Spagulax Constipation effervescent powder 20 sachets

Spagulax effervescent powder 20 sachets is a herbal medicine for the symptomatic treatment of constipation. It is indicated for adults.

Directions for use Spagulax effervescent powder 20 sachets

Dosage Usually one sachet before or after each main meal. Use in children and adolescents under 18 years of age is not recommended (see Warnings and precautions for use).

Method of administration Oral administration. Dilute the powder in a large glass of water. Shake and drink immediately. SPAGULAX should be taken at least ½ hour to 1 hour before or after other medications, and never immediately before bedtime.

Onset of action: 12 to 24 hours. When preparing the oral suspension, it is important to avoid inhaling the powder to minimize any risk of sensitization to the ispaghul seed coat.

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

Precautions for use Spagulax effervescent powder 20 sachets

Contraindications:

- Patients suffering from stenosing diseases of the gastrointestinal tract, esophageal and cardiac diseases, latent or overt intestinal obstruction (ileus), intestinal paralysis or megacolon;

- Hypersensitivity to the active substance or to any of the excipients listed under Excipients;

- Patients with abrupt changes in bowel function persisting for more than 2 weeks;

- Rectal bleeding of undetermined cause or failure to defecate after using another laxative;

- Inflammatory organic diseases (ulcerative colitis, Crohn's disease);

- Abdominal pain syndromes of undetermined cause;

- Faecal impaction;

- Patients with swallowing difficulties or throat disorders.

Warnings and other special precautions:

There is a risk of bezoar formation, usually requiring endoscopy.

Sufficient fluid should always be taken (200 mL) (see Dosage and administration). When SPAGULAX is taken with insufficient fluid, it may cause obstruction of the throat or esophagus, leading to respiratory shock. Associated symptoms may include chest pain, vomiting or difficulty swallowing or breathing.

Ispaghul products should not be used in the event of digestive tract obstruction, abdominal pain syndromes, nausea or vomiting without medical advice, as these symptoms may indicate latent or overt intestinal obstruction (ileus).

If abdominal pain occurs, or if faeces are irregular, SPAGULAX should be discontinued and medical advice sought.

Treatment of elderly or debilitated patients requires medical supervision. Elderly patients should be given sufficient fluids.

To reduce the risk of gastrointestinal obstruction (ileus), ispaghul seed coat should only be used with drugs known to inhibit intestinal peristalsis (e.g. opioids) under medical supervision.

In cases of megacolon due to impaired colonic motricity, and in bedridden patients, prescribing must be cautious (risk of fecal impaction).

Patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases) should not take this medicine.

This medicine contains 120 mg sodium per sachet and 360 mg per day, equivalent to 18% of the WHO-recommended maximum daily dietary intake of 2 g sodium per adult.

Prolonged use in the treatment of constipation is not recommended.

Medicinal treatment of constipation is only an adjunct to hygienic dietary therapy

- Enriching the diet with vegetable fibers and beverages;

- Advice on physical activity and exoneration rehabilitation.

Pediatric population

SPAGULAX is not recommended for children and adolescents under 18 years of age. In children and adolescents, treatment is essentially dietary and requires medical advice.

In infants and children under 6 years of age, laxatives should only be prescribed in exceptional cases, taking into account the risk of interfering with the normal functioning of the exoneration reflex.

Hypersensitivity warning

People who may come into prolonged contact with ispaghul seed coats (e.g. healthcare professionals, carers) may experience allergic reactions if the powder is inhaled, and this is more frequent in sensitive (allergic) people. This can sometimes lead to (possibly severe) hypersensitivity reactions (see Adverse reactions).

It is advisable to assess those at risk and, if warranted, perform specific hypersensitivity tests.

In the event of a hypersensitivity reaction, all exposure to the product should be immediately discontinued (see Contraindications).

Pregnancy and lactation :

Pregnancy

To date, SPAGULAX SUGAR-FREE has not been clinically shown to have any particular malformative or foetotoxic effects. However, follow-up of pregnancies exposed to ispaghul is insufficient (less than 300 pregnancies) to exclude any risk.

Reproduction toxicity studies in animals are insufficient (see Preclinical safety data).

Consequently, the use of this drug during pregnancy should be considered only if necessary and if dietary modification is ineffective.

Ballast laxatives should be used before any other laxative.

Breast-feeding

The use of this drug should be considered during breast-feeding only if necessary and if dietary modification is ineffective.

Fertility

In rats, no effect on fertility has been demonstrated after oral administration (see Preclinical safety data).

Effects on ability to drive and use machines :

Not applicable.

Composition Spagulax effervescent powder 20 sachets

effervescent powder for drinkable suspension: Ispaghul, seed coats 2.143 g.

Excipients: Citric acid anhydrous, Sodium bicarbonate, Sodium saccharin, Mandarin dry flavoring, Orange yellow S (E 110), Sucrose, qsp 1 sachet.

Excipients à effet notoire : jaune orangé S (E110), saccharose, sodium.

Spagulax effervescent powder 20 sachets is a herbal medicine for the symptomatic treatment of constipation. It is indicated for adults.

Directions for use Spagulax effervescent powder 20 sachets

Dosage Usually one sachet before or after each main meal. Use in children and adolescents under 18 years of age is not recommended (see Warnings and precautions for use).

Method of administration Oral administration. Dilute the powder in a large glass of water. Shake and drink immediately. SPAGULAX should be taken at least ½ hour to 1 hour before or after other medications, and never immediately before bedtime.

Onset of action: 12 to 24 hours. When preparing the oral suspension, it is important to avoid inhaling the powder to minimize any risk of sensitization to the ispaghul seed coat.

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

Precautions for use Spagulax effervescent powder 20 sachets

Contraindications:

- Patients suffering from stenosing diseases of the gastrointestinal tract, esophageal and cardiac diseases, latent or overt intestinal obstruction (ileus), intestinal paralysis or megacolon;

- Hypersensitivity to the active substance or to any of the excipients listed under Excipients;

- Patients with abrupt changes in bowel function persisting for more than 2 weeks;

- Rectal bleeding of undetermined cause or failure to defecate after using another laxative;

- Inflammatory organic diseases (ulcerative colitis, Crohn's disease);

- Abdominal pain syndromes of undetermined cause;

- Faecal impaction;

- Patients with swallowing difficulties or throat disorders.

Warnings and other special precautions:

There is a risk of bezoar formation, usually requiring endoscopy.

Sufficient fluid should always be taken (200 mL) (see Dosage and administration). When SPAGULAX is taken with insufficient fluid, it may cause obstruction of the throat or esophagus, leading to respiratory shock. Associated symptoms may include chest pain, vomiting or difficulty swallowing or breathing.

Ispaghul products should not be used in the event of digestive tract obstruction, abdominal pain syndromes, nausea or vomiting without medical advice, as these symptoms may indicate latent or overt intestinal obstruction (ileus).

If abdominal pain occurs, or if faeces are irregular, SPAGULAX should be discontinued and medical advice sought.

Treatment of elderly or debilitated patients requires medical supervision. Elderly patients should be given sufficient fluids.

To reduce the risk of gastrointestinal obstruction (ileus), ispaghul seed coat should only be used with drugs known to inhibit intestinal peristalsis (e.g. opioids) under medical supervision.

In cases of megacolon due to impaired colonic motricity, and in bedridden patients, prescribing must be cautious (risk of fecal impaction).

Patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases) should not take this medicine.

This medicine contains 120 mg sodium per sachet and 360 mg per day, equivalent to 18% of the WHO-recommended maximum daily dietary intake of 2 g sodium per adult.

Prolonged use in the treatment of constipation is not recommended.

Medicinal treatment of constipation is only an adjunct to hygienic dietary therapy

- Enriching the diet with vegetable fibers and beverages;

- Advice on physical activity and exoneration rehabilitation.

Pediatric population

SPAGULAX is not recommended for children and adolescents under 18 years of age. In children and adolescents, treatment is essentially dietary and requires medical advice.

In infants and children under 6 years of age, laxatives should only be prescribed in exceptional cases, taking into account the risk of interfering with the normal functioning of the exoneration reflex.

Hypersensitivity warning

People who may come into prolonged contact with ispaghul seed coats (e.g. healthcare professionals, carers) may experience allergic reactions if the powder is inhaled, and this is more frequent in sensitive (allergic) people. This can sometimes lead to (possibly severe) hypersensitivity reactions (see Adverse reactions).

It is advisable to assess those at risk and, if warranted, perform specific hypersensitivity tests.

In the event of a hypersensitivity reaction, all exposure to the product should be immediately discontinued (see Contraindications).

Pregnancy and lactation :

Pregnancy

To date, SPAGULAX SUGAR-FREE has not been associated with any particular malformative or fetotoxic effects. However, follow-up of pregnancies exposed to ispaghul is insufficient (less than 300 pregnancies) to exclude any risk.

Reproduction toxicity studies in animals are insufficient (see Preclinical safety data).

Consequently, the use of this drug during pregnancy should be considered only if necessary and if dietary modification is ineffective.

Ballast laxatives should be used before any other laxative.

Breast-feeding

The use of this drug should be considered during breast-feeding only if necessary and if dietary modification is ineffective.

Fertility

In rats, no effect on fertility has been demonstrated after oral administration (see Preclinical safety data).

Effects on ability to drive and use machines :

Not applicable.

Composition Spagulax effervescent powder 20 sachets

effervescent powder for drinkable suspension: Ispaghul, seed coats 2.143 g.

Excipients: Citric acid anhydrous, Sodium bicarbonate, Sodium saccharin, Mandarin dry flavoring, Orange yellow S (E 110), Sucrose, qsp 1 sachet.

Excipients à effet notoire : jaune orangé S (E110), saccharose, sodium.