CPCFX.SuJNTSN.V2P2 PACKAGE LEAFLET: INFORMATION FOR THE USER

CEFALEXIN 125 mg/5 ml and 250 mg/5 ml ORAL SUSPENSION

(cefalexin)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If any of the side effects gets serious, talk to your doctor, pharmacist or dentist (if the medicine has been prescribed by your dentist). This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET

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

2.    What you need to know 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.    C ontents of the pack and other information

WHAT 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.

WHAT YOU NEED TO KNOW BEFORE YOU . TAKE CEFALEXIN ORAL SUSPENSION

Do not take Cefalexin Oral Suspension if you:

•    are allergic to cefalexin or other cephalosporins (similar antibiotics) and medicines.

•    are allergic to any of the other ingredients of this medicine (listed in section 6).

•    have porphyria Warnings and precautions

Talk to your doctor or pharmacist before taking Cefalexin Oral Suspension if you:

•    have had an allergic reaction to cefalexin, cephalosporins, penicillins, or other drugs in the past

•    have a relative with porphyria

•    develop diarrhoea

•    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.

•    have problems with your kidneys.

•    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.

•    are about to have a blood test, as Cefalexin Oral Suspension can interfere with a Coombs test.

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

Other medicines and Cefalexin Oral Suspension

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines -whether prescribed or bought without a prescription.

•    If 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 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.

•    Drugs used to treat leukaemia.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Cefalexin Oral Suspension may cause side effects such as dizziness, fatigue and confusion and may affect your ability to drive or operate machinery. if affected, do not drive or operate machines.

Cefalexin Oral Suspension contains sucrose and lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Cefalexin Oral Suspension 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.

This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per dose.

HOW TO TAKE CEFALEXIN ORAL . SUSPENSION

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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 125 mg/5 ml Oral Suspension every 8 hours

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

•    1 x 5 ml spoonful of Cefalexin 250 mg/5 ml Oral Suspension every 6 hours

500 mg taken as:

•    4 x 5 ml spoonfuls of Cefalexin 125 mg/5 ml Oral Suspension every 12 hours

•    2 x 5 ml spoonfuls of Cefalexin 250 mg/5 ml Oral Suspension every 12 hours

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

Older People

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.

Use in children and adolescents 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 125 mg/5 ml Oral Suspension every 8 hours

Children over 5 years

The usual dose is 250 mg taken as:

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

•    1 x 5 ml spoonful of Cefalexin 250 mg/5 ml Oral Suspension 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 you 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

The following side effects have been reported

•    Feeling of sickness or being sick

•    Indigestion

•    Diarrhoea (which may be bloody) or stomach pains

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

•    Itching

•    Red wheals on the skin (urticaria) (alone)

•    Itching around the genitals or anus

•    Thrush or discharge from the vagina

•    Rash with wide spread joint pain and / or stiffness, swollen lymph glands, fever and possibly cloudy urine

•    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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5 HOW TO STORE CEFALEXIN ORAL . SUSPENSION

KEEP OUT OF THE SIGHT AND REACH 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).

Do not use this medicine after the expiry date which is stated on the pack after EXP The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

CONTENTS OF THE PACK AND OTHER . INFORMATION

. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are very rare.

Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

Serious side effects

The following side effects are serious. You should stop taking this medicine and contact your doctor immediately if you experience them:

-    serious peeling or blistering of the skin

-    severe diarrhoea.

What Cefalexin Oral Suspension contains:

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

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

This leaflet was last revised in February 2015

CP.CFX.SuJNT.SN.V2P2

Customer: SN Originated by: AWG Product: CefALEXin Oral Suspension JNT Dimensions: 175mm x 315mm Item Code: CP.CFX.Su.JNT.SN.V2P2 Proof No and Date: 1    09/02/15

Revision:

ARTWORK FOR SUBMISSION Supersedes: n/a_