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FYBOGEL is a brand name for Ispaghula Husk. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used 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 colostomy, ileostomy, haemorrhoids, anal fissure, chronic diarrhoea associated with…
Verbatim from this product's MHRA label. Tap a section to expand.
If there have been no bowel movements after 3 days of treatment a doctor or health care professional should be consulted. 4 ‘Special warnings and precautions for use’) Posology Adults: One sachet, morning and evening.
Elderly:
There is no indication the dosage need be modified for the elderly.
Paediatric Population Children over 12 years:
One sachet, morning and evening.
Children aged 6 to12 years:
Half to one level 5ml spoonful depending on size and age, morning and evening. 4 ‘Special warnings and precautions for use’) The effects start 12-24 hours later. 4). Fybogel 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 sensitization to the active ingredient.
). It is recommended to assess clinically the possible sensitisation of individuals at risk and, if justified, to perform specific diagnostic tests. 3 Contraindications). Paediatric Population Use is not recommended in children below 6 years of age due to insufficient data on safety and efficacy.
Laxative bulk producers should be used before using other purgatives if change of nutrition is not successful. 5 Interaction with other medicinal products and other forms of interaction 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. 6 Fertility, pregnancy and lactation Pregnancy There are limited amount of data (less than 300 pregnancy outcomes) from the use of ispaghula husk in pregnant women.
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.
7 Effects on ability to drive and use machines Fybogel has no or negligible influence on the ability to drive and use machines. 4 Special warnings and precautions for use). Adverse events which have been associated with ispaghula husk are given below, tabulated by system organ class and frequency.
Frequencies are defined as:
). 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. Fybogel 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. 4 Special warnings and precautions for use The product should not be taken dry and should always be taken mixed with fluid (5 fluid ounces or 150 mL of water or other liquid per sachet).
Ispaghula husk should not be used by patients with faecal impaction and symptoms such as abdominal pain, nausea and vomiting unless advised by a doctor because these symptoms can be signs of potential or existing intestinal blockage (ileus).
If abdominal pain occurs or in cases of any irregularity of faeces, the use of ispaghula husk should be discontinued and medical advice must be sought. When taken with inadequate fluid amounts, bulk forming agents can cause obstruction of the throat and oesophagus with choking and intestinal obstruction.
Symptoms can be chest pain, vomiting, or difficulty in swallowing or breathing. The treatment of debilitated patients and / or elderly patients requires medical supervision. g. opioids) and then only under medical supervision. The last dose should not be taken immediately before going to sleep since impaired or reduced gastric motility may impair the intestinal passage and then cause sub-obstruction.
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.
1 (See Section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ispaghula Husk in United Kingdom.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
System Organ Class Frequency Adverse Events Immune System Disorders Not known Hypersensitivity disorders1,2 Eye Disorders Not known Conjunctivitis2 Respiratory, Thoracic and Mediastinal Disorders Not known Rhinitis2 Gastrointestinal Disorders Not known Flatulence, abdominal distension, intestinal obstruction, oesophageal obstruction, faecal impaction3 Skin and Subcutaneous Tissue Disorders Not known Skin rash2 Description of Selected Adverse Reactions 1 Including rash, anaphylaxis, pruritus, and bronchospasm 2 Ispaghula/psyllium husk contains potent allergens.
The exposure to these allergens is possible through oral administration, contact with the skin and, in the case of powder formulations, also by inhalation. As a consequence to this allergic potential, individuals exposed to the product can develop hypersensitivity reactions such as rhinitis, conjunctivitis, bronchospasm and in some cases, anaphylaxis.
Cutaneous symptoms such as exanthema and/or pruritus have also been reported. 3 A small amount of flatulence and abdominal distension may sometimes occur during the first few days of treatment, but should diminish during continued treatment.
Abdominal distension and risk of intestinal or oesophageal obstruction and faecal impaction may occur, particularly if swallowed with insufficient fluid. Reporting of Suspected Adverse Reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
This medicine contains less than 1 mmol sodium (23 mg) in each sachet, that is to say essentially ‘sodium-free’. 76 mg) potassium per sachet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
If symptoms persist longer than 3 days, the patient should call a doctor or health care professional. e. healthcare workers, caregivers) allergic sensitization may occur due to inhalation, this is more frequent in atopic individuals.
8 Undesirable effects). It is recommended to assess clinically the possible sensitisation of individuals at risk and, if justified, to perform specific diagnostic tests. 3 Contraindications). Paediatric Population Use is not recommended in children below 6 years of age due to insufficient data on safety and efficacy.
Laxative bulk producers should be used before using other purgatives if change of nutrition is not successful.