How well do you know NICE’s constipation guidance?

77% of constipation patients want a treatment that helps them to maintain regularity.1 How can you meet their needs AND align with NICE guidance? View in browser Greetings, When it comes to short-term constipation management, there is a disconnect in patient needs. Although 77% of constipation patients want a treatment that helps them to maintain regularity, a similar number seek fast-acting relief.1 NICE guidance is clear: if lifestyle changes are ineffective, a bulk-forming laxative should be the first choice treatment.2 However, the drive to meet patients' needs for a fast-acting option means just 14% of pharmacists recommend bulk-forming laxatives, such as Fybogel, first-line.3 What patients may not realise is that Fybogel can usually start to work within 12-24 hours.† This provides you with an opportunity to educate patients on the NICE approach to constipation management: try bulk-forming laxatives first, like Fybogel, before supplementing with other laxatives, where necessary. NICE recommends a three-step approach to tackle short-term constipation:2 Bulk-forming laxatives, such as the ispaghula husk found in Fybogel Add or switch to an osmotic laxative, such as a macrogol, if stools remain hard or difficult to pass. Lactulose should be reserved for when macrogols are ineffective or not tolerated A stimulant laxative, such as senna, can be added if stools are soft but difficult to pass or the patient feels there has been inadequate emptying. Greetings, When it comes to short-term constipation management, there is a disconnect in patient needs. Although 77% of constipation patients want a treatment that helps them to maintain regularity, a similar number seek fast-acting relief.1 NICE guidance is clear: if lifestyle changes are ineffective, a bulk-forming laxative should be the first choice treatment.2 However, the drive to meet patients' needs for a fast-acting option means just 14% of pharmacists recommend bulk-forming laxatives, such as Fybogel, first-line.3 What patients may not realise is that Fybogel can usually start to work within 12-24 hours.† This provides you with an opportunity to educate patients on the NICE approach to constipation management: try bulk-forming laxatives first, like Fybogel, before supplementing with other laxatives, where necessary. NICE recommends a three-step approach to tackle short-term constipation:2 Bulk-forming laxatives, such as the ispaghula husk found in Fybogel Add or switch to an osmotic laxative, such as a macrogol, if stools remain hard or difficult to pass. Lactulose should be reserved for when macrogols are ineffective or not tolerated A stimulant laxative, such as senna, can be added if stools are soft but difficult to pass or the patient feels there has been inadequate emptying. *If lifestyle changes have been ineffective. †If there has been no bowel movement after three days of treatment a doctor or healthcare professional should be consulted. References: 1. Reckitt. UK market research in 1000 adults. July 2019. 2. NICE. Clinical Knowledge Summaries. Constipation. November 2020. Accessed May 2021. https://cks.nice.org.uk/topics/constipation. 3. RB Data on File. Laxatives Pharmacy staff survey. 2019 (n=203). Essential Information RB-M-34568 | May 2021 Fybogel Hi-Fibre Orange PL 00063/0064 Active Ingredients: A sachet contains 3.5g ispaghula husk EP. Indications: 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. Dosage and Administration: 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. Contraindications: 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. 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 psyllium seed 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 (e.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. • 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 consideration by patients with reduced kidney function or patients on a controlled potassium diet. • 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 (i.e. healthcare workers, caregivers) allergic sensitization may occur due to inhalation, this is more frequent in atopic individuals. This sensitization usually leads to hypersensitivity reactions which could be serious (see 4.8 Undesirable effects). • It is recommended to assess clinically the possible sensitization of individuals at risk and, if justified, to perform specific diagnostic tests. • In case of proven sensitisation leading to hypersensitivity reactions, exposure to the product should be stopped immediately and avoided in the future (see 4.3 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. 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. 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. Side effects: Special attention should be given to individuals manipulating the powder formulations routinely (see 4.4 Special warnings and precautions for use). Adverse events which have been associated with ispaghula husk are given qbelow, 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 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. Legal Classification: GSL Licence Holder: Reckitt Benckiser Healthcare (UK) Limited Dansom Lane Hull HU8 7DS United Kingdom Price: £3.99 (10s); £8.99 (30s) Last Revised: 11 December 2020 Name and Active substances: Senokot 7.5 mg Tablets Adult. Each tablet contains powdered Alexandrian Senna fruit (pods) and Tinnevelly Senna fruit (pods) equivalent to 7.5mg hydroxyanthracene glycosides, calculated as sennoside B. Each tablet also contains 15.82 mg lactose monohydrate. Indications: For the short-term relief of occasional constipation. Dosage Instructions: For oral administration. The correct individual dose is the smallest required to produce a comfortable soft-formed motion.Adults and the elderly: Swallow one to two tablets at night Should not be used in children or adolescents under the age of 18 years. New users should start with the lowest dose and increase it to the maximum dose if necessary. Once regularity has been regained dosage should be reduced and can usually be stopped. If no bowel action has occurred after three days of progressively increased dosage, a medical examination should be considered. Duration of use Not to be used for more than 1 week. Usually it is sufficient to take this medicinal product up to two to three times during that week. If the symptoms persist during the use of the medicinal product, a doctor or a pharmacist should be consulted. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Not to be used at the same time as other laxative agents. Cases of intestinal obstructions and stenosis, atony, appendicitis, inflammatory bowel diseases (e.g Crohn's disease, ulcerative colitis), abdominal pain of unknown origin, severe dehydration state with water and electrolyte depletion Warnings & Precautions: If the symptoms worsen during the use of the medicinal product or there is no bowel movement after three days, a doctor or pharmacist should be consulted. If laxatives are needed every day, or abdominal pain persists, a doctor should be consulted. If laxatives are needed every day the cause of the constipation should be investigated. Long-term use of laxatives should be avoided. The product contains lactose monohydrate. One tablet contains 15.82mg lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Do not exceed the stated dose. Patients taking cardiac glycosides, antiarrhythmic medicinal products, medicinal products inducing QT-prolongation, diuretics, adrenocorticosteroids or liquorice root, have to consult a doctor before taking senna leaf preparation concomitantly. Like all laxatives, Senokot should not be taken by patients suffering from faecal impaction and undiagnosed, acute or persistent gastro-intestinal complaints, e.g. abdominal pain, nausea and vomiting, unless advised by a doctor, because these symptoms can be signs of potential or existing intestinal blockage (ileus). Long-term use of stimulant laxatives should be avoided, as use for more than a brief period of treatment may lead to impaired function of the intestine and dependence on laxatives. If laxatives are needed every day the cause of the constipation should be investigated. This product should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of bulk forming agents. Prolonged use may precipitate the onset of an atonic, non-functioning colon. Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalaemia. Patients with kidney disorders should be aware of possible electrolyte imbalance. Intestinal loss of fluids may promote dehydration. Symptoms may include thirst and oliguria. In patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency, elderly patients) Senokot should be discontinued and only be restarted under medical supervision. When products containing senna/sennoside preparations are administered to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces. Should not be used in children or adolescents under the age of 18 years. Stimulant laxatives (including Senokot) do not help with weight loss. The leaflet will state: "Before you take this medicine" section Does this help with weight loss? Stimulant laxatives (including Senokot) do not help with weight loss. They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss. Overuse of laxatives may damage your health by: •Causing disturbances of electrolyte and mineral balances. Sodium, potassium, magnesium, and phosphorus are electrolytes and minerals that are present in very specific amounts necessary for proper functioning of the nerves and muscles, including those of the colon and heart. Upsetting this delicate balance can cause incorrect functioning of these vital organs. • Severe dehydration may cause tremors, weakness, blurry vision, fainting, kidney damage, and, in extreme cases, death. Dehydration often requires medical treatment. • Overuse of laxatives can cause the colon to stop reacting to usual doses of laxatives so that larger and larger amounts of laxatives may be needed to produce bowel movements. • Laxative dependency occurs from overuse. The label will state: Front of pack: • Does not help with weight loss. • Overuse can be harmful. • The following warnings must also be included: • Do not take more medicine than the label tells you to. • If there is no bowel movement after 3 days, or if symptoms persist, in particular if you have persistent abdominal pain or are passing blood, consult your doctor. • Fertility, pregnancy and lactation: There are no reports of undesirable or damaging effects during pregnancy and on the foetus when used at the recommended dosage schedule. However, as a consequence of experimental data concerning a genotoxic risk of several anthranoids, e.g emodin and aloe-emodin, use is not recommended during pregnancy. Use during breastfeeding is not recommended as there are insufficient data on the excretion of metabolites in breast milk. Small amounts of active metabolites (rhein) are excreted in breast milk. A laxative effect in breast fed babies has not been reported. There are no data on the effects of the product on fertility. Side-Effects: Hypersensitivity, urticaria, asthma, hypogammaglobulinaemia, hypokalaemia, cachexia, abdominal pain, abdominal spasm, diarrhoea, gastrointestinal tract mucosal pigmentation, pruritus, local or generalised exanthema, chromaturia, finger clubbing, tetany and hypertrophic osteoarthropathy. Frequency unknkown. Retail Price: £2.99 Marketing Authorisation: PL 00063/5000R Marketing Authorisation Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS Supply Classification: GSL Date of preparation: April 2020 Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Reckitt Benckiser Healthcare (UK) Ltd on: 0333 200 5345 Pharmacy Magazine is part of the Pharmacy Network, a learning system developed and operated by Communications International Group, the UK's largest provider of community pharmacy learning content.   We are sending you this alert on behalf of one of our valued partners. Should you not wish to continue to receive these alerts simply click unsubscribe below. Unsubscribe   Ι  Contact  Ι  Privacy Policy  Ι  Become a Member