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Cefalexin 500mg Tablets

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Document: leaflet ACTAVIS_PL 04520-0008 change

PACKAGE LEAFLET: INFORMATION FOR THE USER


Cefalexin Tablets 250mg or 500mg

(cefalexin)

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, pharmacist or dentist (if the medicine has been prescribed by your dentist).

•    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, pharmacist or dentist (if the medicine has been prescribed by your dentist).

In this leaflet:

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

2.    Before you take Cefalexin Tablets

3.    How to take Cefalexin Tablets

4.    Possible side effects

5.    How to store Cefalexin Tablets

6.    Further information

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

The name of your medicine is Cefalexin Tablets.

This medicine belongs to a family of medicines called antibiotics. Antibiotics are used to kill the bacteria or "germs" which cause infections.

Your doctor, or dentist, will have prescribed this medicine for treating an infection. Cefalexin Tablets are used for treating a variety of infections including chest (respiratory tract), urinary tract, skin and soft tissues, ear, and other infections.

2.    Before you take Cefalexin Tablets

Do not take this medicine before telling your doctor if:

•    You are allergic to cefalexin or other antibiotics and medicines.

•    You are allergic to any of the other ingredients in this medicine.

Take special care with Cefalexin Tablets:

•    You are pregnant or breast-feeding. Your doctor will decide whether it is safe for you to take this medicine while you are pregnant or breast-feeding.

•    You have problems with your kidneys.

•    You test your urine for glucose using a method which is not based on glucose oxidation reactions as this medicine might give a false positive result.

•    You are taking oral contraceptives. Cefalexin may reduce the efficacy of oral contraceptives and you may need additional contraceptive measures whilst taking this medicine.

Taking other medicines

Please inform your doctor if you are taking or have recently taken any other medicines, even those not prescribed, particularly:

•    Uricosuric drugs (medicines used to treat gout and other conditions which require lowering of blood uric acid levels, e.g. probenecid).

•    Diuretics (medicines which reduce water retention by increasing the volume of urine, e.g. furosemide, ethacrynic acid).

•    Anticoagulants (medicines that prevent the clotting of blood, e.g. warfarin).

•    Any other antibiotics (eg. aminoglycosides, polymyxin, colistin).

•    If you are taking metformin (a medicine used to treat diabetes).

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Do not drive or operate machine if this medicine affects your ability to drive or to use machines.

Important information about some of the ingredients of Cefalexin

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

3. How to take Cefalexin Tablets

Each dose should be swallowed with a drink of water.

Try to space the doses as evenly as possible throughout the day. For example, if you have been told to take Cefalexin Tablets three times a day in 8 hour intervals, then:

•    Take your first dose when you wake up, e.g. 7.00 am

•    Take your next dose mid-afternoon, e.g. 3.00 pm

•    Take your last dose just before you go to bed, e.g. 11.00 pm

If you have been told to take our medicine four times a day in approximately 6 hour intervals, then:

•    Take your first dose when you wake up, e.g. 6.00 am

•    Take your second dose around noon, e.g. 12.00 pm

•    Take your third dose early evening, e.g. 6.00 pm

•    Take your last dose when you go to bed, e.g. 11.00 pm

Dosage Instructions

Your doctor will tell you how much to take and how often. Do not take more than the dose your doctor has recommended.

If any of the above apply to you or you are unsure, please talk to your doctor before taking the tablets.

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Adults

The usual dose for adults is 1-4g daily in divided doses. For most infections the dose will be 500mg (2 x 250mg tablets or 1 x 500mg tablet) every 8 hours. This may vary depending on the type of infection you have. For example a dose of 250mg (1 x 250mg tablet) taken every 6 hours or 500mg (2 x 250mg tablets or 1 x 500mg tablet) every 12 hours is used to treat skin, soft tissue, throat or urinary tract infections, or those caused by less susceptible organisms.

Elderly

The dosage for the elderly is the same as for adults, but may be reduced if you have poor kidney function.

Children

For most infections, the usual dose is; 125mg (half a 250mg tablet) every 8 hours for children under 5 years, or 250mg (1 x 250mg tablet) every 8 hours for children 5 years and over.

For skin and soft tissue infections, urinary tract infections and sore/dry throat caused by bacterial infections, the total daily dose may be divided and administered every 12 hours. In severe infections the dosage may be doubled, for certain infections such as ear infections doses even higher than double the normal above may be required. Infections caused by certain bacteria may require treatment for at least 10 days.

Keep taking your medicine until the course is finished. Do not stop taking your medicine just because you feel better. If you stop too soon the infection may start up again

If your symptoms persist, tell your doctor

If you take more Cefalexin Tablets than you should

Always take your medicine as recommended by your doctor. If you take too much medicine, tell your doctor immediately or go to your local hospital emergency department

If you forget to take Cefalexin Tablets.

If you miss a dose, take another as soon as you remember and then carry on as before. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

All medicines sometimes cause unwanted effects in some people. Tell your doctor if you think your medicine is making you feel unwell or if you get any of the following side effects;

An allergic reaction which may occur as

•    a rash on your skin (which might be severe)

•    sudden wheeziness or tightness of the chest

•    swelling of your eyelids, lips or face

•    skin lumps and hives

If you think you are having an allergic reaction stop taking your medicine and tell your doctor immediately or go to your hospital emergency department as severe allergic reactions may require emergency treatment.

•    A feeling of sickness or being sick

•    Diarrhoea (which may be bloody) o r stomach pains

•    Reversible liver diso rd er or jaundice (yellowing of the skin and eyes)

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•    Itching around the genitals or anus

•    Thrush or discharge from the vagina

•    Dizziness

•    Tiredness

•    Headache

•    Agitation, confusion and hallucinations

•    Pain or swelling in the joints

•    Kidney disorders or blood disorders, including an increase or decrease in the number of white blood cells, and a decrease in the number of platelets. Symptoms of blood disorders include tiredness, sore throat, bruising easily and susceptibility to infection

If you experience these or any other unusual or unexpected symptoms, tell your doctor or pharmacist

5.    How to store Cefalexin Tablets

Keep all medicines out of the reach and sight of children.

Blister packs - Store in the original packaging, in order to protect the tablets from the light and moisture.

Plastic containers - Keep the container tightly closed, in order to protect the capsules from light and moisture.

Do not store above 25°C.

Your medicine should not be used after the expiry date printed on the pack.

Unless your doctor advises otherwise, any unused medicine should be returned to your local pharmacist for safe disposal.

6.    Further information

What Cefalexin Tablets contains:

The active ingredient of Cefalexin Tablets is either 250mg or 500mg of cefalexin. The film-coated tablets also contain magnesium stearate, povidone (E1201), sodium starch glycollate, macrogol 6000, lactose, saccharin sodium (E954), talc (E553b) and peppermint oil. The tablet coating contains titanium dioxide (E171) and hypromellose (E464).

Cefalexin Tablets 250mg come in plastic containers of 20,

21,28, 50, 100 and 500 and

blister packs of 20, 21 and 28 tablets.

Cefalexin Tablets 500mg come in plastic containers of 12, 15, 20, 21,24, 28, 50, 100,

250 and 500 tablets, and blister packs of 14, 15, 20, 21,

28, 30 and 56 tablets.

Cefalexin Tablets 250mg are round, film-coated and white to yellowish in colour. The tablets are scored on one side and have "CX" above the score and "250" below. The unscored side is without markings.

Cefalexin Tablets 500mg are oblong, film-coated and white to yellowish in colour. The tablets are scored on each side.

Product licence holder and manufacturer:

Sandoz GmbH, A 6250 Kundl, Tirol, Austria.

This leaflet was last revised in 08/2008.

Actavis, Barnstaple, EX32 8NS, UK