Mucilin/Mucilin SF

Ispaghula husk.

Mucilin Orange Flavour (sachet): Each sachet (5 g) contains ispaghula husk 2.45 g.
Mucilin Orange Flavour (bottle): Each 11 g (2 teaspoonfuls) contains ispaghula husk 3.4 g.
Mucilin SF (Orange Flavour): Each sachet (5 g) contains ispaghula husk 3.5 g.
Mucilin SF Mixed Berry Flavour: Each sachet (5 g) contains ispaghula husk 3.5 g.

Pharmacology: Pharmacodynamics: Mechanism of Action: Ispaghula husk is capable of absorbing up to 40 times its own weight in water. Isphaghula husk consists of 85% water-soluble fiber; it is partly fermentable and acts by hydration in the bowel. Gut motility and transit rate can be modified by ispaghula husk through mechanical stimulation of the gut wall as a result of the increase in intestinal bulk by water and the decrease in viscosity of the luminal contents. When taken with a sufficient amount of liquid (at least 30 ml per 1 g of herbal substance) ispaghula husk produces an increased volume of intestinal contents due to its highly bulking properties and hence a stretch stimulus, which triggers defecation; at the same time the swollen mass of mucilage forms a lubricating layer, which makes the transit of intestinal contents easier.
Progress of action: ispaghula husk usually acts within 12 to 24 hours after single administration. Sometimes the maximum effect is reached after 2 to 3 days.
Pharmacokinetics: Absorption: The material hydrates and swells to form mucilage because it is only partially solubilized. Polysaccharides, such as those which dietary fibres are made of, must be hydrolysed to monosaccharides before intestinal uptake can occur.
Less than 10% of the mucilage gets hydrolysed in the stomach.
Psyllium (ispaghula husk) is not absorbed systemically.
Elimination: Human intestinal flora in the large intestine degrades the polysaccharides.

For the treatment of habitual constipation.
In conditions in which easy defaecation with soft stool is desirable, e.g., in cases of painful defaecation after rectal or anal surgery, anal fissures and haemorrhoids.
In patients to whom an increased daily fiber intake may be advisable, e.g., as an adjuvant in constipation predominant IBS (Irritable Bowel Syndrome), as an adjuvant to diet in hypercholesterolemia.

Recommended Doses: For the treatment of habitual constipation and in conditions in which easy defaecation with soft stool is desirable.
Adolescents over 12 years of age, adults, elderly: 7-11 g in 1-3 doses daily as following: Mucilin Orange Flavour (sachet): orally, one sachet three times a day.
Mucilin Orange Flavour (bottle): orally, 2 teaspoonfuls two or three times a day.
Mucilin SF (Orange Flavour): orally, one sachet two or three times a day.
Mucilin SF Mixed Berry Flavour: orally, one sachet two or three times a day.
Children from 6 to 12 years of age: Half to two-thirds of the adult dose (3-8 g) in 1-3 doses daily as following: Mucilin Orange Flavour (sachet): orally, half sachet three times a day.
Mucilin Orange Flavour (bottle): orally, 1 teaspoonful two or three times a day.
Mucilin SF (Orange Flavour): orally, half sachet two or three times a day.
Mucilin SF Mixed Berry Flavour: orally, half sachet two or three times a day.
The use in children under 6 years of age is not recommended.
In patients to whom an increased daily fiber intake may be advisable: Adolescents over 12 years of age, adults, elderly: 7-20 g in 1-3 doses daily.
The use in children under 12 years of age is not recommended.
Mode of Administration: Mix one sachet or 2 teaspoonfuls of Mucilin with 150 ml of cool water, milk, fruit juice or other drinking liquid.
Stir briskly and drink immediately.
Followed by an additional glass of water or other drinking liquid.
Instruction to take this medicine: Do not swallow ispaghula husk powder without water or other drinking liquid.
A sufficient amount of liquid should always be taken. Take this product (1 sachet of 5 g or 2 teaspoonfuls of 11 g) with at least 150 ml of water or other drinking liquid. With inadequate fluid amounts, this bulk forming agent can swell and cause obstruction of the throat or oesophagus with choking and intestinal obstruction. Symptoms can be chest pain, vomiting, or difficulty in swallowing or breathing.
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. This is more frequency in atopic individuals.
Do not mix ispaghula husk powder in hot water.
Drink ispaghula husk mixture immediately after mixing, avoid consuming when it turns into jelly.
Do not take ispaghula husk immediately prior to bed-time. The product should be taken during the day at least ½ hour before or after intake of other medicine.
The effect starts 12 - 24 hours later.

Overdose with ispaghula husk may cause abdominal discomfort, flatulence and intestinal obstruction. Adequate fluid intake should be maintained and management should be symptomatic.

Ispaghula husk is not to be used by patients with a sudden change in bowel habit that persists for more than 2 weeks, undiagnosed rectal bleeding and failure to defaecate following the use of a laxative.
Ispaghula husk is not to be used by patients suffering from abdominal constrictions in the gastro-intestinal tract, with diseases of the oesophagus and cardia, potential or existing intestinal blockage (ileus), paralysis of the intestine or megacolon.
Patients who have difficulty in swallowing or any throat problems.
Hypersensitivity to ispaghula husk or any component of the formulation.

Ispaghula husk is not to 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 the constipation does not resolve within 3 days or if abdominal pain occurs or in case of any irregularity of faeces, the use of ispaghula husk should be discontinued and medical advice must be sought.
The use of ispaghula husk as an adjuvant to diet in hypercholesterolemia requires medical supervision.
The treatment of the debilitated patients and/or elderly patients requires medical supervision.
Do not take this product if the patient ever had difficulty in swallowing or have any throat problems. If experiencing chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.
Mucilin SF contains aspartame, patients suffering from phenylketonuria should not take this product.
Use in Children: Use is not recommended in children below 6 years of age as there is insufficient efficacy data in the treatment of habitual constipation and in conditions in which easy defaecation with soft stool is desirable.
Use is not recommended in children below 12 years of age due to insufficient efficacy data in patients to whom an increased daily fiber intake may be advisable.

Pregnancy: Psyllium (ispaghula husk) is not absorbed systemically. When administered with adequate fluids, use is considered safe for the treatment of occasional constipation during pregnancy.
Lactation: Ispaghula husk may be used during pregnancy and lactation, if necessary and if change of nutrition is not successful.

In common with all bulk laxatives, ispaghula husk may increase or cause flatulence, although this usually disappears in the course of treatment. There is a risk of abdominal distension and intestinal or oesophageal obstruction and faecal impaction, particularly if ispaghula seed or husk is swallowed dry or without sufficient fluid. Allergic reactions, through oral administration, contact with the skin and, in the case of powder formulations, also by inhalation, can occur. These include skin symptoms such as exanthema and/or pruritus, rhinitis, conjunctivitis, bronchospasm and (rarely) anaphylactic reactions. Special attention should be given to individuals manipulating the powder formulations routinely (i.e. healthcare workers).

Enteral absorption of concomitantly administered medicines such as minerals, vitamins (B 12), 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 husks 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.

Store below 30°C.
Keep in well-closed container and protect from moisture.

Laxatives, Purgatives

A06AC01 - ispaghula (psylla seeds) ; Belongs to the class of bulk-producing laxatives.

NDD