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KEFLEX SUSPENSION 125MG/5ML

Active substance(s): CEFALEXIN MONOHYDRATE

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Package leaflet: Information for the user



Keflex Suspension
125mg & 250mg/5ml





Cefalexin
The name of your medicine is Keflex Suspension 125mg
& 250mg/5ml, which will be referred to as Keflex
suspension throughout this document.
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 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 suspension is and
what it is used for
2. Before you take Keflex suspension
3. How to take Keflex suspension
4. Possible side effects
5. How to store Keflex suspension
6. Further information

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



Middle ear infection (otitis media)
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.

2 Before you take Keflex suspension
Do not take Keflex suspension if
■ 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 suspension if you
■ have had an allergic reaction to cefalexin,
cephalosporins, penicillins, or other drugs in the past
■ develop diarrhoea
■ have a severe kidney disorder (you may need a
reduced dose).
Tell your doctor if you are having blood or urine tests.
Keflex suspension 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 suspension:
■ probenecid (a treatment for gout)
■ metformin ( a treatment for diabetes)
■ drugs used to treat leukaemia.
It may still be all right for you to be given Keflex
suspension 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 suspension should not affect your ability to drive
or use machines.
Important information about the ingredients of
Keflex suspension
Keflex suspension contains sucrose. If you have been told
by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.
Keflex suspension contains allura red (E129) which may
cause allergic reactions.

3 How to take Keflex suspension
Always take Keflex suspension exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
The bottle is turned upside down and tapped to loosen
the powder. Then a total of 60ml water in two portions
is added, shaking after each addition until all the
powder is in suspension. The suspension should be
shaken well before use.
Your pharmacist should make up the suspension before
you are given it.
Dosage
Adults and the elderly
The usual total daily dose is 1-4g orally, in
divided doses.
■ 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.

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.
■ For skin and soft tissue infections, sore throat, 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 suspension 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:
■ serious peeling or blistering of the skin
■ severe diarrhoea.

The following side effects have been reported
diarrhoea
■ feeling sick (nausea)
■ vomiting
■ indigestion
■ stomach pains
■ measle-like rash, (alone)
■ itching
■ red wheals on the skin (urticaria) (alone)
■ rash with wide spread joint pain and / or stiffness,
swollen lymph glands, fever and, possibly,
cloudy urine
■ changes in blood counts, which may show up as
bruising or a very tired feeling. You will need a blood
test to confirm this.
■ damage to your liver or kidneys which can only be
detected by a blood and / or urine test
■ jaundice (yellow skin and eyes)
■ weakness
■ fainting
■ abnormally excitable behaviour
■ agitation
■ tiredness
■ headache
■ confusion
■ dizziness
■ seeing or hearing things (hallucinations)
■ 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.


5 How to store Keflex suspension
Keep out of the sight and reach of children.
Do not store above 25°C.
After mixing, Keflex suspension should be stored in a
cool place (6°C-15°C) or in a refrigerator (2°C-8°C) and
be used within 10 days.

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 suspension contains
The active substance is cefalexin monohydrate.
The other ingredients are:
sucrose, imitation guarana flavour, allura red AC,
sodium lauryl sulphate, methylcellulose 15, dimeticone,
xanthan gum and pregelatinised starch
What Keflex suspension looks like and
contents of the pack
100 ml plastic bottles with screw caps.
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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