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CEFPODOXIME PROXETIL 100MG FILM-COATED TABLETS

Active substance(s): CEFPODOXIME PROXETIL / CEFPODOXIME PROXETIL

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Sandoz GmbH
Cefpodoxime Proxetil 100 mg
Film-Coated Tablets

Confidential
PL 04520/0136

Patient Information Leaflet
13/11/2013

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFPODOXIME PROXETIL 100mg FILM-COATED TABLETS
Cefpodoxime proxetil
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.

What is in this leaflet:
1.
What Cefpodoxime proxetil 100 mg Film-coated tablets is and what it is used for
2.
What you need to know before you take Cefpodoxime proxetil 100 mg Film-coated
tablets
3.
How to take Cefpodoxime proxetil 100 mg Film-coated tablets
4.
Possible side effects
5.
How to store Cefpodoxime proxetil 100 mg Film-coated tablets
6.
Contents of the pack and other information
1. What Cefpodoxim proxetil film-coated tablets is and what it is used for
Cefpodoxime is an antibiotic. It belongs to a group of antibiotics that are called
cephalosporins. These types of antibiotics are similar to penicillin.
Cefpodoxime kills bacteria and it can be used against various sorts of infections.
Like all antibiotics, cefpodoxime is only effective against some types of bacteria. So, it is
only suitable for treating some types of infection.
Cefpodoxime can be used to treat:
• sinus infections
• throat infections
• chest infections such as bronchitis and some types of pneumonia

2. What you need to know before you take Cefpodoxim proxetil 100 mg film-coated
tablets
Do not take Cefpodoxim proxetil 100 mg film-coated tablets:

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Sandoz GmbH
Cefpodoxime Proxetil 100 mg
Film-Coated Tablets

-

Confidential
PL 04520/0136

Patient Information Leaflet
13/11/2013

If you are allergic to cefpodoxime proxetil or to any of the other ingredients of this
medicine (listed in section 6).
If you are allergic (hypersensitive) to any other cephalosporin type of antibiotic
If you have ever had a severe allergic reaction to any sort of penicillin antibiotic

Not all people who are allergic to penicillins are also allergic to cephalosporins.
However, you should not take this medicine if you have ever had a severe allergic
reaction to any penicillin. This is because you might also be allergic to this medicin e.
If you are not sure about anything, ask your doctor or pharmacist:
Warnings and precautions
-

Talk to your doctor or pharmacist before taking Cefpodoxime 100 mg Film-coated tablets:
If you have ever had an allergic reaction to any antibiotic, tell your doctor or
pharmacist before you take this medicine.

-

If you have ever been told that your kidneys do not work very well. Also, if you are
having any sort of treatment (like dialysis) for kidney failure. You may take
cefpodoxime but you may need a lower dose.
If you have ever had inflammation of your bowel, called colitis or any other severe
disease affecting your gut.
This medicine can alter the results of some blood tests (such as cross-matching blood
and the Coombs' test). It is important to tell the doctor that you are taking this
medicine if you have to have any of these tests.
This medicine can also alter the results of 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.

-

-

Talk to your doctor or pharmacist if any of the above apply to you.
Other medicines and Cefpodoxime 100 mg Film-coated tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines..
This medicine can be affected by other medicines that are removed by the kidneys. This is
especially if these other medicines also affect how well kidneys work. There are many
medicines that can do this, so should check with your doctor or pharmacist before taking
this medicine.
In particular, tell your doctor or pharmacist if you are taking:
 Antibiotics called aminoglycosides (such as gentamicin)
 Water tablets or injections (diuretics) such as furosemide. It might be necessary to
check your kidneys often during treatment. This can be done with blood and urine
tests.
 Probenecid (used with a medicine called cidofovir to stop kidney damage)
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Sandoz GmbH
Cefpodoxime Proxetil 100 mg
Film-Coated Tablets

Confidential
PL 04520/0136

Patient Information Leaflet
13/11/2013

 Coumarin anti-coagulants such as warfarin (used to thin the blood)
Oestrogens such as in the contraceptive pill
Do not take cefpodoxime at the same time as medicines which act against stomach
acid. These include:
 Antacids
 Medicines like ranitidine, famotidine or cimetidine (called H 2-receptor antagonists).
Leave two or three hours after taking this medicine before taking any of these other
medicines.
Cefpodoxime Proxetil 100 mg Film-coated tablets with food and drink
Take this medicine with meals. This is because it helps this medicine to be absorbed into the
body.
Pregnancy and breast-feeding
• Are you pregnant, or do you think you might be pregnant? Although this medicine is not
known to harm the unborn child, it will only be given to a pregnant woman if it is really
necessary.
• Are you breast-feeding? This medicine should not be given to women who are
breastfeeding. This is because small amounts of it enter the milk.
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.
Driving and using machines
You may get dizzy when taking this medicine. This may affect your ability to drive or
operate machinery. If this happens, do not drive or use machines.
Cefpodoxime proxetil 100mg film-coated tablets contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
3. How to take Cefpodoxime Proxetil 100 mg Film-coated tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The dispensing label will tell you much of this medicine you should take and how often
you should take. Please read it carefully. 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 will explain this to you.
Information on how many tablets and how often they should be taken will exactly be
written on the dispensing label. Please read it carefully.
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Sandoz GmbH
Cefpodoxime Proxetil 100 mg
Film-Coated Tablets

Confidential
PL 04520/0136

Patient Information Leaflet
13/11/2013

The tablets should be taken with meals because this improves the absorption of
cefpodoxime into the body.
The recommended doses are given below. However, your doctor may prescribe a different
dose to those below: if this applies to you, discuss it with your doctor if you have not
already done so. The dose you are prescribed will depend on the type and severity of the
infection.
The recommended dose is:
Adults and Elderly with no kidney problems:
Sinus infections:
200mg twice a day.
Throat infections:
100mg twice a day.
Chest infections:
100-200mg twice a day,dependent
on the severity of the infection.
Children:
Cefpodoxime proxetil 40mg/5ml Powder for Oral Suspension is available to treat infants
over the age of two weeks and children.
Adults with kidney problems:
Depending on how serious the kidney problems are, the usual dose of cefpodoxime for
the type of infection you have may need to be given only once a day instead of twice a
day or even once every two days. Your doctor will decide how much you need to take.
If you are on haemodialysis you will usually be given a dose after each dialysis
session. Your doctor will tell you how much to take each time.
If you take more of Cefpodoxim proxetil 100mg film-coated tablets than you should
If you have taken more of this medicine than you should, talk to your doctor straight away or
go to the nearest hospital accident and emergency department. Take the medicine with you in
the carton, so that staff will know exactly what has been taken.
If you forget to take Cefpodoxim proxetil 100mg film-coated tablets
If you forget to take a dose of this medicine at the right time, take it as soon as you remember.
Do not take a double dose to make up for forgotten doses.
If you stop taking Cefpodoxim proxetil 100mg film-coated tablets
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
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R001: Renewal

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Sandoz GmbH
Cefpodoxime Proxetil 100 mg
Film-Coated Tablets

Confidential
PL 04520/0136

Patient Information Leaflet
13/11/2013

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 medicine, ask your doctor or pharmacist.

4. Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions to this medicine are very rare (may affect up to 1 in 10
000 people). These can include:
-

Sudden wheeziness and tightness of chest
Swelling of eyelids, face or lips
Severe skin rashes that can blister and may involve the eyes, mouth and throat and
genitals.
- Loss of consciousness (fainting).
All of these allergic reactions need urgent medical attention. If you think you are having
any of these types of reaction, stop taking this medicine and contact your doctor or your
nearest hospital accident and emergency department.
Other possible side effects
Common side effects (may affect up to 1 in 10 people) include:
bloating, nausea, vomiting, stomach pain, flatulence (wind) and diarrhoea. loss of
appetite.
Uncommon side effects (may affect up to 1 in 100 people) include:
hypersensitivity reactions (These are skin rashes that are less severe allergic reactions
than mentioned above, lumpy rash (hives), itching)
headaches, pins and needles, dizziness
ringing in the ears
feeling or being sick, weakness and a feeling of generally being unwell.
Rare side effects (may affect up to 1 in 1000 people) include:
changes in blood tests that check how your liver is working; Blood problems: anaemia,
drops in the numbers of different cells in the blood (symptoms can include tiredness, new
infections and easy bruising or bleeding), increases in some types of white blood cells,
increases in the numbers of small cells that are needed for clotting of the blood.
If you have severe diarrhoea or if you see blood in your diarrhoea you should stop taking
this medicine and talk to your doctor immediately.
Very rare side effects (may affect up to 1 in 10 000 people) include:

PIL.0136.005d

R001: Renewal

KP

Sandoz GmbH
Cefpodoxime Proxetil 100 mg
Film-Coated Tablets

Confidential
PL 04520/0136

Patient Information Leaflet
13/11/2013

anaphylactic reactions(e.g. bronchospasms, purpura and edema of the face and
extremities);
changes in kidney function;
liver damage causing jaundice (this may show as a yellowing of the skin or whites of the
eyes);
a type of anaemia that can be severe and is caused by red blood cells breaking up. If you
are having a blood test for any reason, tell the person who is taking your blood sample
that you are taking this medicine as it may affect your result.
Not known (frequency cannot be estimated from the available data)
•Having a course of cefpodoxime can temporarily increase the chance that you can get
infections caused by other sorts of germs. For example, thrush may occur.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
5. How to store Cefpodoxim proxetil film-coated tablets
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. The
expiry date refers to the last day of that month. Do not use the medicine after the expiry
date.

Alu-PVC/PVCD blister: Do not store above 25ºC. Store in the original package.
Alu/Alu blister: Store in the original package.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines that you no longer use. These measures will help protect the
environment.
6. Contents of the pack and other information
What Cefpodoxime Proxetil 100 mg Film-coated tablets contains
The active substance is: cefpodoxime proxetil, equivalent to 100mg cefpodoxime.
The other ingredients are: carboxymethylcellulose calcium, lactose monohydrate,
crospovidone, hydroxypropylcellulose, magnesium stearate, sodium lauryl sulphate,
hypromellose, talc and titanium dioxide (E171)
What Cefpodoxim Proxetil 100 mg Film-coated tablets look like
Cefpodoxime tablets are round, white to yellowish tablets with a diameter of approx. 9 mm.
Cefpodoxime Tablets are available in blister packs of 10, 12, 20 or 30 tablets
PIL.0136.005d

R001: Renewal

KP

Sandoz GmbH
Cefpodoxime Proxetil 100 mg
Film-Coated Tablets

Confidential
PL 04520/0136

Patient Information Leaflet
13/11/2013

Marketing Authorisation Holder and Manufacturer
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl
Austria

This leaflet was last revised in 11/2013

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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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