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CEFALEXIN 250MG/5ML POWDER FOR ORAL SUSPENSION

Active substance: CEFALEXIN MONOHYDRATE

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PATIENT INFORMATION LEAFLET

CEFALEXIN 125mg/5ml POWDER FOR ORAL SUSPENSION
CEFALEXIN 250mg/5ml POWDER FOR ORAL SUSPENSION
(cefalexin monohydrate)
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 get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor.
IN THIS LEAFLET
1. What Cefalexin Oral Suspension is and what it is used for
2. Before you take Cefalexin Oral Suspension
3. How to take Cefalexin Oral Suspension
4. Possible side effects
5. How to store Cefalexin Oral Suspension
6. Further information

1.

WHAT CEFALEXIN ORAL SUSPENSION
IS AND WHAT IT IS USED FOR

Cefalexin belongs to a class of antibiotics called
“cephalosporins” which are used to treat a variety
of bacterial infections.
Cefalexin Oral Suspension is used to treat
infections of the airways from nose to lung, ear,
bones and joints and urine or reproduction
systems, including inflammation of the prostate
gland. It is also used to treat dental infections.

2.

BEFORE YOU TAKE CEFALEXIN
ORAL SUSPENSION

Do not take Cefalexin Oral Suspension if you
have:
an allergy (hypersensitivity) to the cephalosporin
group of antibiotics, or to any of the ingredients in
the product (see Section 6 and end of Section 2)
porphyria; a hereditary metabolic disorder
Take special care with Cefalexin Oral Suspension
if you have:
kidney problems, inflammation of the large
intestine, symptoms include: diarrhoea, pain and
fever.
You should be aware that Cefalexin Oral
Suspension may give a false result for: certain
blood tests (i.e. Coombe’s test), tests for glucose
in the urine.
Taking other medicines
Please inform your doctor if you are taking or
have recently taken any other medicines,
including those obtained without a prescription.
In particular, tell your doctor if you are taking any
of the following:
other antibiotics, especially amphotericin,
capreomycin, vancomycin, aminoglycosides- a
broad spectrum antibiotic (for example,
gentamicin or neomycin)
loop diuretics (water tablets).
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or planning to
become pregnant. Cefalexin passes into breast
milk; ask your doctor for advice before taking any
medicine.
Driving and using machines
Cefalexin Oral Suspension is not expected to
affect your ability to drive or operate machinery.
Important information about some of the
ingredients of Cefalexin Oral Suspension
Sorbitol (each 5ml spoonful contains 900mg)the medicine is unsuitable if you have hereditary
fructose intolerance, and can cause stomach
upset and diarrhoea.

Sodium benzoate- this can cause irritation to the
mucous membranes which line your mouth,
stomach and intestines. If you are sensitive to
sodium benzoate, you may notice slight
discomfort after taking the suspension. It can also
increase the risk of jaundice in newborn babies.
Sodium- may be harmful to people on a low
sodium diet.

3.

HOW TO TAKE CEFALEXIN ORAL
SUSPENSION

For oral use only.
You must take this medicine exactly as your
doctor has told you to. The pharmacist’s label will
tell you how much to take and when.
The usual adult dose is 500mg every 8 hours,
although your doctor may advise taking 1g to 4g a
day- split into smaller doses. For certain
infections, 250mg every 6 hours or 500mg every
12 hours may be required.
If you are elderly, take the normal adult dose,
unless you have severe kidney problems when
the maximum daily dose will be 500mg.
Children can take Cefalexin Oral Suspension.
The doctor will calculate the correct dose for them
depending on their body weight. The usual daily
dose is 25mg to 50mg for each kilogram of their
weight, split into smaller amounts taken every 8
or 12 hours. If your child is taking this medicine
for an ear infection, he or she may have to take
75mg to 100mg for each kilogram of their weight,
split into smaller doses throughout the day.
For most infections the following is recommended:
Children under 5 years: 125mg every 8 hours.
Children 5 years and over: 250mg every 8 hours.
Take all the suspension your doctor has given
you, even if you feel better.
If you take more Cefalexin Oral Suspension
then you should
Contact your doctor or nearest hospital casualty
department if you or a child has swallowed too
much medicine. Take this leaflet and any
remaining suspension with you, if possible.
Symptoms of overdose include nausea, vomiting,
stomach upset, appearance of blood in the urine.
If you forget to take Cefalexin Oral
Suspension
If you miss a dose, take the suspension as soon
as you remember. If it is almost time to take the
next dose, wait until then and then carry on as
before (do not take a double dose to make up for
the forgotten one).

If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

to give an orange suspension with an odour of
orange.
Both suspensions are supplied in plastic bottles of
100ml.

Like all medicines, Cefalexin Oral Suspension can
cause side effects, although not everyone gets
them.

Marketing Authorisation Holder
Athlone Pharmaceuticals Limited, Ballymurray,
Co. Roscommon, Ireland.

You may suffer an allergic reaction, symptoms
of which include rash, itching, difficulty in
breathing or swelling of the face, lips, throat
or tongue. If this happens to you, stop taking
the suspension immediately and seek medical
help.

Distributor
Kent Pharmaceuticals Limited, Repton Road,
Measham, DE12 7DT, U.K.

The following may also be experienced:
• blood abnormalities
• hepatitis (inflammation of the liver), cholestatic
jaundice (yellowing of the skin and whites of
the eyes)
• inflammation of the kidney
• colitis (inflammation of the colon)
• severe skin reactions such as erythema
multiforme, Stevens-Johnson syndrome
• itching round the anus or genitals, inflamed
vagina or unusual discharge from the vagina
• nausea, vomiting, indigestion, stomach pain,
diarrhoea
• painful or swollen joints, extreme muscle
tension
• dizziness, tiredness and headache, sleep
disorders, nervousness
• feeling agitated, confused, extreme
restlessness
• hallucinations
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor.

5.

HOW TO STORE CEFALEXIN ORAL
SUSPENSION

KEEP OUT OF THE REACH AND SIGHT OF
CHILDREN
Dry powder: Store below 25°C, tightly closed in
the container.
Made-up suspension: Store at 2-8°C. Discard any
unused medicine after 14 days.
Do not use Cefalexin Oral Suspension after the
expiry date stated on the pack.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.

6.

FURTHER INFORMATION

What Cefalexin Oral Suspension contains
The active substance is cefalexin monohydrate,
125mg or 250mg in a 5ml spoonful.
The other ingredients are sodium benzoate
(E211), disodium edetate, citric acid, sodium
citrate, sorbitol powder, saccharin sodium,
colloidal silicon dioxide, monoammonium
glycyrrhizinate and xanthan gum.
The 125mg/5ml suspension contains colour E127
(erythrosine) and strawberry flavour. The
250mg/5ml suspension contains colour E104
(quinoline yellow) and orange flavour.
What Cefalexin Oral Suspension looks like
and contents of the pack
125mg/5ml powder- pale pink, free flowing
granular powder, which readily mixes in water to
give a pink suspension with a flavour of
strawberry.
250mg/5ml powder- pale orange, free flowing
granular powder, which readily disperses in water

This leaflet was last revised in August 2011.

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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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