Presentation and Status in Health Basket
The maximum daily dose of hydroxyanthracene derivatives is 30 mg. On average, this is equivalent to 10 g (= 2 teaspoonfuls) of Agiolax® granules.
Adults and children over 12 years of age: 1 to 2 teaspoonfuls Agiolax® granules once daily, to be taken with plenty of liquid after the evening meal.
The correct individual dose is the smallest required to produce a comfortable soft formed motion.
Mode of administration and duration of use: The granules should be swallowed unchewed with plenty of liquid (a quarter of a litre).
When other medicinal products are used concomitantly, it is recommended to take this product 30 minutes to one hour later.
At best, Agiolax® should be taken in the evening. The effect occurs after 8 to 12 hours. The laxative should not be used for a longer than 1 to 2 weeks and not be taken in higher doses.
Short-term treatment of constipation.
Hypersensitivity reactions to the active substances or any of the other ingredients. Pathological gastrointestinal tract stenosis, ileus, acute inflammatory bowel diseases, such as Crohn’s disease, ulcerative colitis, appendicitis, abdominal pain of unknown origin, severe dehydration states with
water and electrolyte depletion. Children under 12 years of age; patients with difficult to control diabetes mellitus.
If stimulating laxatives are taken for longer than a brief period of treatment, this may lead to aggravation of the constipation.
The product should only be used if a therapeutic effect cannot be achieved by a change in diet or the administration of bulk forming agents.
Note: When Agiolax® is administered to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces.
Very rarely abdominal pain and spasm may occur. In such cases, a dose reduction is necessary.
In the course of treatment, red coloration of urine may occur, which is not clinically significant.
Chronic use/abuse may lead to disorders in water equilibrium and electrolyte metabolism. Diarrhoea may especially cause potassium depletion which may lead to cardiac disorders and muscular asthenia, particularly where cardiac glycosides, diuretics and adreno-corticosteroids are being taken at the same time. Chronic use may result in albuminuria and hematuria. Furthermore, Chronic use may cause pigmentation of the intestinal mucosa (pseudomelanosis coli), which usually recedes when the patient stops taking the preparation.
Very rarely, hypersensitivity reactions to Ispaghula may occur.
Very rarely, oesophagus obstruction may be experienced.
Due to potassium depletion, chronic use/abuse may enhance the effect of cardiac glycosides and affect the action of antiarrhythmic agents.
Combination with diuretics, adrenocorticosteroids and liquorice roots may enhance potassium depletion.
The absorption orally co-administered medicinal products may be reduced. In insulin-dependent diabetics, a reduction in the insulin dose may be required.
Pregnancy and Lactation
Pregnancy: In the first three months of pregnancy Agiolax® should be taken only if constipation cannot be resolved by a change in diet or the administration of bulk forming agents.
Lactation: Small amount of active metabolites (such as rhein) are excreted in breast milk. A laxative effect in breast-fed babies has not been reported.
Accidental or intentional overdose may cause painful intestinal spasm and severe diarrhoea with consequent losses of fluid and electrolytes as well as severe gastrointestinal discomfort.
In the package leaflet, the attention of patients is drawn to the following: In case of suspected overdosing, contact a doctor immediately. He/she will decide which counter measures (e.g., administration of fluid and salts/electrolytes) if any – are necessary.