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Cefalexin 250mg/5ml Oral Suspension

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Document: leaflet TEVA UK_PL 04520-0002 change

CEFALEXIN ORAL SUSPENSION 125 mg/5 ml OR 250 mg/5 ml (cefalexin)

PACKAGE LEAFLET: INFORMATION FORTHE USER

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 get 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).

INTHIS LEAFLET

1.    What Cefalexin Oral Suspension is and what it is used for

2.    Before you take Cefalexin Oral Suspension

3.    How to take Cefalexin Oral Suspension

4.    Possible side effects

5.    How to store Cefalexin Oral Suspension

6.    Further information

OWHAT CEFALEXIN ORAL SUSPENSION IS AND WHAT IT IS USED FOR

The name of your medicine is Cefalexin Oral Suspension. Cefalexin Oral Suspension 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 Cefalexin Oral Suspension for treating an infection. Cefalexin Oral Suspension is 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.

©BEFORE YOU TAKE CEFALEXIN ORAL SUSPENSION

Do not take this medicine before telling your doctor if:

• You are pregnant or thinking of becoming pregnant

• You are breast-feeding • You are allergic to cefalexin or other antibiotics and medicines • You are allergic to any of the other ingredients in Cefalexin Oral Suspension • You have problems with your kidneys.

Take special care with Cefalexin Oral Suspension:

Each bottle of Cefalexin Oral Suspension 125 mg /5 ml contains 50 g of sucrose, which means each 5 ml spoonful contains 2.5 g of sucrose. Each bottle of Cefalexin Oral Suspension 250 mg /5 ml contains 48 g of sucrose, which means each 5 ml spoonful contains 2.4 g of sucrose. This sucrose content may be unsuitable if you suffer from hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency.

Cefalexin Oral Suspension also contains sodium benzoate which may irritate the soft tissue lining of the gut and mouth, and may also increase the risk of jaundice in newborn babies.

If you test your urine for glucose using a method which is not based on glucose oxidation reactions, Cefalexin Oral Suspension might give a false positive result.

If any of the above is of concern please consult your doctor or pharmacist before taking Cefalexin Oral Suspension.

Taking other medicines

Make sure that you tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines - whether prescribed or bought without a prescription.

•    If you are taking oral contraceptives

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

If you are taking any other medicines, such as;

•    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/frusemide).

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

•    Any other antibiotics.

Cefalexin may reduce the efficacy of oral contraceptives and you may need additional contraceptive measures whilst taking Cefalexin Oral Suspension.

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.

©HOW TO TAKE CEFALEXIN ORAL SUSPENSION

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

Shake the bottle well before measuring and swallowing each dose your doctor has recommended.

Try to space the doses as evenly as possible throughout the day. For example if you have been told to take Cefalexin Oral Suspension 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 Adults

The usual dose is 500 mg taken as:

• 4 x 5 ml spoonfuls of Cefalexin Suspension 125 mg/5 ml every 8 hours • 2 x 5 ml spoonfuls of Cefalexin Suspension 250 mg/5 ml) every 8 hours.

The dose may vary depending on the type of infection you have. For skin, soft tissue, throat or urinary tract infections your doctor may prescribe:

250 mg taken as:

• 2 x 5 ml spoonfuls of Cefalexin Suspension 125 mg/5 ml every 6 hours • 1 x 5 ml spoonfuls of Cefalexin Suspension 250 mg/5 ml) every 6 hours

500 mg taken as:

• 4 x 5 ml spoonfuls of Cefalexin Suspension 125 mg/5 ml every 12 hours • 2 x 5 ml spoonfuls of Cefalexin Suspension 250 mg/5 ml) every 12 hours

Larger doses may be used to treat more severe infections, or those caused by less susceptible organisms.

Elderly

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

Children

The dose for children is based on their weight and is usually 25-50 mg per kg body weight, per day. It is given in divided doses, usually taken every 8 hours.

For example;

Children under 5 years

The usual dose is 125 mg taken as

•    1 x 5 ml spoonful of Cefalexin Suspension 125 mg/5 ml every 8 hours.

Children over 5 years

The usual dose is 250 mg taken as

•    2 x 5 ml spoonfuls of Cefalexin Suspension 125 mg/5 ml every 8 hours.

•    1 x 5 ml spoonful of Cefalexin Suspension 250 mg/5 ml every 8 hours.

The dose or frequency may vary from the above. For example Cefalexin Oral Suspension is given more frequently to treat ear infections and less frequently for skin, soft tissue, throat and mild, uncomplicated urinary tract infections.

If you are not sure how much to take, ask your doctor or pharmacist.

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 Oral Suspension 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 Oral Suspension

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.

O 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;

Serious side effects

If any of the following happens, stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital:

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.

Other possible side effects

Tell your doctor if any of the following side effects bother you:

•    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)

•    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 disorder

•    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 any other unusual or unexpected symptoms, also tell your doctor.

A HOW TO STORE CEFALEXIN ORAL w SUSPENSION

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

Do not store above 25°C. Once reconstituted store at 2°C - 8°C (in a refrigerator).

Keep the container tightly closed.

Do not use this medicine after 14 days of reconstitution (date of dispensing). Any unused medicine should be returned to your local pharmacist for safe disposal.

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

Q FURTHER INFORMATION

What Cefalexin Oral Suspension contains:

The active ingredient of Cefalexin Oral Suspension is cefalexin. One 5 ml spoonful of Cefalexin Oral Suspension 125 mg / 5 ml contains 125 mg of cefalexin and one 5 ml spoonful of Cefalexin Oral Suspension 250 mg /

5 ml contains 250 mg of cefalexin. The label on the bottle will tell you which strength of Cefalexin Oral Suspension your doctor has prescribed for you. Each bottle contains 100 ml of Cefalexin Oral Suspension.

Cefalexin Oral Suspension also contains:

saccharin sodium (E954), sodium benzoate (E211), citric acid anhydrous (E330), sucrose, purified water, iron oxide yellow (E172), simethicone, guar gum (E412), strawberry flavour, apple flavour, raspberry flavour, and tutti frutti flavour. The flavour contents include benzyl alcohol, magnesium hydroxide carbonate (E504), acetic acid (E260), propylene glycol, ethanol (0.015%) and traces of glycerol (E422) and lactose.

Product licence holder and manufacturer:

Sandoz GmbH, A 6250 Kundl, Tirol, Austria.

Date of Leaflet preparation: 02/2009

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TEVA UK LIMITED