Document: leaflet MAH GENERIC_PL 30464-0074 change

• leaflet KENT_PL 30464-0074
• leaflet MAH GENERIC_PL 30464-0074

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PATIENT INFORMATION LEAFLET

(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 if 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. See section 4.

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

Do not take Cefalexin Capsules if you have:

•    an allergy (hypersensitivity) to the cephalosporin 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 Capsules if you have:

•    an allergy to the penicillin group of antibiotics

•    kidney problems

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

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

•    certain blood tests (e.g. Coombs’ test)

•    glucose urine test

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)

•    metformin for treatment of diabetes

•    diuretics (water tablets) such as furosemide, bumetanide

•    probenecid for gout.

•    medication for leukaemia

Taking Cefalexin Capsules with food and drink

These capsules may be taken before, during or after your meals.

Pregnancy,breast-feeding and fertility

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

Important information about some of the ingredients of Cefalexin Capsules

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the Capsules whole with water.

The recommended dose is:

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

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.

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

Use in children and adolescents: Your doctor will calculate the correct dose, depending on the child’s weight. The usual daily dose is 25mg to 50mg for each kilogram of their weight and is usually split up into smaller amounts taken ever 8 or 12 hours. If your child is taking Cefalexin Capsules 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.

If you take more Cefalexin Capsules than you should

Contact your doctor or nearest hospital casualty department IMMEDIATELY for advice if you (or someone else) have swallowed too many capsules. Take this leaflet, any remaining capsules and the pack they were in 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 Capsules

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

Like all medicines, Cefalexin Capsules 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 signs of an allergic reaction. Stop taking the capsules immediately

•    severe skin rash with flushing, fever, blisters or ulcers in your nose or mouth, or redness, peeling and swelling of the skin

•    blood disorders (if you bruise more easily, have a sore throat, fever or a chill)

•    severe diarrhoea containing blood or mucus. Colitis (inflammation of the colon) can also occur during or after treatment

•    liver damage, e.g. jaundice (yellowing of the skin and whites of eyes), hepatitis (swelling and inflammation of the liver)

•    nephritis (inflamed kidneys)

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

•    feeling or being sick, indigestion, stomach pain, diarrhoea

•    Red wheals on the skin (urticaria)

•    skin rashes

•    dizziness, tiredness, headache, sleep disorders, nervousness

•    feeling confused or agitated, hallucinations, extreme restlessness, hyperactivity

•    painful or swollen joints, extreme muscle tension

•    itching around the anus or genitals, inflamed vagina, discharge from the vagina Laboratory Values

Slight elevations in some laboratory blood tests of liver function have been observed.

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

Reporting of side effects

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

KEEP OUT OF THE SIGHTAND REACH OF CHILDREN.

Do not store above 25°C.

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

Do not use the capsules 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 Capsules contain

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

The other ingredients are lactose, magnesium stearate. The capsule shell contains black iron oxide (E172), titanium dioxide (E171), erythrosin (E127), quinoline yellow (E104) and gelatin.

What Cefalexin Capsules look like and contents of the pack

Cefalexin Capsules are grey/orange capsules containing white powder and printed with ‘CHX 250’ (250mg) or ‘CHX 500’ (500 mg).

They are available in blister packs of 7, 14, 20, 21, 28, 30, 50, 56, 60, 100 or 500 capsules (not all pack sizes may be marketed).

Marketing Authorisation holder

Athlone Pharmaceuticals Limited, Ballymurray, Co.Roscommon, Ireland.

Distributor

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

PL 30464/0074 and PL 30464/0075

This leaflet was last reviewed in 18^th July 2014