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PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER

Read all of this leaflet carefully because II contains important information for you.

This medicine Is available without prescription.

However you still need to take Rbrellef carefully to get the best results from it.

I Keep this leaflet. You may need to read it again.

I Ask your pharmacist if you need more information or advice.

I You must contact a doctor It your symptoms worsen or do not Improve.

I 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 Fibrelet is and what it Is used for

2.    Before you take Fibrelief

3.    How to take Fibreliet

4.    Possible side effects

5.    How to store Fibreliet

6.    Further information

1.    What Fibrelief Is and what It Is used tor

Fibrelief contains Ispaghula husk which is a bulking agent. This means that when it is taken with water it increases the size of Ihe faeces (stools) and helps solid waste to pass through the body.

Fibrelief sachets are used to treat constipation and In conditions where it Is better for the patient to have soil stools. They are also used tor patents who require a high fibre diet

2.    Before you take Rbrellef

Do not take Fibrelief if you are or have:

■    a blockage of the bcwel (Intestinal obstruction or faecal Impaction)

■    allergic reaction (breathing and swallowing difficulty, chest pain and vomiting) to isphaghulaor any of the ingredients in these sachets (see section 6 for more details)

■    severe stomach pain, which has ccntnued for several hours alongside vomltng (sickness) and constpatlon

■    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 meHitus (insulin-dependent diabetes)

■    younger than 12 years of age.

Take special care with Flbrellel and tell your doctor it you have or have had:

■    phenylketonuria (an Inherited condition) as this product contains aspartame (E951) which could make the condition worse

■    difficulty in swallowing or breathing

■    any throat problems.

While you are taking this medicine you should drink plenty ol fluid to help the medicine work properly, and to avoid side-etfecls Taking other medicines

Please tell your doctor or pharmacist it 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.

Taking Fibrelief 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 tor more details.

Pregnancy and breast-teeding

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

Always take Fibrelief 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 dcsefor adults, the elderly and children over 12yearsis4-20g (1-5 sachets) In 1 to 3 doses.

M lx one sachet in about 150 ml (quarter pint) of cool water, stir briskly and swallow as quickly as possible.

/continued owrleat)

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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 Fibre-Met 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

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 anylurther questions on the use of this product ask your doctor or pharmacist

4. Possible side effects

Like all medicines Fibrelief can cause side effects, although not everybody gels 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 swal lowing

■    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 Fib relief and contact your doctor immediately.

Other side effects such as flatulence which disappear within the treatment have been reported.

It any ot these side effects gets serious, or it you notice any side effects not listed In this leaflet please tell your doctor or phaimacist

5. How to store Fibrelief

Keep out of fhe 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 contains

Each sachet contains the active ingredient ispaghula husk 3.5 g It also contains aspartame (E961), citric acid mcnohydrate 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 ora) 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, NN82QY, United Kingdom.

The leaflet was last revised In November 2007

MANX

Pharma

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