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PATIENT INFORMATION LEAFLET

(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.

Cefalexin Tablets contain cefalexin as the active ingredient, which belongs to a class of antibiotics called ‘cephalosporins’. The Tablets are used to treat a variety of bacterial infections. These include infections of the airways from nose to lungs ear, bones and joints, and urine or reproduction systems, including inflammation of the prostate gland. They are also used to treat dental infections.

Do not take Cefalexin Tablets if you have:

•    an allergy (hypersensitivity) to the cephalosporin or penicillin group of antibiotics, or to any of the ingredients in the product (see section 6).

•    porphyria; a hereditary metabolic disorder.

Take special care with Cefalexin Tablets if you have:

•    kidney problems

•    inflammation of the large intestine, symptoms include: diarrhoea, pain and fever.

You should be aware that Cefalexin Tablets may give a false result for:

•    certain blood tests

•    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, or an aminoglycoside - a broad spectrum antibiotic (for example, gentamicin or neomycin)

•    diuretics (water tablets) such as furosemide, bumetanide or probenecid for gout.

Taking Cefalexin Tablets with food and drink

These tablets maybe taken before, during or after your meals.

Pregnancy and breast-feeding

Ask your doctor for advice before taking any medicine if you are pregnant or planning to become pregnant.

Cefalexin passes into breast milk, so tell your doctor if you are breast-feeding.

Driving and using machines

Cefalexin Tablets are not expected to affect your ability to drive or operate machinery.

The doctor will decide on the most appropriate dose for you, based on the nature and severity of your infection. The label will tell you how many Tablets you need to take as well as how often to take them.

Swallow the tablets whole with water.

Adults: The usual dose is 500mg every 8 hours, although your doctor may tell you to take 1g to 4g a day, split up into smaller doses.

Elderly: You should take the normal adult dose, unless you have severe kidney problems, when the maximum daily dose will be 500mg.

Children over 5 years: Your doctor will calculate the correct dose, depending on the child’s weight. The usual daily dose is 250mg to 500mg for each kilogram of their weight and is usually split up into smaller

amounts taken every 8 or 12 hours. If your child is taking Cefalexin Tablets for ear infections, he or she may have to take 75mg to 100mg for each kilogram of their weight, split up into smaller doses throughout the day.

This medicine is not recommended for use in children under 5 years of age.

Use all the tablets your doctor has given you. Do not stop taking them, even if you feel better.

If you take more Cefalexin Tablets than you should

Contact your doctor or nearest hospital casualty department immediately for advice if you or your child have swallowed too many tablets. Take this leaflet, the pack or any tablets with you, if you can.

If you forget to take Cefalexin Tablets

If you miss a dose, take it as soon as you remember. If it is almost time to take the next dose, skip the missed dose and carry on as before. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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

Tell your doctor at once if you notice any of these rare side effects:

•    rash, fever, itchy skin, swelling of the lips, eyes, tongue or difficulty breathing normally are signs of an allergic reaction. Stop taking the Tablets immediately

•    flaky skin, red or purple inflamed skin patches; pus in your eyes; blisters in your nose or mouth

•    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)

•    nephritis (inflamed kidneys).

Tell your doctor if you suffer from any of the following for more than a few days:

•    feeling or being sick, heartburn, stomach pains, diarrhoea

•    skin rashes

•    dizziness, tiredness, headache, sleep disorders, nervousness

•    feeling confused or agitated, hallucinations, extreme restlessness

•    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.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not store above 25°C.

Store Cefalexin Tablets in their original package and keep containers tightly closed.

Do not use the tablets after the expiry ‘EXP’ date which is printed on the carton (the expiry date refers to the last day of the month stated).

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 Tablets contain

The active ingredient is cefalexin, 250mg or 500mg.

The other ingredients are pregelatinised starch, colloidal anhydrous silica, magnesium stearate and microcrystalline cellulose. The coating contains hypromellose, polyethylene glycol, titanium dioxide (E171) and erythrosine lake (E127).

What Cefalexin Tablets look like and contents of the pack

Cefalexin Tablets are round, pink and film-coated, embossed with ‘CHX 250’ (250 mg) or ‘CHX 500’ (500 mg) on one face with twin triangles on the reverse.

They are available in bulk packs of 30, 50, 100 and 500 tablets, as well as in blisters of pack size 21s and 28s (not all pack sizes may be marketed).

Marketing Authorisation holder

Athlone Pharmaceuticals Limited, Ballymurray, Co.Roscommon, Ireland. This leaflet was last reviewed in July 2011.