Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
: Fybogel Hi-Fibre Orange contains the active substance Ispaghula Husk. It is an easy and
/ convenient way to increase the fibre in your diet helping your digestive system work more | 'efficiently and gently relieving constipation the natural way. As it works naturally with your , _ body, it takes care of constipation without undue straining, discomfort or unnatural : | urgency, helping to restore and maintain regularity.
' Fybogel Hi-Fibre Orange can be used whenever increased fibre is needed in your diet to 'relieve constipation; including constipation during pregnancy. It can also be used to help
you are allergic to Ispaghula husk or any of the other ingredients (see section 6) : You have a sudden change in bowel habit that has persisted for more than two weeks.
* you are suffering from a blockage of the bowel (intestinal obstruction, faecalimpaction) | ~~ if you have a weakness of the bowel wall (colonic atony) : the speed in which material moves through your gut has always been slow (naturally occurring reduced gut motility).
You have difficulty in swallowing or any throat problems
'Tell your doctor, pharmacist or nurse if:
* you have phenylketonuria (an inherited genetic disorder) as this product contains aspartame, a source of phenylalanine.
'* You are suffering from undiagnosed rectal bleeding and unable to pass stools following
the use if laxatives.
'* your symptoms worsen or do not improve after 3 days. 1 If stomach pain occurs or in cases of a sudden change in bowel habit please stop using this ; : product and speak to your doctor. : 'Take special care:
:* ifyou are a healthcare worker or care giver as allergic sensitisation may occur due to
inhalation. + if not taken with enough liquid, can cause chest pain, vomiting or difficulty swallowing. + elderly and debilitated (weak) patients may require medical supervision.
: Other medicines and Fybogel Hi-Fibre Orange :
'You must not take this medicine if you are taking other medicines which may cause
_ constipation (e.g. codeine or morphine).
'Do not take Fybogel Hi-Fibre Orange within / to 1 hour before or after the following 'Medicines.
|* Insulin - if you are diabetic and use insulin, you may need to reduce your dose of insulin
if you take Fybogel Hi-Fibre Orange with meals. * medicines for thyroid problems - your doctor may need to change the dose of the thyroid hormones you are taking.
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' Pregnancy and breast-feeding : i ' This medicine may be used during pregnancy and breast-feeding. ' ' This medicine contains 16mg aspartame in each sachet. Aspartame is a source of ' ' phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder ! in which phenylalanine builds up because the body cannot remove it properly. | This medicine contains less than 1 mmol sodium (23 mg) in each sachet, that is to say | essentially 'sodium-free'. | This medicine contains 0.25 mmol (or 9.76 mg) potassium per sachet. To be taken into 1 ' consideration by patients with reduced kidney function or patients on a controlled ' potassium diet. |
:3. How to take Fybogel Hi-Fibre Orange
'4. Possible side effects
'5. How to store Fybogel Hi-Fibre Orange
,6. Contents of the pack and other information
:
| Like all medicines, this medicine can cause side effects, although not everybody gets them. | This product can cause allergic reactions with symptoms including difficulty in breathing, | wheezing or coughing, skin rash, itching and a sudden life-threatening allergic reaction. ' This product contains allergens and it is possible to come into contact with them via skin, 'inhalation or when taking the product by mouth and may cause red or itchy eyes, runny or | blocked nose and a skin rash. If symptoms appear, you should immediately stop using this product and contact your doctor or pharmacist. Due to the increased fibre intake of your | diet you may experience wind (flatulence) or bloating during the first few days of taking | 'this product, which should lessen as you continue to take it. If you have any other ' : symptoms after taking this product, tell your doctor or pharmacist. ' ' 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 internet at! ; www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine. |
Fybogel and @ are trade marks of the Reckitt group Leaflet last revised May 2024. Lo ee 0000000
Fybogel Hi-Fibre Orange Granules comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Fybogel Hi-Fibre Orange Granules is ispaghula husk.
Medicines with the same active substance include: Fybogel Hi-Fibre Lemon Granules, Fybogel Lemon Granules, Fybogel Orange Granules, Fybogel Plain Granules. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Fybogel Hi-Fibre Orange Granules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the treatment of patients requiring a high fibre regimen: for example, for the relief of constipation, including constipation in pregnancy and the maintenance of regularity; for the management of bowel function in patients with haemorrhoids.
If there have been no bowel movements after 3 days of treatment a doctor or healthcare professional should be consulted. (See section 4.4 'Special warnings and precautions for use')
Posology
Adults: One sachet, morning and evening
Elderly: There is no indication that dosage needs to be modified for the elderly.
Paediatric Population
Children over 12 years: One sachet, morning and evening.
Children aged 6 to 12 years: Half to one level 5 ml spoonful, depending on age and size, morning and evening.
Children under 6 years: The use in children under 6 years of age is not recommended (See section 4.4 'Special warnings and precautions for use').
The effects start 12-24 hours later.
Method of Administration
The medicine is intended for oral use as a suspension in a full drink of water (See section 4.4). The granules should be stirred into a glass of water and taken as soon as possible, preferably after meals.
The product should be taken during the day at least ½ to 1 hour before or after intake of other medicines and should not be taken immediately before going to sleep.
When preparing the product for administration, it is important to try to avoid inhaling any of the powder in order to minimize the risk of sensitisation to the active ingredient.
Hypersensitivity to ispaghula husk or to any of the excipients listed in Section 6.1 (See Section 4.4 Special warnings and precautions for use).
Patients with a sudden change in bowel habit that has persisted more than two weeks.
Undiagnosed rectal bleeding and failure to defecate following the use of a laxative.
This medicine is contra-indicated in patients suffering from abnormal constrictions in the gastro-intestinal tract, with diseases of the oesophagus and cardia, intestinal obstruction, faecal impaction, natural or drug-induced reduction of gut motility and colonic atony such as senile mega-colon.
Patients who have difficulty in swallowing or any throat problems.
Enteral absorption of concomitantly administered medicines such as minerals, vitamins (B12), cardiac glycosides, coumarin derivatives, carbamazepine and lithium may be delayed. For this reason the product should not be taken ½ to 1 hour before or after intake of other medicinal products.
Diabetic patients should take ispaghula husk only under medical supervision because adjustment of anti-diabetic therapy may be necessary.
Use of ispaghula husk concomitantly with thyroid hormones requires medical supervision because the dose of the thyroid hormones may have to be adjusted.
Pregnancy
There are limited amount of data (less than 300 pregnancy outcomes) from the use of ispaghula husk in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3 Preclinical safety data).
Breast-feeding
The use of ispaghula husk may be considered during pregnancy and lactation, if necessary and if change of nutrition is not successful. Laxative bulk producers should be used before using other purgatives.
Fertility
No known effects.
The product has no or negligible influence on the ability to drive and use machines.
Symptoms
Overdose with ispaghula husk may cause abdominal discomfort, flatulence and intestinal obstruction.
Management
Adequate fluid intake should be maintained, particularly if the granules have been taken without water contrary to administration instructions, and management should be symptomatic.
Ask anything about Fybogel Hi-Fibre Orange Granules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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