Cefixime 400 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
CeFIXime 400 mg Film-coated Tablets
(Cefixime)
The name of your medicine is CeFIXime 400 mg Film-coated Tablets and will be referred to as Cefixime throughout the rest of this document.
Read all of this leaflet carefully before
you start taking this medicine
• Keep this leaflet. You may need to read it again
• If you have any further questions, Please 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Cefixime is and what it is used for
2. Before you take Cefixime
3. How to take Cefixime
4. Possible side effects
5. How to store Cefixime
6. Further information
1. WHAT CEFIXIME IS AND WHAT IT IS USED FOR
Cefixime belongs to a group of medicines called Cephalosporins, which are used for treating infections.
Cefixime is used to treat:
• infection of the middle ear
• sinus infection
• throat infection
• infection causing sudden worsening of long-standing bronchitis
• lung infections (pneumonia) acquired outside of hospital
• infections in the urinary tract including some infections of the kidneys
2. BEFORE YOU TAKE CEFIXIME
Do not take cefixime if you
• are allergic (hypersensitive) to cefixime or any of the ingredients in the tablet (see section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
• are allergic (hypersensitive) to any other cephalosporin type of antibiotic.
• have ever had a severe allergic reaction to penicillin antibiotic or to any other beta-lactam type of antibiotic.
Take special care with Cefixime
Cefixime is not suitable for everyone.
Before you take Cefixime you should tell your doctor if you:
• are allergic to penicillin antibiotics or to any other beta-lactam type of antibiotics. Not all people who are allergic to penicillins are also allergic to cephalosporins. However, you should not take this medicine if you ever had a severe allergic reaction to any penicillin. This is because you might also be allergic to this medicine.
In patients who develop severe allergic reaction or anaphylaxis (serious allergic reaction which causes difficulty in breathing or dizziness) after administration of Cefixime, the medicine should be withdrawn and appropriate treatment should be given.
• have ever been told that your kidneys do not work very well. Also, if you are taking any sort of treatment (like dialysis) for kidney failure. You may take Cefixime but you may need a lower dose.
• are taking other medicines which are known to be harmful to your kidneys. Also inform your doctor if you have any kidney problems. Your doctor may perform certain test regularly to measure how well your kidneys are working during the treatment.
• have severe or persistent diarrhoea with stomach pain or cramps during or shortly after treatment with Cefixime, stop taking this medicine and contact your doctor
immediately. Medicines which may slow or stop bowel movements must not be taken.
Having a course of Cefixime can temporarily increase the chance that you can get infections caused by other sort of germs on which Cefixime does not act. For example, thrush (infection caused by a yeast germ called Candida) may occur.
Effect on laboratory tests
If you are to undertake any blood or urine tests, inform your doctor that you are taking Cefixime, as cefixime can alter the results of some of these tests.
Cefixime can alter the results of some urine tests for sugar (such as Benedict's or Fehling's tests). If you have diabetes and routinely test your urine, tell your doctor. This is because other tests may have to be used to monitor your diabetes while you are having this medicine. Cefixime may alter the results of a blood test for antibodies called the direct Coomb's test.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor or pharmacist if you are taking:
• medicines which are known to be harmful to your kidneys like
- antibiotics include aminoglycoside antibiotics, colistin, polymyxin and viomycin.
- medicines that increase the amount of urine your body produces (diuretics) such as ethacrynic acid or furosemide.
• nifedipine, a medicine used for the treatment of high blood pressure or heart problems
• anticoagulants (blood thinning medicines) such as warfarin. In some patients, Cefixime causes problems with blood clotting and may increase the time taken for the blood to clot.
• oral contraceptives (the birth control pill)
Taking Cefixime with food and drink
Cefixime may be taken with or without food. The tablet should be swallowed with a glass of water.
Pregnancy and breast-feeding
If you are pregnant, likely to become pregnant or breast-feeding, you must tell your doctor before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Cefixime does not usually affect your ability to drive or use machines. However, if you feel light-headed or dizzy, do not drive or use machines.
Important information about some of the ingredients of Cefixime
Nothing to declare.
. HOW TO TAKE CEFIXIME
Dosage
Always take cefixime exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The dose your doctor prescribes depends on the type of infection and how bad the infection is. It also depends on how well the kidneys are working. Your doctor or pharmacist will explain this to you.
The usual dose is Adults
The usual adult dose is one tablet taken once daily. The medicine should always be taken at the same time each day.
Patients with kidney problems In patients with kidney problems, the dosage of Cefixime may need to be reduced. Your doctor will calculate the right dose for you according to the results of blood or urine tests that measure how well your kidneys are working.
There are insufficient data regarding the use of Cefixime in children and adolescents with kidney problems. Cefixime is therefore not recommended for use in these patients.
Elderly
No change in dose is needed for elderly patients, provided the kidneys are normal. Adolescents 12 years of age and older Adolescents 12 years of age and older may be given the same dose as adults.
Children older than 6 months and up to 11 years of age
Children older than 6 months and up to 11 years should be given Cefixime as an oral suspension (liquid to be taken by mouth) rather than as a tablet.
Children less than 6 months of age Cefixime is not recommended for use in children less than 6 months of age.
If you take more Cefixime than you should
If you or your child have taken more of this medicine than you should, talk to your doctor or contact your nearest hospital emergency department immediately.
If you forget to take Cefixime
If you forget to take a tablet, take one as soon as you remember. However, if the next dose is due in less than 6 hours, skip the missed dose and go back to your regular dosing schedule. Do not take double doses.
If you stop taking Cefixime
It is important that you take this medicine until you finish the prescribed course. You should not stop the medicine just because you feel better. If you stop too soon, the infection may start up again. If the person being treated still feels unwell at the end of the prescribed course of treatment, or feels worse during treatment, tell your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cefixime can cause side effects, although not everybody gets them.
The following side effects are important and will require immediate action if you experience them. You should stop taking Cefixime and see your doctor immediately if the following symptoms occur:
Very rare side effects (affect less than 1 in
10.000 patients) include:
• watery and severe diarrhoea that may also be bloody
• sudden severe allergic reactions (anaphylactic shock) such as skin rash or hives, itchiness, swelling of the face, lips, tongue or other parts of the body, tightness of the chest, wheezing and collapse.
• severe skin illness with blistering of the skin, mouth, eyes and genitals (Stevens Johnson syndrome, toxic epidermal necrolysis)
Common side effects (affect less than 1 in 10 patients) include:
• diarrhoea
Uncommon side effects (affect less than 1 in 100 patients) include:
• headache
• nausea
• vomiting
• abdominal (tummy) pain
• changes in blood tests that check how your liver is working
• skin rash
Rare side effects (affect less than 1 in 1000 patients) include:
• an increased chance that you can get infections caused by germs that Cefixime does not act on. For example, thrush
• increase in the numbers of white blood cells called eosinophils
• allergic reaction
• loss of appetite
• dizziness
• flatulence (wind)
• itchy skin
• inflammation of mucus (moist) linings such as the mouth and / or other internal surfaces
• fever
• changes in blood tests that check how your kid neys are working
Very rare side effects (affect less than 1 in
10.000 patients) include:
• fall in the number of different cells in the blood (symptoms can include tiredness, new infections and easy bruising or bleeding)
• allergic reaction characterised by skin rashes, fever, joint pains and enlarged organs
• restlessness and increased activity
• liver problems including jaundice (yellowing of the skin or whites of the eyes)
• inflammation of the kidney
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CEFIXIME
This medicinal product does not require any special storage conditions.
Keep out of the reach and sight of children. Keep blister in the outer carton.
Do not take Cefixime after the expiry date which is stated on the blister and carton after "EXP”.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Cefixime contains
The active substance is Cefixime. Each film-coated tablet contains 447.63mg Cefixime trihydrate equivalent to 400mg Cefixime (anhydrous).
The other ingredients are microcrystalline cellulose, Pre-gelatinised starch, calcium hydrogen phosphate, magnesium stearate, silica colloidal anhydrous, opadry white (Y-1-7000).
Opadry White (Y-1-7000) contains hydroxy propyl methyl cellulose (E 464). titanium dioxide (E 171), macrogol / PEG 400 (E 1520).
What Cefixime looks like and contents of the pack
White to off white, film-coated, rectangular shaped tablet having partial break line on both sides.
The product is available in:
PVC/ PVdC/Aluminium blister pack: 3s, 5s, 7s, 10s & 100s.
PVC/Aclar/Aluminium blister pack: 3s, 5s, 7s, 10s & 100s.
Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer
Orchid Europe Ltd.
Building 3, Chiswick Park,
Chiswick High Road,
Chiswick, London, W4 5YA United Kingdom
This medicinal product is authorised in the Member states of the EEA under the following names:
United Kingdom - Cefixime 400 mg Film-coated Tablets
Austria - Cefixim Orchid 400 mg
Filmtabletten
Germany - Cefixim Orchid 400 mg Filmtabletten
This leaflet was last approved in 12/2010.