CEFIXIME NORMON 400 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Cefixima Normon 400 mg Hard Capsules 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 Normon 400 mg and what is it used for
2. What you need to know before you take Cefixima Normon 400 mg
3. How to take Cefixima Normon 400 mg
4. Possible side effects
5. Storage of Cefixima Normon 400 mg
6. Contents of the pack and other information

1. What is Cefixima Normon 400 mg and what is it used for

Cefixima Normon contains a medicine called cefixime, which belongs to a group of antibiotics called “cephalosporins”, used to treat infections caused by bacteria.

Cefixima Normon is used to treat

• Acute sinusitis
• Middle ear infection
• Infection that causes sudden worsening of long-term bronchitis
• Uncomplicated acute bladder infection
• Uncomplicated kidney infection

2. What you need to know before you take Cefixima Normon 400 mg

Do not take Cefixima Normon

• if you are allergic to cefixime or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to any other type of cephalosporin antibiotic,
• if you have had a severe allergic reaction to penicillin or any other beta-lactam antibiotic.

Do not take this medicine if you meet any of the above criteria. If you are unsure, talk to your doctor or pharmacist before taking cefixime.

Warnings and precautions

Consult your doctor or pharmacist before starting to take cefixime:

• if you have had colitis at any time
• if you have kidney problems
• if the person taking this medicine is under 12 years of age

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

Cefixima is not suitable for everyone.

Before taking cefixima, you must tell your doctor:

• if you are allergic to penicillin or any other beta-lactam antibiotic.

An allergic reaction can consist of a skin rash (hives), itching, difficulty swallowing or breathing, or swelling of the face, lips, throat, and tongue. Not all people who are allergic to penicillins are also allergic to cephalosporins. However, you should be especially cautious if you have ever had an allergic reaction to any penicillin, as you may also be allergic to this medicine.

If a patient experiences a severe allergic reaction or anaphylaxis (a severe allergic reaction that causes difficulty breathing or dizziness) after administration of cefixima, the administration will be discontinued and the corresponding treatment will be provided.

• if you are taking other medicines that are harmful to the kidneys. Also, inform your doctor if you have any kidney problems. Your doctor may perform certain tests periodically to measure kidney function during treatment.

• if you have had severe or persistent diarrhea with stomach pain or cramps during treatment with cefixima or after, stop taking this medicine and contact your doctor immediately. You will not be able to take medicines that slow down or stop intestinal movements.

If you experience a syndrome known as DRESS (skin rash with eosinophilia and systemic symptoms), Stevens-Johnson syndrome, or a skin reaction known as toxic epidermal necrolysis (see section 4. Possible side effects) while taking cefixima, stop taking this medicine and contact your doctor immediately.

Treatment with a cycle of cefixima may temporarily increase the likelihood of developing infections caused by other types of germs that cefixima does not affect. For example, you may develop oral candidiasis (an infection caused by a yeast-like fungus called Candida).

Other medicines and Cefixima Normon

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

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

• medicines that damage the kidneys, such as
• antibiotics like aminoglycosides, colistin, polymyxin, and viomycin
• medicines that increase the amount of urine your body produces (diuretics), such as ethacrynic 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. Cefixima can cause coagulation problems and may increase the time it takes for blood to clot
• oral contraceptives (birth control pills)

Effect on laboratory tests

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

Cefixima may alter the results of some urine sugar tests (such as Benedict's or Fehling's tests). If you have diabetes and have regular urine tests, inform your doctor, as other tests may need to be used to monitor your diabetes while taking this medicine.

Cefixima may alter the results of some tests for measuring ketones in the urine. Inform your doctor that you are taking cefixima, as other tests may need to be used.

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

Taking Cefixima Normon with food and drinks

Cefixima can be taken with or without food. The capsule should be swallowed with a glass of water.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Cefixima is unlikely to affect your ability to drive or use machines.

3. How to take Cefixima Normon 400 mg

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again. The dose your doctor prescribes will depend on the type of infection and its severity. It also depends on kidney function. Your doctor or pharmacist will explain it to you.

The recommended dose is:

Adults

The recommended dose in adults is 400 mg (1 capsule of Cefixima Normon 400 mg or 2 capsules of Cefixima Normon 200 mg) once daily as a single oral dose, or divided into two equal doses of 200 mg (1 capsule of Cefixima Normon 200 mg) every 12 hours. The medicine should be taken at the same time every day.

Patients with kidney problems

In patients with kidney problems, it may be necessary to reduce the dose of cefixima. Your doctor will calculate the correct dose for you based on the results of blood or urine tests that measure kidney function.

There is insufficient data available on the use of cefixima in children and adolescents with kidney problems. Therefore, cefixima is not recommended for use in these patients.

Older adults

No dose adjustment is necessary for older adults with normal kidney function.

Adolescents 12 years of age and older

Adolescents 12 years of age and older can receive the same dose as adults.

Children under 12 years of age

The capsule formulation is not suitable for children under 12 years of age.

If you take more Cefixima Normon than you should

Consult your doctor or pharmacist.

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

If you forget to take Cefixima Normon

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

If you stop taking Cefixima Normon

It is important to take this medicine until you finish the prescribed treatment cycle. Do not stop taking cefixima just because you feel better. If you stop taking it too soon, the infection may recur. If the person being treated continues to feel unwell at the end of the prescribed treatment cycle or worsens during treatment, inform your doctor.

If you have any further questions about 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.

Most are considered mild and temporary.

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

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

• Watery and severe diarrhea, which can also be bloody

• Sudden severe allergic reactions (anaphylactic shock) such as skin rash or hives, itching, swelling of the face, lips, tongue, or other parts of the body, tightness in the chest, wheezing, or fainting.

• 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 Normon - Warnings and precautions).

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

• Severe skin rash, fever, enlarged lymph nodes, and increased number of a type of white blood cell called eosinophils (DRESS syndrome) (see section 2. What you need to know before you take Cefixima Normon - Warnings and precautions).

The following side effects have also been reported:

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

• Diarrhea

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

• Headache
• Nausea
• Vomiting
• Abdominal pain (in the stomach)
• Changes in blood tests that measure liver function
• Skin rash

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

• Increased risk of infection by germs that cefixima does not affect. For example, oral candidiasis.
• Increased number of a type of white blood cell called eosinophils
• Allergic reaction
• Loss of appetite
• Dizziness
• Flatulence (gas)
• Itching of the skin
• Inflammation of the mucous membrane that lines the mouth or other internal surfaces
• Fever
• Changes in blood tests that measure kidney function

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

• Reduction in the number of various blood cells (symptoms may include fatigue, new infections, and propensity to bruise or bleed)
• Allergic reaction characterized by skin rash, fever, joint pain, and enlarged organs
• Restlessness and increased activity
• Liver problems, such as jaundice (yellowing of the skin or the whites of the eyes)
• Kidney inflammation

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

• Increased number of platelets (thrombocytosis)
• Reduced number of a type of white blood cell (neutropenia)
• Indigestion

• 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 the soles of the feet. These can be signs of a severe allergy to the medicine, known as "erythema multiforme".

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is 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 Normon 400 mg

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

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C. Store in the original packaging.

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

6. Contents of the pack and other information

Composition of Cefixima Normon

• The active substance is cefixime. One capsule contains 400 mg of cefixime (as trihydrate).
• The other ingredients (excipients) are: colloidal anhydrous silica, macrogol stearate 40, and magnesium stearate. Capsule components: gelatin, yellow iron oxide (E-172), and titanium dioxide (E-171).

Appearance of the product and pack contents

Cefixima Normon 400 mg are hard yellow capsules that are packaged in PVC/Aluminum blisters and presented in packs of 1 and 10 hard capsules.

Not all 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 last revision of this leaflet:October 2016

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66397/P_66397.html