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180 mm

Package leaflet: Information for the patient

Ispagel® Orange
Ispaghula Husk
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

The name of your medicine is lspagel® Orange. It contains the active
ingredient ispaghula husk in the form of granules which, when dispersed
in water, make an orange flavoured drink.
Ispaghula husk is a type of natural fibre that belongs to a group of medicines
known as bulk-forming laxatives. It works by increasing the bulk of your
stools, which encourages your bowels to move these stools through
your digestive system, which in turn relieves constipation.
Ispagel® Orange is recommended wherever increased fibre is needed in
your diet to help relieve constipation – this includes constipation during
pregnancy. It is also recommended to help maintain a normal bowel
function among patients suffering from any of the following conditions:
• irritable bowel syndrome
• colostomy or ileostomy
• haemorrhoids (piles)
• anal fissure
• persistent diarrhoea associated with diverticular disease
• ulcerative colitis.

2. What you need to know before you take
Ispagel® Orange


Do not take Ispagel® Orange if you:
• are allergic to ispaghula husk or any of the other ingredients of this
medicine (listed in section 6)
• have severe pain, cramps or swelling in your abdomen, vomiting
(being sick). You may have a blockage in your intestine
• have compressed and hardened faeces causing a blockage
of the bowel (faecal impaction)
• have been told by your doctor that the muscles in the wall of your
bowel are weak or not working
• have a disease called phenylketonuria (an inherited disorder of protein

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Warnings and precautions
• As per the instructions, always take Ispagel® Orange with plenty of
water (see section 3). Taking it with too little water could cause it to
stick in your gullet or throat, making it difficult for you to swallow or
breath, to have pain in your chest or to be sick. If this happens seek
urgent medical help.
• Make sure that you drink enough fluid during the day while you are
taking this medicine (see ‘Taking Ispagel® Orange with food and
drink’ below). If you are elderly or debilitated, you may need someone
to help you do this.
• If you have been informed by your doctor that you have narrowing of
the intestines or reduced bowel motility, talk to your pharmacist or
doctor before taking Ispagel® Orange to make sure that it is suitable
for you.
• If your constipation is not relieved or your symptoms persist, consult
your doctor.
• Absorption of calcium, iron, vitamins and minerals from your digestive
system may be reduced while taking this medicine.
Other medicines and Ispagel® Orange
Tell your doctor or pharmacist if you are taking or have recently taken or
might take any other medicines. In particular the following:
• Mineral or vitamin B 12 supplements
• Medicines for heart failure (cardiac glycosides)
• Medicines to thin the blood such as warfarin
• Lithium for bipolar disorder.
Taking Ispagel® Orange with food and drink
• Maintain an adequate fluid intake whilst taking this medicine by drinking
enough water. You should aim to drink at least eight large glasses of
water a day.
• To prevent constipation it is important to eat a well balanced diet
containing fibre (whole grain breads and cereals, bran, fruit and green
leafy vegetables) and to take daily exercise.

1. What Ispagel® Orange is and what it is used for

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What is in this leaflet
1. What Ispagel® Orange is and what it is used for
2. What you need to know before you take Ispagel® Orange
3. How to take Ispagel® Orange
4. Possible side effects
5. How to store Ispagel® Orange
6. Contents of the pack and other information

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Drinks containing caffeine (tea, coffee) or alcohol can make constipation
worse as they have a diuretic effect, which means they cause a loss
of fluid from the body, causing dehydration.

Pregnancy and breast-feeding
There is no restriction to the use of Ispagel® Orange during pregnancy
and breast-feeding.
Ispagel® Orange contains aspartame (E951) and sodium
Aspartame contains a source of phenylalanine. May be harmful for
people with phenylketonuria.
Also contains 68.81 mg of sodium per sachet. To be taken into
consideration by patients on a controlled sodium diet.

inflammation of the membrane that covers the inner surface of the

You may experience flatulence, bloating or abdominal discomfort during
the first few days of taking Ispagel® Orange. These effects should lessen
as you continue to take Ispagel® Orange.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
yellowcard. By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Ispagel® Orange

3. How to take this medicine
Always take this medicine exactly as described in this leaflet or as your
doctor or pharmacist has told you. Check with your doctor or pharmacist
if you are not sure.

How to prepare Ispagel® Orange drink:

Stir briskly for 3-5 seconds.
Drink straight away, preferably after meals.
The recommended dose is:
Adults, the elderly and children over 12 years: One sachet Ispagel®
Orange in the morning and evening or as prescribed by your doctor.
Children aged 12 years and under: Ispagel® Orange should not be
used in children aged 12 years and under. Other pharmaceutical forms
may be more appropriate for administration to this population.
Do not take Ispagel® Orange without water.
If there has been no bowel movement after three days of treatment,
consult your doctor.
If you take more Ispagel® Orange than you should
If you accidentally take too much of Ispagel® Orange, drink plenty of
water and see your doctor straightaway.
If you forget to take Ispagel® Orange
If you forget to take a dose, just take your next dose as normal.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If you get any of the following side effects you should stop taking Ispagel®
Orange and contact your doctor, as these may be signs of an allergic
reaction to the medicine:
• a skin rash resembling hives (itchy, raised swollen areas on the
skin) or nettle rash
• itchy or runny nose
• shortness of breath

6. Contents of the pack and other information
What Ispagel® Orange contains
• The active substance is Ispaghula husk. Each sachet contains 3.5 g
of Ispaghula husk.
• The other ingredients are sodium bicarbonate, orange flavour 501071
AP0551 (maize maltodextrin, alpha-tocopherol (E307), flavouring
components), beta-carotene, aspartame (E951), citric acid anhydrous,
riboflavin-5-sodium phosphate
What Ispagel® Orange looks like and contents of the pack
Ispagel® Orange is available in single dose sachets containing effervescent
granules, in cartons of 3, 5, 10, 30 or 60 sachets. Not all pack sizes may
be marketed.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Limited,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Herts, HP4 1EG, UK
+44 (0) 1442200922
Fax: +44 (0) 1442873717
Ispagel® Orange; PL 17907/0397
This leaflet was last revised in December 2016.
To request a copy of this leaflet in Braille, large print or audio format,
please contact the licence holder at the address (or telephone, fax, email)


Put the contents of the sachet into an empty glass.
Add 150ml of cold water.

Keep this medicine out of the sight and reach of children.
Do not store above 250C. Store in the original package.
Do not use this medicine after the expiry date which is stated on the
label after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

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Expand Transcript

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.