Action and mechanism

- Laxative. A combination of plants with stimulant (buckthorn and cascara sagrada) and mechanical (fucus) laxative activity.
Buckthorn and cascara sagrada are plants rich in anthraquinone heterosides (frangulins and glucofrangulins in buckthorn; cascarosides in cascara sagrada). These compounds appear to irritate intestinal nerve endings, releasing mediators such as serotonin and histamine, which increase intestinal peristalsis. Furthermore, they may also have an effect on Na+/K+ ATPase, blocking the reabsorption of water, sodium, and chloride, and increasing potassium secretion. The result is an increased osmotic load in the intestinal lumen, which promotes the release of more water.
Fucus, for its part, is an algae rich in mucilages, non-digestible polysaccharides with a great capacity to absorb water, forming a viscous and voluminous gel, which increases stool volume and promotes peristalsis, contributing to the laxative effect.
Effects usually appear 6-12 hours after administration.

Indications

- [CONSTIPATION]. Treatment of occasional constipation.

Posology

Dosage:

- Adults, oral: 1 tablet every 24 hours. It is advisable to avoid treatment lasting longer than 6 days.

- Children, oral:
* Children over 12 years: 1 tablet/24 h.
* Children 12 years of age and younger: Safety and efficacy have not been evaluated.

Rules for correct administration

The tablets should be taken at night, before going to bed.

Contraindications

- Hypersensitivity to any component of the medication.

- [INTESTINAL OBSTRUCTION]. It is recommended to avoid the use of laxatives in patients in whom intestinal transit is difficult or impeded, such as in the case of [ILEUS], as well as in those with [APPENDICITIS], in whom stimulation of intestinal transit could be dangerous.

- Chronic inflammatory bowel diseases, such as [ULCERATIVE COLITIS] or [CROHN'S DISEASE]. Anthraquinone heterosides exert intense irritating effects on the intestinal mucosa, which could precipitate an attack of this disease.

- [HEMORRHOIDS]. Anthraquinone heterosides may increase hemorrhoidal bleeding and worsen hemorrhoid symptoms, so their use is not recommended.

- [DEHYDRATION]. It is recommended to avoid the use of stimulant laxatives in patients with dehydration or electrolyte imbalances such as [HYPONATREMIA] or [HYPOKALEMIA], as they may worsen the patient's condition.

- Nonspecific gastrointestinal symptoms. Laxative effects could mask serious illnesses, such as intestinal obstruction, appendicitis, or even colon cancer. Patients who frequently experience abdominal pain of unknown origin, as well as nausea or vomiting, are advised to avoid using any laxative and consult their doctor for an accurate diagnosis.

- [HYPERTHYROIDISM]. Fucus is an iodine-rich seaweed, so it may worsen the condition of patients with hyperthyroidism.

- [HEPATITIS].

- [INTERSTITIAL NEPHRITIS].

Warnings on excipients:

- This medicine contains glucose. Patients with glucose-galactose malabsorption should not take this medicine.

Warnings on excipients:

- This medicine contains lactose. Patients with hereditary [LACTOSE INTOLERANCE] or galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

Warnings on excipients:

- This medicinal product contains sucrose. Patients with hereditary [FRUCTOSE INTOLERANCE], glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicinal product.

Precautions

- Heart disease. The iodine content in fucus may stimulate heart function, potentially worsening conditions such as [HEART FAILURE], [HIGH PRESSURE], or [CARDIAC ARRHYTHMIA]. Patients with heart disease should use fucus with great caution.

- Renal impairment. Patients with renal impairment should exercise extreme caution due to the increased risk of fluid and electrolyte imbalance.

- Preventing dehydration. Patients are recommended to consume adequate amounts of water and electrolytes daily during treatment to prevent possible dehydration. If the patient experiences dizziness, intense thirst, fatigue, or muscle weakness, they should discontinue treatment and seek medical advice.

- Abuse. The use of laxatives has been linked to the development of dependence on their effects, worsening of constipation due to electrolyte loss, and cases of abuse. It is recommended to avoid prolonged treatment of more than 6 days. If the patient requires almost daily use of laxatives, it is advisable to investigate the cause of their constipation.

- Thyroid hormone levels. The use of high doses of fucus for prolonged periods has resulted in cases of elevated thyroid hormone levels and even hyperthyroidism. It is advisable not to exceed the prescribed doses and to monitor thyroid hormone levels in patients showing symptoms of hyperthyroidism (feeling hot, unexplained weight loss, nervousness, insomnia, palpitations).

- Urine staining. The use of anthraquinone glycosides may cause urine to turn dark yellow to brownish. This symptom should not alarm the patient, as it is due to the elimination of the active ingredients in the urine.

Warnings on excipients:

- Because it contains methyl parahydroxybenzoate, it may cause allergic reactions (possibly delayed).

Warnings on excipients:

- Because it contains ethyl parahydroxybenzoate, it may cause allergic reactions (possibly delayed).

Warnings on excipients:

- Because it contains propyl parahydroxybenzoate, it may cause allergic reactions (possibly delayed).

Patient Advice

- The use of laxative medications should not be an alternative to other dietary and hygienic measures to prevent constipation, such as consuming an adequate amount of fiber daily, along with drinking plenty of fluids, as well as exercising, or practicing habits such as having a regular time for going to the bathroom.

- The tablets should be taken at night, before going to bed.

- This medication is not indicated for the long-term treatment of constipation. Continuous treatment for more than 6 days is not recommended.

- If symptoms persist or worsen after 4 days of treatment, it is advisable to consult your doctor or pharmacist.

- Continued use may lead to dependence and worsening of constipation.

- It is not recommended to use laxative medications in cases of abdominal pain of unknown origin, nausea or vomiting.

- People over 65 years of age are more sensitive to the adverse reactions of stimulant laxatives, so extreme caution is recommended when starting treatment.

- It is recommended to drink an adequate amount of water (about two liters daily) during treatment with this medication, to enhance the laxative effects and prevent dehydration.

- It is advisable to notify your doctor if you experience bloody stools, abdominal pain of unknown origin, dizziness, intense thirst, fatigue, or muscle pain.

- The appearance of a yellowish or brownish color in the urine is normal, but is not important.

- If the patient is taking other oral medications, they should allow at least 30-60 minutes between taking these medications.

Special warnings

- Before prescribing a laxative to a patient with abdominal pain of unknown origin, it is advisable to rule out other serious pathologies.

- Before starting treatment, the patient must be adequately hydrated and have normal electrolyte levels. Treatment should not be started if these levels are likely to be altered.

- Elderly or debilitated patients are more prone to adverse reactions from laxatives.

- It is recommended to investigate the cause of constipation in patients who require daily use of laxatives.

- The possibility of hyperthyroidism should be considered in patients treated with high doses of fucus for prolonged periods. If the patient shows symptoms of hyperthyroidism, measuring thyroid hormone levels is recommended.

Interactions

In general, it should be noted that due to its laxative effects, this medication may reduce the absorption of any other drug administered orally. Bladderwrack, in particular, can form a dense gel that traps other drugs, limiting their absorption. Therefore, it is advisable to stagger the intake of bladderwrack and other active ingredients, allowing at least 30-60 minutes between doses.

- Digoxin. If hypokalemia occurs, digoxin toxicity may increase. It is advisable to drink plenty of water during treatment and not exceed the recommended dose or duration of treatment.

- Hypokalemic drugs (ACTH, beta-adrenergic agonists, amphotericin B, corticosteroids, thiazide or loop diuretics, licorice). There is an increased risk of hypokalemia. Adequate daily intake of water and electrolytes and avoiding prolonged treatment are recommended.

- QT interval prolongers (5-HT3 antagonists, class Ia and III antiarrhythmics, high-dose antidepressants, certain H1 antihistamines, antimalarials, arsenic trioxide, formoterol, gadolinium contrast agents, ivabradine, levacetylmethadol, levosimendan, macrolides, neuroleptics, pentamidine, some fluoroquinolones, dasatinib, sunitinib, suxamethonium, tacrolimus, vardenafil). Hypokalemia may increase the risk of QT interval prolongation and the occurrence of serious ventricular cardiac arrhythmias such as torsades de pointes. Extreme caution is advised in these patients, monitoring kalemia and correcting it if hypokalemia occurs.

Pregnancy

There are no adequate and well-controlled human studies that determine the efficacy and safety of this medication during pregnancy, although there have been no reports of adverse reactions to the fetus at the recommended doses. Some anthraquinone heterosides, such as emodin, frangulin, chrysophanol, and fiscion, have been associated with genotoxic and oxytocic effects. Furthermore, cases of arteriovenous malformations have been reported in children of mothers who used fucus during pregnancy, although a strong causal relationship has not been established. Therefore, it is recommended to avoid its use unless, in the absence of safer therapeutic alternatives, the benefits outweigh the potential risks.

Lactation

It is unknown whether the components of this medication can be excreted in breast milk, and their possible consequences for the infant. Some anthraquinone heterosides, such as rhein, are excreted in milk in small amounts, although no side effects have been reported in the infant. Due to the risk of laxative effects in the child and possible hyperthyroidism, it is recommended to avoid using this medication or discontinue breastfeeding.

Children

Safety and efficacy have not been evaluated in children 12 years of age or younger, so it is recommended to avoid its use.

Seniors

In general, laxatives should be used with caution in the elderly because they may cause excessive fluid and electrolyte loss and exacerbate weakness, hypotension, and psychomotor incoordination, with the resulting risk of falls and fractures.

Adverse reactions

- Digestive: [ABDOMINAL PAIN], [ABDOMINAL SPASM], [DIARRHEA]. A discoloration of the intestinal mucosa (pseudomelanosis coli) may appear, which disappears when treatment is discontinued.

- Urinary: [ALBUMINURIA], [HEMATURIA].

- Allergic: [HYPERSENSITIVITY REACTIONS].

- Metabolic: [DEHYDRATION], [HYPOKALEMIA].

Overdose

Symptoms: In the event of an overdose, an increase in adverse reactions is expected, with diarrhea, cramping abdominal pain, abdominal cramps, and loss of water and electrolytes. In severe cases, this may lead to hypokalemia. Hypokalemia may cause cardiac arrhythmias, muscle weakness and cramps, and in the most severe cases, nephritis. Chronic ingestion may cause hepatitis.
Treatment: It is recommended to discontinue administration and institute symptomatic treatment, especially rehydration and mineral salts if necessary.