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Cefalexin 500mg Capsules

Document: leaflet MAH GENERIC_PL 10622-0207 change

PATIENT INFORMATION LEAFLET Cefalexin 500mg Capsules

Please read this leaflet carefully before you start to use your tablets.

•    This leaflet contains important information about your treatment. If you have any doubts or questions, or you are not sure about anything, ask your doctor or pharmacist.

•    Keep this leaflet. You may need to read it again.

•    Your medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

This leaflet contains the following information:

1.    What are Cefalexin 500mg Capsules used for?

2.    Information to read BEFORE taking Cefalexin 500mg Capsules.

3.    How to take your capsules.

4.    Can your capsules have any side-effects?

5 . Storing your capsules.

The name of your medicine is Cefalexin 500mg Capsules. These are grey/orange, size 0 capsules containing white powder, marked with CHX 500 and a twin triangle logo. Each capsule contains 500mg of active substance cefalexin.

Other ingredients are magnesium stearate and lactose monohydrate. Capsule shell contains gelatin, black iron oxide (E172), titanium dioxide (E171), erythrosine (E127) and quinoline yellow (E104) .

Cefalexin 500mg Capsules are available in packs containing 7, 14, 20, 21,

28, 30, 50, 56, 60, 100 and 500 capsules. Not all packs are marketed.

Marketing Authorisation Holder: PLIVA Pharma Ltd., Vision House, Bedford Road, Petersfield, Hampshire, GU32 3QB, England.

Manufacturer: Norton Healthcare Ltd, Albert Basin, Royal Docks, London, E16 2QJ.

1.    What are Cefalexin 500mg Capsules used for?

Cefalexin is one of a group of antibiotics called cephalosporins. Cefalexin capsules are used to treat infections due to sensitive bacteria, including chest infections, infections of the ear, bones and joints, skin and soft tissues, and genitor-urinary tract, including inflammation of the prostate gland. They are also used to treat dental infections.

2.    Information to read BEFORE using Cefalexin 500mg Capsules.

Please take the time to read the following information carefully as this may stop you from being able to take Cefalexin Capsules.

When should you NOT take Cefalexin 500mg Capsules?

Ask yourself the following questions:

•    Have you ever taken a medicine containing cefalexin, another cephalosporin (e.g. cefuroxime, ceftazidime) or penicillin antibiotic or any of the other ingredients listed above and had an unusual or allergic reaction?

•    Do you suffer from an inherited metabolic disorder called porphyria?

•    Are you pregnant or is there a chance you may be pregnant?

•    Are you breastfeeding?

If the answer to any of these questions is YES and you have not already discussed this with your doctor or pharmacist, you should do so as soon as possible and before taking any capsules.

When should you take special care while taking Cefalexin 500mg Capsules?

Ask yourself the following questions:

•    Have you ever had problems with your kidneys?

•    Are you taking probenecid for gout or are you taking other medicines including ones that you have bought for yourself without a prescription?

•    Have you suffered from diarrhoea after taking Cefalexin Capsules?

If the answer to any of these questions is YES and you have not already discussed this with your doctor or pharmacist, you should do so as soon as possible and before taking any capsules.

Tell you doctor if you know you are allergic to other drugs. He or she can then decide whether it will be safe for you to take Cefalexin Capsules.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you need to test for glucose in your urine (for example, because you are diabetic), Cefalexin Capsules may give a false result.

If you are to have a Coomb's Test (a blood test to test for rhesus antibodies on your red blood cells), or if you have just had a baby who is to be given a Coomb's Test, tell the doctor that you have been taking Cefalexin Capsules. Your medicine may affect the result.

If you see another doctor or visit a hospital, remember to tell them what medicines you are already taking.

Effects on your ability to drive and use machines

This medication should not affect your ability to drive or use machines.

3. How to take your capsules.

It is important to take the capsules as directed by your doctor. Check the medicine label to see how many capsules to take and how often to take them.

If you are not sure, ask your doctor or pharmacist. You may take your capsules with or without food.

Adults

The usual dosage for adults is 1 - 4g daily, in divided doses. However, for most infections 500mg every 8 hours is effective. For certain infections such as skin, throat and urinary infections, your doctor may tell you to take 250mg every 6 hours, or 500mg every 12 hours. If a daily dose of more than 4g is required, your doctor may give you 'injectable' doses of the drug.

Elderly

The usual adult doses may normally be used. If you have severe kidney problems the doctor may reduce your dose.

Children 5 years and over

Children who are five or over can take Cefalexin Capsules. Your doctor will work out the correct dose for them depending on their weight. The usual daily dose is 25mg to 50mg for each kilogram of their weight. The daily dose is usually split up into smaller amounts and taken every 8 or 12 hours i.e. 250mg every 8 hours. If the child is taking Cefalexin Capsules for an ear infection, he or she may have to take 75mg to lOOmg for each kilogram of their weight, split up in 4 doses throughout the day.

Children under 5 years

The capsules are not suitable for children under 5 years old since they should not take more than 125mg every 8 hours. An alternative liquid preparation of this medicine may be given to children under 5 years.

It is important that you follow your doctors' instructions as to the dosage of cefalexin capsules and for how long you should continue to take your capsules. Always complete the course.

If you take too many capsules

It is important to stick to the dose on the label of your medicine. If you or someone else swallows several of these capsules all together, or you think a child has swallowed any of these capsules, contact your doctor, pharmacist or hospital emergency department immediately. Always take any capsules left over with you and also the box, as this will allow easier identification of the capsules. Symptoms of overdose may include feeling or being sick, indigestion, diarrhoea or blood in the urine.

If you forget to take a dose

If you forget to take a dose, take it as soon as you remember. Do not take two doses together. However, if it is nearly time for your next dose, miss the forgotten dose altogether and continue with the rest of the capsules as normal.

If you start to feel better

Even when you start to feel better it is important for you to keep on taking your capsules for as long as your doctor tells you.

4. Can your capsules have any side-effects?

Like all medicines, Cefalexin 500mg Capsules can have side-effects, although they are usually well tolerated.

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

•    Skin rashes.

•    Dizziness, tiredness and headache.

•    Feeling confused or agitated, hallucinations, feeling or being sick, heartburn and stomach pain, painful or swollen joints.

•    Itching round the anus and genitals, inflamed vagina or a discharge from the vagina.

Occasionally Cefalexin Capsules may cause the following:

•    You may become allergic to your capsules. Dead flakey skin or red inflamed skin patches. You may also have ulcerated eyes with a discharge. These reactions usually end if you stop taking these capsules.

•    Blood disorders. You may find you bruise more easily or you may have a sore throat, fever or a chill. You may also experience weakness, breathlessness and your skin may become slightly yellow.

•    Liver damage, for example jaundice (your skin and the whites of your eyes may become slightly yellow). You may notice blood in your urine.

• Rarely, you may suffer from severe diarrhoea which may contain blood or mucous and pain. Tell your doctor at once if this happens.

If you suffer from any of the following side-effects, stop taking your Cefalexin capsules and either tell your doctor immediately or go to your nearest hospital. You may be experiencing a severe allergic reaction to the capsules:

•    swelling of the hands, feet, ankles, face, lips, mouth or throat, severe itching of the skin

problems with swallowing or breathing.

If you suffer from any of the side-effects listed and they are severe or prolonged or if you experience any other side-effects not mentioned on this leaflet, please inform your doctor or pharmacist immediately.

5. Storing your capsules.

Store your capsules in the original package. KEEP OUT OF THE REACH AMD SIGHT OF CHILDREN.

Do not use this medicine after the 'use by' date on the carton. If you have any capsules that are out of date, return them to your pharmacist for disposal.

Remember: this treatment is for YOU. Only a doctor can prescribe it for you. Never give it to others.

Date of preparation: February 2004


IL) PLIVA