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CEFALEXIN 250MG/5ML POWDER FOR ORAL SUSPENSION

Active substance(s): CEFALEXIN / CEFALEXIN MONOHYDRATE / CEFALEXIN / CEFALEXIN MONOHYDRATE / CEFALEXIN / 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 because it
contains important information for you.
- 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 only. Do not pass it on to others. It
may harm them, even of their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
IN THIS LEAFLET:
1. What Cefalexin Oral Suspension is and what it is used for
2. What you need to know 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. Contents of the pack and other 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. WHAT YOU NEED TO KNOW 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).
• medication for leukameia
Pregnancy,breast-feeding and fertility
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.
Adults: 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.
Elderly: you should take the normal adult dose, unless you have severe kidney problems
when the maximum daily dose will be 500mg.
Children: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.

If you stop taking your medicine
Keep taking this medicine until your doctor tells you to stop. DO NOT stop taking it just
because you feel better. If you stop taking this medicine, your infection may return or get
worse.
If you take more Cefalexin Oral Suspension then you should
Contact your doctor or nearest hospital casualty department if you (or someone else) has
swallowed too much medicine. Take this leaflet and any remaining suspension with you,
to the hospital. 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
Like all medicines, Cefalexin Tablets can cause side effects, although not everyone gets them.
STOP taking your medicine immediately and contact your doctor if you experience:
• rash, fever, itchy skin, swelling of the lips, eyes, tongue or difficulty breathing. These are the
signs of an allergic reaction. Stop taking the Tablets immediately
Serious side effects
The following side effects are serious. You should stop taking this medicine and contact your
doctor immediately if you experienced them:
• flaky or peeling skin, swelling of the skin, red or purple inflamed skin patches; pus in your
eyes; blisters in your nose or mouth, severe skin rash with flushing, fever, blisters or ulcers
(Stevens-Johnson syndrome), reddening, peeling and swelling of the skin that looks like a
burn (toxic epidermal necrolysis)
• blood disorders (if you bruise more easily, have a sore throat, fever or a chill)
• lower gut pain, nausea, vomiting, severe diarrhoea containing blood or mucus. Colitis
(inflammation of the colon) can also occur during or after treatment
• liver damage, for example jaundice (yellowing of the skin and whites of eyes), transient
hepatitis
• nephritis (inflamed kidneys).
Tell your doctor if you suffer from any of the following for more than a few days:








feeling or being sick, vomiting, heartburn, stomach pains, diarrhoea
skin rashes
dizziness, tiredness, headache, sleep disorders, nervousness
feeling confused or agitated, hallucinations, hyperactivity, nausea
painful or swollen joints, extreme muscle tension
itching around the anus or genitals, inflamed vagina, discharge from the vagina.

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. CONTENTS OF THE PACK AND OTHER 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 to give an orange suspension with an odour of orange.
Both suspensions are supplied in plastic bottles of 100ml.
Marketing Authorisation Holder
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.
Distributor
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

This leaflet was last revised in July 2014.

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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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