Document: label-leaflet MAH GENERIC_PL 20416-0210 change

• label-leaflet MAH GENERIC_PL 20416-0077
• label-leaflet MAH GENERIC_PL 20416-0210
• leaflet MAH GENERIC_PL 20416-0077
• leaflet MAH GENERIC_PL 20416-0210

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Qrescent Pharma..

FIUCCOMCJLLIN

When prepared as directed, >each£ml sp^nfui gpntains 250mg ₍ FAicl^agllin (as fliKloxacillin sodiiJiJ^AIso includes ^psucr“e, aspartam*E951).

E123, E217, E219 and sodium.

To the Pharmacist: Before reconstitution, Do not store above 25°C. Keep the bottle tightly _closed. To dispense, add 58ml of aterGncfthakefteil until H tt# • poCder isOissoivCd. •    •

To the Parent: ^jjake well before each use. Store in a refrigerator Land u^ v^hin 7 days. tor^lete phe practiced course onreatment. For owl admWistration, as dire^d by#idftoctor.    •    •

For further information, see enclo^fd Pa^nt 'nformrdc'

^Lei% •    • •

y<^P OUT OF TAE REACH AND rSIGHT OF CHILDREN

M0175TB PL20416/0210

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Code: KR/DRUGS/KTK/28/337/2003 PL20416/0210    I POM I

To the Pharmacist: Before -

reconstitution, Do not store above 25°C. Keep the bottle tightly closed. To dispense, add 58ml of water and shake well until all the powder is dissolved.

To the Patient: Shake well before each use. Store in a refrigerator and use within 7 days. Complete the prescribed course of treatment.

For oral administration, as directed by the doctor.

For further information, see enclosed Patient Information Leaflet.

KEEP OUT OF THE REACH AND SIGHTOF CHILDREN

FLUCLOXACILLIN

250mg/5ml GRANULES FOR ORAL SOLUTION

When prepared as directed, each 5ml spoonful contains 250mg Flucloxacillin (as flucloxacillin sodium). Also includes sucrose, aspartame (E951),

E123, E217, E219 and sodium.

PATIENT INFORMATION LEAFLET

Flucloxacillin 250mg/5ml Granules for Oral Solution

Please read all of this leaflet carefully before you start taking this medicine.

Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, ask your doctor or

pharmacist.

This medicine is for you. Only a doctor can prescribe it. Never give the medicine to someone else. It may harm them even if their symptoms are the same as yours.

IN THIS LEAFLET:

1.    What this medicine is and what it is used for

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Further information

1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR

Each 5ml of oral solution contains 250mg of flucloxacillin (as flucloxacillin sodium) as the active ingredient.

This medicine belongs to the penicillin group of antibiotics. It is used to treat various bacterial infections by killing the bacteria or preventing their growth. These include skin and soft tissue infections, throat and

chest infections, other infections such as urinary tract infection and prevention of an infection occurring during surgery.

Do not take this medicine if:

•    you are allergic to any penicillin or other kind of antibiotic or to any of the other ingredients listed (see section 6).

•    you have ever had any liver problems after taking flucloxacillin

Check with your doctor before taking this medicine if:

•    you are pregnant, think you may be pregnant or breastfeeding

•    you have a history of allergy

•    you have liver or kidney problems

•    you have any serious illness

•    you are 50 years old or over

•    you are giving this medicine to a newborn child

Taking other medicines

Check with your doctor or pharmacist before taking this medicine if you are taking other medicines, including any that you can buy without a prescription. This is important if you are taking other medicines, especially:

•    probenecid or sulfinpyrazone - used for treatment of gout

•    oral anti-coagulants e.g. warfarin - used for thinning blood

•    methotrexate - a cancer drug which can also be used to treat psoriasis

•    piperacillin (an antibiotic given by injection)

•    the oral typhoid vaccine

•    sugammadex (used with general anaesthetics)

•    birth control pills Tests:

Your doctor may want to carry out regular monitoring of your kidney

or liver function if you are taking this medicine long term.

If you need to have a liver function test, tell your doctor you are taking this medicine as it may affect the results.

Driving and using machinery:

This medicine should not affect your ability to drive or operate machinery. However, if you think you are affected do not drive or operate machinery.

Important information about some of the ingredients of this

medicine:

-    Each 5 ml dose contains 3.0g sucrose; this should be taken into account in patients with diabetes mellitus. Also if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

-    Amaranth may cause allergic reactions.

-    Aspartame contains a source of phenylalanine which may be harmful for people with phenylketonuria.

-    E217 and E219 may cause allergic reactions (possibly delayed).

-    Each 5ml dose contains approx 16mg of sodium. This may need to be taken into consideration in patients on a controlled sodium diet, particularly if you are prescribed more than the usual dose.

3. HOW TO TAKE THIS MEDICINE

For oral use. Shake the bottle well before use. Take the medicine half an hour to an hour before meals.

Follow your doctor’s instructions about taking your medicine. The label will also tell you how much to take and how often. The dose for this medicine may be different for different patients.

Adults (including the elderly): 250mg (one 5ml spoonful) 4 times a day; your doctor may prescribe double this dose where necessary.

Children, over 10 years: The usual dose is the same as the adult dose. Children 2 to 10 years of age: Half the adult dose i.e.125mg (2.5ml) 4 times a day.

Under 2 years of age: A quarter of the adult dose i.e. 62.5mg (1.25ml) 4 times a day, (this 250mg/5ml strength medicine is not suitable for use).

The length of time for treatment varies depending on the severity and type of infection. However, it is important to finish your prescribed dose of this medicine. If you stop taking this medicine too soon, your symptoms may return.

If you forget to take a dose: take your dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your normal dosing schedule. DO NOT DOUBLE THE DOSES.

If you experience any of the following very rare effects (could happen

to less than 1 in 10,000 people) while you are taking this medicine,

STOP taking it and contact your doctor IMMEDIATELY:

•    sudden wheeziness, difficulty breathing, swelling of the face, eyes, lips, tongue or throat, itching or itchy skin rashes (may be signs of allergy or a severe allergic reaction)

•    severe bloody diarrhoea with fever and abdominal pain.

Tell your doctor if you notice any of the following side effects or notice

any others not listed:

Common effects (that could happen to less than 1 in 10 people):

•    minor stomach upsets such as feeling sick or diarrhoea.

Very rare effects (that could happen to less than 1 in 10,000 people):

•    inflammation of the kidney or liver and a type of jaundice (symptoms include swollen ankles, yellowing of the skin or whites

of the eyes, loss of appetite, pale stools, dark urine). Some of these effects may be delayed and may not occur until up to 2 months after you have stopped taking this medicine

•    reduction in the numbers of blood cells which can cause unexplained bleeding, bruising, pale skin, weakness, tiredness

•    joint or muscle pain or fever, which may develop 2 days or more from the start of treatment

•    effects on the skin such as rashes, red patches, peeling, swelling, blistering.

5. HOW TO STORE THIS MEDICINE

Store in a refrigerator. Use within 7 days of preparation.

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF

CHILDREN

Do not take this medicine if the expiry date on the pack has passed.

If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

6. FURTHER INFORMATION Ingredients

Each 5ml of oral solution contains 250mg of flucloxacillin (as flucloxacillin sodium) as the active ingredient.

It also contains the inactive ingredients: amaranth (E123), cherry flavour, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), sodium citrate, aspartame (E951), citric acid anhydrous, sucrose and water (when dispensed by the pharmacist).

Although the bottle of your medicine appears to be only partially full, it contains the correct amount of the solution. The extra space is to allow you to shake the medicine.

What the medicine looks like:

Flucloxacillin Oral Solution is a clear, red solution.

Each bottle contains 100 ml.

Who makes this medicine and holds the product licence:

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units,

Polhampton Lane, Overton, Hants, RG25 3ED

Date leaflet prepared: September 2012

If you would like this leaflet in a different format please contact the

licence holder at the above address.