CEFALEXIN 250MG CAPSULES

Active substance: CEFALEXIN MONOHYDRATE

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SZ00000LT000

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cefalexin Capsules 250 mg or 500 mg
(cefalexin)
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, pharmacist or dentist (if the medicine has
been prescribed by your dentist).
• 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 gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor, pharmacist or dentist (if the medicine has been prescribed by your
dentist).
In this leaflet:
1. What Cefalexin Capsules are and what
they are used for
2. Before you take Cefalexin Capsules
3. How to take Cefalexin Capsules
4. Possible side effects
5. How to store Cefalexin Capsules
6. Further information
Taking other medicines
Please inform your doctor if you are taking or
have recently taken any other medicines, even
those not prescribed, particularly:
The name of your medicine is Cefalexin Capsules. • Uricosuric drugs (medicines used to treat gout
and other conditions which require lowering of
This medicine belongs to a family of medicines
blood uric acid levels, e.g. probenecid).
called antibiotics. Antibiotics are used to kill the
• Diuretics (medicines which reduce water
bacteria or “germs” which cause infections.
retention by increasing the volume of urine,
e.g. furosemide, ethacrynic acid).
Your doctor, or dentist, will have prescribed this
• Anticoagulants (medicines that prevent the
medicine for treating an infection. Cefalexin
clotting of blood, e.g. warfarin).
Capsules are used for treating a variety of
• Any other antibiotics (eg. aminoglycosides,
infections including chest (respiratory tract),
polymyxin, colistin).
urinary tract, skin and soft tissues, ear, and other
• If you are taking metformin (a medicine used
infections due to sensitive organisms.
to treat diabetes).

1

What Cefalexin Capsules are and
what they are used for

2

Before you take Cefalexin Capsules Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.

Do not take this medicine before telling your
Driving and using machines
doctor if:
• You are allergic to cefalexin or other antibiotics Do not drive or operate machines if this medicine
affects your ability to drive or to use machines.
and medicines.
• You are allergic to any of the other ingredients
in this medicine.
Take special care with Cefalexin Capsules if:
• You are pregnant or breast-feeding. Your doctor
will decide whether it is safe for you to take this
medicine while you are pregnant or breast-feeding.
• You have problems with your kidneys.
• You test your urine for glucose using a method
which is not based on glucose oxidation
reactions as this medicine might give a false
positive result.
• You are taking oral contraceptives. Cefalexin
may reduce the efficacy of oral contraceptives
and you may need additional contraceptive
measures whilst taking this medicine.
If any of the above apply to you or you are
unsure, please talk to your doctor before taking
the capsules.

3

How to take Cefalexin Capsules

Swallow each capsule whole with a drink of
water. Try to space the doses as evenly as
possible throughout the day. For example if you
have been told to take your medicine three times
a day in 8 hour intervals, then:
Take your first dose when you wake up, e.g. 7.00 am
Take your next dose mid-afternoon, e.g. 3.00 pm
Take your last dose just before you go to bed,
e.g. 11.00 pm
Dosage Instructions
Your doctor will tell you how much to take and
how often. Do not take more than the dose your
doctor has recommended.
Continued on the next page >>

Artwork Proof Box
A healthy decision
Sandoz Ltd,
37 Woolmer Way, Bordon,
Hampshire, GU35 9QE,
United Kingdom.
T: 01420 478301
F: 01420 474427
W: www.uk.sandoz.com
E: sandozartwork2@btconnect.com

Ref: Type II Variation - update excipients (generic PIL)
Proof no.
2u

Date prepared:
03/08/2009

Prepared by:
DW

RA Approved?
Yes

Date approved:
03/08/2009

Approved by:
RT

Colours:
Black
Black 20%

Fonts:
Helvetica

Dimensions: 175 x 315 mm

PROPOSED
MOCK UP

Artwork/RA Checklist:
Product name
Strength/dosage

Font size: 10pt
Pack size
PL number
Storage

Warnings
Excipients
Braille

Adults
The usual dose for adults is 1-4g daily in divided
doses. For most infections the dose will be
500 mg (2 x 250 mg capsules or 1 x 500 mg
capsule) every 8 hours. This may vary
depending on the type of infection you have. For
example a dose of 250 mg (1 x 250 mg capsule)
taken every 6 hours or 500 mg (2 x 250 mg
capsules or 1 x 500 mg capsule) every 12 hours
is used to treat skin, soft tissue, throat or urinary
tract infections. Larger doses may be used to
treat more severe infections, or those caused by
less susceptible organisms.










Elderly
The dosage for the elderly is the same as for
adults, but may be reduced if you have poor
kidney function.

If you experience these or any other unusual or
unexpected symptoms, tell your doctor or
pharmacist.

Children
The dose for children is based on their weight
and is usually 25-50 mg/kg in divided doses.
The dose or frequency may vary.

Itching around the genitals or anus
Thrush or discharge from the vagina
Dizziness
Tiredness
Headache
Agitation, confusion and hallucinations
Pain or swelling in the joints
Kidney disorders or blood disorders, including
an increase or decrease in the number of
white blood cells, and a decrease in the
number of platelets. Symptoms of blood
disorders include tiredness, sore throat,
bruising easily and susceptibility to infection.

5

How to store Cefalexin Capsules

Keep all medicines out of the reach and sight of
children.

Keep taking your medicine until the course is
Store in the original packaging, in order to
finished. Do not stop taking your medicine just
because you feel better. If you stop too soon the protect the capsules from light and moisture.
infection may start up again.
Do not store above 25°C.
If your symptoms persist, tell your doctor.
Your medicine should not be used after the
If you take more Cefalexin Capsules than you expiry date printed on the pack.
should
Always take your medicine as recommended by Unless your doctor advises otherwise, any
your doctor. If you take too much medicine, tell
unused medicine should be returned to your
your doctor immediately or go to your local
local pharmacist for safe disposal.
hospital emergency department.

6

If you forget to take Cefalexin Capsules.
Further information
If you miss a dose, take another as soon as you
remember and then carry on as before. Do not
take a double dose to make up for a forgotten dose. What Cefalexin Capsules contain:
The active ingredient in Cefalexin Capsules is
either 250mg or 500mg of cefalexin. The
capsules also contain magnesium stearate and
Possible side effects
cellulose microcrystalline (E460).

4

All medicines sometimes cause unwanted
effects in some people. Tell your doctor if you
think your medicine is making you feel unwell or
if you get any of the following side effects;

The capsule shells contain gelatine, erythrosine
(E127), quinoline yellow (E104), black iron oxide
(E172), titanium dioxide (E171), shellac (E904)
and propylene glycol (E1520).

An allergic reaction which may occur as
• a rash on your skin (which might be severe)
• sudden wheeziness or tightness of the chest
• swelling of your eyelids, lips or face
• skin lumps and hives

Different pack sizes of Cefalexin Capsules are
available:
Cefalexin Capsules 250 mg come in blister
packs of (14, 21, 28, 30 or 56 capsules) in
plastic containers of (12, 20, 21, 24, 28, 50, 100,
250 or 500 capsules),

If you think you are having an allergic reaction
stop taking your medicine and tell your doctor
immediately or go to your hospital emergency
department as severe allergic reactions may
require emergency treatment.
• A feeling of sickness or being sick
• Diarrhoea (which may be bloody) or stomach
pains
• Reversible liver disorder or jaundice (yellowing
of the skin and eyes)

Cefalexin capsules 500 mg come in blister packs
of (14, 15, 20, 21, 28, 30 or 56 capsules) in
plastic containers of (12, 15, 20, 21, 24, 28, 50,
100, 250 or 500 capsules)
Product licence holder and manufacturer:
Sandoz GmbH, A 6250 Kundl, Tirol, Austria.
This leaflet was last approved in 08/2009 (to be
amended after approval).
SZ00000LT000

Artwork Proof Box
A healthy decision
Sandoz Ltd,
37 Woolmer Way, Bordon,
Hampshire, GU35 9QE,
United Kingdom.
T: 01420 478301
F: 01420 474427
W: www.uk.sandoz.com
E: sandozartwork2@btconnect.com

Ref: Type II Variation - update excipients (generic PIL)
Proof no.
2u

Date prepared:
03/08/2009

Prepared by:
DW

RA Approved?
Yes

Date approved:
03/08/2009

Approved by:
RT

Colours:
Black
Black 20%

Fonts:
Helvetica

Dimensions: 175 x 315 mm

PROPOSED
MOCK UP

Artwork/RA Checklist:
Product name
Strength/dosage

Font size: 10pt
Pack size
PL number
Storage

Warnings
Excipients
Braille

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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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