixima Reiwa Healthcare and what is it used for

This medicine contains cefixime, which is an antibiotic belonging to the beta-lactam family, from the group of cephalosporins known as 3rd generation, a group close to the group of penicillins.

This medicine is indicated for the treatment of:

• Bronchial and pulmonary infections,
• Sinusitis and acute ear infections,
• Acute pyelonephritis without uropathy,
• Uncomplicated lower urinary tract infections, except for prostatitis,
• Uncomplicated gonococcal urethritis in men.

2. What you need to know before you take Cefixima Reiwa Healthcare

Do not takeCefixima Reiwa Healthcare:

• If you are allergic to cefixime, to any other cephalosporin antibiotic or to any of the other components of this medicine (listed in section 6).
• If you have ever had an immediate or severe allergic reaction to penicillin or any other beta-lactam antibiotic. An allergic reaction can include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

Warnings and precautions

Consult your doctor or pharmacist before taking cefixime:

• If you are allergic to penicillin or any other type of beta-lactam antibiotics. Not all people allergic to penicillin are also allergic to cephalosporins. However, be extra careful if you have ever had an allergic reaction to any penicillin. This is because you may also be allergic to this medicine.
• If you have ever been told that your kidneys do not work very well. Also, if you are undergoing any treatment (such as dialysis) for kidney failure. You can take cefixime but you may need a lower dose.
• If you have asthma.
• If you have previously had hemolytic anemia after taking a cephalosporin antibiotic, including cefixime (a decrease in red blood cells, which can cause paleness, weakness or difficulty breathing).

During or after treatment, you must inform your doctor immediately:

• If you have severe or persistent diarrhea that may be bloody and may be associated with stomach pain or cramps: these symptoms can occur during or shortly after treatment and the signal is a rare but potentially fatal adverse reaction. Stop taking cefixime and contact your doctor immediately. Do not take medications that can slow down or stop bowel movements.
• Observe changes in the way your kidneys work or in the blood in your urine or your child's urine. They can be signs of acute kidney failure, including inflammation of the kidney that affects its structure and function (acute kidney failure, including tubulointerstitial nephritis). In this case, the administration of cefixime should be discontinued and appropriate treatment should be administered.
• Treatment with a cycle of cefixime may temporarily increase the possibility of contracting infections caused by other types of germs that cefixime does not act on. For example, thrush (infection caused by a yeast germ called Candida) may occur.
• If you have an allergic reaction, the symptoms can range from rash and urticaria with itching to potentially fatal anaphylaxis (severe allergic reaction that causes difficulty breathing or dizziness) with low blood pressure, swelling of the face or throat, difficulty breathing.
• If you have a severe skin reaction, such as skin peeling or blisters, that can spread rapidly throughout the body and put you at risk (Lyell's syndrome, Stevens-Johnson syndrome) or symptoms similar to those of the flu and a rash on the face followed by widespread skin rash with high body temperature (drug reaction with eosinophilia and systemic symptoms, DRESS). Your doctor may decide to discontinue treatment with this medicine and/or prescribe appropriate treatment (see section 4 "Possible side effects").
• If you develop paleness, weakness or difficulty breathing while taking this medicine. These can be symptoms of a disease called hemolytic anemia.
• If you have fatigue, nausea or decreased urine production. These can be symptoms of acute kidney failure.
• As with all medicines belonging to this class of antibiotics (beta-lactam antibiotics), there is a risk of encephalopathy, which can cause seizures, confusion, altered consciousness or movement disorders, especially in the case of overdose or kidney failure. If these disorders occur, consult your doctor or pharmacist immediately (see sections 3 and 4).

In case of laboratory tests:

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

Cefixime may alter the results of some urine sugar tests (such as Benedict, Fehling or copper sulfate tests). If you have diabetes and your urine is routinely analyzed, inform your doctor. This is because other tests may need to be used to monitor your diabetes while you are taking this medicine.

Cefixime may alter the results of some tests to measure ketones in the urine. Inform your doctor that you are taking cefixime because other tests may need to be performed.

Cefixime may alter the results of a blood test for antibodies called the direct Coombs test.

Other medicines and Cefixima Reiwa Healthcare

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In particular, tell your doctor or pharmacist if you are taking:

• medicines that can damage the kidneys, as they may increase the risk of kidney failure. Examples:
• • antibiotics such as aminoglycosides, colistin, polymyxin and viomycin,
  • medicines that increase the amount of urine your body produces (diuretics), such as etacrynic acid or furosemide,
• nifedipine, a medicine used to treat high blood pressure or heart problems,
• anticoagulants (medicines that prevent blood clotting) such as warfarin. In some patients, cefixime may cause coagulation problems and may increase the time it takes for the blood to clot.
• oral contraceptives (birth control pill)
• antacids containing aluminum or magnesium hydroxide. They should be taken 2 hours before or after cefixime.

Cefixima Reiwa Healthcare with food and drinks

Cefixime can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine:

Driving and using machines

Cefixime is unlikely to affect your ability to drive or use machines. However, if you feel dizzy or drowsy, do not drive or use machines.

3. How to take Cefixima Reiwa Healthcare

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Dose

Your doctor will decide the correct dose of cefixime and tell you how long you should take your medicine. The amount of Cefixima Reiwa Healthcare 200 mg film-coated tablets you need to take will depend on your condition. Follow your doctor's instructions exactly and never change the dose yourself. Ask your doctor or pharmacist if you are not sure about the amount of medicine you should take or when you should take it. The medicine should always be taken at the same time every day.

Cefixime is recommended for adults.

Adults

The usual dose is one to two tablets per day. If two cefixime tablets are prescribed per day, they can be taken as a single dose or in two divided doses.

In order to be effective, this antibiotic must be used regularly in the prescribed doses and for the duration that your doctor has indicated.

Adolescents over 12 years

Adolescents over 12 years may receive the same dose as recommended for adults.

Children under 12 years

Cefixime may not be suitable for children under 12 years, so the use of other pharmaceutical forms of cefixime should be considered.

Elderly patients

For elderly patients, the doses are the same as those for adults, provided that kidney function is normal.

Patients with kidney problems

In adult patients with kidney problems, it may be necessary to reduce the dose of cefixime. Your doctor will calculate the appropriate dose for you based on the results of blood or urine tests that measure how well your kidneys are working and also based on the severity of your infection. There is not enough data on the use of cefixime in children and adolescents with kidney problems. Therefore, the use of cefixime is not recommended in these patients.

Method of administration

Oral. The film-coated tablet should be swallowed with a glass of water.

If you take more Cefixima Reiwa Healthcare than you should:

As with all medicines belonging to this class of antibiotics (beta-lactam antibiotics), the administration of this medicine, especially in case of overdose, can cause a risk of encephalopathy, which can cause seizures, confusion, altered consciousness or abnormal movements. If these disorders occur, consult your doctor or pharmacist immediately (see sections 2 and 4).

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

If you forget to take Cefixima Reiwa Healthcare

If you forget to take a dose, take it as soon as you remember. However, if the next dose is due in less than 6 hours, skip the missed dose and return to your regular dosing schedule. Do not take a double dose to make up for missed doses.

If you stop taking Cefixima Reiwa Healthcare

It is important that you take this medicine until you finish the prescribed cycle. Do not stop taking cefixime just because you feel better. If you stop taking it too soon, the infection may come back. If you still feel unwell at the end of the prescribed treatment cycle or feel worse during treatment, inform your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects are important and will require immediate action if you experience them. Stop taking cefixime and consult your doctor immediately if you experience the following symptoms:

• Very rare side effects (may affect up to 1 in 10,000 people):
• • antibiotic-associated colitis and pseudomembranous colitis, which can cause watery and severe diarrhea that may also be bloody
  • hemolytic anemia, which can cause paleness, weakness or difficulty breathing
  • sudden severe allergic reactions (anaphylactic shock) such as rash or urticaria, itching, swelling of the face, lips, tongue or other parts of the body, feeling of tightness in the chest, wheezing or fainting,
  • reaction similar to serum sickness (an allergic reaction that can include symptoms such as skin rash, joint pain, muscle pain, fever),
  • severe skin disease with blisters on the skin, mouth, eyes and genitals (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2: What you need to know before you take Cefixima Netpharmalab)

• Side effects of unknown frequency (cannot be estimated from the available data):
• • severe rash, fever, enlarged lymph nodes, increased number of a type of white blood cells called eosinophils (DRESS syndrome) (see section 2: What you need to know before you take Cefixima Netpharmalab)

The following side effects have been reported:

Common side effects (may affect up to 1 in 10 people):

• diarrhea (if you have severe diarrhea or if you notice blood in your stool, you should stop taking this medicine and talk to your doctor immediately because you may have a very rare infection of the large intestine that requires special treatment).

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

• headache
• nausea
• vomiting
• abdominal pain (in the abdomen),
• changes in blood tests that measure liver function,
• skin rash

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

• infections caused by germs that cefixime does not act on. For example, candidiasis
• an increase in the number of a type of white blood cells called eosinophils
• a decrease in the number of a type of white blood cells called granulocytes
• hypersensitivity reactions (these are less severe allergic reactions, skin rash with bumps [urticaria], itching)
• loss of appetite
• flatulence (gas)
• changes in a blood test that checks kidney function (increased urea in blood)
• fever
• dizziness
• swelling of the skin and mucous membranes, which can affect the face, tongue or throat (angioedema)
• itching of the skin
• inflammation of the lining of the mouth and/or other internal surfaces (mucous membranes)

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

• decrease in the number of different cells in the blood (symptoms can be fatigue, new infections and ease of bruising or bleeding)
• allergic reaction characterized by rash, fever, joint pain and enlargement of certain organs
• restlessness and increased activity.
• liver problems, including jaundice (yellowing of the skin or the whites of the eyes)
• changes in a blood test that checks kidney function (increased creatinine in blood)

Side effects of unknown frequency (cannot be estimated from the available data):

• increased number of platelets (thrombocytosis), decreased number of a type of white blood cell (neutropenia),
• strong heartbeats (palpitations)
• decreased blood pressure
• difficulty breathing
• abnormal bronchial contractions (bronchospasm)
• seizures (convulsions)
• hallucinations
• agitation
• confusion
• indigestion (stomach upset),
• Skin rash or skin lesions with a pink/ red ring and a pale center, which can be itchy, scaly or fluid-filled. The rash appears especially on the palms of the hands or soles of the feet. They can be signs of a severe allergy to the medicine, called erythema multiforme.
• acute kidney failure, including inflammation of the kidney that affects its structure and function (acute kidney failure, including tubulointerstitial nephritis).

Reporting of suspected adverse reactions

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefixima Reiwa Healthcare

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

Do not use this medicine after the expiry date which is stated on the carton, after EXP. The expiry date refers to the last day of the month shown.

Store below 25°C.

Keep the blister in the outer packaging to protect it from light.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Packaging Content Additional Information

Composition of Cefixima Reiwa Healthcare

• The active ingredient is cefixime. Each film-coated tablet contains 200 mg of cefixime (equivalent to 223.84 mg of cefixime trihydrate).

• The other components are:

Tablet core

Microcrystalline cellulose

Anhydrous calcium hydrogen phosphate,

Pregelatinized corn starch

Magnesium stearate,

Coating

Hypromellose,

Macrogol,

Titanium dioxide (E-171)

Appearance of the Product and Packaging Content

Film-coated tablet, round, white to off-white in color, with smooth and intact edges.

Packaging of 14 film-coated tablets in PVC/aluminum paper blisters in a cardboard box.

Marketing Authorization Holder

Reiwa Healthcare S.L

Carretera de Fuencarral, 22

28108 – Alcobendas

Madrid

Spain

Manufacturer

Netpharmalab Consulting Services S.L

Carretera de Fuencarral, 22

28108 – Alcobendas

Madrid

Spain

This Medicinal Product is Authorized in the Member States of the European Economic Area under the Following Names

Hungary: Cefixime Reiwa Healthcare 200 mg filmtabletta

Germany: Cefixim Reiwa Healthcare 200 mg Filmtabletten

Spain: Cefixima Reiwa Healthcare 200 mg film-coated tablets EFG

Date of the Last Revision of this Leaflet:May/2022

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/)