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CEFALEXIN 500 MG CAPSULES

Active substance(s): CEFALEXIN MONOHYDRATE

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Cefalexin 500mg Capsules
Cefalexin
The name of your medicine is Cefalexin 500 mg capsules,
which will be referred to as Cefalexin throughout the rest of
this document.
Read all of this lea et carefully before you start taking
this medicine.
• Keep this
t. 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 sid
ects gets serious, or if you notice any
si
ects not listed in this l et, please tell your doctor
or pharmacist.

In this lea et:
1 What Cefalexin is and what it is used for
2 Before you take Cefalexin
3 How to take Cefalexin
4 Possible side e ects
5 How to store Cefalexin
6 Further information

1 What Cefalexin is and what it is used for
Cefalexin is an antibiotic. It belongs to a group of
antibiotics that are called cephalosporins. These types of
antibiotics are similar to penicillin.
Cefalexin kills bacteria and it can be used against various
sorts of infections. Like all antibiotics, Cefalexin is only
ective against some types of bacteria. So, it is only
suitable for treating some types of infection.
Cefalexin can be used to treat:
• Acute throat and ear infections
• Chest infections such as acute bronchitis and some
types of pneumonia
• Kidney and bladder infections
• Acute infection of the prostate gland
• Infections in the skin and layers just under the skin
• Infections of the bones and joints

2 Before you take Cefalexin
Do not take Cefalexin if:
• you are allergic (hypersensitive) to cefalexin, or
to any of the other ingredients of this medicine (see
Further Information in Section 6).
• you are allergic (hypersensitive) to any other
cephalosporin type of antibiotic or to any sort of
penicillin antibiotic.
Not all people who are allergic (hypersensitive) to
penicillins are also allergic to cephalosporins. However,
you should not take this medicine if you ever had a severe
allergic reaction to any penicillin. This is because you
might also be allergic to this medicine.
An allergic (hypersensitive) reaction may include rash,
itching, di culty in breathing or swelling of the face, lips,
throat or tongue.

Take special care with Cefalexin if you:
• ever have had an allergic (hypersensitive) reaction
to any antibiotic . Tell your doctor or pharmacist before
you take this medicine.
• have ever had in ammation of your bowel, called colitis
or any other severe dis
ecting your gut.
• have ever been told that your kidneys do not work very
well. You may take Cefalexin but you may need a lower
dose.
continued top of next column

This medicine can alter the results of some blood tests
(such as cross-matching blood and the Coombs’ test). It
is important to tell your doctor that you are taking this
medicine if you have to have these tests.
This medicine can also alter the results of urine tests for
sugar (such as Benedict’s or Fehling’s tests or with copper
sulphate test tablets). If you have diabetes and routinely
test your urine, tell your doctor. This is because other tests
may have to be used to monitor your diabetes while you
are having this medicine.
Cefalexin is not suitable for everyone. Before treatment
with Cefalexin, talk to your doctor or pharmacist if any of
the above applies to you.
If you have been on Cefalexin treatment for a prolonged
period, it may result in the overgrowth of organisms on
which Cefalexin does not act. This may need for you to be
treated by other antimicrobial agents.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken other medicines, including medicines
obtained without a prescription.
In particular, tell your doctor or pharmacist if you are
taking the following medicines which are known to
interact with Cefalexin:
• probenecid (a medicine used in the treatment of gout)
• metformin ( a medicine used in the treatment of
diabetes)
It may still be all right for you to be given Cefalexin and
your doctor will be able to decide what is suitable for you.

Taking Cefalexin with food and drink
Cefalexin can be taken regardless of meals.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking
any medicine.
Before starting treatment, you must tell your doctor if
you are pregnant or if you intend to become pregnant.
Cefalexin is not known to harm the unborn child, but
has not been deemed as safe. It will only be given to a
pregnant woman if it is absolutely necessary.
Mothers who wish to breast-feed should discuss with
their doctor, as small amounts of Cefalexin enters the
milk. Inform your doctor if your baby develops diarrhoea
or if you notice anything unusual.

Driving and using machines
ect your ability to drive or
Cefalexin does not usual
use machines. However, if you feel light-headed or dizzy,
do not drive or use machines and check with your doctor.
Important information about some of the ingredients
of Cefalexin
Cefalexin contains colouring agents including Brilliant
Blue FCF (E133) and Sunset yellow FCF (E110), which
may cause allergic (hypersensitive) reactions.

3 How to take Cefalexin
Dosage
Always take Cefalexin exactly as your doctor has told you.
You should check with your doctor or pharmacist if you
are not sure.
The usual dose is:
Adults and the elderly with normal kidney function
The recommended adult dosage range for Cefalexin
is 1 g to 4 g per day, given daily in divided doses. In the
majority of infections, Cefalexin is given in a dose of 500
mg every 8 hours (three times a day).
For treating infections in the skin and the layers just under
the skin, streptococcal pharyngitis (sore throat), and mild,
uncomplicated urinary tract infections, Cefalexin is given
in a dosage of 250 mg every 6 hours (four times a day) or
500 mg every 12 hours (twice daily).
For more severe infections, larger doses may be needed.
continued over page

Adults (including the elderly) with impaired kidney
function
In patients with impaired kidney function, the
dosage of Cefalexin is usually reduced.
Children
The dose for children is based on their weight. The
usual dosage range for children is 25 mg to 50 mg
per kg body weight daily, given in divided doses.
For infections in the skin and the layers just under
the skin, streptococcal pharyngitis, and mild,
uncomplicated urinary tract infections, the total
daily dose may be divided and administered every
12 hours.
For most infections, the following schedule is
suggested:
• Children under 5 years : 125 mg every 8 hours.
• Children 5 years and over : 250 mg every 8 hours.
In severe infections, the dose may be doubled. In the
therapy of otitis media (middle ear infection), a daily
dose of 75 to 100 mg per kg bodyweight in 4 doses
is given.

Method and/or route(s) of administration
Cefalexin comes as a capsule to be taken orally. The
capsules should be swallowed whole and taken with
a full glass of water.

Frequency of administration
Depending on various factors, you may be asked
to take Cefalexin every 6 hours (four times a day) or
every 8 hours (three times a day) or every 12 hours
(twice a day).

Duration of treatment
Your doctor will advise you on how long your
treatment should last. The duration of therapy
depends on the type and course of the disease.
In the treatment of beta-haemolytic streptococcal
(a type of bacteria) infections in adults and children,
treatment with Cefalexin is usually given for at least
10 days.

If you take more Cefalexin 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.
Symptoms of overdose may include nausea (feeling
sick), severe vomiting, pain in the upper abdomen,
diarrhoea and passing blood in the urine. In addition
to treatment of the symptoms of overdose, the
doctors may also try to reduce the levels of Cefalexin
in the blood by dialysis.

If you forget to take Cefalexin
If you miss a dose, take it as soon as possible.
However if it is nearly time for your next dose, skip
the missed dose and carry on as before. Do not take
a double dose to make up for a forgotten dose.

If you stop taking Cefalexin
It is important that you take this medicine until you
nish 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
product, ask your doctor or pharmacist.

4 Possible side e ects
Like all medicines, Cefalexin can cause sid
ects,
although not everybody gets them.
The following sid
ects are important and will
require immediate action if you experience them.
You should stop taking Cefalexin and see your
doctor immediately if the following symptoms occur:
Rare sid
ects a ect fewer than 1 in 1,000 patients
• swelling of the face, tongue and windpipe which
can cause great di culty in breathing
• a sudden allergic reaction with shortness of breath,
rash, wheezing and drop of blood pressure
• severe, extensive, blistering skin rash
• watery and severe diarrhoea that may also be
bloody
continued top of next column

The following side- ects have also been reported:
ects (a ect less than 1 in 10 people)
Common sid
include:
• Nausea
• diarrhoea
ect
ect less than 1 in 100
Uncommon sid
people) include:
• Skin rash, hives, itching
• changes in blood tests that check how your liver is
working
Rare s
ects (a ect less than 1 in 1000 people)
include:
• fall in the numbers o
erent cells in the blood
(symptoms can include susceptibility to new
infections, easy bruising or bleeding, pallid
appearance or shortness of breath caused by
anaemia)
• headaches, dizziness
• discharge and itch of the vagina and surrounding
skin
• abdominal pain, vomiting, indigestion
• liver problems that may lead to jaundice (yellowing
of the skin or whites of the eyes)
• kidney problems
Other s
ects ( ecting an unknown number of
people) include:
• tiredness, hallucinations, restlessness, confusion
• painful joints
• vaginal thrush
If you are having a blood test or a urine test for any
reason, tell the person who is doing the test that you
are taking this medicine as it may ect your result.
If any of the side e ects gets serious, or if you
notice any side ects not listed in this l
et,
please tell your doctor or pharmacist.

5 How to store Cefalexin
Keep out of the sight and reach of children.
This medicine does not require any special storage
conditions. Keep container tightly closed.
Do not use Cefalexin after the expiry date which is
stated on the carton. The expiry date refers to the last
day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicine no longer required. These
measures will help to protect the environment.

6 Further information
What Cefalexin contain:
The active substance is Cefalexin. Each capsule
contains, as the active ingredient, Cefalexin
monohydrate equivalent to 500 mg of Cefalexin
base.
The other ingredients are- capsule contents:
Cellulose Microcrystalline, Croscarmellose Sodium,
Magnesium Stearate; capsule shell: Sodium
laurilsulfate, Brilliant Blue FCF (E 133) and Sunset
yellow FCF (E110), Titanium dioxide, gelatin and
black printing ink (containing shellac, propylene
glycol, potassium hydroxide and iron oxide, black
(E172)).

What Cefalexin looks like and contents of
the pack
Cefalexin capsules are hard gelatin capsules with
a green coloured opaque cap and opaque white
coloured body, imprinted with black “CEF” on cap &
“500“ on body lled with white to
ite granular
powder.
The products ar lled into plastic bottles 20 or 100
capsules, or blister packs of 21 or100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer

DAWA Ltd.
5 Sandridge Close,
Harrow, Middlesex HA1 1XD,
United Kingdom.
This l

et was last revised in August 2012

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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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