PACKERS CODE

Patient Information Leaflet for

CEFALEXIN ORAL SUSPENSION BP 125 mg/5 ml or 250 mg/5 ml

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 was 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 was prescribed by your dentist).

IN THIS LEAFLET

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

2.    Before you take Cefalexin Oral Suspension BP

3.    How to take Cefalexin Oral Suspension BP

4.    Possible side effects

5.    How to store Cefalexin Oral Suspension BP

6.    Further information

1.    WHAT CEFALEXIN ORAL SUSPENSION BP IS AND WHAT IT IS USED FOR ?

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

2.    BEFORE YOU TAKE CEFALEXIN ORAL SUSPENSION BP

I 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 BP • you have problems with your kidneys.

Take special care with Cefalexin Oral Suspension BP:

• each bottle of Cefalexin Oral Suspension BP 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 BP 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 BP 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 BP 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 BP.

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, eg. Probenecid)

•    diuretics (medicines which reduce water retention by increasing the volume of urine, eg. Furosemide/Frusemide)

•    anticoagulants (medicines that prevent the clotting of blood, eg. Warfarin)

•    any other antibiotics.

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

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 effects you ability to drive or to use machines.

3. HOW TO TAKE CEFALEXIN ORAL SUSPENSION BP

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 BP three times a day in 8 hour intervals, then:

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

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

•    Take your last dose just before you go to bed, eg. 1 1.00 pm.

Dosage Instructions

Adults - The usual dose for adults is 500 mg

PACKERS CODE

(4x5 ml spoonfuls of Cefalexin Oral Suspension BP 125 mg/5 ml or 2 x 5 ml spoonfuls of Cefalexin Oral Suspension BP 250 mg/5 ml) every 8 hours. This may vary depending on the type of infection you have. For example a dose of 250 mg (2 x 5 ml spoonfuls of Cefalexin Oral Suspension BP 125 mg/5 ml or 1 x 5 ml spoonfuls of Cefalexin Oral Suspension BP 250 mg/5 ml) taken every 6 hours or 500 mg 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.

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

Children - The dose for children is based on their weight and is usually 25-50 mg/kg per day in divided doses,usually taken every 8 hours. For example;

For children under 5 years of age the usual dose is: 125 mg (one 5 ml spoonful of Cefalexin Oral Suspension BP 125 mg/5 ml) taken every 8 hours.

For children over 5 years the usual dose is:

250 mg (two 5 ml spoonfuls of Cefalexin Oral Suspension BP 125 mg/5 ml or one 5 ml spoonful of Cefalexin Oral Suspension BP 250 mg/5 ml) taken every 8 hours.

The dose or frequency may vary from the above. For example Cefalexin Oral Suspension BP is given more frequently to treat ear infections.

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 BP 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 BP - 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) 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.

5.    HOW TO STORE CEFALEXIN ORAL SUSPENSION BP

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.

6.    FURTHER INFORMATION

What Cefalexin Oral Suspension BP contains - The active ingredient of Cefalexin Oral Suspension BP is cefalexin. One 5 ml spoonful of Cefalexin Oral Suspension BP 125 mg/5 ml contains 125 mg of cefalexin and one 5 ml spoonful of Cefalexin Oral Suspension BP 250 mg/5 ml contains 250 mg of cefalexin. The label on the bottle will tell you which strength of Cefalexin Oral Suspension BP your doctor has prescribed for you. Each bottle contains 100 ml of Cefalexin Oral Suspension BP.

Cefalexin Oral Suspension BP also contains: saccharin sodium (E954), sodium benzoate (E21 1), citric acid anhydrous (E330), sucrose, purified water, iron oxide yellow (El 72), 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.

Distributed by - Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL.

Date of revision:August 2009    10001 675