Cefuroxime Milan

Leaflet accompanying the packaging: patient information

Cefuroxime Mylan, 250 mg, coated tablets

Cefuroxime Mylan, 500 mg, coated tablets

Cefuroxime

Read the 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 a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 bacteria that cause infections. It belongs to a group of medicines called cephalosporins. Cefuroxime Mylan is used to treat infections of:

• the throat
• sinuses
• middle ear
• lungs or chest
• urinary tract
• skin and soft tissues.

Cefuroxime Mylan may also be used:

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

The doctor may check what type of bacteria caused the patient's infection and check during treatment if the bacteria are sensitive to Cefuroxime Mylan.

2. Important information before taking Cefuroxime Mylan

When not to take Cefuroxime Mylan:

• if the patient is allergic to cefuroxime axetil, to any other cephalosporin antibiotics, or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams, or carbapenems).
• if the above applies to the patient, they should not take Cefuroxime Mylan without consulting a doctor.

Cefuroxime Mylan should not be taken without consulting a doctor.

Warnings and precautions

Before taking Cefuroxime Mylan, the patient should discuss it with their 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, the patient should be aware of the following symptoms: allergic reactions, fungal infections (e.g., thrush), and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See “Symptoms to watch out for”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 the patient is to have blood tests, they should:

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

Cefuroxime Mylan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.

• Medicines that reduce the amount of acid in the stomach (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 the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Cefuroxime Mylan may cause dizziness and other side effects that can affect the patient's ability to drive or use machines. The patient should not drive or use machines if they 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

This medicine should always be taken exactly as advised by the doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist again. Cefuroxime Mylan should be taken after a meal. This will help increase the effectiveness of the treatment. The tablets should be swallowed whole with water. The tablets should not be chewed, crushed, or divided - this may reduce the effectiveness of the treatment. Other more suitable preparations, e.g., oral suspension, may be appropriate for patients who are unable to swallow tablets. The recommended dose of Cefuroxime Mylan is 250 mg to 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 body weight (not more than 125 mg) to 15 mg/kg body weight (not more than 250 mg) twice daily, 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 the patient has kidney problems, the doctor may change the dose of Cefuroxime Mylan. If this applies to the patient, they should tell their doctor.

Taking more than the recommended dose of Cefuroxime Mylan

If the patient takes more than the recommended dose of Cefuroxime Mylan, they may experience neurological disorders, in particular, an increased risk of seizures (epileptic fits).

• The patient should not delay and should immediately contact their doctor or call an emergency number. If possible, they should show the packaging of Cefuroxime Mylan.

Missing a dose of Cefuroxime Mylan

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.

Stopping treatment with Cefuroxime Mylan

The patient should not stop taking Cefuroxime Mylan unless their doctor advises them to do so. It is important not to shorten the prescribed treatment period with Cefuroxime Mylan. The patient should not stop treatment without their doctor's advice, even if they feel better. Shortening the recommended treatment period may lead to a recurrence of the disease. If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Cefuroxime Mylan can cause side effects, although not everybody gets them.

Symptoms to watch out for

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 blisters and peeling skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis).

Other symptoms to watch out for while taking Cefuroxime Mylan:

• fungal infections. Medicines like Cefuroxime Mylan can cause an overgrowth of yeast (Candida) in the body, which can lead 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 known as a Jarisch-Herxheimer reaction. These symptoms usually last from a few hours to a day.

If the patient experiences any of these symptoms, they should contact their 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 number of white blood cells (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 number of platelets (cells involved in blood clotting)
• decreased number of white blood cells (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
• liver inflammation

Side effects that may be seen in blood tests:

• rapid breakdown of red blood cells (hemolytic anemia)

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 4921 309, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Cefuroxime Mylan

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging and blister after EXP. There are no special precautions for storage. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cefuroxime Mylan contains

Cefuroxime Mylan 250 mg coated tablets contain 250 mg of cefuroxime (as cefuroxime axetil). Cefuroxime Mylan 500 mg 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, coated tablets, are 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, coated tablets are available in packs of 8, 10, 12, 14, and 16 tablets. Cefuroxime Mylan, 500 mg, coated tablets, are 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, 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. For more information on this medicine and its authorized names in 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