Medicines
Update of 29/01/2026
PSYLIA®
psyllium
Forms and presentations
Effervescent powder (beige) for oral suspension: Sachets, boxes of 10, of 20 and of 24.Composition
| sachet pack | |
| Psyllium (Plantago ovata Forssk) (seed coat of)
|
3,6 g |
Excipients with known effect : potassium, sorbitol (E420).
Potassium content: 3,75 mEq/sachet, corresponding to 146,625 mg/sachet.
Indications
Herbal medicine indicated for the symptomatic treatment of constipation.Psylia, effervescent powder for oral suspension in sachet is indicated in adults.
Dosage and administration
DosageAdults:
1 sachet, one to three times a day, as needed, before or after each of the main meals.
Paediatric population:
Use in children and adolescents under 18 years of age is not recommended (see Warnings and Precautions for Use).
Method of administration:
Oral use.
Dissolve the powder in a large glass of water (200 mL). Stir and drink the preparation immediately. An adequate fluid intake must be maintained.
When preparing the oral suspension, it is important to avoid inhaling the powder in order to minimise any risk of sensitisation to the psyllium seed coat.
Psylia must be taken during the day at least 1/2 hour to 1 hour before or after taking other medicines and never immediately before bedtime.
The effect appears on average within 12 to 24 hours after the first administration.
Duration of treatment:
If symptoms persist beyond 3 days of treatment, a doctor or pharmacist should be consulted.
Contraindications
- Hypersensitivity to the active substance (also known as blond psyllium) or to any of the excipients listed in section Composition.
- Patients presenting with a sudden change in bowel function persisting for more than 2 weeks.
- Rectal bleeding of undetermined cause and no defecation after use of another laxative.
- 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.
- Abdominal painful syndromes of undetermined cause.
- Faecaloma.
- Patients with difficulty swallowing or throat disorders.
Warnings and precautions
A sufficient quantity of liquid must always be taken (200 mL) (see Posology and Method of administration). When Psylia is taken with an insufficient quantity of liquid, it may cause an 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 Psylia should be stopped and medical advice 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 seed coat of psyllium may only be used with medicines known to inhibit intestinal peristalsis (e.g. opioids) under medical supervision.
In cases of megacolon due to impaired colonic motility and in bedridden subjects, prescription must be cautious (risk of faecaloma).
Drug treatment of constipation is only an adjunct to dietary and lifestyle measures:
- Enrichment of the diet with plant fibres and fluids.
- Advice on physical activity and rehabilitation of evacuation.
Prolonged use of a laxative is not recommended.
This medicine contains potassium. This medicine contains 3,75 mmol (146,63 mg) of potassium per dose. To be taken into account in patients with renal impairment or in patients following a hypokalaemic diet.
This medicine contains sorbitol. Patients with hereditary fructose intolerance (HFI) must not take this medicine.
Paediatric population:
Psylia is not recommended in children and adolescents under 18 years of age. In children and adolescents, treatment is essentially dietary and requires medical advice.
Warning related to hypersensitivity risks:
In people who may be in prolonged contact with the seed coat of psyllium (e.g. healthcare professionals, nursing assistants), allergic reactions may occur on inhalation of the powder, this being more frequent in hypersensitive (allergic) individuals. This may sometimes lead to hypersensitivity reactions (possibly severe) (see Undesirable effects).
It is recommended to assess at-risk people and, where justified, to carry out specific hypersensitivity tests.
In the event of a confirmed sensitisation leading to hypersensitivity reactions, exposure to the product must be stopped immediately and avoided in future (see Contraindications).
Interactions
Enteral absorption of concomitantly administered medicines such as minerals, vitamins (B12), cardiac glycosides, coumarin derivatives, carbamazepine and lithium may be delayed.
For this reason, Psylia must not be taken within 1/2 hour before or after taking any other medicine.
Diabetic patients should only take Psylia 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
Pregnancy:
In clinical practice, no particular malformative or foetotoxic effect has appeared to date with Psylia. However, the follow-up of pregnancies exposed to ispaghul is insufficient (fewer than 300 pregnancy follow-ups) to exclude any risk.
Animal reproductive toxicity studies are insufficient (see Preclinical safety).
Consequently, the use of this medicine should only be considered during pregnancy if necessary and if the change in diet is ineffective. Bulk-forming laxatives must be used before any other laxative.
Breastfeeding:
In the absence of data, the use of this medicine should only be considered during breastfeeding if necessary and if the change in diet is ineffective. Bulk-forming laxatives must be used before any other laxative.
Fertility:
No effect on fertility has been observed in rats after oral administration (see Preclinical safety).
Adverse effects
Frequency not determined (cannot be estimated from available data):
Possibility of flatulence, which generally disappears during treatment.
Possibility of abdominal bloating, risk of oesophageal or intestinal obstruction and faecaloma, in particular when Psylia is swallowed with an insufficient amount of water.
Ispaghul contains potent allergens. Exposure to these allergens is possible orally, through skin contact and, in the case of powder formulations, also by inhalation. Because of this allergenic potential, persons exposed to the product may develop hypersensitivity reactions such as rhinitis, conjunctivitis, bronchospasm and, in some cases, anaphylactic shock. Skin symptoms such as exanthema and/or pruritus have also been reported. Particular attention should be paid to persons who regularly handle powder formulations (see Warnings and Precautions for Use).
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
An overdose with ispaghul seed husk may cause abdominal discomfort, flatulence and intestinal occlusion. Adequate hydration must be maintained and treatment must be symptomatic.
Pharmacodynamics
Pharmacotherapeutic class: Bulk-forming laxative (ATC code: A06AC01; A: alimentary tract and metabolism).
Mechanism of action:
The ispaghul seed husk exerts a mechanical laxative action through a bulking effect. It increases faecal mass and modifies its consistency by forming a hydrophilic colloidal gel.
The active substance, ispaghul seed husk or Psyllium seed husk, is contained in the epidermis and in the adjacent layers removed from the seeds of Plantago ovata Forssk. The ispaghul seed husk is particularly rich in dietary fibres and mucilages. The mucilage content is higher than that of other Plantago species. The ispaghul seed husk can absorb up to 40 times its own weight in water. The ispaghul seed husk, composed of 85 % water-soluble fibres, is partially fermented (72 % non-fermentable residues in vitro) and acts by hydration in the intestine. The pharmacological effects of ispaghul seed husk on intestinal motility and transit speed are thought to be due to mechanical stimulation of the intestinal wall through an increase in the volume of intestinal contents by the action of water, and a decrease in stool viscosity.
Taken with a sufficient amount of liquid (at least 30 mL per gram of plant), the ispaghul seed husk causes an increase in stool volume due to its highly swelling properties and a stimulus triggering defecation; at the same time, the mass of mucilage forms a lubricating layer that facilitates intestinal transit.
The laxative effect appears within 12 to 24 hours following the first administration. Sometimes, the maximum effect is reached after 2 to 3 days of treatment.
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, causing production of 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 and are fermented to some extent, resulting in an increase in faecal concentration and excretion of short-chain fatty acids.
Preclinical safety
Psyllium seed husk was administered to rats at concentrations of up to 10 % of their diet for periods of up to 13 weeks (three studies of 28 days, one study of 13 weeks). Intake ranged from 3876 to 11 809 mg/kg/day (3 to 16 times the human dose calculated for a 60 kg person). The observed effects were a decrease in total serum protein, albumin, globulin, total iron-binding capacity, calcium, potassium and cholesterol, and an increase in aspartate transaminase and alanine transaminase levels.
The absence of an increase in urinary protein and of any difference in growth of rats fed with psyllium seed husk could demonstrate the absence of an undesirable effect on protein metabolism. No treatment-related effect was observed in histopathological studies limited to the gastrointestinal tract, liver, kidneys and macroscopic lesions.
In a fertility, embryo-foetal development, pre- and postnatal study (multigenerational study), psyllium seed husk (0, 1, 2,5 or 5 % of the diet) was administered over two generations of rats. For reproduction, foetal development and teratogenesis, the maximum dose without observable adverse effect was 5 % of the diet, while for growth and development, the maximum dose without observable adverse effect was 1 % of the diet based on reduced pup weight.
An embryo-foetal development study in rabbits (psyllium seed husk at 0, 2,5, 5 or 10 % of the diet) was carried out but no conclusion can be drawn from it.
No genotoxicity or carcinogenicity studies have been performed.
Storage conditions
- Shelf life
- 4 years.
Protect from moisture.
Prescription, supply and reimbursement
| Marketing authorisation (AMM) | 3400933022044 (1993, SmPC rev 19.11.2024) box of 10. |
| 3400933022105 (1988, SmPC rev 19.11.2024) box of 20. | |
| 3400933022273 (1993, SmPC rev 19.11.2024) box of 24. |
| Price: | 2,53 euros (20 sachets). |
| Box of 20: Reimbursed by social security at 30 %. Collective. | |
| Boxes of 10 and of 24: Not reimbursed by social security and not approved for collective use. | |
TECHNI-PHARMA Laboratories
7, rue de l'Industrie. BP 717. 98014 Monaco cdx
Tel: 00 377 92 05 75 10
Source: VIDAL · Updated on 11/11/2026. This information does not replace advice from a healthcare professional.