Cefixime Mylan

PACKAGE LEAFLET

Package leaflet: information for the user

Cefixima Mylan 400 mg film-coated tablets

cefixime
Generic medicine
Please read this entire leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

The active substance in Cefixima Mylan is cefixime, an antibiotic belonging to the
third-generation cephalosporin class. Cefixime works by killing the bacteria that cause
infection. It is indicated for the treatment of the following infections, when it is considered that the bacteria
responsible for these infections are sensitive to cefixime:

• Acute middle ear infection (acute otitis media);
• Bacterial infections of the sinuses (sinusitis), throat (pharyngitis), or tonsils (tonsillitis);
• Bacterial infections in patients with long-term inflammation of the lungs (acute exacerbation of chronic bronchitis);
• Pneumonia acquired outside the hospital (community-acquired pneumonia);
• Urinary tract infection, including bladder or kidneys (uncomplicated urinary tract infections);
• Genital infections caused by the bacterium gonorrhoeae (uncomplicated acute gonorrhoea).

2. What you need to know before taking Cefixima Mylan

Do not take Cefixima Mylan

• if you are allergic (hypersensitive) to cefixime or to antibiotics of the penicillin class (beta-lactams). In rare cases, a sudden and severe allergic reaction (anaphylactic reaction/anaphylactic shock) may occur, even with the first dose of this class of antibiotics. Symptoms may include chest tightness, dizziness, discomfort, fainting or shortness of breath, erythema. If any of these symptoms occur, consult a doctor immediately and stop taking Cefixima Mylan;
• if you are allergic (hypersensitive) to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Cefixima Mylan.
Pay particular attention:

• if you have renal impairment (a reduced dose of Cefixima Mylan may be required);
• if you are already being treated concomitantly with diuretics (e.g. furosemide) or other medicines that may cause kidney damage (e.g. aminoglycoside antibiotics);
• if you are pregnant or breastfeeding.

During treatment, a certain type of anaemia (haemolytic anaemia) has been observed, which in rare cases may be fatal.
If this anaemia has previously occurred during treatment with Cefixima Mylan, it may lead to a relapse of the disease.
Children
The safety of this medicine has not been established in newborns or children under 12 years of age.
Other medicines and Cefixima Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, such as:

• certain other antibiotics and diuretics, which may affect kidney function;
• anticoagulant tablets; your doctor may consider it necessary to perform more frequent monitoring tests.

Cefixima Mylan with food and drinks
The effect of cefixime is not affected by taking it with food.
The tablets may be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
There is insufficient information on the use of Cefixima Mylan in pregnant women, and it is not known whether Cefixima Mylan is excreted in human breast milk.
If treatment during pregnancy or breastfeeding is necessary, your doctor will evaluate and discuss the benefits and risks.
If you are breastfeeding while taking Cefixima Mylan and your baby develops diarrhoea or a Candida infection, speak to your doctor as soon as possible, as it may be necessary to change the treatment or discontinue breastfeeding.
Driving and using machines
There are no known cases of cefixime interfering with the ability to drive vehicles or operate machinery.

3. How to take Cefixima Mylan

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Cefixima Mylan is for oral use. The tablets should be swallowed with a glass of water. The
scored line is intended to facilitate breaking the tablet in case you have difficulty
swallowing it whole, and to divide it into equal doses. It is recommended to take Cefixima Mylan
at approximately the same time each day.
The recommended dose is:
Adults or children over 12 years of age: 400 mg daily (1 tablet) as a single dose or
200 mg (half a tablet) every 12 hours.
For uncomplicated urinary tract infections, a daily dose of 200 mg (half a tablet) is effective.
Elderly patients may take the same dose as adults, unless they suffer from severe
renal impairment (in which case, consult your doctor).
The duration of treatment varies depending on the type of infection being treated. Your doctor will tell you
how long to take this medicine. The treatment must be completed in full.
If you take more Cefixima Mylan than you should
If you take more Cefixima Mylan than prescribed, inform your doctor as soon as possible. Bring the
package and this leaflet with you to show the doctor.
If you forget to take Cefixima Mylan
If you forget to take a dose, take it as soon as you remember on the same day. If you miss a
day, take the usual dose the next day. Do not take a double dose to make up for the
missed dose.
If you stop taking Cefixima Mylan
Continue taking Cefixima Mylan for the full duration of the treatment, even if you feel better.
To fight the infection, it is necessary to take all prescribed doses. If some bacteria survive,
they may cause a new infection, which could recur or worsen (relapse).
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

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

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

• Diarrhoea

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

• Headache
• Abdominal pain
• Malaise (nausea)
• Vomiting
• Rash
• Abnormal liver function test results (increased transaminases and alkaline phosphatase)

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

• Bacterial superinfection
• Fungal superinfection
• Eosinophilia (increased number of eosinophils, a type of white blood cells)
• Hypersensitivity (allergic reactions)
• Reduced appetite (anorexia)
• Dizziness
• Flatulence (gas)
• Inflammation of the liver (hepatitis)
• Yellowing of the skin and eyes (jaundice)
• Drug reaction with eosinophilia and systemic symptoms (DRESS) (a serious reaction affecting the skin, blood and internal organs)
• Inflammation of moist body surfaces (mucosa), such as the lining of the mouth and nose
• Fever
• Increased blood urea

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

• Antibiotic-associated colitis (inflammation of the large intestine causing pain and diarrhoea)
• Haemolytic anaemia (excessive breakdown of red blood cells leading to fatigue and pallor)
• Anaphylactic shock (sudden and severe allergic reaction with breathing difficulties, swelling, mild confusion, rapid heartbeat, sweating and loss of consciousness)
• Rheumatoid arthritis (a disease causing painful swelling and damage to joints)
• Restlessness (psychomotor hyperactivity)
• Raised red spots on the skin that may appear all over the body (erythema multiforme)
• Itching
• Life-threatening reaction with flu-like symptoms and painful rash affecting skin, mouth, eyes and genitals (Stevens-Johnson syndrome)
• Life-threatening reaction with flu-like symptoms and blisters on skin, mouth, eyes and genitals (toxic epidermal necrolysis)
• Itchy rash (urticaria)
• Kidney inflammation (interstitial nephritis)
• Increased creatinine (a muscle breakdown product removed by the kidneys) in the blood

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Cefixime Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Store below 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cefixima Mylan contains

• The active substance is cefixime. Each film-coated tablet contains 447.68 mg of cefixime trihydrate, equivalent to 400 mg of cefixime.
• The other components are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, pregelatinized starch, magnesium stearate.

Film coating: Opadry II White 85F18422 [poly(vinyl alcohol), titanium dioxide (E171),
macrogol (MW 3350, 4000 JP), talc], iron oxide red (E172), iron oxide yellow (E172).

Description of the appearance of Cefixima Mylan and package contents
The 400 mg Cefixima Mylan tablets are film-coated, light brown in colour, oval, biconvex, and marked with a score line on both sides.
The tablets are packaged in PVC-aluminum blisters.
Pack sizes: 5, 7 or 10 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer
Medochemie Ltd Factory C
Michael Irakleous 2,
Agios Athanassios Industrial Area,
4101, Agios Athanassios, Limassol
Cyprus

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Bulgaria Cefixime Viatris 400 mg film-coated tablets
Cyprus Cefixime Viatris
Germany Cefixim Viatris 400 mg Filmtabletten
Italy Cefixima Mylan
Slovakia Cefixime Viatris 400 mg
[To be completed at national level]