SPAGULAX MUCILAGE PUR Gel in Sachet-Dose 20 Sachets

VIDAL
Medicines
Update of 20/06/2024

SPAGULAX^® PURE MUCILAGE
psyllium

Forms and presentations

Granules (light brown):  
Multidose sachet of 700 g with 5 ml dosing spoon.

Single-dose sachets, box of 20.

Composition

	per single-dose sachet	for 100 g
Ispaghul (Plantago ovata Forssk) (seed coat of)	7 g	70 g

Excipient (common): sucrose.

Excipient with known effect: sucrose (30 g per 100 g of granules).

Indications

Herbal medicine for the symptomatic treatment of constipation.
This medicine is indicated in adults.

Dosage and administration

Dosage

Method of administration:

Oral use.

• Multidose sachet: use the dosing spoon. Swallow the granules from each level dosing spoon without chewing them and with a sufficient quantity of liquid (approximately 70 ml of water, milk, fruit juice or similar liquid). In total, the patient should drink a large glass of liquid of at least 200 ml, with the three level dosing spoons.
  
• Single-dose sachet: divide the contents of the sachet into 3 doses (1 sachet = 3 teaspoons of 5 ml). Swallow the granules from each teaspoon without chewing them and with a sufficient quantity of liquid (approximately 70 ml of water, milk, fruit juice or similar liquid). In total the patient must drink a large glass of liquid of at least 200 ml per sachet.
  

Spagulax Mucilage Pur must be taken at least ½ hour to 1 hour before or after taking other medicines and never immediately before bedtime.

Onset of action at the start of treatment: 12 to 24 hours.

Spagulax Mucilage Pur must never be taken while lying down (see Warnings and Precautions for Use).

Duration of treatment:

If symptoms persist beyond 3 days of treatment, a doctor or pharmacist should be consulted (see Warnings and Precautions for Use).

Contraindications

• Patients suffering from stenosing conditions of the gastrointestinal tract, oesophageal and cardia diseases, latent or declared intestinal obstruction (ileus) or paralysis of the intestine or megacolon.
  
• Hypersensitivity to the psyllium seed husk or to any of the excipients mentioned in the section Composition.
  
• Patients presenting with a sudden change in bowel function persisting for more than 2 weeks.
  
• Rectal bleeding of undetermined cause or no bowel movement after use of another laxative.
  
• Inflammatory organic colopathies (ulcerative colitis, Crohn's disease).
  
• Abdominal painful syndromes of undetermined cause.
  
• Faecaloma.
  
• Patients with difficulty swallowing or throat disorders.
  

Warnings and precautions

There is a risk of bezoar formation, most often requiring endoscopy.

A sufficient quantity of liquid must always be taken (see Posology and Method of administration).

When Spagulax Mucilage Pur is taken with an insufficient quantity of liquid, it may cause obstruction of the throat or oesophagus and lead to respiratory shock. Associated symptoms may include chest pain, vomiting, or difficulty swallowing or breathing.

Psyllium-based products must not be used in case of obstruction of the digestive tract, abdominal pain syndromes, nausea or vomiting without medical advice, as these symptoms may be a sign of latent or declared intestinal obstruction (ileus).

If abdominal pain occurs, or if stools are irregular, use of Spagulax Mucilage Pur should be stopped and the advice of a doctor should be sought.

Treatment of elderly or debilitated patients requires medical supervision. In elderly people, ensure that fluid intake is sufficient.

In order to reduce the risk of gastrointestinal obstruction (ileus), the psyllium seed husk may be used with medicines known to inhibit intestinal peristalsis (e.g. opioids) only under medical supervision.

In cases of megacolon due to impaired colonic motility and in bedridden subjects, prescription must be cautious (risk of faecaloma).

This medicine contains sucrose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency.

Prolonged use in the treatment of constipation is not recommended.

Drug treatment of constipation is only an adjunct to dietary and lifestyle measures:

• enrichment of the diet with vegetable fibres and fluids,
  
• Advice on physical activity and rehabilitation of evacuation.
  

Interactions

Enteral absorption of concomitantly administered medicines such as minerals (e.g., lithium), vitamins (B12), cardiac glycosides, coumarin derivatives and carbamazepine may be delayed. For this reason, Spagulax Mucilage Pur must not be taken the ½ hour before or the hour after taking any other medicine.

Diabetic patients must take Spagulax Mucilage Pur only under medical supervision, as it may be necessary to adjust antidiabetic treatment.

The seed coat of psyllium should only be used concomitantly with thyroid hormones under medical supervision, as it may be necessary to adjust the thyroid hormone dose.

Fertility, pregnancy and breastfeeding

In clinical use, no particular malformative or foetotoxic effect has appeared to date with Spagulax Mucilage Pur. However, follow-up of pregnancies exposed to psyllium is insufficient (fewer than 300 followed pregnancies) to exclude any risk.

Animal reproductive toxicity studies are insufficient (see Preclinical safety).

Consequently, use of this medicine should be considered during pregnancy and breastfeeding only if necessary and if a change in diet is ineffective.

Bulk-forming laxatives must be used before any other laxative.

Adverse effects

Possibility of flatulence and abdominal bloating.

Cases of bezoars with oesophageal obstruction, most often requiring endoscopy, have been reported in elderly people, some of whom had impaired oesophageal motility (particularly when the product is swallowed with an insufficient amount of water). The frequency is not known.

Intestinal obstruction and faecaloma may also occur when Spagulax Mucilage Pur is swallowed with an insufficient amount of water. The frequency is not known.

Due to the potentially allergenic nature of ispaghula, patients must be informed of possible hypersensitivity reactions, such as rhinitis, conjunctivitis, bronchospasm and, in some cases, anaphylactic shock. The frequency is not known.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.

Overdose

Overdose with psyllium seed husk may cause abdominal discomfort, flatulence and oesophageal or intestinal obstruction. Adequate hydration must be ensured, together with symptomatic treatment.

Pharmacodynamics

Pharmacotherapeutic class: Bulk-forming laxative (ATC code: A06AC01; A: alimentary tract and metabolism).

Pharmacokinetics

The partially soluble active substance absorbs water and swells to form a mucilage. Polysaccharides, such as those contained in certain dietary fibres, are hydrolysed into monosaccharides before intestinal absorption.

The xylose residues of the main chain and side chains are linked by ß-glucosidic bonds, which cannot be broken by human digestive enzymes.

Less than 10 % of the mucilage is hydrolysed in the stomach, with formation of free arabinose. Intestinal absorption of arabinose is approximately 85 % to 93 %.

To varying degrees, dietary fibres are fermented by bacteria in the colon, producing carbon dioxide, hydrogen, methane, water and short-chain fatty acids, which are absorbed and pass into the hepatic circulation. In humans, such fibres reach the large intestine in highly polymerised form, which is fermented up to a certain limit, resulting in an increase in faecal concentration and excretion of short-chain fatty acids.

Preclinical safety

In 3 studies of 28 days and 13 weeks, rats were fed psyllium seed husk at high doses representing up to 10 % of their diet over periods of up to 13 weeks: 3,876 to 11,809 mg/kg/day (3 to 16 times the human dose for a man weighing 60 kg). The effects observed were a decrease in serum proteins, albumin, globulin, iron-binding capacity, calcium, potassium and cholesterol, and an increase in AST and ALT levels.

The absence of an increase in urinary protein and of any difference in growth in rats fed psyllium seed husk may demonstrate the absence of an undesirable effect on protein metabolism. Since absorption of psyllium seed husk is very low, histopathology was limited to the gastrointestinal tract, liver, kidneys and macroscopic lesions, with no treatment-related effect demonstrated.

In a reproduction study on embryofetal, pre- and postnatal development (multigenerational study), psyllium seed husk (0, 1, 2,5 or 5 % of the diet) was administered continuously over two generations of rats. For reproduction, fetal development and teratogenesis, the maximum dose with no observable adverse effect was 5 % of the diet, while for growth and development of their offspring, the maximum dose with no observable adverse effect was 1 % of the diet, based on the reduction in their body weight.

The embryofetal development study in rabbits (psyllium seed husk at 0, 2,5, 5 or 10 % of the diet) must be considered preliminary. No conclusion can be drawn from it.

No genotoxicity or carcinogenicity studies have been performed.

Storage conditions

No special precautions for storage.

HANDLING/DISPOSAL INSTRUCTIONS

No special requirements.

Prescription, supply and reimbursement

Marketing authorisation (AMM)	3400934064357 (1955/92, SmPC rev 11.08.2017) 20 sachet.
	3400930984710 (1955/92, SmPC rev 12.07.2018) 700 g.

Not reimbursed by Social Security and not approved for Collectivités.

ALMIRALL SAS
3-5, bd Galliéni. 92130 Issy-les-Moulineaux
Tel: 01 46 46 19 20. Fax: 01 46 46 19 66
E-mail: pharmacovigilance.fr@almirall.com