Cefuroxime Sandoz

Patient Information Leaflet

Cefuroxime Sandoz 125 mg film-coated tablets, 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, pharmacist, or nurse.
• 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 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 Cefuroxime Sandoz is and what it is used for
2. What you need to know before taking Cefuroxime Sandoz
3. How to take Cefuroxime Sandoz
4. Possible side effects
5. How to store Cefuroxime Sandoz
6. Contents of the pack and other information

1. What Cefuroxima Sandoz is and what it is used for

Cefuroxima Sandoz 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.
Cefuroxima Sandoz 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

Cefuroxima Sandoz may also be used:

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

2. What you need to know before taking Cefuroxime Sandoz

Do not take Cefuroxime Sandoz:

• if you are allergic to cefuroxime, to any antibiotic of the cephalosporin class, or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously experienced a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams, and carbapenems). If you think this applies to you, do not take Cefuroxime Sandoz before consulting your doctor.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Cefuroxime Sandoz.
Cefuroxime Sandoz 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 Sandoz. This will help reduce the risk of potential problems. See 'Conditions requiring caution' in section 4.
If you need blood tests
Cefuroxime Sandoz may interfere with test results for blood sugar levels or with a blood test known as the Coombs test. If you need blood tests:
Inform the person taking the sample that you are taking Cefuroxime Sandoz.

Other medicines and Cefuroxime Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines without a prescription.
Medicines used to reduce stomach acid (e.g., antacids used to treat heartburn) may affect the activity of Cefuroxime Sandoz.
Probenecid
Oral anticoagulants
Inform your doctor or pharmacist if you are taking any of these medicines.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Your doctor will assess the benefit of treatment with Cefuroxime Sandoz against the potential risk to the baby.

Driving and using machines
Cefuroxime Sandoz may cause dizziness and other side effects that may impair alertness.
Do not drive or operate machinery if you do not feel well.

Cefuroxime Sandoz film-coated tablets contain aspartame and sodium.
125 mg: film-coated tablet contains 0.2 mg of aspartame.
250 mg: film-coated tablet contains 0.3 mg of aspartame.
500 mg: film-coated tablet contains 0.4 mg of aspartame.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder causing phenylalanine to accumulate because the body cannot eliminate it properly.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e., essentially ‘sodium-free’.

3. How to take Cefuroxime Sandoz

Always follow exactly the instructions given by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.
Take Cefuroxime Sandoz after meals. This will help make the treatment more effective.
Swallow the Cefuroxime Sandoz tablets with water.
Do not chew, crush or split the tablets – doing so may make them difficult to swallow and reduce the effectiveness of the treatment.

Recommended dose:
Adults
The appropriate dose of Cefuroxime Sandoz is 250 mg to 500 mg twice daily, depending on the severity and type of infection.

Use in children and adolescents
The appropriate dose of Cefuroxime Sandoz is 10 mg/kg (up to a maximum of 125 mg) to 15 mg/kg (up to a maximum of 250 mg) twice daily, depending on the severity and type of infection.
Cefuroxime Sandoz 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 how you or your child responds to treatment, the initial dose may be adjusted or more than one course of treatment may be required.

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

If you take more Cefuroxime Sandoz than you should
If you take too much Cefuroxime Sandoz, you may experience neurological disturbances; in particular, you may be more likely to have seizures.
Do not wait. Contact your doctor or the nearest hospital emergency department immediately. If possible, show them the Cefuroxime Sandoz packaging.

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

If you stop treatment with Cefuroxime Sandoz
Do not stop taking Cefuroxime Sandoz without medical advice.
It is important to complete the full course of treatment with Cefuroxime Sandoz. Do not stop unless instructed by your doctor, even if you feel better. If you do not complete the full course, the infection may return.

If you have any doubts about how to use 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 Sandoz experience an allergic reaction or 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 blister-like lesions resembling small targets (a dark spot in the center surrounded by a lighter area with a dark 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.)
• Fungal infections. Medicines such as Cefuroxime Sandoz 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 Sandoz for a long time.
• Severe diarrhoea (pseudomembranous colitis). Medicines such as Cefuroxime Sandoz 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 Sandoz for Lyme disease. This is known as Jarisch-Herxheimer reaction. Symptoms usually last for a few hours up to one day.

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

Common side effects
These may affect up to 1 in 10 patients:

• Fungal infections (such as Candida)
• Headache
• Dizziness
• Diarrhoea
• Nausea
• 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
These may affect up to 1 in 100 patients:

• Vomiting
• Skin rashes

Uncommon side effects that may be detected in blood tests:

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

Other side effects
Other side effects have occurred in a very small number of people, but their exact frequency is unknown:

• Severe diarrhoea (pseudomembranous colitis)
• Allergic reactions
• Skin reactions (including severe ones)
• 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 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cefuroxime Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after
Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
This medicine does not require any special storage temperature.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Cefuroxime Sandoz tablets contain

• The active substance is: Cefuroxime. Cefuroxime Sandoz 125 mg contains 150.36 mg of cefuroxime axetil per coated tablet, equivalent to 125 mg of cefuroxime. Cefuroxime Sandoz 250 mg contains 300.72 mg of cefuroxime axetil per coated tablet, equivalent to 250 mg of cefuroxime. Cefuroxime Sandoz 500 mg contains 601.44 mg of cefuroxime axetil per coated tablet (equivalent to 500 mg of cefuroxime).
• The other components (excipients) are: sodium lauryl sulfate, copovidone, sodium croscarmellose (E468), magnesium stearate (E470B), anhydrous colloidal silica (E551), mannitol (E421), microcrystalline cellulose (E460), crospovidone (E1202) and talc (E553B), mannitol (E421), soluble starch (potato), titanium dioxide (E171) and aspartame (E951).

Description of the appearance of Cefuroxime Sandoz and package contents
Cefuroxime Sandoz tablets are film-coated.
Cefuroxime Sandoz 125 mg are white to slightly yellowish, biconvex, oblong tablets.
Cefuroxime Sandoz 250 mg are white to slightly yellowish, biconvex, oblong, scored tablets on both sides.
Cefuroxime Sandoz 500 mg are white to slightly yellowish, biconvex, oblong tablets.
Cefuroxime Sandoz 125 mg and 250 mg film-coated tablets are available in cardboard cartons containing peelable blisters or strips of 8, 10, 12, 14 and 24 film-coated tablets.
Cefuroxime Sandoz 500 mg film-coated tablets are available in cardboard cartons with peelable blisters or strips of 6, 8, 10, 12, 14 and 24 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA), Italy

Manufacturer responsible for batch release
Sandoz GmbH - Biochemiestrasse 10 - 6250 Kundl – Austria

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