PACKAGE LEAFLET: INFORMATION FOR THE USER SZ00000LT000

Cefalexin Capsules 250 mg or 500 mg

(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 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

What Cefalexin Capsules are and what they are used for

The name of your medicine is Cefalexin Capsules. 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 Capsules are used for treating a variety of infections including chest (respiratory tract), urinary tract, skin and soft tissues, ear, and other infections due to sensitive organisms.

2 Before you take Cefalexin Capsules

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 Capsules if:

•    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.

If any of the above apply to you or you are

unsure, please talk to your doctor before taking

the capsules.

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 machines if this medicine affects your ability to drive or to use machines.

3 How to take Cefalexin Capsules

Swallow each capsule whole 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 your medicine 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

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.

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Sandoz Ltd,

37 Woolmer Way, Bordon, Hampshire, GU35 9QE,

United Kingdom.

T: 01420 478301 F: 01420 474427 W: www.uk.sandoz.com E: sandozartwork2@btconnect.com

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Adults

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

•    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.

Elderly

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

Children

The dose for children is based on their weight and is usually 25-50 mg/kg in divided doses.

The dose or frequency may vary.

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 Capsules 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 Capsules.

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.

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

5 How to store Cefalexin Capsules

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

Store in the original packaging, 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

4 Possible side effects

What Cefalexin Capsules contain:

The active ingredient in Cefalexin Capsules is either 250mg or 500mg of cefalexin. The capsules also contain magnesium stearate and cellulose microcrystalline (E460).

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) or stomach pains

•    Reversible liver disorder or jaundice (yellowing of the skin and eyes)

The capsule shells contain gelatine, erythrosine (E127), quinoline yellow (E104), black iron oxide (E172), titanium dioxide (E171), shellac (E904) and propylene glycol (E1520).

Different pack sizes of Cefalexin Capsules are available:

Cefalexin Capsules 250 mg come in blister packs of (14, 21,28, 30 or 56 capsules) in plastic containers of (12, 20, 21,24, 28, 50, 100, 250 or 500 capsules),

Cefalexin capsules 500 mg come in blister packs of (14, 15,20,21,28, 30 or 56 capsules) in plastic containers of (12, 15, 20, 21,24, 28, 50, 100, 250 or 500 capsules)

Product licence holder and manufacturer:

Sandoz GmbH, A 6250 Kundl, Tirol, Austria.

This leaflet was last approved in 08/2009 (to be

amended after approval).

SZ00000LT000

Sandoz Ltd,

37 Woolmer Way, Bordon, Hampshire, GU35 9QE,

United Kingdom.

T: 01420 478301 F: 01420 474427 W: www.uk.sandoz.com E: sandozartwork2@btconnect.com

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