Cefuroxime Milan

Package Leaflet: Information for the Patient

Cefuroxime Mylan, 250 mg, Film-Coated Tablets

Cefuroxime Mylan, 500 mg, Film-Coated Tablets

Cefuroxime

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Cefuroxime Mylan and what is it used for
• 2. Important information 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 is Cefuroxime Mylan and what is it used for

Cefuroxime Mylan is an antibiotic used in adults and children. The medicine works by killing the bacteria that cause infections. It 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 or chest
• the urinary tract
• the skin and soft tissues.

Cefuroxime Mylan may also be used:

• to treat early stages of Lyme disease (borreliosis - an infection spread by ticks).

Your doctor may check what type of bacteria is causing your infection and check if the bacteria are sensitive to Cefuroxime Mylan during treatment.

2. Important information before taking Cefuroxime Mylan

When not to take Cefuroxime Mylan:

• if you are allergic to cefuroxime axetil, to any other cephalosporin antibiotics, or to any of the other ingredients of this medicine (listed in section 6).
• if you have ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams, or carbapenems).
• if the above applies to you, you should not take this medicine

without consulting your doctor.

Warnings and precautions

Before taking Cefuroxime Mylan, discuss it with your doctor or pharmacist.

Children

Cefuroxime Mylan is not recommended for use in children under 3 months of age, as the safety and efficacy of the medicine in this age group are not known.
During treatment with Cefuroxime Mylan, pay attention to whether the following complaints occur: allergic reactions, fungal infections (e.g., thrush), and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See “Complaints to pay attention to”in section 4.

Blood tests

Cefuroxime Mylan may affect the results of blood tests for sugar in the blood and a blood test called the Coombs test. If you are going to have a blood test, you should:

tell the person taking the blood sample that you are taking Cefuroxime Mylan.

Cefuroxime Mylan and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Cefuroxime Mylan may cause dizziness and other side effects that can impair your attention. You should 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, which is essentially “sodium-free”.

3. How to take Cefuroxime Mylan

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.
Cefuroxime Mylan should be taken after a meal. This will help increase the effectiveness of the treatment.
Swallow the tablets whole with water. Do not chew, crush, or divide the tablets - this may reduce the effectiveness of the treatment. Other more suitable preparations, e.g., oral suspension, may be suitable for patients who are unable to swallow tablets.
The recommended dose of Cefuroxime Mylan is 250 mg to 500 mg twice a day, depending on the severity and type of infection.

Use in children and adolescents

The recommended dose of Cefuroxime Mylan is 10 mg/kg body weight (not more than 125 mg) to 15 mg/kg body weight (not more than 250 mg) twice a day, depending on:

• the severity and type of infection.

Cefuroxime Mylan is not recommended for use in children under 3 months of age, as the safety and efficacy of the medicine in this age group are not known.
Depending on the disease and how the patient responds to treatment, the initial dose may be changed or more than one treatment cycle may be necessary.

Patients with kidney problems

If you have kidney problems, your doctor may change the dose of Cefuroxime Mylan.
If this applies to you, tell your doctor.

Taking more than the recommended dose of Cefuroxime Mylan

If you take more than the recommended dose of Cefuroxime Mylan, you may experience neurological disorders, in particular, the risk of seizures (epileptic fits) increases.

• Do not delay, contact your doctor or emergency services immediately. If possible, show them the packaging of Cefuroxime Mylan.

Missing a dose of Cefuroxime Mylan

Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping treatment with Cefuroxime Mylan

Do not stop taking Cefuroxime Mylan unless your doctor tells you to.
It is important not to shorten the prescribed treatment period with Cefuroxime Mylan. Do not stop treatment without your doctor's advice, even if you feel better. Shortening the recommended treatment period may lead to a relapse of the disease.
If you have any further questions about taking 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.

Complaints to pay attention to

In a small number of people taking Cefuroxime Mylan, an allergic reaction or potentially severe skin reaction has been reported. The symptoms may be:

• severe allergic reaction. Symptoms include raised, itchy rash, swelling, sometimes of the face or mouth, which may make breathing difficult.
• skin rash, which may develop into blisteringand look like small targets(a dark spot in the center surrounded by a lighter border with a dark ring around the edge).
• widespread skin changes with blistering peeling skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis).

Other complaints to pay attention to while taking Cefuroxime Mylan:

• fungal infections. Medicines like Cefuroxime Mylan can cause an overgrowth of yeast (Candida) in the body, leading to a fungal infection (e.g., thrush). The risk of this side effect is greater if Cefuroxime Mylan is taken for a long time.
• severe diarrhea (pseudomembranous colitis). Medicines like Cefuroxime Mylan can cause inflammation of the colon (large intestine), leading to severe diarrhea, usually with blood and mucus, abdominal pain, and fever.
• Jarisch-Herxheimer reaction. When taking Cefuroxime Mylan to treat Lyme disease (borreliosis), some patients may experience a high temperature (fever), chills, muscle and headache, and skin rash. This is called a Jarisch-Herxheimer reaction. These symptoms usually last from a few hours to a day.

If you experience any of these symptoms, contact your doctor or nurse immediately.

Other possible side effects

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

• fungal infections (such as thrush)
• headache
• dizziness
• diarrhea
• nausea
• stomach pain

Common side effects that may be seen in blood tests:

• increased white blood cell count (eosinophilia)
• increased liver enzyme activity

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

• vomiting
• skin rashes

Uncommon side effects that may be seen in blood tests:

• decreased platelet count (thrombocytopenia)
• decreased white blood cell count (leukopenia)
• positive Coombs test result

Unknown: (frequency cannot be estimated from the available data)

• severe diarrhea (pseudomembranous colitis)
• allergic reactions
• skin reactions (including severe)
• high temperature (fever)
• yellowing of the whites of the eyes or skin
• inflammation of the liver

Side effects that may be seen in blood tests:

• rapid breakdown of red blood cells (hemolytic anemia)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 4921 309, e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help 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 packaging and blister after EXP.
There are no special storage instructions for this medicine.
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 other information

What Cefuroxime Mylan contains

Cefuroxime Mylan 250 mg film-coated tablets contain 250 mg of cefuroxime (as cefuroxime axetil)
Cefuroxime 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), colloidal anhydrous silica, hydrogenated vegetable oil, hypromellose (5cP), titanium dioxide (E171), macrogol 400.

What Cefuroxime Mylan looks like and contents of the pack

Cefuroxime Mylan, 250 mg, film-coated tablets, white or almost white, capsule-shaped tablets (approximately 16.1 mm x 6.6 mm) with the inscription “A 33” on one side and smooth on the other.
Cefuroxime Mylan, 250 mg, film-coated tablets are available in packs of 8, 10, 12, 14, and 16 tablets.
Cefuroxime Mylan, 500 mg, film-coated tablets, white or almost white, capsule-shaped tablets (approximately 20.1 mm x 8.6 mm) with the inscription “A 34” on one side and smooth on the other.
Cefuroxime Mylan, 500 mg, film-coated tablets are available in packs of 6, 10, 14, 16, and 24 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Mylan Ireland Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate, Dublin 13
Ireland

Manufacturer/Importer

McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin
Unit 35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland
Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary
To obtain more detailed information on this medicine and its names in the Member States of the European Economic Area, please contact the local representative of the marketing authorization holder:
Mylan Healthcare Sp. z o.o.
Tel: +48 22 54 66 400

Date of last revision of the leaflet: 08.2022