CEFIXIME MABO 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

CefiximeMabo200 mg film-coated tablets EFG

CefiximeMabo400 mg film-coated tablets EFG

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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 Package Leaflet

1. What is Cefixime Mabo and what is it used for
2. What you need to know before you take Cefixime Mabo
3. How to take Cefixime Mabo
4. Possible side effects
5. Storage of Cefixime Mabo

6. Contents of the pack and further information

1. What is Cefixime Mabo and what is it used for

Cefixime Mabo film-coated tablets (called Cefixime Mabo in this leaflet) contain a medicine called cefixime, which belongs to a group of antibiotics called ‘cephalosporins’, used to treat infections caused by bacteria.

Cefixime Mabo is used to treat:

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

• Uncomplicated kidney infection
• Acute throat infection caused by bacteria
• Uncomplicated acute gonorrhea

If you need more information about your condition, ask your doctor.

2. What you need to know before you take Cefixime Mabo

Do not takeCefixime

• 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 not sure, talk to your doctor or pharmacist before taking Cefixime Mabo.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cefixime Mabo if:

• you have had colitis before
• you have kidney problems
• the person taking this medicine is under 12 years of age.

If you are not sure if the above applies to you, consult your doctor or pharmacist before taking this medicine.

Cefixime Mabo is not suitable for everyone.

Before takingCefixime Mabo tell your doctor if:

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

An allergic reaction can include a skin rash (hives), itching, difficulty swallowing or breathing, or swelling of the face, lips, throat, and tongue. Not everyone who is allergic to penicillins is also allergic to cephalosporins. But you should be especially careful if you have ever had an allergic reaction to any penicillin, because you may also be allergic to this medicine. If a patient has a severe allergic reaction or anaphylaxis (a severe allergic reaction that causes difficulty breathing or dizziness) after taking Cefixime Mabo, treatment should be discontinued and appropriate treatment should be provided.

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

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

Taking Cefixime Mabo with other medicines

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 harm the kidneys, such as
• • Antibiotics like aminoglycosides, polymyxin B, colistin, 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. Cefixime can cause coagulation problems and may increase the time it takes for blood to clot.

Interference with laboratory tests- If you have a blood or urine test, tell your doctor that you are taking Cefixime, because cefixime can alter the results of some of these tests.

• Cefixime can alter the results of some urine sugar tests (such as Benedict or Fehling tests). If you have diabetes and have regular urine tests, tell your doctor, because other tests may need to be used to control diabetes while taking this medicine.
• Cefixime can alter the results of some tests to measure ketones in the urine. Tell your doctor that you are taking Cefixime, because other tests may need to be used.
• Cefixime can alter the results of a blood test to detect antibodies called the direct Coombs test.

Taking CefiximeMabowith food and drinks

Cefixime Mabo can be taken with or without food. The tablet 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 or pharmacist before using this medicine.

Driving and using machines

Cefixime can cause dizziness. If you are affected, do not drive or operate machinery.

3. How to take Cefixime Mabo

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

These tablets should be taken orally. You should try to take this medicine at approximately the same time every day. The recommended dose is:

Adults and adolescents over 12 years:1 x 400 mg per day as a single dose or 2 x 200 mg daily dose

Patients with kidney problems

If you have severe kidney problems or are undergoing dialysis, your doctor will reduce your dose.

Your doctor will calculate the correct dose for you based on the results of blood or urine tests that measure kidney function. The available data on the use of cefixime in children and adolescents with kidney problems are insufficient. Therefore, cefixime is not recommended for use in these patients.

Elderly patients

No dose adjustment is necessary for elderly patients with normal kidney function.

Adolescents from 12 years of age onwards

Adolescents from 12 years of age onwards can receive the same dose as adults.

Children under 12 years of age

The tablet formulation is not suitable for children under 12 years of age. You should ask your doctor for more information.

If you take moreCefiximeMabothan you should

If you or your child have taken more of this medicine than you should, tell your doctor or contact the nearest emergency department immediately. Take your tablets with you, even if there are no tablets left in the pack, so that the doctor knows exactly what you have taken.

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 CefiximeMabo

If you forget to take a tablet, take it as soon as you remember. But if it is almost time for the next dose, do not take it and resume your normal schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking CefiximeMabo

Do not stop taking Cefixime Mabo just because you feel better. It is important that you take this medicine until you finish the cycle that your doctor has prescribed. If you stop taking it too soon, the infection may come back. If the person being treated continues to feel unwell at the end of the treatment cycle prescribed by their doctor or worsens during treatment, they should inform their doctor.

If you have any other 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.

The following side effects are important and may require immediate action if you experience them. Stop taking CefiximeMaboand see 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 may 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 Cefixime Mabo - Warnings and precautions).

Frequency not known(cannot be estimated from the 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 Cefixime Mabo - 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), pain, indigestion
• 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 cefixime does not affect. For example, oral candidiasis.
• Increased number of a type of white blood cell called eosinophils
• Allergic reaction
• Lack of appetite
• Dizziness
• Flatulence (gas)
• Itching of the skin
• Inflammation of the mucous membrane that lines the mouth and/or other internal surfaces
• Fever
• Changes in blood tests that measure kidney function

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

• Reduced number of various blood cells (symptoms may include fatigue, new infections, and a tendency to bruise or bleed)
• Allergic reaction characterized by skin rash, fever, joint pain, and enlargement of certain 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 the available data):

• Increased platelet count (thrombocytosis)
• Reduced number of a type of white blood cell called neutrophils (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 usually appears on the palms of the hands or the soles of the feet. They can be signs of a severe allergy to the medicine, known as "erythema multiforme".
• A brain condition with symptoms including seizures (convulsions), feeling confused, feeling less alert or aware than usual, unusual muscle movements, or stiffness. This can be a condition called encephalopathy. This side effect is more likely if you have taken an overdose or if you already have a kidney problem.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of CEFIXIMA MABO

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

Store below 25°C. Do not refrigerate or freeze.

Do not use this medicine after the expiry date which is stated on the carton after {CAD}. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

• Composition of Cefixime Mabo
• The active substance is cefixime. Each film-coated tablet contains 200 mg or 400 mg of cefixime (as trihydrate).
• The other ingredients are: Calcium hydrogen phosphate dihydrate; Pregelatinized maize starch, Microcrystalline cellulose, Magnesium stearate, Hypromellose, Titanium dioxide, Macrogol 3350, Triacetin

Appearance of the product and pack contents

Cefixime Mabo 200 mg film-coated tablets EFG

Film-coated tablets, convex, circular (10.0 to 10.4 mm in diameter), white to light cream in color, engraved with "A 11" on one side and smooth on the other.

Cefixime Mabo 200 mg film-coated tablets are supplied in PVC-Aclar/Aluminum and PVC-PVdC/Aluminum blisters containing 1, 5, 6, 7, 8, 10, 12, 14, 20, and 21 film-coated tablets.

Cefixime Mabo 400 mg film-coated tablets EFG

Film-coated tablets, oblong (18.7 to 19.1 mm long and 8.4 to 8.8 mm wide), white to light cream in color, with a score line on one face of the tablet, engraved with "A" and "10" on one side and smooth on the other.

Cefixime Mabo 400 mg film-coated tablets are supplied in PVC-Aclar/Aluminum and PVC-PVdC/Aluminum blisters containing 1, 3, 5, 6, 7, 8, and 10 film-coated tablets.

The tablet can be divided into equal doses.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

MABO-FARMA S.A.

Calle Rejas 2, planta 1

28821 Coslada (Madrid)

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA3000, Malta

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

Portugal:Cefixime Nectar

Austria:Cefixime Nectar

Bulgaria:Cefixime Nectar

Germany:Cefixime Nectar

Spain:Cefixime Mabo

France:Cefixime Neclife

Hungary:Cefixime Nectar

Romania:Cefixime Nectar

Slovakia:Cefixime Nectar

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Date of last revision of thisleaflet:September 2018

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