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COLOFIBRE

Active substance(s): ISPAGHULA HUSK / ISPAGHULA SEED

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Colofibre®

Granules
(Ispaghula Seed, Ispaghula Husk)

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Colofibre 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 gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Colofibre is and what it is used for
2. Before you take Colofibre
3. How to take Colofibre
4. Possible side effects
5. How to store Colofibre
6. Further information
1. WHAT COLOFIBRE IS AND WHAT IT IS USED FOR
Colofibre Granules is an herbal medicinal combination product of bulk-forming laxatives. It contains Ispaghula Seed and
Ispaghula Husk.
Colofibre is used for the relief of habitual constipation in patients who need to increase their daily fibre intake.
2. BEFORE YOU TAKE COLOFIBRE
Do not take Colofibre:
• if you are allergic (hypersensitive) to Ispaghula Seed and Ispaghula Husk or any of the other ingredients of Colofibre (see
"What Colofibre contains" in section 6.) (An allergic reaction can be a rash, itchiness or shortness of breath).
• if you have narrowing of the gut (gastrointestinal tract)
• if you have difficulty in swallowing or any throat problems
• if you have a blocked bowel (obstruction or paralysis of the intestines)
• if you suffer from any bowel disorders, for example a sudden change in bowel habit lasting for more than 2 weeks,
undiagnosed bleeding from the rectum, enlarged bowel (megacolon) or failure to pass stools after taking a laxative
• if you have diabetes which is difficult to control.
Talk to your doctor before taking this product if any of the above applies to you.
Take special care with Colofibre
• Take each 5 ml spoonful of Colofibre with at least 1 glass (i.e. 150 ml) of water or similar drink, such as milk or fruit juice.
Taking Colofibre without enough liquid may cause it to swell and block your throat, and could cause choking. A
blocked bowel may occur if you do not keep drinking enough fluids. If you have chest pain, vomiting, or difficulty in
swallowing or breathing after taking Colofibre, get medical attention straight away. (See “How to take Colofibre” in
section 3.)
• Make sure you drink enough while taking Colofibre. This will also help your constipation.
• Only take Colofibre if your doctor tells you to do so:
• if you are weak, frail or elderly (you will need to be monitored while taking Colofibre)
• if you have a blocked bowel (dry, hard stools with tummy pain, nausea and vomiting).
• If you get tummy pain or your stools are different in some way, stop taking Colofibre and see your doctor.
• You should first try taking more exercise, changing your diet or taking bulking agents like Colofibre to relieve your
constipation before taking purgatives. Ask your pharmacist or doctor for advice.
Children under 6 years of age
As there is insufficient evidence it is not recommended to use in children under 6 years of age.
If any of these applies to you it is important that you speak to your doctor or pharmacist before taking Colofibre and they
will decide what to do. It may still be safe for you to take Colofibre.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any medicines, including medicines obtained
without a prescription.
In particular tell your doctor or pharmacist about the following medicines and do not take Colofibre within ½ to 1 hour
before or after them:
• mineral or vitamin B12 supplements
• medicines for heart failure (cardiac glycosides)
• medicines to thin the blood such as warfarin
• carbamazepine for epilepsy (fits)
• lithium for bipolar disorder.
• insulin (If you are diabetic and use insulin, you may need to reduce your dose of insulin if you take Colofibre with meals.)
• medicines for thyroid problems ( Your doctor may need to change the dose of the thyroid hormones you are taking.)
It may still be safe for you to take Colofibre; your doctor or pharmacist will be able to advise you further.
Pregnancy and breast-feeding
Talk to your pharmacist or doctor before taking Colofibre if you are pregnant or think you may be pregnant. There is no
restriction to the use of Colofibre.
Laxative bulk producers like Colofibre should be used before taking purgatives if a change of nutrition is not successful.
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or while breast-feeding.
Driving and using machines
Colofibre has no known effect on your ability to drive and use machines.
Important information for patients with diabetes or an intolerance to some sugars
Each heaped 5 ml spoonful of Colofibre contains approximately 0.9 g of sucrose (sometimes called saccharose). If you are
diabetic or have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking
this medicine.

3. HOW TO TAKE COLOFIBRE
If this product has been prescribed by your doctor, the label on the pack will tell you how much you should take and when.
Always take Colofibre exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
Administration
Colofibre should be placed dry on the tongue and swallowed whole, without chewing or crushing, with plenty of water, a
warm drink, milk, fruit juice, or similar liquid (at least one glass (150 ml) for each 5 ml spoonful of Colofibre). (See also section
2 'Take special care with Colofibre'.)
Drink about 10 glasses of fluid every day while you are taking this product.
Colofibre should be taken at least ½ to 1 hour before or after taking other medicines.
The effect starts 12-24 hours later.
Dose
Adolescents over 12 years of age, adults, elderly
The usual dose for adults, the elderly and adolescents over 12 years is two heaped 5 ml spoonfuls once a day every evening
after a meal (at least one hour before going to bed) and if necessary, one extra heaped 5 ml spoonful before breakfast.
Do not take it immediately before bedtime.
Children from 6 to 12 years of age
One heaped 5 ml spoonful daily to be taken every evening after a meal (at least one hour before going to bed).
Do not take it immediately before bedtime.
Pregnant women
Dose as for adults.
(See “Pregnancy and breast-feeding in section 2. for further information.)
Duration of treatment
If the symptoms persist for more than 3 days while using Colofibre, a doctor or pharmacist should be consulted.
(See “Take special care with Colofibre” in section 2.)
If you take more Colofibre than you should
If you take too much Colofibre contact your nearest casualty department or tell your doctor or pharmacist immediately.
Take this leaflet and any remaining granules with you.
If you forget to take Colofibre
If you forget to take your Colofibre, just take your normal dose as soon as you remember.
Do not take a double dose to make up for a missed 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, Colofibre can cause side effects, although not everybody gets them.
If you get any of the following side effects you should stop taking Colofibre and tell your doctor immediately or go to the
casualty department of your nearest hospital, as these may be signs of a severe allergic reaction to the medicine:
• A skin rash resembling hives (itchy, raised, swollen areas on the skin) or nettle rash
• Itchiness or redness
• Shortness of breath
Frequency not known (cannot be estimated from the available data)
• tummy pain
• swollen tummy
• blockage in the throat or gut
• blocked bowel (dry, hard stools collected in the rectum and anus)
particularly if insufficient fluid is drunk
• flatulence (wind) may occur for a short time after starting Colofibre.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE COLOFIBRE
Keep out of the reach and sight of children.
Do not use Colofibre after the expiry date, which is stated on the pack. The expiry date refers to the last day of that month.
Shelf-life after first opening: 6 months. Do not use Colofibre if you notice that the pack is damaged. 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 Colofibre contains
The active substances are Ispaghula Seed and Ispaghula Husk.
Each heaped 5 ml spoonful of Colofibre contains about 3.25 g of Ispaghula Seed and 0.11 g of Ispaghula Husk.
The other ingredients are caraway oil, sage oil, peppermint oil, acacia, talc, iron oxides (E172), titanium dioxide (E171), hard
paraffin, liquid paraffin and sucrose.
What Colofibre looks like and the contents of the pack
Colofibre is presented as yellow-brown sugar-coated granules and is available in packs containing 250g.
Marketing Authorisation Holder and Manufacturer
Madaus GmbH
51101 Cologne
Germany
Distributed by
Speciality European Pharma Ltd.
14 Took’s Court, London, EC4A 1LB, U.K.
This leaflet was last revised May 2014.
Colofibre is a registered Trade Mark

M.-Nr.: 702 849

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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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