CEFPODOXIME PROXETIL 40MG/5ML POWDER FOR ORAL SUSPENSION

Active substance: CEFPODOXIME PROXETIL

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Package Leaflet: Information for the user
Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension
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 Proxetil 40mg/5ml Powder for Oral Suspension is and what it is
used for
2.
Before you take Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension
3.
How to take Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension
4.
Possible side effects
5.
How to store Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension
6.
Further information
1. What Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension 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:
 acute inflammation of the middle ear
 sinus infections
 throat infections
 chest infections such as bronchitis and some types of pneumonia

2. Before you take Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension
Do not take this medicine if:

-

You are allergic (hypersensitive) to cefpodoxime proxetil or to any of the other ingredients
of this medicine (See Further Information in Section 6).
You are allergic (hypersensitive) to any other cephalosporin type of antibiotic
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 medicine.
If you are not sure about anything, ask your doctor or pharmacist:
Take special care with this medicine if:
- You have ever had an allergic reaction to any antibiotic, tell your doctor or pharmacist
before you take this medicine.
- 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.
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.
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.

Do not take these medicines at the same time as medicines which act against stomach acid.
This includes:
 Antacids
 Medicines like ranitidine, famotidine or cimetidine (called H2-receptor antagonists).
Leave two or three hours after taking this medicine before taking any of these other
medicines.
Taking Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension 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.
Ask your doctor or pharmacist for advice before taking any 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.
Important information about some of the ingredients of this medicine
Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension contains sucrose. If you have
been told that you have an intolerance to some sugars, contact your doctor before taking this
medicine.
Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension contains aspartame (E951).
Aspartame contains a source of phenylalanine. This medicine may be harmful for people with
a condition called phenylketonuria.
3. How to take Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension
Always take this medicine exactly as your doctor has told you. You should 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
Adults: Teenagers and adults who need treatment with cefpodoxime are usually given tablets.
Separate patient information leaflets are provided with the tablets.
Children older than 15 days:
The daily amount is worked out according to the weight of the child.
 Usually the total amount each day is 8mg for each kilogram of body weight.
 This is usually split into two doses
 Give each dose every 12 hours with a meal.
The exact dose will have been worked out by the doctor and shown on the label.
The following table provides a guide to usual doses:
Body weight
in kg
5
10
15
20
25

Cefpodoxime dose in mg to be
given twice daily
20 mg
40 mg
60 mg
80 mg
100 mg

Cefpodoxime dose in ml of suspension
to be given twice daily
2.5 ml
5 ml
7.5 ml
10 ml
12.5 ml

How to measure the dose
A 10 ml syringe marked at each half ml is provided with this medicine. It comes with an
adaptor which fits onto the bottle. To measure the medicine:
 Shake the bottle
 Put the adaptor into the mouth of the bottle
 Put the end of the syringe into the adaptor
 Turn the bottle upside-down
 Pull the plunger to measure the dose you need
Ask you doctor or pharmacist if you need advice on how to measure out the medicine.
Children who weigh at least 25kg may have 12.5 ml of the medicine twice a day. Or they
may choose to have a 100mg tablet twice a day.
Children under 15 days old should not take this medicine.
If your child has kidney problems your doctor may prescribe a different dose than usual.
Usually, this means taking doses less often than twice a day.
How to prepare this medicine
A doctor or pharmacist will prepare this medicine for you.

To open the medicine bottle, you need to press the childproof top down and then turn it.
Before preparing the suspension the silica gel desiccant contained in a capsule inside the
cap must be removed and disposed of.
If you need to prepare this medicine yourself, you should fill the bottle with cold water to just
under the measurement line marked on the bottle. Shake it well as soon as you have done that.
Then put more water in right up to the measurement line marked on the bottle and shake it
again.
You should measure the medicine as follows:



For a 50 ml oral suspension, you will need 20g granules of the medicine and 37 ml of
water.
For a 100 ml oral suspension, you will need 40g granules of the medicine and 74 ml of
water.

Each time you do this, shake the bottle well before taking this medicine.
Always remember to shake the bottle before measuring out each dose.
Taking more of this medicine than you should
If you or your child 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 this medicine
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 this medicine
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, this medicine can cause side effects, although not everybody gets them.

Severe allergic reactions to this medicine are very rare (affects less than 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.
Common side effects (affect less than 1 in 10 people) include:
Stomach problems: bloating, nausea, vomiting, stomach pain, flatulence (wind) and
diarrhoea. 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.
Eating problems: loss of appetite.
Uncommon side effects (affect less than 1 in 100 people) include:
Immune system problems: hypersensitivity reactions (These are skin rashes that are less
severe allergic reactions than mentioned above, lumpy rash (hives), itching)
Nervous system disorders: headaches, pins and needles, dizziness
Ear problems: ringing in the ears
General problems: feeling or being sick, weakness and a feeling of generally being
unwell.
Rare side effects (affect less than 1 in 1000 people) include:
Liver and bile problems: 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.
Very rare side effects (affect less than 1 in 10 000 people) include:
Immune system problems: anaphylactic reactions(e.g. bronchospasms, purpura and edema
of the face and extremities);
Kidney problems: changes in kidney function;
Liver and bile problems: liver damage causing jaundice (this may show as a yellowing of
the skin or whites of the eyes);
Infections: 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.

Blood and the lymphatic system problems: 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.
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 this medicine
Keep out of the reach and sight 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.
Do not store above 25ºC. Keep the container tightly closed.
Store the medicine in a refrigerator (2-8 ºC) and do not use any remaining medicine after 14
days.
You should not throw away any medicine through wastewater or household waste. Ask your
pharmacist how to dispose of medicines that you no longer need. This will help to protect the
environment.
6. Further Information
What Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension contains
The active substance is: cefpodoxime proxetil, equivalent to 40 mg cefpodoxime/5 ml.
The other ingredients are: sucrose, guar galactomannan, aspartame, orange flavouring, sodium
benzoate, sodium chloride, citric acid anhydrous, lemon flavouring, sorbitan trioleate, talc,
yellow ferric oxide (E172), silicon dioxide
What Cefpodoxim Proxetil 40mg/5ml Powder for Oral Suspension look like
Cefpodoxime Powder for Oral Suspension is a cream-tinged to orange-yellow powder. After it
is mixed with water it turns into an orange-yellow suspension.
Cefpodoxime 40 mg/5 ml Powder for Oral Suspension is available in brown glass bottles
containing 50 ml, 100 ml or 2 x 100 ml.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation Holder:

Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria

Manufacturer:
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
For any information about this medicinal product, please contact the local representative of
the Marketing Authorisation Holder:
This medicinal product is authorised in the member states of the EEA under the
following names:

[To be completed nationally]
This leaflet was last approved in March 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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