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CEFIXIME 100 MG/5 ML GRANULES FOR ORAL SUSPENSION

Active substance(s): CEFIXIME TRIHYDRATE

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Package leaflet: information for the user

Cefixime
100 mg/5 ml granules for oral suspension
cefixime

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. See section 4.

Effect on laboratory tests
If you are to undertake any blood or urine tests, inform your
doctor that you are taking Cefixime, as cefixime 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 you have diabetes
and routinely test for urine, tell your doctor. This is because
other tests may have to be used to monitor your diabetes while
you are having this medicine.
Cefixime can alter the results of some urine tests for ketones.
Tell your doctor that you are taking Cefixime because other
tests may have to be used.
Cefixime can alter the results of a blood test for antibodies
called the direct Coomb´s test.
Cefixime with food and drink
Cefixime may be taken with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are planning
to have a baby, ask your doctor for advice before taking this
medicine.
Driving and using machines

What is in this leaflet
1. What Cefixime is and what it is used for
2. What you need to know before you take Cefixime
3. How to take 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 contains an active substance called cefixime. This
belongs to a group of antibiotics called “cephalosporins”,
which are used for treating infections caused by bacteria.
Cefixime is used in children above 6 months, adolescents and
adults to treat:
• infection of the middle ear,
• infection causing sudden worsening of long-standing
bronchitis,
• uncomplicated acute infection of the bladder,
• uncomplicated infection of the kidneys.
2. What you need to know before you take Cefixime
Do not take Cefixime:
• if you are allergic to cefixime or to any of the other ingredients
of this medicine (listed in section 6),
• if you are allergic (hypersensitive) to any other cephalosporin
type of antibiotic,
• if you have ever had a severe allergic reaction to penicillin
antibiotic or to any other beta-lactam type of antibiotic.
This medicine should not be administered to preterm newborns and new-borns.
Do not take this medicine if the above applies to you. If you
are not sure, talk to your doctor or pharmacist before taking
Cefixime oral suspension.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Cefixime if:
• you have ever had colitis,
• you have kidney problems,
• your child is under the age of 6 months.
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before taking this medicine.
Cefixime is not suitable for everyone.
Before you take Cefixime you should tell your doctor if you:
• are allergic to penicillin antibiotics or to any other betalactam type of antibiotics. An allergic reaction may include
rash, itching, difficulty in swallowing or breathing or swelling
of the face, lips, throat and tongue. Not all people who are
allergic to penicillins are also allergic to cephalosporins.
However, you should take special care if you ever had an
allergic reaction to any penicillin. This is because you might
also be allergic to this medicine.
In patients who develop severe allergic reaction or
anaphylaxis (serous allergic reaction which causes difficulty
in breathing or dizziness) after administration of Cefixime,
the medicine should be discontinued and appropriate
treatment should be given.
• are taking other medicines which are known to be harmful to
you kidneys. Also inform your doctor if you have any kidney
problems. Your doctor may perform certain test regularly
to measure how well your kidneys are working during the
treatment.
• have severe or persistent diarrhoea with stomach pain or
cramps during or shortly after treatment with Cefixime, stop
taking this medicine and contact your doctor immediately.
Medicines which may slow or stop bowel movements must
not be taken.
If you develop syndrome known as DRESS syndrome or
Stevens-Johnson syndrome or skin reaction known as toxic
epidermal necrolysis (see section 4. Possible side effects)
while you are taking Cefixime, stop taking this medicine and
contact your doctor immediately.
Having a course of Cefixime can temporarily increase the
chance that you can get infections caused by other sort of
germs on which Cefixime does not act. For example, thrush
(infection caused by a yeast germ called Candida) may occur.
This medicine may cause vomiting and diarrhea (see section
4. Possible side effects). In such case, the efficacy of Cefixime
and/ or other medicinal products taken by you (as the birth
control pill) may be impaired.
Other medicines and Cefixime
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking:
• medicines which are known to be harmful to your kidneys
like:
- antibiotics include aminoglycoside antibiotics, colistin,
polymyxin and viomycin,
- medicines that increase the amount of urine your body
produces (diuretics) such as ethacrynic acid or furosemide.
• nifedipine, a medicine used for the treatment of high blood
pressure or heart problems,
• anticoagulants (blood thinning medicines) such as warfarin
in some patients. Cefixime causes problems with blood
clothing and may increase the time taken for the blood to
clot.

Cefixime does not usually affect your ability to drive and use
machines.
Cefixime contains sucrose
This medicine contains 2.52 g of sucrose per 5 ml reconstituted
suspension. This should be taken into account by patients with
diabetes mellitus. If you have been told by your doctor that
you have an intolerance to some sugars (fructose intolerance,
glucose-galactose malabsorption or sucrase-isomaltase
insufficiency), contact your doctor before taking this medicinal
product.
3. How to take Cefixime
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.
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 or pharmacist will
explane this to you.
The reconstituted suspension should be administered
undiluted before or during a meal.
The usual dose is:
Adults
400 mg once daily (= 20 ml of the reconstituted suspension)
as a single dose or 2 times daily 200 mg (= 10 ml) at intervals
of 12 hours.
Elderly
No change in dose is needed for elderly patients, provided the
kidneys are normal.
Adolescents 12 years of age and older
Adolescents 12 years of age and older may be given the same
dose as adults.
Children under 12 years
Cefixime 8 mg / kg body weight / day, either as a single dose
or two divided doses 12 hourly.
The dosing recommendations are given in the following table:
Body weight Daily dose (ml) Daily dose (ml) daily dose
Once daily
Twice daily
(mg)
6.0 kg-9 kg
(for infants
above 6
months)

1 x 2.5 ml

2 x 1.25 ml

50 mg

10.0 kg

4 ml

2 x 2 ml

80 mg

12.5 kg

5 ml

2 x 2.5 ml

100 mg

15.0 kg

6 ml

2 x 3 ml

120 mg

17.5 kg

7 ml

2 x 3.5 ml

140 mg

20.0 kg

8 ml

2 x 4 ml

160 mg

22.5 kg

9 ml

2 x 4.5 ml

180 mg

25.0 kg

10 ml

2 x 5 ml

200 mg

27.5 kg

11 ml

2 x 5.5 ml

220 mg

30.0 kg

12 ml

2 x 6 ml

240 mg

37.5 kg

15 ml

2 x 7.5 ml

300 mg

>37.5 kg

20 ml

2 x 10 ml

400 mg

For adolescents and adults without swallowing problems, the
use of cefixime tablets is recommended.
Renal insufficiency
Cefixime may be administered in the presence of impaired
renal function. Normal dose and schedule may be given in
patients with creatinine clearances of 20 ml/min or greater.
In patients whose c reatinine c learanc e is less than
20 ml/min/1.73 m², it is recommended that a dose of 200 mg
once daily should not be exceeded.
In children under 12 years with a creatinine clearance of
<20 ml/min/1.73 m², a dose of 4 mg cefixime/kg body weight
should be given only once a day.
Preparation of the suspension
60 ml oral suspension: To reconstitute, use the plastic
measuring cup provided in the cardboard box. Add 40 ml of
water in two portions shaking after each addition.
100 ml oral suspension: To reconstitute, use the plastic
measuring cup provided in the cardboard box. Add 66 ml of
water in two portions shaking after each addition.
The reconstituted suspension is an almost white to pale yellow
viscous liquid.
Shake the medicine bottle well before each use.
A graduated plastic oral syringe is used for measuring the
required prescribed amount of suspension. The plastic oral
syringe is included in the package.
How to use the oral syringe:
1. Shake the bottle well before use and remove the bottle cap.
2. Remove the cap from the syringe and insert the syringe
into the bottle.
3. Pull the plunger up the barrel until the barrel’s rim is aligned
with the mark on the plunger corresponding to the required
dose.

Reporting of side effects
If you get 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 Yellow Card
Scheme,
Website: 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

4. Remove the syringe from the bottle.
5. With the patient seated in an upright position, place the tip
of the syringe just inside the patient's mouth, pointing towards
the inside of the cheek.
6. Press the plunger of the syringe in slowly to expel the
medicine without causing choking. Do NOT squirt the
medicine out in a jet.
7. Repeat steps 2-6 in the same way until the whole dose has
been given.
8. After giving the dose replace the bottle cap. Dismantle the
syringe and wash it thoroughly in fresh drinking water. Allow
the plunger and the barrel to dry naturally.
Duration of treatment
The usual course of treatment is 7 days. This may be continued
for up to 14 days according the severity of the infection.
For acute uncomplicated cystitis in women, the treatment
period is 1-3 days.
If you take more Cefixime than you should
If you or your child have taken more of this medicine than you
should, talk to your doctor or contact your nearest hospital
emergency department immediately.
If you forget to take Cefixime
If you forget to take a tablet, take it as soon as you remember.
However, if the next dose is due in less than 6 hours, skip the
missed dose and go back to your regular dosing schedule.
Do not take a double dose.
If you stop taking Cefixime
It is important that you take this medicine until you finish the
prescribed course. You should not stop taking Cefixime 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.

Keep this medicine out of the sight and reach of children.
Unreconstituted product should be stored below 25ºC.
Reconstituted suspension: The reconstituted suspension may
be stored for 14 days at ambient conditions (below 25ºC) or
refrigerated conditions.
Do not use this medicine after the expiry date which is stated
on the carton after EXP. The expiry date refers to the last day
of that month.
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 Cefixime contains
- The active substance is cefixime. Each 5 ml of reconstituted
oral suspension contains 111.9 mg of cefixime trihydrate
equivalent to 100 mg of cefixime (anhydrous).
- The other ingredients are: sucrose, xanthan gum, sodium
benzoate E211, flavour durarome orange (flavouring
ingredients, maltodextrin, sucrose, soy-lecithin E322, silicon
dioxide E551).
What Cefixime looks like and contents of the pack
Cefixime granules for oral suspension are almost white to pale
yellow granules.
The granules for oral suspension is immediate packed in a
150 ml brown neutral glass bottle Ph.Eur. Type III, supplied
with an aluminium screw cap with a polyethylene sealing.
Cardboard box contains one (1) bottle, one plastic
(polypropylene) measuring cup for reconstitution only
graduated on 40 ml or 66 ml, one plastic 5 ml oral syringe
for dosing with scale from 0.5 ml to 5 ml and graduations
on each 0.25 ml imprinted on the plunger of the syringe and
an instruction leaflet. Each bottle contains 32 g granules for
preparation of 60 ml oral suspension or 53 g granules for
preparation of 100 ml oral suspension.
Marketing Authorisation Holder

4. Possible side effects

INN-FARM d.o.o., Maleševa ulica 14, 1000 Ljubljana, Slovenia
Tel.: +386 70 390 711
Fax:+ 386 5191 116
e-mail: info@innfarm.si

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Manufacturer

The following side effects are important and will require
immediate action if you experience them. You should stop
taking Cefixime and see your doctor immediately if the
following symptoms occur:
Very rare (may affect up to 1 in 10,000 people):
• watery and severe diarrhoea that may also be bloody,
• sudden severe allergic reactions (anaphylactic shock) such
as skin rash or hives, itchiness, swelling of the face, lips,
tongue or other parts of the body, tightness of the chest,
wheezing and collapse,
• severe skin illness with blistering of the skin, mouth, eyes
and genitals (Stevens Johnson syndrome, toxic epidermal
necrolysis) (see section 2. What you need to know before
you take Cefixime - Warnings and Precautions).
Not known (frequency cannot be estimated from the available
date)
• Severe skin eruption, fever, enlarged lymph nodes, increase
in the numbers of white blood cells called eosinophils
(DRESS syndrome) (see section 2. What you need to know
before you take Cefixime - Warnings and Precautions).
The following side-effects have also been reported:
Common (may affect up to 1 in 10 people):
• diarrhoea.
Uncommon (may affect up to 1 in 100 people):
• headache,
• nausea,
• vomiting,
• abdominal (tummy) pain,
• changes in blood tests that check how your liver is working,

ALKALOID-INT d.o.o., Šlandrova ulica 4, 1231 Ljubljana –
Črnuče, Slovenia
Tel.: +386 1 300 42 90
Fax: +386 1 300 42 91
email: info@alkaloid.si
This medicine product is authorised in the Member states
of the EEA under the following names:
UK

Cefixime
100 mg/5 ml granules for oral suspension

Austria

Cefixim InnFarm
100 mg/5 ml Granulat zur Herstellung einer
Suspension zum Einnehmen

Czech Republic Cefixime InnFarm
100 mg/5 ml granule pro perorální suspenzi
Germany

Cefixim INN-Farm
100 mg/5 ml Granulat zur Herstellung einer
Suspension zum Einnehmen

Spain

XIFIA
100 mg/5 ml granulado para suspensión oral

Hungary

XIFIA
100 mg/5 ml granulátum
szuszpenzióhoz

Italy

Cefixima INN-FARM

Poland

XIFIA

Portugal

Cefixima InnFarm
100 mg/5 ml granulado para suspensão oral

Romania

XIFIA
100 mg/5 ml granule pentru suspensie orală

• skin rash.
Rare (may affect up to 1 in 1,000 people):
• an increased chance that you can get infections caused by
germs that cefixime does not act on. For example, thrush,
• increase in the numbers of white blood cells called
eosinophils,
• allergic reaction,
• loss of appetite,
• dizziness,
• flatulence (wind),
• itchy skin,
• inflammation of mucus (moist) linings such as the mouth
and / or other internal surfaces,
• fever,
• changes in blood tests that check how your kidneys are
working.
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),
• allergic reaction characterised by skin rashes, fever, joint
pains and enlarged organs,
• restlessness and increased activity,
• liver problems including jaundice (yellowing of the skin or
whites of the eyes),
• inflammation of the kidney.
Not known (frequency cannot be estimated from the available
date):
• rise in the number of blood platelets (thrombocytosis),
• fall in the number of a type of white blood cells (neutropenia),
• dyspepsia,
• skin rash or skin lesions with a pink/red ring and a pale
centre which may be itchy, scaly or filled with fluid. The rash
may appear especially on the palms or soles of your feet.
These could be signs of a serious allergy to the medicine
called ‘erythema multiforme’.

belsőleges

Slovak Republic Cefixime InnFarm
100 mg/5 ml, granulát na perorálnu suspenziu
PL 40168/0005
This leaflet was last revised in 03/2015.

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 medicine:
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 medicines
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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