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BOOTS NATURAL FIBRE DRINK

Active substance(s): ISPAGHULA HUSK

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PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER

ORANGE
Ispaghula husk

Read all of this leaflet carefully because it contains
important information for you.
This medicine is available without prescription.
However, you still need to take Fibrelief Orange
carefully to get the best results from it.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information
or advice.
You must contact a doctor if your symptoms worsen
or do not improve.
If any of the side effects get serious, or if you notice
any side effect not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet
1. What Fibrelief Orange is and what it is used for
2. Before you take Fibrelief Orange
3. How to take Fibrelief Orange
4. Possible side effects
5. How to store Fibrelief Orange
6. Further information

1. What Fibrelief Orange is and what it is
used for
Fibrelief Orange contains ispaghula husk which is a
bulking agent. This means that when it is taken with
water it increases the size of the faeces (stools) and
helps solid waste to pass through the body.
Fibrelief Orange sachets are used to treat constipation
and in conditions where it is better for the patient to
have soft stools. They are also used for patients who
require a high fibre diet.

2. Before you take Fibrelief Orange
Do not take Fibrelief Orange if you are or have:
a blockage of the bowel (intestinal obstruction or
faecal impaction)
allergic reaction (breathing and swallowing
difficulty, chest pain and vomiting) to isphaghula or
any of the ingredients in these sachets (see section
6 for more details)
severe stomach pain, which has continued for
several hours alongside vomiting (sickness) and
constipation
pain when you try to go to the toilet, and only pass
watery fluid-like diarrhoea, even though you feel
you need to open your bowels
passing blood when you go to the toilet

Font - Swiss 721 BT
Subheads in 10pt Bold
Main copy in 9pt Roman

poorly controlled diabetes mellitus (insulindependent diabetes)
younger than 12 years of age.
Take special care with Fibrelief Orange and tell your
doctor if you have or have had:
phenylketonuria (an inherited condition) as this
product contains aspartame (E951) which could
make the condition worse
an intolerance to some sugars
difficulty in swallowing or breathing
any throat problems.
While you are taking this medicine you should drink
plenty of fluid to help the medicine work properly, and
to avoid side-effects.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without prescription.
You must tell your doctor or pharmacist if you are
taking any of the following medicines:
medicines for a heart condition
minerals and vitamins, for example calcium, iron,
lithium, zinc and B12.
You should not take your medicine half to one hour
before or after taking Fibrelief Orange.
Taking Fibrelief Orange with food and drink
Mix one sachet in about 150 ml (quarter pint) of cool
water, stir briskly and swallow as quickly as possible.
Taking this product without enough fluid may cause it
to swell and block your intestines. See section 3 for
more details.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking
any medicines.
Driving and operating machinery
There are no known effects of this medicine on your
ability to drive or use machinery.
Important information about some of the
ingredients in this product
These tablets contain sucrose. If you have been told by
your doctor that you have an intolerance to some
sugars, contact your doctor before taking this product.

(continued overleaf)

Client:
APPROVED
ARTWORK URN:
Job:
Size:
Cutter Guide:
Dragon Ref Date:
BOH Approval Date:
Saved as:
Proof No:
Folder:
Barcode No:
File Location:
Prints:

Manx Pharma Limited
FI02-PIL-03-280508
Fibrelief Orange PIL - Page 1
210 x 148mm
Not applicable
3 March 2009
28 May 2008
13852 Fibrelief PIL-P1.ai
03
Manx 13852
Not applicable
Mac Pocket Drive
1 Colour - Black

3. How to take Fibrelief Orange
Always take Fibrelief Orange exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure. The usual dose is:
The usual daily dose for adults, the elderly and children
over 12 years is 4 - 20 g (1-5 sachets) in 1 to 3 doses.
Mix one sachet in about 150 ml (quarter pint) of cool
water, stir briskly and swallow as quickly as possible.
You should take it at least half to one hour before and
after a meal or taking other medicines.
You should not take it just before you go to bed.
If you take more Fibrelief Orange than you should
If you have taken more than the usual dose, you
should drink plenty of fluid. Consult a doctor if you
develop any stomach pains or start vomiting. If
symptoms persist for more than 3 days please see
your doctor.
If you forget to take Fibrelief Orange
If you forget to take a dose, take one as soon as you
remember. Do not take a double dose to make up for a
forgotten dose.
If you have any further questions on the use of this
product ask your doctor or pharmacist.

4. Possible side effects
Like all medicines Fibrelief Orange can cause side
effects, although not everybody gets them.
If you develop the following rare side effects (may
indicate an allergic reaction) please contact your
doctor immediately and stop taking this medicine:
difficulty with breathing or swallowing
swelling of face, lips, eyelids or throat
rash and itching.
If you develop severe stomach pain, which goes on for
several hours, and start vomiting please stop taking
Fibrelief Orange and contact your doctor immediately.
Other side effects such as flatulence which disappear
within the treatment have been reported.
If any of these side effects gets serious, or if you
notice any side effects not listed in this leaflet
please tell your doctor or pharmacist.

Font - Swiss 721 BT
Subheads in 10pt Bold
Main copy in 9pt Roman

5. How to store Fibrelief Orange
Keep out of the reach and sight of children.
Do not store above 25ºC.
Store in the original container.
Do not use these sachets after the expiry date which is
printed on the packet.
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 Fibrelief Orange contains
Each sachet contains the active ingredient ispaghula
husk 3.5 g. It also contains natural orange flavour
(maltodextrin, acacia gum, natural tocopherol extracts),
aspartame (E951), beta-carotene (maltodextrin, acacia
{E414}, hydrogentated vegetable oil, sucrose, betacarotene {E160a}, sodium ascorbate {E1301},
di-α-tocopherol {E307}, citric acid monohydrate and
pregelatinised starch.
What Fibrelief looks like and contents of the pack
The product is available in boxes of 7, 10, 30 and 60
sachets containing granules for oral suspension. Not
all pack sizes may be marketed.
Marketing Authorisation Holder
Manx Healthcare Limited, Taylor Group House
Wedgnock Lane, Warwick, CV34 5YA, United Kingdom.
Manufacturer
Honeywood Limited, Edmonds Close, Denington
Industrial Estate, Wellingborough, Northants, NN8 2QY,
United Kingdom.
This leaflet was last revised in May 2008

URN:F102-PIL-03-280508

Client:
APPROVED
ARTWORK URN:
Job:
Size:
Cutter Guide:
Dragon Ref Date:
BOH Approval Date:
Saved as:
Proof No:
Folder:
Barcode No:
File Location:
Prints:

Manx Pharma Limited
FI02-PIL-03-280508
Fibrelief Orange PIL - Page 2
210 x 148mm
Not applicable
3 March 2009
28 May 2008
13852 Fibrelief PIL-P2.ai
03
Manx 13852
Not applicable
Mac Pocket Drive
1 Colour - Black

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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.

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