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Cefalexin Capsules 250mg

Document: leaflet MAH GENERIC_PL 00530-0320 change

PL 00530/0320-1 Version 2

Cefalexin Capsules BP 250 mg and 500 mg Patient information leaflet

Please read this leaflet carefully before you start to take your capsules.

It contains important information.

If you are not sure about anything, or you want to know more, ask your doctor or pharmacist. Keep this leaflet safe, as you may want to read it again.

About your capsules

Your capsules are called Cefalexin Capsules BP.

They are part of a group of drugs known as cephalosporin antibiotics.

What is in your capsules

Each capsule contains:

•    Cefalexin BP 250 milligrams (mg) or 500mg (active ingredient); and

•    Lactose and magnesium stearate (inactive ingredients).

The capsules shell contains titanium dioxide (E171), erythrosine (E127), black iron oxide (E172), quinoline yellow (E104) and gelatin.

Cefalexin Capsules 250mg are grey and orange Size 2 capsules containing white powder, printed CHX 250 with a twin triangle logo.

Cefalexin Capsules 500mg are grey and orange Size 0 capsules containing white powder, printed CHX 500 with a twin triangle logo.

Cefalexin Capsules BP come in packs of 28 for the 250mg strength and in packs of 21 for the 500mg strength.

Who makes your capsules

The marketing authorisation holder and company responsible for batch release in the UK is Ivax Pharmaceuticals UK, Royal Docks, London, E16 2QJ, UK.

What your capsules do

Cefalexin Capsules are used to treat a variety of infections caused by a range of bacteria. These infections include infections of the respiratory tract, ear, bones and joints, skin and soft tissues, and genitor-urinary tract, including inflammation of the prostate gland. They are also used to treat mouth infections.

Before you take your capsules

Do not take Cefalexin Capsules BP if you:

•    have ever had a bad reaction to any of the ingredients listed in the “What is in your capsules” section or to other cephalosporin antibiotics or penicillin;

•    suffer from an inherited metabolic disorder called porphyria.

Please tell your doctor before you start to take your capsules if you:

•    are pregnant, may become pregnant or are breastfeeding;

•    have ever had any problems with your kidneys;

•    have an intolerance to some sugars e.g. lactose.

Taking other medicines

Please tell your doctor before you start to take your capsules if you are taking any of the following:

•    probenecid (used to treat gout)

•    aminoglycosides or diuretics, such as furosemide, etacrynic aced or piretanide

•    oral contraceptives,(“the pill”) - this medicine may reduce the effectiveness of the pill, so other precautions, such as condoms should be used.

Tell your 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 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 Coombs’ 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 Coombs’ Test, tell the doctor that you have been taking Cefalexin Capsules. Your medicine may affect the result.

If you are to have a blood test to test your creatinine levels, 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.

How to take your capsules

For oral use.

Adults

You must take your capsules are your doctor has told you to. To label will tell you how many to take and how often to take them. The number of capsules you take is called the “dose”. The usual daily dosage for adults is 1g-4g, in divided doses. However, for most infections, 500mg every 8 hours is effective.

For certain infections such as skin, throat and urinary (i.e. painful when passing water) infections, your doctor may tell you take 250mg every 6 hours, or 500mg every 12 hours.

If a daily dose of more than 4g is required your doctor may provide you with an ‘injectable’ dose of the drug.

Patients with kidney problems Your doctor may reduce your dose.

Elderly patients

If you are elderly you should take the normal adult dose, unless you have severe kidney problems, when the dose may be lower.

Children

Children 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 60mg 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 100mg for each kilogram of their weight, split up into four doses throughout the day. The maximum dose for children is 4g/day.

Higher doses may be required for more serious infections.

Swallow the capsules whole with water. Take all the capsules your doctor has given you.

Do not stop taking them just because you feel better.

If you forget to take a dose at the right time, take it as soon as you remember. Do not take two doses together.

If it is almost time to take the next dose, wait until then and then carry on as before.

What to do if you take too many capsules

It is important not to take too many capsules.

Contact your nearest hospital casualty department or a doctor for advice if you have swallowed too many capsules or if you think a child has accidentally swallowed any.

Take this leaflet, and any capsules that you still have to show the doctor.

After taking your capsules

You may have some side effects while you are taking your capsules.

Tell your doctor if you suffer from any of the following:

•    Skin rashes

•    Dizziness, tiredness and headache

•    Swelling of the eyelids, face and throat as a result of an allergic reaction may be life threatening and you should contact your doctor or nearest accident and emergency depart at once if you experience these side effects

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

Cefalexin Capsules BP may cause dizziness, confusion, agitation or hallucinations. If you suffer from any of these symptoms you should not drive or operate machinery without first talking to your doctor.

Occasionally, Cefalexin Capsules can cause the following:

•    You may become allergic to your capsules with the following symptoms: Red/purple flat rashes, bulbous rashes spreading to the palms of the hands, soles of feet and inside the mouth or severe peeling of large areas of skin. 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)

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

•    Your skin may begin to itch, or swell and you may begin to have trouble breathing normally. Tell your doctor at once if this happens.

•    You may suffer from a yeast infection of the vagina (thrush). Symptoms include burning or irritation/itching of the vagina , burning or pain when you pass water, pain during or after sexual intercourse.

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

Rarely, patients taking cefalexin have suffered from a kidney disorder called interstitial nephritis. The symptoms include changes in the amount of urine when passing water, fever, drowsiness, confusion, nausea, vomiting, swelling of parts of the body, weight gain and blood in the urine.

If you feel unwell in these or any other way, tell your doctor as soon as you can.

Looking after your capsules

Keep you capsules in a safe place where children cannot see or reach them.

You should keep your capsules in a cool dry place below 25°C Keep them in the pack they came in.

Do not put them into another container.

Do not use the capsules after the ‘expiry date’.

You should take any capsules that are out of date or which you no longer need back to your pharmacist.

These capsules are only for you, only a doctor can prescribe them for you. Never give them to anyone else.

This leaflet was last revised in December 2010

PL 00530/0320-1