Drugs List

Therapeutic Indications

Uses

Bowel regulation: bed-ridden patients
Bowel regulation: pregnant women
Constipation
Haemorrhoids: pain-free evacuation

Contraindications

Abdominal pain of unknown cause
Children under 12 years
Appendicitis
Colonic atony
Dehydration
Disease of the oesophagus or cardia
Dysphagia
Electrolyte depletion
Faecal impaction
Gastrointestinal obstruction
Gastrointestinal stenosis
Hereditary fructose intolerance
Inflammatory bowel disease
Megacolon
Paralytic ileus
Uncontrolled diabetes mellitus

Precautions and Warnings

Debilitation
Elderly
Nausea
Vomiting
Breastfeeding
Diabetes mellitus
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
Renal disorder

Preparation contains sucrose
Avoid taking within half to 1 hour of other medicines
Ensure patient has adequate fluid intake
Diabetic control may need adjustment
Advise patient to inform doctor if vomiting occurs after administration
Advise patient to inform their physician if dyspnoea/chest pain occur
Discontinue if irregular bowel movements
Discontinue if severe and persistent abdominal pain occurs
Advise patients not to use for more than 1-2weeks without medical attention
Avoid prolonged use
Advise patient to avoid taking immediately before going to bed
Advise patient to change pads frequently if incontinent
Advise patient to consult a doctor if symptoms persist despite treatment
May discolour urine yellow or brown

Taking this product without adequate fluid may cause it to swell and block the throat or oesophagus and may cause choking. Intestinal obstruction may occur if adequate fluid intake is not maintained.

Each measuring spoon or sachet contains approximately 5g of ispaghula husk with senna fruits. This is equivalent to approximately 1.04g of sucrose. If this medicine is taken together with meals by insulin dependent diabetic patients, it may be necessary to reduce the insulin dose.

Ispaghula husk with senna fruits should only be used if a therapeutic effect cannot be achieved by a healthy diet or the administration of pure bulk forming agents If laxatives are needed every day, it is recommended that the cause of the constipation is investigated.

Long-term use of stimulant laxatives may lead to impaired function of the intestine as well as dependence on laxatives. Prolonged use may precipitate the onset of an atonic, non-functioning colon. Prolonged and excessive use may lead to fluid and electrolyte imbalance and hypokalaemia. Intestinal loss of fluids may promote dehydration. Advise patients that symptoms may include thirst and oliguria. Patients with renal disorders should be aware of possible electrolyte imbalance.

Pregnancy and Lactation

Pregnancy

Ispaghula husk with senna fruits should be used with caution during the first trimester of pregnancy but is considered safe for use during the second and third trimester of pregnancy.

The manufacturer advises that there is little evidence of adverse side effects when this product is used during pregnancy when used at the recommended dosage schedule. However, the manufacturer does also state that as a consequence of experimental data concerning a genotoxic risk of several anthranoids, e.g. emodin and aloe-emodin, it is recommended that the use is to be avoided during the first trimester. This product should only be used intermittently and if other actions like lifestyle changes, dietary improvements and the use of bulk forming agents have failed.

Schaefer (2015) suggests that although senna is a member of the anthraquinine laxative group (contraindicated in pregnancy), traditional use recommends senna as the laxative of choice during the second and third trimesters of pregnancy. It is also suggests that the use of bulking agents such as ispaghula husks are considered safe during pregnancy.

Lactation

Use ispaghula with senna fruits with caution during breastfeeding.

The manufacturer suggests that the use of this product during breastfeeding is not recommended. Although a laxative effect has not yet been seen in nursing infants, small amounts of active metabolites (rhein) are excreted in breast milk.

LactMed notes that several studies using senna products have reported no effect on the infant. Usual doses of senna are considered acceptable to use during breastfeeding. There is limited data on the use of ispaghula during breastfeeding; however, it is known that ispaghula is unabsorbed orally.

Schaefer (2015) suggests that bulking agents and osmotic laxatives are the preferable laxative during breastfeeding.

Side Effects

Abdominal cramps
Abdominal distension
Abdominal pain
Albuminuria
Diarrhoea
Discolouration of urine
Disturbance of fluid balance
Electrolyte disturbances
Exanthema
Faecal impaction
Flatulence
Haematuria
Hypersensitivity reactions
Hypokalaemia
Intestinal obstruction
Melanosis coli
Oesophageal obstruction
Pruritus
Urticaria

Presentation

Granules containing ispaghula and senna fruit.

Drugs List

Therapeutic Indications

Uses

Bowel regulation: bed-ridden patients
Bowel regulation: pregnant women
Constipation
Haemorrhoids: pain-free evacuation

Dosage

Usually it is sufficient to take ispaghula husk with senna fruit granules up to two or three times a week.

Adults

Children

Contraindications

Abdominal pain of unknown cause
Children under 12 years
Appendicitis
Colonic atony
Dehydration
Disease of the oesophagus or cardia
Dysphagia
Electrolyte depletion
Faecal impaction
Gastrointestinal obstruction
Gastrointestinal stenosis
Hereditary fructose intolerance
Inflammatory bowel disease
Megacolon
Paralytic ileus
Uncontrolled diabetes mellitus

Precautions and Warnings

Debilitation
Elderly
Nausea
Vomiting
Breastfeeding
Diabetes mellitus
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
Renal disorder

Preparation contains sucrose
Avoid taking within half to 1 hour of other medicines
Ensure patient has adequate fluid intake
Diabetic control may need adjustment
Advise patient to inform doctor if vomiting occurs after administration
Advise patient to inform their physician if dyspnoea/chest pain occur
Discontinue if irregular bowel movements
Discontinue if severe and persistent abdominal pain occurs
Advise patients not to use for more than 1-2weeks without medical attention
Avoid prolonged use
Advise patient to avoid taking immediately before going to bed
Advise patient to change pads frequently if incontinent
Advise patient to consult a doctor if symptoms persist despite treatment
May discolour urine yellow or brown

Taking this product without adequate fluid may cause it to swell and block the throat or oesophagus and may cause choking. Intestinal obstruction may occur if adequate fluid intake is not maintained.

Each measuring spoon or sachet contains approximately 5g of ispaghula husk with senna fruits. This is equivalent to approximately 1.04g of sucrose. If this medicine is taken together with meals by insulin dependent diabetic patients, it may be necessary to reduce the insulin dose.

Ispaghula husk with senna fruits should only be used if a therapeutic effect cannot be achieved by a healthy diet or the administration of pure bulk forming agents If laxatives are needed every day, it is recommended that the cause of the constipation is investigated.

Long-term use of stimulant laxatives may lead to impaired function of the intestine as well as dependence on laxatives. Prolonged use may precipitate the onset of an atonic, non-functioning colon. Prolonged and excessive use may lead to fluid and electrolyte imbalance and hypokalaemia. Intestinal loss of fluids may promote dehydration. Advise patients that symptoms may include thirst and oliguria. Patients with renal disorders should be aware of possible electrolyte imbalance.

Pregnancy and Lactation

Pregnancy

Ispaghula husk with senna fruits should be used with caution during the first trimester of pregnancy but is considered safe for use during the second and third trimester of pregnancy.

The manufacturer advises that there is little evidence of adverse side effects when this product is used during pregnancy when used at the recommended dosage schedule. However, the manufacturer does also state that as a consequence of experimental data concerning a genotoxic risk of several anthranoids, e.g. emodin and aloe-emodin, it is recommended that the use is to be avoided during the first trimester. This product should only be used intermittently and if other actions like lifestyle changes, dietary improvements and the use of bulk forming agents have failed.

Schaefer (2015) suggests that although senna is a member of the anthraquinine laxative group (contraindicated in pregnancy), traditional use recommends senna as the laxative of choice during the second and third trimesters of pregnancy. It is also suggests that the use of bulking agents such as ispaghula husks are considered safe during pregnancy.

Lactation

Use ispaghula with senna fruits with caution during breastfeeding.

The manufacturer suggests that the use of this product during breastfeeding is not recommended. Although a laxative effect has not yet been seen in nursing infants, small amounts of active metabolites (rhein) are excreted in breast milk.

LactMed notes that several studies using senna products have reported no effect on the infant. Usual doses of senna are considered acceptable to use during breastfeeding. There is limited data on the use of ispaghula during breastfeeding; however, it is known that ispaghula is unabsorbed orally.

Schaefer (2015) suggests that bulking agents and osmotic laxatives are the preferable laxative during breastfeeding.

Counselling

Advise the patient that the granules should be placed on the tongue then, without chewing or crushing, swallowed with at least 150ml of water, milk, fruit juice or a warm drink.

Advise the patient not take immediately before going to bed.

Advise the patient not to take within half to one hour before or after other medications.

Advise the patient not to use for more than one to two weeks and to consult a doctor if symptoms persist despite treatment.

Advise the patient to inform doctor if dyspnoea, dysphagia, chest pain or vomiting occur.

Advise the patient to report severe and persistent abdominal pain or irregular bowel movements during treatment.

Advise the patient that the medicine may discolour the urine yellow or brown.

Advise the patient to change pads frequently if incontinent.

Side Effects

Abdominal cramps
Abdominal distension
Abdominal pain
Albuminuria
Diarrhoea
Discolouration of urine
Disturbance of fluid balance
Electrolyte disturbances
Exanthema
Faecal impaction
Flatulence
Haematuria
Hypersensitivity reactions
Hypokalaemia
Intestinal obstruction
Melanosis coli
Oesophageal obstruction
Pruritus
Urticaria

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: October 2020

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Summary of Product Characteristics: Manevac Granules. Mylan Products Ltd. Revised April 2020.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 October 2020.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Psyllium. Last revised: 7 January 2019
Last accessed: 16 October 2020.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Senna. Last revised: 31 October 2018
Last accessed: 16 October 2020.