CEFUROXIME 250 MG TABLETS - patient leaflet, side effects, dosage

1. what cefuroxime is and what it is used for

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

Cefuroxime is used to treat infections of:

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

Cefuroxime can also be used:

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

2. what you need to know before you take cefuroxime

Do not take Cefuroxime:

• if you are allergic to cefuroxime, to any cephalosporin antibiotics or any of the other ingredients of this medicine (listed in section 6).
• if you have ever had a severe allergic (hypersensitive) reaction to any other type of betalactam antibiotic (penicillins, monobactams and carbapenems).

• – > If you think this applies to you, don’t take Cefuroxime until you have checked with your doctor.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Cefuroxime.

Cefuroxime is not recommended for children aged under 3 months, as the safety and effectiveness are not known in this age group.

You must look out for certain symptoms, such as allergic reactions, fungal infections (such as candida ) and severe diarrhoea (pseudomembranous colitis) while you are taking Cefuroxime. This will reduce the risk of any problems. See ‘Conditions you need to look out for’ in Section 4.

If you need a blood test

Cefuroxime can affect the results of a test for blood sugar levels, or a blood screen called the Coombs test.

If you need a blood test:

• – >Tell the person taking the sample that you are taking Cefuroxime.

Other medicines and Cefuroxime

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. This includes medicines you can obtain without a prescription.

Medicines used to reduce the amount of acid in your stomach (e.g. antacids used to treat heartburn ) can affect how Cefuroxime works.

Probenecid

Oral anticoagulants

• - >Tell your doctor or pharmacist if you are taking any medicine like this.

Pregnancy, breast-feeding and fertility

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

Your doctor will consider the benefit of treating you with Cefuroxime against the risk to your baby.

Driving and using machines

Cefuroxime can make you dizzy and have other side effects that make you less alert.

^Don’t drive or use machines if you do not feel well.

Cefuroxime coated tablets contain aspartame and sodium.

This medicine contains 0.3 mg aspartame in each coated tablet.

Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

This medicine contains less than 1 mmol sodium (23 mg) per coated tablet, that is to say essentially ‘sodium-free’.

3. how to take cefuroxime

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take Cefuroxime after food. This will help to make the treatment more effective.

Swallow Cefuroxime tablets with some water.

Don't chew, crush or split the tablets — this may make the tablets difficult to swallow and the treatment less effective.

The recommended dose is:

Adults

The usual dose of Cefuroxime is 250 mg to 500 mg twice daily depending on the severity and type of infection.

Use in children and adolescents

The usual dose of Cefuroxime is 10 mg/kg (to a maximum of 125 mg) to 15 mg/kg (to a maximum of 250 mg) twice daily depending on:

• the severity and type of infection

Cefuroxime is not recommended for children aged under 3 months, as the safety and effectiveness are not known in this age group.

Depending on the illness or how you or your child responds to treatment, the initial dose may be changed or more than one course of treatment may be needed.

Patients with kidney problems

If you have a kidney problem, your doctor may change your dose.

^Talk to your doctor if this applies to you.

If you take more Cefuroxime than you should

If you take too much Cefuroxime you may have neurological disorders, in particular you may be more likely to have fits (seizures).

^ Don't delay. Contact your doctor or your nearest hospital emergency department immediately. If possible, show them the Cefuroxime pack.

If you forget to take Cefuroxime

Don't take a double dose to make up for a forgotten dose.

Just take your next dose at the usual time.

If you stop taking Cefuroxime

Don’t stop Cefuroxime without advice

It is important that you take the full course of Cefuroxime.

Don’t stop unless your doctor advises you to – even if you are feeling better. If you don't complete the full course of treatment, the infection may come back.

If you have any further questions on the use of 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.

Conditions you need to look out for

A small number of people taking Cefuroxime get an allergic reaction or potentially serious skin reaction. Symptoms of these reactions include:

• severe allergic reaction. Signs include raised and itchy rash, swelling, sometimes of the face or mouth causing difficulty in breathing.
• skin rash, which may blister, and looks like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge).
• a widespread rash with blisters and peeling skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• fungal infections. Medicines like Cefuroxime can cause an overgrowth of yeast (Candida) in the body which can lead to fungal infections (such as thrush). This side effect is more likely if you take Cefuroxime for a long time.
• severe diarrhoea (Pseudomembranous colitis). Medicines like Cefuroxime can cause inflammation of the colon (large intestine), causing severe diarrhoea, usually with blood and mucus, stomach pain, fever.
• Jarisch-Herxheimer reaction. Some patients may get a high temperature (fever), chills, headache, muscle pain and skin rash while being treated with Cefuroxime for Lyme disease. This is known as the Jarisch-Herxheimer reaction. Symptoms usually last a few hours or up to one day.

^Contact a doctor or nurse immediately if you get any of these symptoms.

Common side effects

These may affect up to 1 in 10 people:

• fungal infections (such as Candida)
• headache
• dizziness
• diarrhoea
• feeling sick
• stomach pain.

Common side effects that may show up in blood tests:

• an increase in a type of white blood cell (eosinophilia)
• an increase in liver enzymes.

Uncommon side effects

These may affect up to 1 in 100 people:

• being sick
• skin rashes.

Uncommon side effects that may show up in blood tests:

• a decrease in the number of blood platelets (cells that help blood to clot)
• a decrease in the number of white blood cells
• positive Coomb’s 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)
• high temperature (fever)
• yellowing of the whites of the eyes or skin
• inflammation of the liver (hepatitis).

Side effects that may show up in blood tests:

• red blood cells destroyed too quickly (haemolytic anaemia).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme: or search for MHRA

Yellow Card in Google play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store cefuroxime

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 label and carton after EXP. The expiry date refers to the last day of that month.

Store in the original packaging in order to protect from moisture.

This medicine does not require any special temperature storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Cefuroxime contains

• The active substance is cefuroxime.

Cefuroxime 250 mg Tablets contains 300.72 mg of cefuroxime axetil per coated tablet equivalent to 250 mg of cefuroxime.

• The other ingredients (excipients) are sodium laurylsulfate, copovidone, croscarmellose sodium (E468), magnesium stearate (E470B), anhydrous colloidal silicon dioxide (E551), granulated mannitol (E421), microcrystalline cellulose (E 460), crospovidone (E1202) and talc (E553B), mannitol (E421), soluble (potato) starch, titanium dioxide (E171) and aspartame (E951).

What Cefuroxime looks like and contents of the pack

Cefuroxime Tablets are coated.

Cefuroxime 250 mg coated tablets are white to slightly yellowish, biconvex, oblong tablets scored on both sides.

Cefuroxime 250 mg coated tablets are available in carton boxes with blister(s) tear-off or strips containing 8, 10, 12, 14, 15, 16, 20, 24 and 500 coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Limited

Park View, Riverside Way

Watchmoor Park

Camberley, Surrey

GU15 3YL

United Kingdom

Manufacturer

Sandoz GmbH,

Biochemiestrasse 10, 6250 Kundl, Austria.

This leaflet is last revised in 11/2020.

00000000 SZ00­000LT000

K' Artwork Proof Box:		1
Variation:	N006– Excipients alignment with SPC	Technical Colours:
Proof no:	015.0	| Legend:
Date prepared:	27/11/2020	| Cutting:
Font size:	7.5 pt
Fonts:	Helvetica
Dimensions:	175 × 315 mm
Technical data:
SKUs:	997600
SZ codes:	SZ00000LT000
Item codes:	00000000	Colours:
Pharma codes:	00000000	| Black
Novartis data if applicable:
Version:	0000000
Print Proof date:	0000000
AQWA#:	0000000
Production site:	0000000
Technical num:	0000000
Old Comp num:	0000000

j Signature Panel:
	1
__ __