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INFORMATION FOR THE USER Cefuroxime Axapharm

INFORMATION FOR THE USER Cefuroxime Axapharm

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PACKAGE LEAFLET: <strong>IN<strong>FOR</strong>MATION</strong> <strong>FOR</strong> <strong>THE</strong> <strong>USER</strong><br />

Read all of this leaflet carefully before you start taking this medicine. This medicine has been prescribed for you. Do not pass it on to<br />

others. It may harm them, even if their symptoms are the same as yours. Keep this leaflet. You may need to read it again.<br />

<strong>Cefuroxime</strong> <strong>Axapharm</strong> ®<br />

What <strong>Cefuroxime</strong> <strong>Axapharm</strong> is and what it is used for<br />

<strong>Cefuroxime</strong> <strong>Axapharm</strong> is an antibiotic, the use of which kills bacteria<br />

that cause infections. <strong>Cefuroxime</strong> <strong>Axapharm</strong> is suitable for the<br />

treatment of infection of the ear, nose and throat, the airways,<br />

sexual organs, skin and soft tissues.<br />

It may be taken only with a doctor‘s prescription.<br />

Before you take <strong>Cefuroxime</strong> <strong>Axapharm</strong><br />

Do not forget that this medicine was prescribed for you to treat<br />

your current illness. It must not be used to treat other illnesses and<br />

not be passed on to other persons.<br />

The antibiotic contained in <strong>Cefuroxime</strong> <strong>Axapharm</strong> cannot be used<br />

indiscriminately against all microorganisms that cause infectious<br />

diseases. To prevent the protracted complications that can be<br />

caused by an incorrectly chosen or incorrectly dosed anti-infectious<br />

agent, you should also not use <strong>Cefuroxime</strong> <strong>Axapharm</strong> for new<br />

infections at a later date without a doctor‘s prescription.<br />

Do not take <strong>Cefuroxime</strong> <strong>Axapharm</strong><br />

- if you have presumed or known hypersensitivity to<br />

cephalosporin antibiotics.<br />

- you must tell the doctor if you have presumed or known<br />

allergy to penicillin.<br />

Take special care with <strong>Cefuroxime</strong> <strong>Axapharm</strong><br />

This medicine can impair reactions and thus impair the ability to<br />

drive vehicles and to used tools or machines.<br />

If you have ever had an allergic reaction to penicillin, you must inform<br />

your doctor of this. Also tell your doctor if you have a generally<br />

tendency to allergies. If difficulty in breathing, a feeling of constriction<br />

in the chest, swelling of the eyelids, face or lips, skin rash (red<br />

spots), swelling of the skin, nettle rash or very severe diarrhoea occurs<br />

during the treatment, you should inform your doctor immediately<br />

before continuing with the <strong>Cefuroxime</strong> <strong>Axapharm</strong> therapy.<br />

Medicines taken for excessive stomach acid production may alter<br />

the action of <strong>Cefuroxime</strong> <strong>Axapharm</strong>.<br />

If you are taking an oral contraceptive (pill), it is possible that its<br />

efficacy may be reduced during antibiotic therapy. This information<br />

also applies to <strong>Cefuroxime</strong> <strong>Axapharm</strong>. Consequently, additional<br />

contraceptive measures should be taken.<br />

Tell your doctor or pharmacist if you<br />

- are suffering from other diseases<br />

- have allergies or<br />

- are taking other medicines, including those used externally<br />

and those obtained without a prescription.<br />

Pregnancy and breast feeding<br />

Tell your doctor if you are pregnant or are breast feeding. Only<br />

in cases of urgent necessity is the use of <strong>Cefuroxime</strong> <strong>Axapharm</strong><br />

indicated during pregnancy and especially during the first three<br />

months. <strong>Cefuroxime</strong> <strong>Axapharm</strong> passes into breast milk in small<br />

amounts.<br />

How to use <strong>Cefuroxime</strong> <strong>Axapharm</strong><br />

Please keep strictly to the dose and duration of treatment stipulated<br />

by your doctor and in no case stop the treatment without a<br />

doctor‘s permission.<br />

<strong>Cefuroxime</strong> <strong>Axapharm</strong> should be taken with meals.<br />

Swallow the film-coated tablets with a little fluid without chewing<br />

(due to the bitter taste).<br />

Unless prescribed otherwise by your doctor, the following dosage<br />

guidelines apply:<br />

Adults and adolescents over 12 years:<br />

Normally 1 film-coated tablet of 250 mg each morning and evening<br />

(every 12 hours). For certain infections: 1 film-coated tablet of<br />

500 mg each morning and evening (every 12 hours).<br />

Children from 5 years (with a body weight of at least 20 kg) to 12 years:<br />

In children from 5 years (with a body weight of at least 20 kg) to 12<br />

years, <strong>Cefuroxime</strong> <strong>Axapharm</strong> may be used only to treat middle ear<br />

inflammation or severe infections. In cases of middle ear inflammation<br />

or severe infection, the dose is 1 film-coated tablet of 250 mg<br />

twice daily. This dose must not be exceeded.<br />

Children under 5 years:<br />

<strong>Cefuroxime</strong> <strong>Axapharm</strong> is not suitable for the treatment of children<br />

under 5 years.<br />

In certain cases the doctor may prescribe a different dose for you.<br />

Do not yourself change the prescribed dose if you think that the<br />

medicine is working too weakly or too strongly, but speak to your<br />

doctor or pharmacist.<br />

Possible side effects of <strong>Cefuroxime</strong> <strong>Axapharm</strong><br />

The following side effects may arise when taking <strong>Cefuroxime</strong><br />

<strong>Axapharm</strong>:<br />

Gastrointestinal disorders such as abdominal pain, heartburn,<br />

nausea and vomiting, or headaches and dizziness may occur occasionally.<br />

In such cases it is usually not necessary to stop taking<br />

<strong>Cefuroxime</strong> <strong>Axapharm</strong>. However, you should tell your doctor or<br />

pharmacist about it.<br />

Stop taking <strong>Cefuroxime</strong> <strong>Axapharm</strong> and inform your doctor as<br />

quickly as possible if one or more of the following symptoms occurs:<br />

severe nausea, severe diarrhoea or considerable stomach pain;<br />

bleeding from the back passage; onset of a yellow colour of the<br />

skin or eyes.<br />

If difficulty in breathing, a feeling of constriction in the chest, swelling<br />

of the eyelids, face or lips, skin rash (red spots), swelling of the<br />

skin or nettle rash occurs, you should inform your doctor immediately<br />

and only continuing taking <strong>Cefuroxime</strong> <strong>Axapharm</strong> if expressly<br />

ordered by your doctor.<br />

If you notice any side effects not listed in this leaflet, please tell your<br />

doctor or pharmacist.


Further information<br />

In diabetics, the blood sugar assays may show false-positive results<br />

if methods based on the reduction of copper are used (e.g. Fehling,<br />

Benedict, Clinitest); an enzyme test should therefore be used.<br />

If your illness treated with <strong>Cefuroxime</strong> <strong>Axapharm</strong> has not improved<br />

significantly or disappeared after finishing a pack of the medicine,<br />

you should inform your doctor immediately.<br />

After completing the treatment, please return the pack with the remaining<br />

contents to your doctor or pharmacist for correct disposal.<br />

Your doctor or pharmacist can give you further information. They<br />

have access to extensive technical information.<br />

<strong>Cefuroxime</strong> <strong>Axapharm</strong> film-coated tablets should be stored in the<br />

closed original pack at room temperature (15–25°C) out of the reach<br />

of children.<br />

Do not use the medicine after the expiry date shown on the pack<br />

after «EXP.».<br />

What <strong>Cefuroxime</strong> <strong>Axapharm</strong> contains<br />

1 <strong>Cefuroxime</strong> <strong>Axapharm</strong> film-coated tablet of 250 mg contains:<br />

250 mg cefuroxime in the form of cefuroxime axetil and excipients.<br />

1 <strong>Cefuroxime</strong> <strong>Axapharm</strong> film-coated tablet of 500 mg contains:<br />

500 mg cefuroxime in the form of cefuroxime axetil and excipients.<br />

Marketing authorisation number<br />

58,694 (Swissmedic)<br />

Where <strong>Cefuroxime</strong> <strong>Axapharm</strong> can be obtained and available<br />

pack sizes<br />

Available in pharmacies on non-repeat medical prescription.<br />

<strong>Cefuroxime</strong> <strong>Axapharm</strong> 250 mg: pack with 14 film-coated tablets.<br />

<strong>Cefuroxime</strong> <strong>Axapharm</strong> 500 mg: pack with 14 film-coated tablets.<br />

Marketing authorisation holder<br />

<strong>Axapharm</strong> AG, 6340 Baar<br />

This patient information leaflet was last checked by the Medicines<br />

Agency (Swissmedic) in October 2008.

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