Cefpodoxime Proxetil 40mg/5ml Powder For Oral Suspension
Package leaflet: Information for the patient
Cefpodoxime 40mg/5ml Powder for Oral Suspension
cefpodoxime (as proxetil)
Read all of this leaflet carefully before you start giving this medicine to your child 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 your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s.
- If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Cefpodoxime is and what it is used for
2. What you need to know before you give Cefpodoxime
3. How to give Cefpodoxime
4. Possible side effects
5. How to store Cefpodoxime
6. Contents of the pack and other information
1. What Cefpodoxime is and what it is used for
Cefpodoxime suspension contains cefpodoxime, which 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 bacterial sinus infections
• throat infections
• chest infections such as bronchitis and some types of pneumonia
• acute otitis media
2. What you need to know before you give Cefpodoxime Do not give Cefpodoxime if your child:
- is allergic to cefpodoxime or to any of the other ingredients of this medicine (listed in section 6).
- is allergic to any other cephalosporin type of antibiotic.
- has ever had a severe allergic reaction to any sort of penicillin antibiotic.
- suffers from phenylketonuria.
- is less than 28 days (4 weeks) old.
- is four weeks to three months of age and has kidney problems.
Not all people who are allergic to penicillins are also allergic to cephalosporins.
However, your child should not be given this medicine if they have ever had a severe allergic reaction to any penicillin. This is because they 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 giving Cefpodoxime if your child:
- has ever had an allergic reaction to any antibiotic.
- has any other allergies, e.g. hayfever, asthma.
- has ever been told that their kidneys do not work very well. Also, if your child is having any sort of treatment (like dialysis) for kidney failure. Your child may take cefpodoxime but you may need to give a lower dose.
- has ever had inflammation of their bowel, called colitis or any other severe disease affecting their gut.
- has, or has recently had, severe diarrhoea and sickness (vomiting).has diabetes and you routinely test their urine, this medicine can alter the results of urine tests for sugar (such as Benedict's or Fehling's tests). Other tests may have to be used to monitor their diabetes while they are taking this medicine.
During treatment
- 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 your child is taking this medicine if they have to have any of these tests.
- Talk to your doctor or pharmacist if your child suffers from severe diarrhoea or being sick especially if they are also taking other medicines.
- If your child gets other infections such as thrush, talk to your doctor or pharmacist.
Other medicines and Cefpodoxime
Tell your doctor or pharmacist if your child is taking, has 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 you should check with your doctor or pharmacist before giving this medicine.
In particular, tell your doctor or pharmacist if your child is taking:
- Antibiotics called aminoglycosides (such as gentamicin) or other antibiotics such as chloramphenicol, erythromycin, tetracycline or sulfonamides (e.g. co-trimoxazole).
- Water tablets or injections (diuretics) such as furosemide used to increase the flow of water (urine). It might be necessary to check the kidneys often during treatment. This can be done with blood and urine tests.
- Antacids (used to treat indigestion) and medicines for treating ulcers (such as ranitidine or cimetidine): Give antacids and medicines for ulcers 2-3 hours after this medicine as they may reduce the effect of cefpodoxime when taken at the same time.
- Probenecid as it may slow down the kidneys’ ability to get rid of cefpodoxime.
- Coumarin anti-coagulants such as warfarin (used to thin the blood) as their effect may be increased by cefpodoxime.
Cefpodoxime with food
Give this medicine with meals. This is because it helps this medicine to be absorbed into the body.
Pregnancy and breast-feeding
This section may not be applicable to children.
If, however, you are an adult taking this medicine, are you pregnant, think you might be pregnant or planning to have a baby? 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 breast-feeding. This is because small amounts of it enter the milk. This could cause an allergic reaction or other side effects in the breast-fed baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Your child may get dizzy or light-headed when taking this medicine. This may affect their ability to ride bikes etc., or, if you are an adult taking this medicine, your ability to drive or operate machinery. If this happens, do not drive or use machines.
Cefpodoxime contains sucrose.
If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before taking this medicine.
Cefpodoxime contains aspartame (E951)
Aspartame contains a source of phenylalanine. This medicine may be harmful for people with a condition called phenylketonuria.
3. How to give Cefpodoxime
Always give this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The dispensing label will tell you how much of this medicine you should give and how often you should give it. 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 four weeks (28 days) up to 11 years:
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 |
|
5 |
20 mg |
2.5 ml |
|
10 |
40 mg |
5 ml |
|
15 |
60 mg |
7.5 ml |
|
20 |
80 mg |
10 ml |
|
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
- 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 your doctor or pharmacist if you need advice on how to measure out the medicine.
Children who weigh at least 25kg may have 12.5 mls of the medicine twice a day. Or they may choose to have a 100mg tablet twice a day.
Children under four weeks (28 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 giving doses less often than twice a day.
How to prepare this medicine
A doctor or pharmacist will normally prepare this medicine for you.
To open the medicine bottle, you need to press the childproof top down and then turn it.
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.
Always remember to shake the bottle before measuring out each dose.
If you give more Cefpodoxime 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. Your child may be unable to concentrate, lack energy and experience a decrease in consciousness. These effects are more likely to occur if your child has kidney problems. Take the medicine with you in the carton, so that staff will know exactly what has been taken.
If you forget to give Cefpodoxime
If you forget to give a dose of this medicine at the right time, give it as soon as you remember. Do not give a double dose to make up for a forgotten dose.
If you stop giving Cefpodoxime
It is important that you give this medicine until you finish giving the prescribed course. You should not stop giving the medicine just because your child looks or feels 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.
If you notice any of the following side effects, stop giving this medicine and contact your doctor or take your child to the nearest hospital casualty department straight away:
• Blood problems: a reduction of white blood cells that may cause an increase in the number of new infections that your child gets, such as sore throat or mouth ulcers, or damage to red
blood cells, that may cause your child to feel tired and breathless with possible yellowing of the skin.
• Severe allergic reactions which may cause sudden wheeziness and tightness of chest swelling of eyelids, face or lips, loss of consciousness (fainting).
• Severe skin rashes which may include peeling of the skin (Toxic epidermal necrolysis) or that can blister and may involve the eyes, mouth and throat and genitals (Stevens-Johnson syndrome).
• Infections: a course of cefpodoxime can increase the chance that your child gets other types of infection. For example, thrush may occur (white patches on the tongue or a creamy white discharge from the penis or vagina) or severe diarrhoea which may be bloody with stomach pain.
• Liver and bile problems: liver damage causing jaundice (this may show as a yellowing of the skin or whites of the eyes)
• Sudden severe dull pain around the top of the stomach which radiates to the back, feeling and being sick, which may be due to inflammation of the pancreas.
Other possible side effects
Common (may affect up to 1 in 10 people):
• Stomach problems: bloating, feeling or being sick (nausea, vomiting), stomach pain, flatulence (wind) and diarrhoea. If your child has severe diarrhoea or if you see blood in their diarrhoea you should stop giving this medicine and talk to your doctor immediately.
• Eating problems: loss of appetite.
Uncommon (may affect up to 1 in 100 people):
• Skin problems: skin rashes that are less severe allergic reactions than mentioned above, such as lumpy rash (hives), itching, redness or purplish-red patches.
• Nervous system disorders: headaches, pins and needles, dizziness.
• Ear problems: ringing in the ears.
• General problems: weakness, tiredness and a feeling of generally being unwell.
• Increases in the numbers of small cells that are needed for clotting of the blood, which may show up in blood tests.
• Liver and bile problems: changes in blood tests that check how your child’s liver is working. Rare (may affect up to 1 in 1,000 people):
• Blood problems, which may show up in blood tests: a reduction of red blood cells, increases in some types of white blood cells, reduced number of small cells that are needed for clotting of the blood, which may cause easy bruising or bleeding.
• Kidney problems: changes in the way that the kidney is working, which may show up in blood tests.
During treatment
If your child is having a blood test for any reason, tell the person who is taking their blood sample that you are giving this medicine as it may affect their result.
Reporting of side effects
If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Cefpodoxime
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 bottle after EXP. The expiry date refers to the last day of that month.
Before being made up into a solution, do not store above 25°C. Store in the original package.
Once made up into a solution, 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. These measures will help protect the environment.
6. Contents of the pack and other information What Cefpodoxime contains
- The active substance is cefpodoxime proxetil, equivalent to 40 mg cefpodoxime/5 ml
- The other ingredients are: sucrose (see section 2 Cefpodoxime contains sucrose”), guar galactomannan, aspartame (see section 2 “Cefpodoxime proxetil contains aspartame”), orange flavouring, sodium benzoate, sodium chloride, citric acid anhydrous, lemon flavouring, sorbitan trioleate, talc, iron oxide yellow (E172), silicon dioxide.
What Cefpodoxime looks like and contents of the pack
Cefpodoxime is a cream-tinged to orange-yellow powder. After it is mixed with water it turns into an orange-yellow suspension.
Cefpodoxime is available in amber glass bottles containing 50 ml, 100 ml or 2 x 100 ml.
Marketing Authorisation Holder
Generics [UK] Limited Station Close Potters Bar Herts.
EN6 1TL
Manufacturer
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
Mylan dura GmbH, WittichstraBe 6, D-64295 Darmstadt, Germany
Generics [UK] Ltd Station Close, Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom
Mc Dermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Mylan Hungary Kft H-2900 Komarom
Mylan utca 1 Hungary
This medicinal product is authorised in the Member States of the EEA under the following names:
|
Germany: UK: Italy: |
Cefpodoxim-dura 40 mg/5 ml Pulver zur Herstellung einer Suspension zum Einnehmen Cefpodoxime 40 mg/5 ml Powder for Oral Suspension Cefpodoxima Mylan |
This leaflet was last revised in September 2015
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