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Cefalexin 500mg Capsules

Document: leaflet MAH GENERIC_PL 21880-0082 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cefalexin Capsules 250 mg Cefalexin Capsules 500 mg

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


In this leaflet:

1.    What Cefalexin Capsules are and what they are used for

2.    Before you take Cefalexin Capsules

3.    How to take Cefalexin Capsules

4.    Possible side effects

5.    How to store Cefalexin Capsules

6.    Further information

1. WHAT CEFALEXIN CAPSULES ARE AND WHAT THEY ARE USED FOR

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, and urine or reproduction systems, incuding inflammation of the prostate gland. They are also used to treat dental infections.

2. BEFORE YOU TAKE CEFALEXIN CAPSULES

Do not take Cefalexin Capsules 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 Capsules if you have:

•    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

•    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 Capsules with food and drink

These capsules may be 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 Capsules are not expected to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Cefalexin Capsules

Lactose - if you know you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE CEFALEXIN CAPSULES

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 capsules you need to take as well as how often to take them. Swallow the Capsules whole with water.

Adults: The usual dose is 500 mg 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 500 mg.

Children over 5 years: Your doctor will calculate the correct dose, depending on the child’s weight. The usually dose is 25mg to 50mg 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 Capsules for ear infections, he or she may have to take 75 mg to 100 mg 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 capsules your doctor has given you. Do not stop taking them, even if you feel better

If you take more Cefalexin Capsules than you should

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

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

, POSSIBLE SIDE EFFECTS

Like all medicines, Cefalexin Capsules 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 in breathing normally are signs of an allergic reaction. Stop taking the capsules 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 pain, 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.

5. HOW TO STORE CEFALEXIN CAPSULES

KEEP OUT OF SIGHT AND 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.

6. FURTHER INFORMATION

What Cefalexin Capsules contain

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

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 capsule containing white powder and printed with ‘CHX 250’ (250 mg) or ‘CHX 500’ (500 mg).

They are available in tubular containers with a temper-evident tear strip or in blister pack of 7, 14, 20, 21,28, 30, 50, 56, 60, 100 or 500 capsules (not all pack sizes may be marketed).

Cefalexin 250 mg Capsules : PL 21880/0079 Cefalexin 500 mg Capsules : PL 21880/0082

This leaflet was last revised in 26/04/2013

Marketing Authorisation Holder and Manufacturer MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham TW13 7HF, UK E-mail: info@medreich.co.uk

1211370