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CEFIXIME 400 MG FILM-COATED TABLETS

Active substance(s): CEFIXIME TRIHYDRATE

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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.

3. 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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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