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PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER

Fibre|ief 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.

I 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

■    poorly controlled diabetes mellitus (insulin-dependent 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)

Font - Swiss 721 BT Subheads in 10pt Bold

Main copy in 9pt Roman

DRAGON DESIGN COMPANY	Client:	Manx Pharma Limited
	APPROVED ARTWORK URN:	FI02-PIL-03-280508
	Job:	Fibrelief Orange PIL - Page 1
	Size:	210 x 148mm
■	Cutter Guide:	Not applicable
	Dragon Ref Date:	3 March 2009
	BOH Approval Date:	28 May 2008
	Saved as:	13852 Fibrelief PIL-P1.ai
	Proof No:	03
	Folder:	Manx 13852
	Barcode No:	Not applicable
	File Location:	Mac Pocket Drive
	Prints:	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.

5.    How to store Fibrelief Orange

Keep out of the reach and sight of children.

Do not store above 25°C.

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, beta-carotene {E160a}, sodium ascorbate {E1301}, di-a-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

MANX

Healthcare

URN:F102-PIL-03-280508