CEFPODOXIME 40 MG/5 ML GRANULES FOR ORAL SUSPENSION

Active substance: CEFPODOXIME PROXETIL

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Cefpodoxime 40 mg/5 ml granules for oral suspension
Cefpodoxime
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, 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 Cefpodoxime is and what it is used for
2 Before you take Cefpodoxime
3 How to take Cefpodoxime
4 Possible side effects
5 How to store Cefpodoxime
6 Further information
1. WHAT CEFPODOXIME IS AND WHAT IT IS USED FOR
Cefpodoxime is an antibiotic used to kill bacteria, which cause infection in your body. It
belongs to a group of antibiotics called cephalosporins.
Your doctor has prescribed Cefpodoxime because you have one (or more) of the following
types of infection:
·
tonsilitis
·
sinusitis
·
otitis media
·
pneumonia
2. BEFORE YOU TAKE CEFPODOXIME
DO NOT TAKE Cefpodoxime
· allergic (hypersensitive) to cefpodoxime or other cephalosporins or any of
if you are
the other ingredients of this medicine (listed in section 6).
· had a severe allergic reaction to particular antibiotics (penicillins,
if you have
monobactams and carbapenems) as you may also be allergic to cefpodoxime.
Tell your doctor before you start on Cefpodoxime if you think that this applies to you.
You must not be given Cefpodoxime.
Take special care with Cefpodoxime
· ever been told that your kidney do not work very well. Also, if you are having
If you have
any sort of treatment (like dialysis) for kidney failure. You may take cefpodoxime but you
may need a lower dose.
· ever had inflammation of your bowel, called colitis or any other severe
If you have
disease affecting your gut.
·
This medicine can alter the results of some blood tests (such as cross-matching blood
and the coomb's 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.
Taking other medicines
Please tell to your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
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:
·
antacids (used to treat indigestion)
· agents (used to treat ulcer) such as ranitidine or cimetidine
anti-ulcer
·
diuretics (used to increase urine flow)
·
aminoglycoside antibiotics used to treat infections
· (used in the treatment of gout)
probenecid
·
anti-coagulants e.g. warfarin

Black

P150

P150

Cefpodoxime

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cefpodoxime

Pharmacode position may change as per Supplier's m/c requirement & additional
small pharma code may appear on the front / back panel

Antacids and anti-ulcer treatments (such as ranitidine and cimetidine) should be taken 2-3
hours after taking Cefpodoxime. Your doctor knows about these and will alter the treatment if
considered necessary.
If you require any tests (blood, urine or diagnostic), whilst taking this medicine, please
ensure that your doctor knows that you are taking Cefpodoxime.
Important information about some of the ingredients of Cefpodoxime
Cefpodoxime contains lactose and sucrose. 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
Always take Cefpodoxime exactly as your doctor has told you. You should check with your
doctor or pharmacist, if you are not sure.
Instructions for Reconstitution
Before preparing the suspension the silica gel
desiccant contained in the stopper inside the
closure must be removed and disposed off. To
prepare the suspension first shake the bottle to
loosen granules. Add water up to about half of
the 100 ml ring mark and shake vigorously.
Further add water up to the 100 ml ring mark of
the bottle and shake vigorously to obtain an
evenly dispersed suspension

100 ml

100 ml

Ring Mark

Label

The recommended mean dosage for children (up to 11 years) is 8 mg/kg/day administered
in two divided doses at 12-hour intervals.
The dose to be taken is indicated on the measuring spoon. The graduations correspond to
the child's weight in kg from 5 kg to 25 kg with intermittent graduations of 1 kg each. The
dose to be taken is read directly from the spoon. For example, if your child weighs 12kg, the
spoon is filled to the 2nd graduation after 10 kg graduation mark.
The measuring spoon is only adequate for this oral suspension.
The following table provides dosage regimen for children as per the bodyweight graduations
provided on the measuring spoon:
Body weight in kg
5

Cefpodoxime dose in mg to be used twice daily
20

10

40

15

60

20

80

25

100

Children who weigh at least 25 kg can take 12.5 ml suspension twice daily or alternatively
100 mg film-coated tablet twice daily.
Children with kidney problems:
Depending on how serious the kidney problems are, you may need to take cefpodoxime less
often, e.g. only once a day or every other day. Your doctor will decide how much you need to
take.
It is important that you take your medicine at the right times of day.
How to take:
It is important that you take your medicine at the right times of day. This medicine may be
taken with or without food.
If you take more Cefpodoxime than you should
If you accidentally take too much medicine, contact your doctor or pharmacist who will
recommend what action you should take.
If you forget to take Cefpodoxime
If you do forget to take a dose of your medicine at the correct time, you should take it as
soon as possible. However, if it is almost time for your next dose, skip the missed dose. Do
not take a double dose to make up for a forgotten dose. Just take the next dose at the
correct time. Carry on as before.
If you stop taking Cefpodoxime
Keep taking your medicine until your doctor has told you to stop. Do not stop taking it just
because you feel better. If you stop taking the medicine, your condition may reoccur or get
worse.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

What Cefpodoxime contains

Like all medicines, Cefpodoxime can cause side effects, although not everybody gets them.
The side effects are listed by frequency.

The active substance is cefpodoxime.

Conditions you need to look out for
The following serious side effects have occurred in a small number of people but their exact
frequency is unknown:
·
severe allergic reaction. Signs include raised and itchy rash, swelling, sometimes of
the face or mouth causing difficulty in breathing.
· which may blister, and looks like small targets (central dark spot
Skin rash,
surrounded by a paler area, with a dark ring around the edge).
·
A widespread rash with blisters and peeling skin. (These may be signs of StevensJohnson syndrome or toxic epidermal necrolysis).
All of these 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.
Common side effects (affects more than 1 person in 100 but less than 1 in 10):
·problems: Bloating, nausea, vomiting, stomach pain, flatulence (wind) and
Stomach
diarrhoea
·
Loss of appetite
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.
Uncommon side effects (affects more than 1 person in 1,000 but less than 1 in 100):
·
Hypersensitivity reactions (These are skin rashes that are less severe allergic reactions
than mentioned above, lumpy rash (hives), itching)
·
Headache
·needles
Pins and
·
Dizziness
· the ears
Ringing in
· and a feeling of generally being unwell.
Weakness
Rare side effects (affects more than 1 person in 10,000 but less than 1 in 1,000):
·in blood tests that check how your liver is working
Changes
·
Anaemia
· numbers of blood cells (symptoms can include tiredness, new infections
Drops in the
and easy bruising or bleeding)
·in some types of white blood cells
Increase
·in the numbers of small cells that are needed for clotting of the blood.
Increase
Very rare side effects (affects less than 1 person in 10,000):
·
Anaphylactic reactions (e.g. bronchospasms, purpura and edema of the face and
extremities)
· in the kidney function
Worsening
·
Liver damage
·course of cefpodoxime can temporarily increase the chance that you can get
Having a
infections caused by other sorts of germs. For example, thrush may occur.
·anaemia that can be severe and is caused by red blood cells breaking up.
A type of
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 CEFPODOXIME
Keep out of the reach and sight of children.
Do not take Cefpodoxime after the expiry date which is stated on the carton. The expiry date
refers to the last day of that month.
Bottle: Store below 25°C.
Store in the original package in order to protect from light.
Reconstituted suspension: Store in a refrigerator (2°C - 8°C) for not more than 10 days.
Discard any remaining liquid after 10 days.
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.

Each 5 ml of suspension contains 52.18 mg cefpodoxime proxetil (equivalent to 40 mg
cefpodoxime).
· ingredents are lactose monohydrate, maize starch, croscarmellose sodium,
The other
ferric oxide yellow, hydroxypropyl cellulose, dispersible cellulose, silica colloidal
anhydrous, citric acid anhydrous, sodium citrate, sodium benzoate, durarome flavour
banana, sucrose.
What Cefpodoxime looks like and contents of the pack
Granules for oral suspension.
Off white colored granular powder forming a off white suspension with banana flavor, on
constitution with water.
Cefpodoxime 40mg/5ml granules for oral suspension is available in HDPE containers of
pack size of 100ml suspension.
A measuring spoon with graduations from 5 kg to 25 kg is provided with the bottle for correct
dosing.
Marketing Authorization Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in the Member States of the EEA under the
following names:
Austria
France
Germany
Italy
Spain
United Kingdom

Cefpodoxim Aurobindo 40 mg/ 5 ml Granulat zur Herstellung einer
Suspension zum Einnehmen
Cefpodoxime Arrow Génériques Enfants et Nourrissons 40 mg/ 5 ml,
granulés pour suspension buvable
Cefpodoxim Aurobindo 40 mg/ 5 ml Granulat zur Herstellung einer
Suspension zum Einnehmen
Cefpodoxima Aurobindo 40 mg/ 5 ml granulato per sospensione orale
Cefpodoxima Aurobindo 40 mg/ 5 ml granulado para suspension oral
Cefodoxime 40 mg/ 5 ml granules for oral suspension

This leaflet was last approved in 07/2014.
Advice/medical education
Antibiotics are used to cure bacterial infections. They are ineffective against viral infections.
If your doctor has prescribed antibiotics, you need them precisely for your current illness.
Despite antibiotics, some bacteria may survive or grow. This phenomenon is called
resistance: some antibiotic treatments become ineffective.
Misuse of antibiotics increases resistance. You may even help bacteria become resistant
and therefore delay your cure or decrease antibiotic efficacy if you do not respect
appropriate:
dosage
schedules
duration of treatment.
Consequently, to preserve the efficacy of this drug:
1 Use antibiotics only when prescribed.
2 Strictly follow the prescription.
3 Do not re-use an antibiotic without medical prescription, even if you want to treat a
similar illness.
4 Never give your antibiotic to another person; maybe it is not adapted to her/his illness.
5 After completion of treatment, return all unused drugs to your chemist's shop to ensure
they will be disposed of correctly.

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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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