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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.

-    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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Cefalexi

n 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.

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).

Pregnancy and breast-feeding

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.

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.

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.

If you are elderly, take the normal adult dose, unless you have severe kidney problems when the maximum daily dose will be 500mg.

Children can take Cefalexin Oral Suspension. 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.

Take all the suspension your doctor has given you, even if you feel better.

If you take more Cefalexin Oral Suspension then you should

Contact your doctor or nearest hospital casualty department if you or a child has swallowed too much medicine. Take this leaflet and any remaining suspension with you, if possible. 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.

Like all medicines, Cefalexin Oral Suspension can cause side effects, although not everyone gets them.

You may suffer an allergic reaction, symptoms of which include rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue. If this happens to you, stop taking the suspension immediately and seek medical help.

The following may also be experienced:

•    blood abnormalities

• hepatitis (inflammation of the liver), cholestatic jaundice (yellowing of the skin and whites of the eyes)

•    inflammation of the kidney

•    colitis (inflammation of the colon)

•    severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome

•    itching round the anus or genitals, inflamed vagina or unusual discharge from the vagina

•    nausea, vomiting, indigestion, stomach pain, diarrhoea

•    painful or swollen joints, extreme muscle tension

•    dizziness, tiredness and headache, sleep disorders, nervousness

•    feeling agitated, confused, extreme restlessness

•    hallucinations

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

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.

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.

This leaflet was last revised in August 2011.