FLUCLOXACILLIN 250MG/5ML GRANULES FOR ORAL SOLUTION

Active substance: FLUCLOXACILLIN SODIUM

View full screen / Print PDF » Download PDF ⇩

Transcript


FLUCLOXACILLIN

Job No.: 300766
Date: 17th October 2012

250mg/5ml
GRANULES FOR
ORAL SOLUTION

PROOF 1

100ml

Expiry Date:

When prepared as directed,
each 5ml spoonful contains 250mg
Flucloxacillin (as flucloxacillin
sodium). Also includes
sucrose, aspartame (E951),
E123, E217, E219
and sodium.

Batch No.:

PL20416/0077
POM
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
SIGHT OF CHILDREN

M0173TB

Peel here to open but do not remove

PL Holder:
Crescent Pharma Limited
Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton, Hampshire RG25 3ED

Code: KR/DRUGS/KTK/28/337/2003

100%

Colour Reference:

Label Code M0173TB





Black

667

Base Label:

50 x 135mm

Leaflet Page 1:

50 x 88mm

Left Hand Opening



Overall Leaflet Size:

Text Size
8 pt

50 x 590

Page Widths: 88 85 84 83 83 84 83

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
SIGHT OF 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.

100ml

M0173TB
PL20416/0077

POM



FLUCLOXACILLIN

Job No.: 300766
Date: 17th October 2012

250mg/5ml
GRANULES FOR
ORAL SOLUTION

PROOF 1

100ml

Expiry Date:

When prepared as directed,
each 5ml spoonful contains 250mg
Flucloxacillin (as flucloxacillin
sodium). Also includes
sucrose, aspartame (E951),
E123, E217, E219
and sodium.

Batch No.:

PL20416/0077
POM
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
SIGHT OF CHILDREN

M0173TB

Peel here to open but do not remove

PL Holder:
Crescent Pharma Limited
Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton, Hampshire RG25 3ED

Code: KR/DRUGS/KTK/28/337/2003

100%

Colour Reference:

Label Code M0173TB





Black

667

Base Label:

50 x 135mm

Leaflet Page 1:

50 x 88mm

Left Hand Opening



Overall Leaflet Size:

Text Size
8 pt

50 x 590

Page Widths: 88 85 84 83 83 84 83

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
SIGHT OF 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.

100ml

M0173TB
PL20416/0077

POM

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.
2.
3.
4.
5.
6.

What this medicine is and what it is used for
Before you take this medicine
How to take this medicine
Possible side effects
How to store this medicine
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.

2. BEFORE YOU TAKE THIS MEDICINE
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 machiner y:
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.

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
SIGHT OF 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.

100ml

M0173TB
PL20416/0077

POM

If you have taken too much medicine:
Contact your doctor straight away or go to the nearest hospital casualty
department. Take with you any remaining medicine and the pack so
that the medicine can be identified.

4. POSSIBLE SIDE EFFECTS

Flucloxacillin is usually well tolerated; however, some people may have
side-effects when taking this medicine. If you have any unwanted sideeffects you should seek advice from your doctor, pharmacist or other
healthcare professional. Also you can help to make sure medicines
remain as safe as possible by reporting any unwanted side-effects via
the internet at www.mhra.gov.uk/yellowcard alternatively you can call
Freephone 0808 100 3352 (available between 10am-2pm MondayFriday) or fill in a paper form available
from your local pharmacy.

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.
Ver y 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.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)