Package leaflet: Information for the user

Keflex Suspension 125mg & 250mg/5ml

Cefalexin

The name of your medicine is Keflex Suspension 125mg & 250mg/5ml, which will be referred to as Keflex suspension throughout this document.

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 or pharmacist.

■    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 or pharmacist.

In this leaflet:

1. What Keflex suspension is and what it is used for

2.    Before you take Keflex suspension

3.    How to take Keflex suspension

4.    Possible side effects

5.    How to store Keflex suspension

6.    Further information

1 What Keflex suspension is and what it is used for

Keflex suspension contains the active ingredient cefalexin monohydrate, which is an antibiotic.

Keflex suspension is used to treat the following infections caused by bacteria that can be killed by cefalexin:

■    Respiratory tract (lung and airways) infections e.g. tonsillitis, pharyngitis and bronchitis

■    Middle ear infection (otitis media)

■    Skin and soft tissue (e.g. muscle) infections

■    Bone and joint infections

■    Infections of the reproductive organs and urinary tract (e.g. cystitis), including acute inflammation of the prostate (prostatitis)

■    Dental infections.

2 Before you take Keflex suspension

Do not take Keflex suspension if

■    you are allergic (hypersensitive) to cefalexin, other cephalosporins (similar antibiotics) or any of the other ingredients (these are listed in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

Take special care with Keflex suspension if you

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

■    develop diarrhoea

■    have a severe kidney disorder (you may need a reduced dose).

Tell your doctor if you are having blood or urine tests. Keflex suspension may interfere with these tests.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. This is especially important of the following, as they may interact with your Keflex suspension:

■    probenecid (a treatment for gout)

■    metformin ( a treatment for diabetes)

■    drugs used to treat leukaemia.

It may still be all right for you to be given Keflex suspension and your doctor will be able to decide what is suitable for you.

Pregnancy and breast-feeding

You should tell your doctor if you are pregnant or breast-feeding. Ask your doctor or pharmacist before taking any medication.

Driving and using machines

Keflex suspension should not affect your ability to drive or use machines.

Important information about the ingredients of Keflex suspension

Keflex suspension contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Keflex suspension contains allura red (E129) which may cause allergic reactions.

3 How to take Keflex suspension

Always take Keflex suspension exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The bottle is turned upside down and tapped to loosen the powder. Then a total of 60ml water in two portions is added, shaking after each addition until all the powder is in suspension. The suspension should be shaken well before use.

Your pharmacist should make up the suspension before you are given it.

Dosage

Adults and the elderly

The usual total daily dose is 1-4g orally, in

divided doses.

■    Most infections can be treated by 500mg every 8 hours.

■    For skin and soft tissue infections, sore throat (streptococcal pharyngitis), and mild, uncomplicated urinary tract infections, the usual dose is 250mg every 6 hours, or 500mg every 12 hours.

■    For more severe infections, larger doses may be needed.

■    A reduced dose is needed for patients with severe kidney disorders.

The usual total daily dose for children is 25-50mg/kg (body weight) in divided doses.

■    For skin and soft tissue infections, sore throat, and mild, uncomplicated urinary tract infections, the total daily dose may be divided and administered every 12 hours.

For most infections the following schedule is suggested: Children under 5 years 125mg every 8 hours.

Children 5 years and over

250mg every 8 hours.

In severe infections, the dose may be doubled. In the treatment of middle ear infections, a total daily dose of 75 to 100mg/kg in 4 doses is required.

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

4 Possible side effects

Like all medicines, Keflex suspension 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.

The following side effects have been reported

■    diarrhoea

■    feeling sick (nausea)

■    vomiting

■    indigestion

■    stomach pains

■    measle-like rash, (alone)

■    itching

■    red wheals on the skin (urticaria) (alone)

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

■    changes in blood counts, which may show up as bruising or a very tired feeling. You will need a blood test to confirm this.

■    damage to your liver or kidneys which can only be detected by a blood and / or urine test

■    jaundice (yellow skin and eyes)

■    weakness

■    fainting

■    abnormally excitable behaviour

■    agitation

■    tiredness

■    headache

■    confusion

■    dizziness

■    seeing or hearing things (hallucinations)

■    itching of the vagina or anus caused by thrush (candidiasis).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5 How to store Keflex suspension

Keep out of the sight and reach of children.

Do not store above 25°C.

After mixing, Keflex suspension should be stored in a cool place (6°C-15°C) or in a refrigerator (2°C-8°C) and be used within 10 days.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6 Further information

What Keflex suspension contains

The active substance is cefalexin monohydrate.

The other ingredients are: sucrose, imitation guarana flavour, allura red AC, sodium lauryl sulphate, methylcellulose 15, dimeticone, xanthan gum and pregelatinised starch

What Keflex suspension looks like and contents of the pack

100 ml plastic bottles with screw caps.

Marketing Authorisation Holder

Flynn Pharma Ltd Alton House 4 Herbert Street Dublin 2 Ireland

Manufacturer

Facta Farmaceutici SpA Via Laurentina, Km 24 Pomezia 00040 Rome Italy

This leaflet was last revised in

October 2011

FLYNN

PHARMA

LTD