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ISPAGHULA HUSK is a brand name for Ispaghula Husk. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Used for the treatment of habitual constipation; conditions in which easy defecation with soft stools is desirable, for example, in cases of anal fissures, haemorrhoids, after rectal or anal surgery as well as in pregnancy; adjuvant symptomatic therapy in cases of diarrhoea from various causes; conditions which need…
Verbatim from this product's MHRA label. Tap a section to expand.
For oral use only Adults, elderly, children over 12 years of age: one sachet up to three times a day as needed. Additional doses up to a maximum of 5 sachets can be used if required.
Maximum daily dose = 5 sachets Method of administration:
Mix one sachet in 150ml (¼ pint) cool water, stir briskly and swallow as quickly as possible. Then maintain adequate fluid intake. The product should be taken during the day at least ½ to 1 hour before or after intake of food or other medicines.
Warning: not to be taken immediately prior to going to bed. The effect starts 12 -14 hours later. When preparing the product for administration, it is important to try to avoid inhaling any of the powder in order to minimise the risk of sensitisation to the active ingredient.
Duration of administration:
Medical advice should be sought if the symptoms persist more than 3 days in order to make a definitive diagnosis as to the cause of constipation.
). It is recommended to assess clinically the possible sensitisation of individuals at risk and, if justified, to perform specific diagnostic tests. 3 Contraindications). Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Due to its aspartame content, ispaghula husk should not be given to patients with phenylketonuria. 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.
Paediatric Population Use is not recommended in children below 12 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. g. opioids) unless under medical supervision. 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). Lactation 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.
1 3 PHARMACEUTICAL FORM Granules for oral suspension. 1 Therapeutic indications Used for the treatment of habitual constipation; conditions in which easy defecation with soft stools is desirable, for example, in cases of anal fissures, haemorrhoids, after rectal or anal surgery as well as in pregnancy; adjuvant symptomatic therapy in cases of diarrhoea from various causes; conditions which need an increased daily fibre intake, for example, irritable bowel syndrome.
2 Posology and method of administration For oral use only Adults, elderly, children over 12 years of age: one sachet up to three times a day as needed. Additional doses up to a maximum of 5 sachets can be used if required.
Maximum daily dose = 5 sachets Method of administration:
Mix one sachet in 150ml (¼ pint) cool water, stir briskly and swallow as quickly as possible. Then maintain adequate fluid intake. The product should be taken during the day at least ½ to 1 hour before or after intake of food or other medicines.
Warning: not to be taken immediately prior to going to bed. The effect starts 12 -14 hours later. When preparing the product for administration, it is important to try to avoid inhaling any of the powder in order to minimise the risk of sensitisation to the active ingredient.
Duration of administration:
Medical advice should be sought if the symptoms persist more than 3 days in order to make a definitive diagnosis as to the cause of constipation. 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. Ispaghula husk is contraindicated 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.
1 (See Section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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3 ‘Preclinical safety data’). 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:
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 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 or search for MHRA Yellow Card in the Google Play or Apple App store.
Patients who have difficulty in swallowing or any throat problems. Product not to be used by children aged less than 12 years. 4 Special warnings and precautions for use The product should not be taken dry and should always be taken mixed with fluid (150ml 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. In order to decrease the risk of gastrointestinal obstruction ispaghula husk should not be used together with medicinal products known to inhibit peristaltic movement (eg opioids) unless 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. If symptoms persist longer than 3 days, the patient should consult a doctor or healthcare professional.
Warning on hypersensitivity reactions:
In individuals with continued occupational contact to powder of Plantago ovata seeds (ie 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). Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Due to its aspartame content, ispaghula husk should not be given to patients with phenylketonuria. 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.
Paediatric Population Use is not recommended in children below 12 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.