Package Insert: Information for the Patient

CefiximaMabo200 mg Film-Coated Tablets

CefiximaMabo400 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

6.Contents of the pack and additional information

CEFIXIMAMABOfilm-coated tablets(referred to as Cefixime Maboin this leaflet) contain a medicine called cefixime,which belongs to a group of antibiotics called «cephalosporins», used to treat infections caused by bacteria.

Do not store or reuse this medication. If you have leftover antibiotics after completing treatment, return them to the pharmacy for proper disposal. Do not dispose of medications through the drain or trash

Cefixima Mabois used to treat:

• Middle ear infection
• Acute exacerbation of chronic bronchitis
• Uncomplicated urinary tract infection

• Uncomplicated kidney infection
• Acute pharyngitis caused by bacteria
• Uncomplicated gonorrhea

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

Do not takeCefixima

:

• If you are allergic to cefixima or any of the other components of this medication (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 antibiotic or any other type of beta-lactam antibiotic.

Do not take this medication if you meet any of the above criteria. If you are unsure, speak with your doctor or pharmacist before taking CefiximaMabo.

Warnings and precautions

Consult your doctor or pharmacist before starting to take CefiximaMaboif:

• You have had colitis at any time.
• You have kidney problems.
• The person taking this medication is under 12 years of age.

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

CefiximaMabois not suitable for everyone.

Before taking CEFIXIMAMABOyou must tell your doctor if:

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

A severe allergic reaction may include skin rash, itching, difficulty swallowing or breathing, or swelling of the face, lips, throat, and tongue. Not everyone allergic to penicillins is also allergic to cephalosporins. However, you must be especially cautious if you have ever had a severe allergic reaction to any penicillin, as you may also be allergic to this medication. If a patient experiences a severe allergic reaction or anaphylaxis (a severe allergic reaction that causes difficulty breathing or dizziness) after administration of CefiximaMabo, administration will be suspended and appropriate treatment will be provided.

• You are taking other medications that are harmful to the kidneys. 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 intense or persistent diarrhea with stomach pain or cramps during or after treatment with CefiximaMabo, stop taking this medication and contact your doctor immediately. You will not be able to take medications that slow down or stop intestinal movement.

If you experience a condition 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), stop taking this medication and contact your doctor immediately.

Treatment with a cycle of CefiximaMabomay temporarily increase the likelihood of infections caused by other types of germs that cefixima does not act on. For example, you may experience oral candidiasis (infection caused by a levaduriform fungus calledCandida).

Taking CefiximaMabowith other medications

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

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

• Medications that harm the kidneys such as
• • Aminoglycoside antibiotics, polymyxin B, colistin, and viomycin
  • Diuretics, such as etacrynic acid or furosemide, which increase the amount of urine your body produces.
• Nifedipine (a medication used to treat high blood pressure or heart problems)
• Anticoagulants (medications that prevent blood clotting) such as warfarin in some patients. Cefixima causes blood clotting problems and may increase the time it takes for blood to clot.

Interference with analytical 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 sugar tests in urine (such as Benedict or Fehling tests). If you have diabetes and have periodic urine tests, inform your doctor, as it may be necessary to use other tests to control diabetes while taking this medication.

- Cefixima may alter the results of some tests to measure ketones in urine. Inform your doctor that you are taking Cefixima, as it may be necessary to use other tests.

- Cefixima may alter the results of a blood test to detect antibodies called the direct Coombs test.

Taking CefiximaMabowith food and drinks

CefiximaMabocan 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Cefixima may cause dizziness. If you are affected, do not drive or operate machinery.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

These tablets should be taken orally. You should try to take this medication approximately at the same hour every day.
The recommended dose is:
Adults and adolescents over 12 years old:
1 X 400 mg per day as a single dose or
2 x 200mg daily doses

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, it is not recommended to use cefixime in these patients.

Older adults

No adjustment of the dose is necessary for older adults if kidney function is normal.

Adolescents 12 years old and above

Adolescents 12 years old and above can receive the same dose as adults.

Children under 12 years old

The tablet form is not suitable for children under 12 years old. You should ask your doctor for more information.

If you take moreCefixima Mabothan you should

If you or your child have taken more of this medication than you should, inform your doctor or contact the nearest Emergency Service immediately. Bring your tablets with you even if there are no tablets left in the box so that the doctor knows exactly what you have taken.

If you forgot to take Cefixima Mabo

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 the usual schedule. Do not take a double dose to make up for the missed doses.

If you interrupt the treatment with Cefixima Mabo

You should not stop taking Cefixima Mabo simply because you feel better. It is essential to take this medication until you complete the cycle prescribed by your doctor. If you stop taking it too soon, the infection may recur. If the person receiving the treatment continues to feel unwell at the end of the treatment cycle prescribed or worsens during treatment, inform your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects are serious and will require immediate action if you experience them. Stop taking Cefixima Mabo and seek immediate medical attention if you experience the following symptoms:

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

• Severe watery diarrhea that may also be bloody
• Intense sudden allergic reactions (anaphylactic shock) such as skin rash or hives, itching, swelling of the face, lips, tongue, or other parts of the body, feeling of 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 taking CEFIXIMA MABO - Warnings and precautions).

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

• Intense skin rash, fever, swollen lymph nodes, increased eosinophil count (DRESS syndrome) (see section 2. What you need to know before taking CEFIXIMA MABO - Warnings and precautions).

Also, the following side effects have been reported:

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

• Diarhea

Occasional(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 Cefixima does not act against, for example, oral candidiasis.
• Increased eosinophil count
• Allergic reaction
• Loss of appetite
• Dizziness
• Flatulence (gas)
• Itching skin
• Inflammation of the mucous membranes that line 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):

• Reduction in the 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 increased size of certain organs
• Restlessness and increased activity
• Liver problems, such as jaundice (yellowing of the skin or white of the eyes)
• Kidney inflammation

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

• Increased platelet count (thrombocytosis)
• Reduction in the number of a type of white blood cell (neutropenia)
• Indigestion
• Skin rash or skin lesions with a ring of pink/red color and a pale center, which may itch, peel, or be filled with fluid. The rash appears especially on the palms of the hands or soles of the feet. They may be signs of a severe allergy to the medicine, called "erythema multiforme."
• A brain condition with symptoms that include seizures (convulsions), feeling confused, feeling less alert or aware of things than normal, unusual muscle movements, or stiffness. This may be something called encephalopathy. This side effect is more likely if you have taken an overdose or if you already have a problem with your kidneys.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

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

Do not use this medication after the expiration date that appears on the box after {CAD}. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Ask your pharmacist howto dispose of the packaging and medications you no longer need. This will help protect the environment.

Cefixima Mabo Composition

• The active ingredient is cefixima. Each film-coated tablet contains 200 mg or 400 mg of cefixima (as trihydrate).
• The other components are: Calcium dihydrogen phosphate dihydrate; Cornstarch pregelatinized,Microcrystalline cellulose, Magnesium stearate, Hypromellose ,Titanium dioxide, Macrogol 3350, Triacetin

Appearance of the product and contents of the package

Cefixima 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.

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

Cefixima Mabo 400 mg film-coated tablets EFG

Film-coated tablets, oblong (18.7 to 19.1 mm in length and 8.4 to 8.8 mm in width), white to light cream in color, with a groove on one of the faces of the tablet, engraved with "A” and” 10" on one side and smooth on the other.

Cefixima Mabo 400 mg film-coated tablets are supplied in PVC-Aclar / Aluminum blisters 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.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Holder of the marketing authorization

MABO-FARMA

Calle Rejas 2, 1st Floor

28821 Coslada-Madrid

Spain

Responsible for manufacturing

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA3000, Malta

This medicine is authorized in the member states of the European Economic Area with 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

Last date of review of thisleaflet:September 2018

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