KEFLEX TABLETS 500MG

Active substance: CEFALEXIN MONOHYDRATE

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Package leaflet: Information for the user

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Keflex Tablets and
Capsules
250mg & 500mg

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Skin and soft tissue (e.g. muscle) infections
Bone and joint infections
Infections of the reproductive organs and urinary
tract (e.g. cystitis), including acute inflammation of
the prostate (prostatitis)
Dental infections.

Cefalexin
The name of your medicine is Keflex Tablets and
Capsules 250mg and 500mg, which will be referred to
as Keflex throughout this document.
Read all of this leaflet carefully before you start
taking this medicine.
I Keep this leaflet. You may need to read it again.
I If you have any further questions, ask your doctor
or pharmacist.
I 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.
I If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1. What Keflex is and what it is used for
2. Before you take Keflex
3. How to take Keflex
4. Possible side effects
5. How to store Keflex
6. Further information

1 What Keflex is and what it is used for
Keflex contains the active ingredient cefalexin
monohydrate, which is an antibiotic.
Keflex is used to treat the following infections caused by
bacteria that can be killed by cefalexin:
I Respiratory tract (lung and airways) infections
e.g. tonsillitis, pharyngitis and bronchitis
I Middle ear infection (otitis media)

2 Before you take Keflex
Do not take Keflex if
I you are allergic (hypersensitive) to cefalexin, other
cephalosporins (similar antibiotics) or any of the other
ingredients (these are listed in Section 6). An allergic
reaction may include rash, itching, difficulty breathing
or swelling of the face, lips, throat or tongue.
Take special care with Keflex if you
I have had an allergic reaction to cefalexin,
cephalosporins, penicillins, or other drugs in the past
I develop diarrhoea
I have a severe kidney disorder (you may need a
reduced dose).
Tell your doctor if you are having blood or urine tests.
Keflex may interfere with these tests.
Taking other medicines
Please tell your doctor or pharmacist if you are taking,
or have recently taken, any other medicines, including
medicines obtained without a prescription. This is
especially important of the following, as they may
interact with your Keflex:
I probenecid (a treatment for gout)
I metformin ( a treatment for diabetes)
I drugs used to treat leukaemia.
It may still be all right for you to be given Keflex and
your doctor will be able to decide what is suitable for you.
Pregnancy and breast-feeding
You should tell your doctor if you are pregnant or
breast-feeding. Ask your doctor or pharmacist before
taking any medication.

Driving and using machines
Keflex should not affect your ability to drive or
use machines.

3 How to take Keflex
Always take Keflex exactly as your doctor has told you.
You should check with your doctor or pharmacist if you
are not sure.
Dosage
Adults and the elderly
The usual total daily dose is 1-4g orally daily, in
divided doses.
I Most infections can be treated by 500mg every
8 hours. For skin and soft tissue infections, sore throat
(streptococcal pharyngitis), and mild, uncomplicated
urinary tract infections, the usual dose is 250mg
every 6 hours, or 500mg every 12 hours.
I For more severe infections, larger doses may be
needed. A reduced dose is needed for patients with
severe kidney disorders.
The usual total daily dose for children is 25-50mg/kg
(body weight) in divided doses.
I For skin and soft tissue infections, 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: 125mg every 8 hours.
Children 5 years and over: 250mg every 8 hours.
In severe infections, the dose may be doubled. In the
treatment of middle ear infections, a total daily dose of
75 to 100mg/kg in 4 doses is required.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, Keflex can cause side effects,
although not everybody gets them. All medicines can
cause allergic reactions, although serious allergic
reactions are very rare.
Tell your doctor immediately if you get any sudden
wheeziness, difficulty in breathing, swelling of the
eyelids, face or lips, rash or itching (especially
affecting your whole body).
Serious side effects
The following side effects are serious. You should
stop taking this medicine and contact your doctor
immediately if you experience them:
I serious peeling or blistering of the skin
I severe diarrhoea.
The following side effects have been reported
I diarrhoea
I feeling sick (nausea)
I vomiting
I indigestion
I stomach pains
I measle-like rash, (alone)
I itching
I red wheals on the skin (urticaria) (alone)
I rash with wide spread joint pain and / or stiffness,
swollen lymph glands, fever and, possibly,
cloudy urine
I changes in blood counts, which may show up as
bruising or a very tired feeling. You will need a
blood test to confirm this.
I damage to your liver or kidneys which can only be
detected by a blood and / or urine test
I jaundice (yellow skin and eyes)
I weakness
I fainting
I abnormally excitable behaviour
I agitation
I tiredness

headache
confusion
I dizziness
I seeing or hearing things (hallucinations)
I itching of the vagina or anus caused by thrush
(candidiasis).
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
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5 How to store Keflex
Keep out of the sight and reach of children.
Tablets and capsules:
Do not store above 30°C.
Keep containers tightly closed.
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 Keflex contains
The active substance is cefalexin monohydrate.
The other ingredients are:
sodium starch glycollate type A, pregelatinised maize
starch (250mg tablet only), starch dry-flow (250mg
tablet only), stearic acid (250mg tablet only), maize
starch (250mg tablet only), magnesium stearate,
povidone (500mg tablet only),
methylhydroxypropylcellulose, glycerol, talc, titanium
dioxide, iron oxide yellow, iron oxide red, cellulose with
sodium carboxymethylcellulose, dimeticone, magnesium
stearate, patent blue V, quinoline yellow, titanium
dioxide, gelatin.

What Keflex looks like and contents of the pack
Tablets:
Plastic bottles of 20, 100 and 500 tablets, or blister
strips of 28 tablets. The 500mg tablets may be packed
into blisters of 3, 4, 21 or 28 tablets.
Capsules:
Plastic bottles of 20, 100 and 500 capsules, or blister
strips of 28 capsules. The 500mg capsules may be
packed into blisters of 21 or 28 capsules.
250mg tablets are peach and marked GP3.
500mg tablets are peach and marked GP4.
250mg capsules are green and white and marked GP1.
500mg capsules are pale green and dark green and
marked GP2.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Flynn Pharma Ltd
Alton House
4 Herbert Street
Dublin 2
Ireland
Manufacturer
Facta Farmaceutici SpA
Via Laurentina, Km 24
Pomezia 00040
Rome
Italy
This leaflet was last revised in
October 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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