Ispagel Orange
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Ispagel Orange
Ispaghula Husk Granules
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.
* You must talk to a doctor if you do not feel better or if you feel worse.
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
1. What Ispagel Orange is and what it is used for
The name of your medicine is Ispagel 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 so encouraging your bowels to move them through your digestive system and also helping to regulate their passage.
Ispagel Orange is for the treatment of constipation and to help maintain normal bowel function in people with a colostomy or ileostomy, diarrhoea associated with diverticular disease, irritable bowel syndrome (IBS) or ulcerative colitis. It is also for use by people with haemorrhoids (piles) or anal fissures to make bowel movements more regular and easier to pass, and so avoid straining.
2. What you need to know before you take Ispagel Orange
Do not take Ispagel Orange if you:
* are allergic (hypersensitive) to ispaghula husk or any of the other ingredients of Ispagel Orange (see section 6)
* are suffering from a blockage of the intestines or any condition that may lead to you developing a blockage
* have compressed and hardened faeces causing a blockage of the bowel (faecal impaction)
* have stomach pain or your abdomen is swollen or tender to the touch
* have difficulty swallowing
* are being sick (vomiting) or feeling sick (nausea)
* 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 metabolism).
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.
Ispagel Orange may decrease the gastrointestinal absorption of other
drugs. Tell your doctor or pharmacist if you are using, have recently
used or might use any other medicines.
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.
* 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.
Important information about some of the ingredients of
Ispagel Orange
This product contains:
* Aspartame, a source of phenylalanine, which may be harmful for people with phenylketonuria.
* Sodium. Each sachet contains 2.39 mmol sodium - to be taken into consideration by people on a controlled sodium diet.
* Sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Other side effects
* Flatulence (excess wind) and bloating. This is usually only temporary and should lessen after a few days.
* Abdominal discomfort.
* Faecal impaction when a lump of dry, hard stool gets stuck in the rectum (symptoms of this include rectal pain, abdominal cramping, nausea and inability to have a bowel movement).
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
3. How to take Ispagel Orange
5. How to store Ispagel Orange
Always take Ispagel Orange 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.
Always mix Ispagel Orange with plenty of water to make a drink before taking it.
It is helpful to also drink another glass of liquid after taking it.
Do not take this medicine shortly before going to bed.
* Put the contents of one sachet into an empty glass. Add at least 150 ml (1/4 pint) of cold water.
* Stir briskly for 3-5 seconds.
* Drink promptly.
Adults and the Elderly: One sachet (3.5 gram dose) up to three times a day, depending on your need and response.
Children 6 - 12 years: Half the adult dose.
Children under six years: Ispagel Orange should not be given to children under six years except under strict medical supervision.
If you take more Ispagel Orange than you should: drink plenty of water and contact your doctor.
If you forget to take Ispagel Orange
If you forget to take a dose, take it as soon as you remember unless it is almost time for your next dose. 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, Ispagel Orange can cause side effects, although not everybody gets them.
If you experience any of the following, stop taking Ispagel Orange and get immediate medical help:
* wheezing or difficulty breathing; swelling of the face, lips, tongue or throat; a red itchy skin rash; feeling faint and dizzy. You may be having an allergic reaction.
* severe pain, cramps or swelling in your abdomen, vomiting (being sick). You may have a blockage of your intestine.
* Keep this medicine out of the sight and reach of children.
* Do not store Ispagel Orange above 25°C. Store in the original package.
* Do not take this product after the expiry date shown on the pack. 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 to protect the environment.
6. Further Information
What Ispagel Orange contains
The active substance is ispaghula husk (3.5 g per sachet).
The other ingredients are sodium bicarbonate, natural orange flavour [containing maltodextrin, acacia gum, sorbitol syrup (E420), butylated hydroxyanisole (E320)], B-carotene, aspartame (E951), citric acid anhydrous and riboflavin sodium phosphate.
What Ispagel Orange looks like and contents of the pack:
Ispagel Orange is available in single dose sachets containing light tan granules, in cartons of 3, 10, 30 or 60 sachets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Boston Healthcare Ltd., 6 Navigation Court, Calder Park, Wakefield WF2 7BJ, United Kingdom.
Manufacturer:
Madaus S.A., Foc 68 - 82, Barcelona 08038, Spain.
This leaflet was last revised in January 2014 ‘Ispagel’ is a registered trademark.