Cefpodoxime Proxetil 40mg/5ml Powder For Oral Suspension
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Sandoz GmbH |
Confidential |
12/11/2013 |
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Cefpodoxime Proxetil 40 mg/5 ml Powder for Oral Suspension |
PL 04520/0138 |
Package Leaflet: Information for the patient
Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension 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 40mg/5ml Powder for Oral Suspension is and what it is used for
2. What you need to know 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. Contents of the pack and other 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.
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Cefpodoxime Proxetil 40 mg/5 ml Powder for Oral Suspension |
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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. What you need to know before you take Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension
Do not take Cefpodoxime Proxetil 40 mg/5ml Powder for Oral Suspension:
- If you are allergic to cefpodoxime proxetil or to any of the other ingredients of this medicine (listed in section 6).
- Ifuou 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:
Warnings and precautions
Talk to your doctor or pharmacist before taking Cefpodoxime 40 mg/5ml Powder for Oral
Suspension
- 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
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Cefpodoxime Proxetil 40 mg/5 ml Powder for Oral Suspension |
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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 40 mg/5ml Powder for Oral Suspension
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)
■ 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 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.
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.
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Cefpodoxime Proxetil 40 mg/5 ml Powder for Oral Suspension |
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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 40mg/5ml Powder for Oral Suspension contains sucrose and aspartame (E951)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension contains 1.8 g sucrose per 5 ml ready-for-use suspension. This should be taken into account in patients with diabetes mellitus.
Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension contains aspartame (E951), a source of phenylalanine and may be harmful for people with phenylketonuria.
3. How to take Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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Cefpodoxime Proxetil 40 mg/5 ml Powder for Oral Suspension |
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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 |
Cefpodoxime dose in mg to be given twice daily |
Cefpodoxime dose in ml of suspension to be given twice daily |
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5 |
20 mg |
2.5 ml |
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10 |
40 mg |
5 ml |
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15 |
60 mg |
7.5 ml |
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20 |
80 mg |
10 ml |
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25 |
100 mg |
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
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■ 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.
Remove and dispose the desiccant capsule from the cap or the bottle neck.
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.
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Sandoz GmbH |
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Cefpodoxime Proxetil 40 mg/5 ml Powder for Oral Suspension |
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If you take more Cefpodoxime Proxetil 40mg/5ml Powder for Oral Suspension 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 Cefpodoxime 40 mg/5ml Powder for Oral Suspension
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 Cefpodoxime Proxetil 40 mg/5ml Powder for Oral Suspension
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 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.
PIL.0138.006d
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Sandoz GmbH |
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Cefpodoxime Proxetil 40 mg/5 ml Powder for Oral Suspension |
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- 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:
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.
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Sandoz GmbH |
Confidential |
12/11/2013 |
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Cefpodoxime Proxetil 40 mg/5 ml Powder for Oral Suspension |
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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 Cefpodoxime Proxetil 40 mg/5ml Powder for Oral Suspension
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.
Do not store above 25°C. Keep the container tightly closed.
Store the medicine in a refrigerator (2-8 °C) and do not use any remaining medicine after 14 days.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. Thesemeasureswill help protect the environment.
6. Contents of the pack and other 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.
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Sandoz GmbH |
Confidential |
12/11/2013 |
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Cefpodoxime Proxetil 40 mg/5 ml Powder for Oral Suspension |
PL 04520/0138 |
Marketing Authorisation Holder and Manufacturer
Marketing authorisation Holder:
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
Manufacturer:
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria Leaflet was last revised in 11/2013
PIL.0138.006d R001: Renewal KP