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SUPRAX TABLETS 200MG

Active substance(s): CEFIXIME / CEFIXIME / CEFIXIME

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Suprax 200mg Tablets

Taking other medicines

Please tell your doctor or your pharmacist if you
are taking or have recently taken any other
medicines. This includes medicines you buy
Is this leaflet hard to see or read?
without a prescription, including herbal
medicines. This is because Suprax can affect the
Phone 0845 372 7101 for help
way some other medicines work. Also some
Read all of this leaflet carefully before
medicines can affect the way Suprax works.
you start taking this medicine
In particular, tell your doctor if you are taking
• Keep this leaflet. You may need to read it again. the following:
• If you have any further questions, ask your
• Medicines to thin the blood such as warfarin
doctor or your pharmacist.
Pregnancy and breast-feeding
• This medicine has been prescribed for you.
Talk to your doctor before taking this medicine
Do not pass it on to others. It may harm
them, even if their symptoms are the same as if:
• You are pregnant, might become pregnant or
yours.
think you may be pregnant
• If any of the side effects gets serious, or if you

You are breast-feeding or planning to breast
notice any side effects not listed in this leaflet,
feed
please tell your doctor or pharmacist.
Ask your doctor or pharmacist for advice before
In this leaflet:
taking any medicine if you are pregnant or
1. What Suprax is and what it is used for
breast feeding.
2. Before you take Suprax
Test
3. How to take Suprax
If you require any tests (such as blood or urine
4. Possible side effects
tests) while taking this medicine, please make
5. How to store Suprax
sure your doctor knows that you are taking
6. Further information
Suprax.
1. What Suprax is and what it is used for
3. How to take Suprax

Cefixime

Suprax 200mg Tablets (called Suprax in this
leaflet) contains a medicine called cefixime.
This belongs to a group of antibiotics called
‘cephalosporins’.
Suprax is used to treat infections caused by
bacteria.
These include infections of the:
• Ear
• Nose, sinuses (such as sinusitis)
• Throat (such as tonsillitis, pharyngitis)
• Chest and lungs (such as bronchitis, pneumonia)
• Urinary system (such as cystitis and kidney
infections)
2. Before you take Suprax
Do not take this medicine and tell your
doctor if:
x You are allergic (hypersensitive) to cefixime,
any other cephalosporin antibiotics including
penicillin or to any of the other ingredients of
this medicine (see Section 6: Further
information).
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
the lips, face, throat and tongue.
Do not take this medicine if the above applies
to you. If you are not sure, talk to your doctor or
your pharmacist before taking Suprax.
Take special care with Suprax
Check with your doctor or your pharmacist
before taking this medicine if:
▲ You have ever had colitis
▲ You have kidney problems
▲ The person taking this medicine is a child
under the age of 10
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking this medicine.

Taking this medicine
Always use Suprax exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
• Take this medicine by mouth
• Swallow tablets whole with a drink of water
• If you feel the effect of the medicine is too
weak or too strong, do not change the dose
yourself, but ask your doctor.
Carefully read the label from the pharmacist.
Ask your pharmacist if you are not sure about
the dose to take. The medicine should be taken
for the prescribed number of days.
How much to take
The usual dose is:
Adults, Elderly and Children over 10 years
or weighing more than 50kg
• 1-2 tablets each day given as a single or
divided dose
People with kidney problems
• Your doctor may prescribe a lower dose
Children under 10 years old
• Suprax Paediatric should be used instead
If you take more Suprax than you should
If you have too much of this medicine, talk to
your doctor straight away.
If you forget to take Suprax
If you forget to take a dose, take it as soon as
you remember it. However, if it is nearly time
for the next dose, skip the missed dose. Do not
take a double dose to make up for a forgotten
dose.
If you stop taking Suprax
Do not stop taking this medicine without
talking to your doctor. You should not stop
taking Suprax just because you feel better.
This is because the infection may come
back or get worse again.

If you have any further questions on the
use of this product, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, Suprax can cause side
effects, although not everybody gets them.
Tell your doctor straight away or go to the
nearest hospital casualty department if you
notice any of the following serious side
effects – you may need urgent medical
treatment:
• You have an allergic reaction. The signs may
include: a rash, joint pain, swallowing or
breathing problems, swelling of your lips,
face, throat or tongue
• Blistering or bleeding of the skin around the
lips, eyes, mouth, nose and genitals. Also
flu-like symptoms and fever. This may be
something called ‘Stevens-Johnson’ syndrome.
• Severe blistering rash where layers of the skin
may peel off to leave large areas of raw
exposed skin over the body. Also a feeling of
being generally unwell, fever, chills and
aching muscles. This may be something called
‘Toxic epidermal necrolysis’
• You have a skin rash or skin lesions with a
pink/red ring and a pale centre which may be
itchy, scaly or filled with fluid. The rash may
appear especially on the palms or soles of
your feet. These could be signs of a serious
allergy to the medicine called ‘erythema
multiforme’
• You get infections more easily than usual. This
could be because of a blood disorder. This
normally gets better after stopping the
medicine
• You bruise or bleed more easily than normal.
This could be because of a blood disorder.
This normally gets better after stopping the
medicine
• If your child gets nose bleeds, bleeding gums,
chills, tiredness, pale skin (often with a yellow
tinge), shortness of breath. This may be due to
haemolytic anaemia.
• Changes in the way the kidneys are working or
blood in your child’s urine
Stop taking this medicine and contact your
doctor without delay if you get:
• Severe watery diarrhoea that will not stop and
you are feeling weak and have a fever. This
may be something called ‘Pseudomembranous
colitis’

5. How to store Suprax
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date
which is stated on label and blister pack
Store below 25° C.
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 Suprax 200mg Tablets contain
• Each tablet contains 200mg of the active
substance, cefixime.
• The other ingredients are microcrystalline
cellulose, pregelatinised starch, calcium
hydrogen phosphate dihydrate, magnesium
stearate, hypromellose, macrogol 6000 and
titanium dioxide (E171).
What Suprax looks like and content of the
pack
Suprax is available as an off-white, convex, film
coated tablet engraved with ‘ORO’ on one side.
Suprax is available in blister packs containing
1, 2, 7 or 14 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street
Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi .com
Manufacturer
S.C. Zentiva, S.A.
50 Theodor Pallady Blvd., District 3, Bucharest,
032266 Romania
This leaflet does not contain all the information
about your medicine. If you have any questions
or are not sure about anything, ask your doctor
or pharmacist.
This leaflet was last revised in
December 2016
© Sanofi, 1998-2016

148x250
183

Tell your doctor if any of the side effects gets
serious or lasts longer than a few days, or if you
notice any side effects not listed in this leaflet.

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 the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

27031001568

Tell your doctor or pharmacist if any of the
following side effects get serious or lasts
longer than a few days:
• Feeling sick (nausea) or being sick (vomiting)
• Stomach pains, indigestion or wind
• Headaches
• Feeling dizzy
• Feeling itchy in the genital or vaginal area

Blood tests
Suprax Tablets can cause blood clots or small
changes to the way the liver and kidney work.
This would be shown up in blood tests. This is
not common and goes back to normal after
stopping this medicine.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

T he person taking this medicine is a child under the
age of 10
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before taking this medicine.



Suprax 200mg Tablets
Cefixime

Taking other medicines

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help

 ead all of this leaflet carefully before taking
R
this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
your 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 your pharmacist.
In this leaflet:
1. What Suprax is and what it is used for
2. Before you take Suprax
3. How to take Suprax
4. Possible side effects
5. How to store Suprax
6. Further information

Please tell your doctor or your pharmacist if you are
taking or have recently taken any other medicines. This
includes medicines you buy without a prescription,
including herbal medicines. This is because Suprax can
affect the way some other medicines work. Also some
medicines can affect the way Suprax works.
In particular, tell your doctor if you are taking the
following:
• Medicines to thin the blood such as warfarin
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if
• You are pregnant, might become pregnant or think
you may be pregnant
• You are breast-feeding or planning to breast feed
Ask your doctor or pharmacist for advice before taking
any medicine if you are pregnant or breast feeding.
Tests
If you require any tests (such as blood or urine tests)
while taking this medicine, please make sure your doctor
knows that you are taking Suprax.

1. What Suprax is and what it is used for
Suprax 200mg Tablets (called Suprax in this leaflet)
contains a medicine called cefixime. This belongs to a
group of antibiotics called ‘cephalosporins’.
Suprax is used to treat infections caused by bacteria.
These include infections of the:
• Ear
• Nose, sinuses (such as sinusitis)
• Throat (such as tonsillitis, pharyngitis)
• Chest and lungs (such as bronchitis, pneumonia)
• Urinary system (such as cystitis and kidney infections)

3. How to take Suprax
Taking this medicine
Always use Suprax exactly as your doctor has told you.
You should check with your doctor or pharmacist if you
are not sure.
• Take this medicine by mouth
• Swallow tablets whole with a drink of water
• If you feel the effect of the medicine is too weak or too
strong, do not change the dose yourself, but ask your
doctor.
Carefully read the label from the pharmacist. Ask
your pharmacist if you are not sure about the dose to
2. Before you take Suprax
take. The medicine should be taken for the prescribed
number of days.
Do
not
take
this
medicine
and
tell
your
doctor
if:

How much to take
x You are allergic (hypersensitive) to cefixime, any other
The usual dose is:
cephalosporin antibiotics including penicillin or to any
Adults, Elderly and Children over 10 years or
of the other ingredients of this medicine (see Section 6:
weighing more than 50kg
Further information).
• 1-2 tablets each day given as a single or divided dose
Signs of an allergic reaction include: a rash, swallowing
People with kidney problems
or breathing problems, swelling of the lips, face, throat
• Your doctor may prescribe a lower dose
and tongue.
Children under 10 years old
Do not take this medicine if the above applies to you. If
• Suprax Paediatric should be used instead
you are not sure, talk to your doctor or your pharmacist
If you take more Suprax than you should
before taking Suprax.
If you have too much of this medicine, talk to your
Take special care with Suprax
doctor straight away.
Check with your doctor or your pharmacist before
If you forget to take Suprax
If you forget to take a dose, take it as soon as you
taking this medicine if:
remember it. However, if it is nearly time for the
▲ You have ever had colitis
▲ You have kidney problems
next dose, skip the missed dose. Do not take
31037284

31037284-NOTICE SUPRAX 200MG 7CPR UKv2.0.indd 1

05/02/16 09:02

a double dose to make up for a forgotten dose
If you stop taking Suprax
Do not stop taking this medicine without talking to your
doctor. You should not stop taking Suprax just because
you feel better. This is because the infection may come
back or get worse again.

• Feeling dizzy
• Feeling itchy in the genital or vaginal area
Tell your doctor if any of the side effects gets serious
or lasts longer than a few days, or if you notice any
side effects not listed in this leaflet
Blood tests
If you have any further questions on the use of this Suprax Tablets can cause blood clots or small changes to
the way the liver and kidney work. This would be shown
product,
ask your doctor or pharmacist.

up in blood tests. This is not common and goes back to
4. Possible side effects
normal after stopping this medicine.
Reporting of side effects
Like all medicines, Suprax can cause side effects,
If you get any side effects talk to your doctor, pharmacist
although not everybody gets them.
or nurse. This includes any possible side effects not listed
Tell your doctor straight away or go to the nearest
hospital casualty department if you notice any of the in this leaflet. You can also report side effects directly via
following serious side effects – you may need urgent the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
medical treatment:
information on the safety of this medicine.
• You have an allergic reaction. The signs may include:
a rash, joint pain, swallowing or breathing problems,
5. How to store Suprax
swelling of your lips, face, throat or tongue
Keep
out of the reach and sight of children.
• Blistering or bleeding of the skin around the lips, eyes,
mouth, nose and genitals. Also flu-like symptoms and
Do not use this medicine after the expiry date which is
fever. This may be something called ‘Stevens-Johnson
stated on label and blister pack
syndrome.
Store below 25° C.
• Severe blistering rash where layers of the skin may peel Medicines should not be disposed of via wastewater or
off to leave large areas of raw exposed skin over the
household waste. Ask your pharmacist how to dispose of
body. Also a feeling of being generally unwell, fever,
medicines no longer required. These measures will help
chills and aching muscles. This may be something
to protect the environment.
called ‘Toxic epidermal necrolysis’
6. Further information
• You have a skin rash or skin lesions with a pink/red
ring and a pale centre which may be itchy, scaly or
What Suprax 200mg Tablets contain
filled with fluid. The rash may appear especially on
• Each tablet contains 200mg of the active substance,
the palms or soles of your feet. These could be signs
cefixime.
of a serious allergy to the medicine called ‘erythema
• The other ingredients are microcrystalline cellulose,
multiforme’
pregelatinised starch, calcium hydrogen phosphate
• You get infections more easily than usual. This could
dihydrate, magnesium stearate, hypromellose,
be because of a blood disorder. This normally gets
macrogol 6000 and titanium dioxide (E171).
better after stopping the medicine
What
Suprax looks like and content of the pack
• You bruise or bleed more easily than normal. This
Suprax is available as an off-white, convex, film coated
could be because of a blood disorder. This normally
tablet engraved with ‘ORO’ on one side. Suprax is
gets better after stopping the medicine
available in blister packs containing 1, 2, 7 or 14 tablets.
• If your child gets nose bleeds, bleeding gums, chills,
Not all pack sizes may be marketed.
tiredness, pale skin (often with a yellow tinge),
Marketing Authorisation Holder and Manufacturer
shortness of breath. This may be due to haemolytic
anaemia.
Marketing Authorisation Holder
• Changes in the way the kidneys are working or blood in Sanofi, One Onslow Street
your child’s urine
Guildford, Surrey, GU1 4YS, UK
• Fits (convulsions) - Frequency not known
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Stop taking this medicine and contact your doctor
without delay if you get:
Manufacturer
• Severe watery diarrhoea that will not stop and you are Famar Lyon, Avenue de General Gaulle, Saint Genis Laval,
feeling weak and have a fever. This may be something France
called ‘Pseudomembranous colitis’
This leaflet does not contain all the information about
Tell your doctor or pharmacist if any of the following your medicine. If you have any questions or are not sure
side effects get serious or lasts longer than a few
about anything, ask your doctor or pharmacist.
days
This leaflet was last revised in 02/2016
• Feeling sick (nausea) or being sick (vomiting)
© Sanofi, 1998 - 2016
• Stomach pains, indigestion or wind
• Headaches
31037284

31037284-NOTICE SUPRAX 200MG 7CPR UKv2.0.indd 2

05/02/16 09:02

Expand Transcript

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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