CEFIXIME 100 MG/5 ML POWDER FOR ORAL SUSPENSION

Active substance: CEFIXIME

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Cefixime 100 mg/5 ml Powder for Oral Suspension
cefixime
Read all of this leaflet carefully before giving this medicine to your child.
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. 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 of the side effects talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1.
What Cefixime is and what it is used for
2.
What you need to know before you give Cefixime
3.
How to give Cefixime
4.
Possible side effects
5.
How to store Cefixime
6.
Contents of the pack and other information
1.

WHAT CEFIXIME IS AND WHAT IT IS USED FOR

Cefixime belongs to a group of medicines called cephalsporins, which are antibiotics used for
treating infections.
Cefixime can be used to treat:
infection of the middle ear
sinus infection
throat infection
infection causing sudden worsening of long-standing bronchitis
serious lung infections (such as pneumonia) acquired outside the hospital
infections in the urinary tract
kidney infection
2.

BEFORE YOU GIVE CEFIXIME

Do not give Cefixime to your child if
- they are allergic (hypersensitive) to cefixime or any of the other ingredients of this
medicine (listed in section 6).
- they are allergic (hypersensitive) to any other cephalsporin type of antibiotic.
- they have ever had a severe allergic reaction to penicillin or to any other beta-lactam
type of antibiotic.
- your child has been born prematurely or is a newborn infant under 1 month old
Warnings and precautions
Before giving this medicine to your child you should tell your doctor if:
your child is allergic to penicillin antibiotics or to any other beta-lactam type of
antibiotics. Not all people who are allergic to penicillin are also allergic to
cephalsporins. However, you should take special care, as your child might also be
allergic to this medicine.
- - they have any kidney problems the use of cefixime is not recommended. If you are an
adult who has kidney problems your doctor may recommend a lower dose for you.

Effect on laboratory tests
If your child needs any blood or urine tests, inform your doctor that they are taking Cefixime,
as it can alter the results of some of these tests.
Cefixime can alter the results of some urine tests for sugar (such as Benedict’s or Fehling’s
tests). If your child has diabetes and you routinely test their urine, tell your doctor. This is
because other tests may have to be used to monitor diabetes while your child is taking this
medicine.
Cefixime may alter the results of a blood test for antibodies called the Coombs’ test.
Other medicines and Cefixime
Please tell your doctor or pharmacist if your child is taking or has recently taken any other
medicines, including medicines obtained without a prescription.
Cefixime may increase the time it takes for blood to clot. This should be taken into account if
your child is taking medicines to thin the blood such as warfarin.
Nifedipine, a calcium channel blocker, may increase the amount of cefixime in the body.
Taking Cefixime with food and drink
Food/meals have no effect on the medicine. Cefixime can be given with or without food.
Pregnancy and breast-feeding
This medicine is specially made for children but if you are taking it as an adult and you are
pregnant, likely to become pregnant or are breast-feeding, you must tell your doctor before
taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Cefixime does not usually affect the ability to drive or use machines. However, if you are an
adult taking Cefixime and feel light-headed or dizzy, do not drive or operate machinery.
Cefixime contains sucrose. If you have been told by your doctor that your child has an
intolerance to some sugars, contact your doctor before giving this medicinal product.
Each 5 ml contains 2.43 g of sucrose. This should be taken into account in patients with
diabetes mellitus.
3.

HOW TO GIVE CEFIXIME

Always give Cefixime exactly as your doctor has told you to. You should check with your
doctor or pharmacist if you are not sure. Your doctor will decide the right dose of Cefixime
and how long it must be taken for. Do not stop giving your child Cefixime early even if their
symptoms improve, otherwise the infection might come back.
 This medicine can be given as a single dose or in two divided doses each day.
 If your doctor has prescribed one dose a day, it should be given every 24 hours.
 If your doctor has prescribed two doses a day, each dose should be given every 12
hours, one dose in the morning and the other in the evening. The medicine should
always be given at the same time each day.
The usual dose is:

Adults, and children over 10 years of age or who weigh more than 50 kg: The usual dose is
200-400 mg of Cefixime daily. The correct dose is given using the syringe provided and
pulling the top ring up to the 25kg mark twice to give a dose of 200mg and 4 times to give a
dose of 400mg (see instructions below on how to measure the correct dose).
Elderly: For elderly patients, the doses are the same as adults provided that your kidney
function is normal.
Children less than 10 years of age: The dose depends on your child’s weight. Your doctor
will prescribe the correct amount to give to your child. The usual dose is 8mg/kg daily.
Patients with kidney problems: In adults with kidney problems, the dose of Cefixime can be
reduced. Your doctor will tell you exactly how much to take according to the results of blood
or urine tests that measure how well your kidneys are working and also according to the
severity of your infection. Cefixime is not recommended to be given to children and
adolescents with kidney problems.
Children less than 6 months of age: Cefixime should not be given to children under 6
months of age.
The medicine comes with a 5ml syringe (pipette) graduated by body weight.
1 kg on the syringe corresponds to 0.2 ml (equivalent to 4 mg of cefixime)
5 kg on the syringe corresponds to 1 ml (equivalent to 20 mg of cefixime)
The syringe should be used to measure the exact amount of medicine you need to give. The
amount per dose is indicated in ‘kg’ on the pull-out of the syringe, corresponding to your
child’s weight. To use the syringe correctly please read the instructions below.
If your doctor has prescribed one dose to be given twice a day you should withdraw the
amount of suspension corresponding to your child’s weight on the syringe.
If your doctor prescribes a single daily dose, you should withdraw suspension equivalent to
twice your child weight on the syringe.
How to prepare the suspension and measure the correct dose:
1. Remove the child-proof cap. Push the plastic screw cap down while turning it counter
clockwise
2. Add water in two portions to the dry powder mixture until the suspension reaches the line
on the neck of the bottle. Shake well after each addition and let any froth settle before adding
the second portion of water. This corresponds to adding 68ml of water.
3. Insert the syringe into the bottle (Figure 1).
4. While holding the bottom ring, pull the top ring up to the mark that corresponds to your
child’s weight (Figure 2). Check the following table for the correct dose.

Body
weight (kg)
5 kg
10 kg
12 kg
15 kg
17 kg
20 kg
23 kg
25 kg

Daily dose (mg)

Daily dose according to the syringe graduation in kg

40 mg
80 mg
96 mg
120 mg
136 mg
160 mg
184 mg
200 mg

2 times x 5 kg (once daily) or 1 time x 5 kg (twice daily)
2 times x 10 kg (once daily) or 1 time x 10 kg (twice daily)
2 times x 12 kg (once daily) or 1 time x 12 kg (twice daily)
2 times x 15 kg (once daily) or 1 time x 15 kg (twice daily)
2 times x 17 kg (once daily) or 1 time x 17 kg (twice daily)
2 times x 20 kg (once daily) or 1 time x 20 kg (twice daily)
2 times x 23 kg (once daily) or 1 time x 23 kg (twice daily)
2 times x 25 kg (once daily) or 1 time x 25 kg (twice daily)

5. Holding the bottom ring, remove the syringe from the bottle (Figure 3).

6. Empty the contents of the syringe into your child’s mouth
7. Close the bottle tightly and store the bottle below 25oC
8. Rinse the syringe with some water, ready for re-use
9. Make sure to shake the bottle well before each use.
If you give your child more Cefixime than you should
Contact your doctor or nearest hospital immediately. Take the container with you.
If you forget to give Cefixime to your child
Give the next dose as soon as you remember unless it is almost time for the next dose.
Do not give a double dose to make up for a forgotten dose.
If you stop giving Cefixime to your child
Do not stop giving Cefixime because your child feels better. It is important for the dose to be
taken for as long as your doctor has prescribed, otherwise the infection might come back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Cefixime can cause side effects, although not everybody gets them.
If any of the following happen, stop giving Cefixime and tell your doctor immediately or go
to your nearest hospital emergency department:
 Severe diarrhoea with blood in the stools, stomach pain and fever during or after
taking Cefixime. This may be something called pseudomembranous colitis and may
occur over two months after treatment with Cefixime has stopped.
 Dark urine, pale stools, jaundice (yellowing of the skin and/or eyes), nausea, fever
 Allergic reactions including rashes have been reported with Cefixime. In very rare
cases, difficulty in breathing, fainting and swelling of the face and throat can occur
which may need emergency treatment. Allergic rashes may range in severity from
mild itchy skin eruptions to a rarer, more serious condition called Stevens-Johnson
syndrome (which may cause ulceration of the mouth, lips and skin) or toxic
epidermal necrolysis (which causes severe illness and sloughing of the skin).
In the unlikely event that your child’s infection has been caused by a bug which Cefixime
cannot treat, the symptoms may get worse. If this happens, you should consult your doctor.
Other side effects:
Common (may affect up to 1 in 10 people):
 diarrhoea

Uncommon (may affect up to 1 in 100 people)
 headache
 nausea
 vomiting
 stomach (abdominal) pain
 changes in blood tests that show how your liver is working
 skin rash
Rare (may affect up to 1 in 1,000 people)
 infections caused by germs that cefixime does not act on, for example thrush
 loss of appetite (anorexia)
 flatulence (wind)
 changes in blood tests that show how your kidney is working
 fever
 dizziness
 itchy skin
 inflammation of the lining of the mouth and/or internal surfaces
 increase in some white blood cells
Very rare (may affect up to 1 in 10,000 people):
 fall in the number of different cells in the blood (symptoms can include tiredness,
new infections and easy bruising or bleeding)
 restlessness and increased activity
 liver problems
 inflammation of the kidney
Reporting of side effects
If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: 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 CEFIXIME

Keep out of the sight and reach of children.
Do not use Cefixime after the expiry date which is stated on the carton and bottle after EXP.
The expiry date refers to the last day of that month.
The unopened bottle should not be stored above 25º C.
After reconstitution, store the suspension below 25º C. Do not freeze. Keep the bottle tightly
closed and shake well before each use.
After 14 days throw away any unused suspension. Do not throw away the medicine via
wastewater but ask your pharmacist how to throw it away. These measures will help to
protect the environment.
Do not add more water to the suspension once it is made up to the mark on the bottle.
6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Cefixime contains
- The active substance is cefixime.
- The other ingredients are xanthum gum, sodium benzoate, silica colloidal anhydrous,
sucrose, flavour strawberry (maltodextrin, triethyl acetate – E1505, propylene glycol
– E1520).
What Cefixime looks like and contents of the pack
Each 5 ml of reconstituted suspension contains 111.917 mg of cefixime trihydrate equivalent
to 100 mg of cefixime (anhydrous).
Cefixime powder for oral suspension is an off-white to pale yellow coloured powder with
characteristic odour and it gives a cream colour to pale yellow coloured viscous suspension
after reconstitution with water.
This medicine comes in an amber coloured, round glass bottle with 100ml ring mark and with
a plastic child resistant cap inside which is a seal liner.
Bottles are supplied with a single 5 ml plastic dosing pipette (plunger, barrel and piston).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan,
Potters Bar,
EN6 1TL,
United Kingdom
Manufacturer
Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
This leaflet was last revised in 06/2013.

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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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