Cefuroxime Mylan

Patient Information Leaflet

Cefuroxime Mylan 250 mg film-coated tablets, 500 mg film-coated tablets

Generic medicine
Please read this 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Cefuroxime Mylan is an antibiotic used in adults and children. It works by killing the bacteria that cause infections and belongs to a group of medicines called cephalosporins.
Cefuroxime Mylan is used to treat infections of:

• the throat
• the sinuses
• the middle ear
• the lungs and chest
• the urinary tract
• the skin and the tissue around organs and bones (this is known as soft tissues).

Cefuroxime Mylan may also be used to:

• treat Lyme disease (an illness spread by parasites called ticks).

Your doctor may identify the type of bacteria causing the infection and check whether the bacteria are sensitive to Cefuroxime Mylan during treatment.

2. What you need to know before taking Cefuroxime Mylan

Do not take Cefuroxime Mylan:

• if you are allergic to cefuroxime axetil or to any antibiotic of the cephalosporin class, or to any of the other ingredients of this medicine (listed in section 6).
• if you have developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after treatment with cefuroxime or with any other antibiotic of the beta-lactam class (such as cephalosporins).
• if you have had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams, and carbapenems).
• if you think any of the above applies to you, do not take Cefuroxime Mylan before consulting your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Cefuroxime Mylan.
Exercise special caution with Cefuroxime Mylan
Severe skin reactions have been reported during treatment with cefuroxime, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.
Children and adolescents
Cefuroxime Mylan is not recommended for children under 3 months of age, as safety and efficacy have not been established in this age group.
Be alert for certain symptoms such as allergic reactions, fungal infections (such as Candida), and severe diarrhoea (pseudomembranous colitis) while taking Cefuroxime Mylan. This will help reduce the risk of potential problems. See “Conditions requiring caution” in section 4.
If you need blood tests
Cefuroxime Mylan may interfere with blood test results for blood glucose levels or with the blood test known as the Coombs test. If you need blood tests:
Inform the person taking the sample that you are taking Cefuroxime Mylan.
Other medicines and Cefuroxime Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• Medicines used to reduce stomach acid (e.g. antacids used to treat heartburn) may affect the activity of Cefuroxime Mylan.
• Probenecid (used to treat gout).
• Oral anticoagulants (e.g. warfarin).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Cefuroxime Mylan may cause dizziness and other side effects that may reduce alertness. Do not drive or operate machinery if you do not feel well.
Cefuroxime Mylan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Cefuroxime Mylan

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take Cefuroxime Mylan after a meal. This will help make the treatment more effective. Swallow the Cefuroxime Mylan tablets with a glass of water. Do not chew, break, or divide the tablets – this could reduce the effectiveness of the treatment. Other formulations more suitable for patients unable to swallow tablets, such as oral suspension, are available.
The recommended dose of Cefuroxime Mylan is 250 mg – 500 mg twice daily, depending on the severity and type of infection.

Use in children and adolescents
The recommended dose of Cefuroxime Mylan is 10 mg/kg (up to a maximum of 125 mg) – 15 mg/kg (up to a maximum of 250 mg) twice daily, depending on:

• the severity and type of infection.

Cefuroxime Mylan is not recommended for children under 3 months of age, as safety and efficacy have not been established in this age group.
Depending on the illness or your child's response to treatment, the initial dose may be adjusted or more than one treatment course may be required.

Patients with kidney problems
If you have kidney problems, your doctor may adjust the dose.
Inform your doctor if this applies to you.

If you take more Cefuroxime Mylan than you should
If you take too much Cefuroxime Mylan, you may experience neurological disturbances, particularly seizures (fits).

• Do not wait. Contact your doctor or the nearest hospital emergency department immediately. If possible, show them the Cefuroxime Mylan packaging.

If you forget to take Cefuroxime Mylan
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.

If you stop taking Cefuroxime Mylan
Do not stop treatment with Cefuroxime Mylan unless instructed by your doctor.
It is important to complete the full course of treatment with Cefuroxime Mylan. Do not stop treatment unless advised by your doctor, even if you feel better.
If you do not complete the full course of treatment, the infection may return.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Conditions requiring attention

A small number of people being treated with Cefuroxime Mylan experience an allergic reaction or a potentially serious skin reaction. Symptoms of these reactions include:

• Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes of the face or mouth, causing difficulty in breathing.
• Skin rash with blisters resembling small targets (a dark spot in the centre surrounded by a light area with a black ring around the edge).
• Widespread rash with blisters and peeling of the skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature, swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain occurring in the context of allergic reactions, which may be a symptom of a heart attack caused by an allergy (Kounis syndrome).

Other conditions requiring attention during treatment with Cefuroxime Mylan include:

• Fungal infections. Medicines such as Cefuroxime Mylan may cause overgrowth of fungi (Candida) in the body, leading to fungal infections (such as thrush). This side effect is more likely if you take Cefuroxime Mylan for a long time.
• Severe diarrhoea (pseudomembranous colitis). Medicines such as Cefuroxime Mylan may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, usually with blood and mucus, stomach pain, and fever.
• Jarisch-Herxheimer reaction. Some patients may experience high temperature (fever), chills, headache, muscle pain, and skin rash during treatment with Cefuroxime Mylan for Lyme disease. This is known as Jarisch-Herxheimer reaction. Symptoms usually last for a few hours or up to one day.

Contact your doctor or nurse immediately if you experience any of these symptoms.

Other possible side effects

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

• Fungal infections (such as Candida)
• Headache
• Dizziness
• Diarrhoea
• Feeling unwell
• Stomach pain

Common side effects that may be detected in blood tests:

• Increase in a type of white blood cells (eosinophilia)
• Increase in liver enzymes

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

• Feeling unwell
• Skin rash

Uncommon side effects that may be detected in blood tests:

• Decrease in the number of blood platelets (cells that help blood clotting)
• Decrease in the number of white blood cells
• Positive Coombs test

Not known: (frequency cannot be estimated from available data)

• Severe diarrhoea (pseudomembranous colitis)
• Allergic reactions
• Skin reactions (including severe)
• High temperature (fever)
• Yellowing of the whites of the eyes or skin
• Inflammation of the liver (hepatitis)

Side effects that may be detected in blood tests:

• Too rapid destruction of red blood cells (haemolytic anaemia)

Reporting of side effects

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

5. How to store Cefuroxime Mylan

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 and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Cefuroxima Mylan contains
Cefuroxima Mylan 250 mg film-coated tablets contain 250 mg of cefuroxime (as
cefuroxime axetil).
Cefuroxima Mylan 500 mg film-coated tablets contain 500 mg of cefuroxime (as
cefuroxime axetil).
The other ingredients are: microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate
(E487), anhydrous colloidal silica, hydrogenated vegetable oil, hypromellose, titanium dioxide (E171),
macrogol.

Description of the appearance of Cefuroxima Mylan and contents of the pack
Cefuroxima Mylan 250 mg film-coated tablets: white to off-white, film-coated, capsule-shaped tablets (approximately 16.1 mm x 6.6 mm) with "A 33" engraved on one side and smooth on the other side.
Cefuroxima Mylan 250 mg film-coated tablets are available in blisters containing 8, 10, 12,
14 and 16 tablets.
Cefuroxima Mylan 500 mg film-coated tablets: white to off-white, film-coated, capsule-shaped tablets (approximately 20.1 mm x 8.6 mm) with "A 34" engraved on one side and smooth on the other side.
Cefuroxima Mylan 500 mg film-coated tablets are available in blisters containing 6, 10, 14,
16 and 24 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milano, Italy

Manufacturer
McDermott Laboratories operating as Gerard Laboratories operating as Mylan Dublin
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland
Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary

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

| Member State | Name of the medicinal product | |--------------|-------------------------------| | Italy | Cefuroxima Mylan | | Netherlands | Cefuroxim Mylan 250 mg, 500 mg, filmomhulde tabletten |