Agiolax granules

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Herbal medicinal product for short-term use in occasional constipation (obstipation).

Application

1. What is Agiolax and what is it used for?

Agiolax is a herbal laxative.
The seeds and seed coats of the Indian flea seed absorb water, swell up and support the softening of the stool through their mucilages. In addition, the intestinal activity is increased by laxative active ingredients from the senna fruits. The effect starts 8 to 10 hours after ingestion.

Agiolax is used for a short time in occasional constipation (obstipation).

How is it used?

What is Agiolax and what is it used for?

Herbal medicinal product for short-term use in occasional constipation (obstipation).

The seeds and seed coats of the Indian flea seed absorb water, swell up and support the softening of the stool through their mucilages. In addition, the intestinal activity is increased by laxative active ingredients from the senna fruits. The effect starts 8 to 10 hours after ingestion.


This medicinal product is used in adults and adolescents aged 12 years and over.

If you do not feel better or even worse after 7 days, contact your doctor.

What should you consider before taking it?

What should you consider before taking Agiolax?

Agiolax must not be taken,

• if you are allergic to flea seeds, senna fruits or any of the other ingredients of this medicinal product listed in section 6
• in acute or chronic inflammatory diseases of the intestine, e.g. Crohn's disease, ulcerative colitis, appendicitis
• in severe fluid deficiency with water and electrolyte loss
• In rectal bleeding (rectal bleeding) of unexplained cause
• in pathological constrictions in the gastrointestinal tract or esophagus
• in intestinal obstruction
• in paralysis of the intestine or in enlargement of the colon (megacolon)
• in nausea
• in abdominal pain of unknown cause
• in difficulty swallowing or other discomfort in the throat area
• in excessive stool hardening (fecal stones, fecal stasis)
• in severely adjustable diabetes mellitus (diabetes)
• by children under 12 years of age

Warnings and Precautions

Please talk to your doctor or pharmacist before taking Agiolax.

Patients taking cardiac glycosides, antiarrhythmics, drugs that can lead to prolongation of the QT interval, cortisone-containing or diuretic drugs or liquorice root must consult a doctor before taking senna fruits at the same time (see Taking Agiolax with other medicinal products).

Like all laxatives, Agiolax should not be taken without medical advice if you suffer from fecal impaction or gastrointestinal complaints of unknown cause such as abdominal pain, nausea and vomiting, as these symptoms may be an indication of impending or already existing intestinal obstruction (ileus).

Agiolax must not be taken for a prolonged period (more than 1 to 2 weeks) without a doctor's order. The preparation should only be used if the constipation cannot be relieved by a change in diet (high-fiber diet).
If laxatives are needed every day, the cause of the constipation should be determined.

Taking laxatives that stimulate (stimulate) bowel movements beyond the short-term use can lead to dependence with the need for increased dosages, intestinal relaxation with reduced function and increased intestinal sluggishness.

The dose required for a safe effect may vary from case to case. Diarrhea is a sign of overdose.
Agiolax should be taken at least 1/2 to 1 hour before or after taking other medicines (see Taking Agiolax with other medicines).

If Agiolax is taken without sufficient fluid intake, the medicinal product may swell and block the throat or esophagus, leading to choking. Constipation may occur or existing constipation may be aggravated due to insufficient fluid intake. If chest pain, vomiting, difficulty swallowing or breathing occur after taking the medicine, or if abdominal pain or fecal stasis occurs, a doctor should be consulted immediately.

To reduce the risk of intestinal obstruction, drugs that inhibit bowel movement (e.g. opiates) should only be taken together with Agiolax under medical supervision.

Patients with kidney disease should pay particular attention to possible electrolyte imbalances.

In adults who cannot hold back their stools, prolonged skin contact with the stools should be avoided by changing the template frequently when taking Agiolax.

Flea seeds contain potent allergens that can lead to allergic sensitization in exposed individuals. This sensitization can trigger severe hypersensitivity reactions. It is recommended to clinically check the possible sensitization of persons with risk factors and, if justified, to carry out specific
diagnostic tests. In the event of confirmed sensitization with hypersensitivity reactions, contact with the product must be stopped immediately and avoided in the future.
The intake must be stopped immediately if any of the allergic
symptoms listed in section 4 occur.

Agiolax is not suitable for reducing body weight.


Taking Agiolax with other medicinal products

Tell your doctor or pharmacist if you are taking / using, have recently taken / used or intend to take / use any other medicines.

With continuous use (abuse!), a potassium deficiency in the blood can be triggered, which can lead to an increase in the effect of certain drugs that affect the heart muscle or the heart rhythm (cardiac glycosides and antiarrhythmics) and thus to a QT prolongation (a form of heart rhythm disorder).

If carbenoxolone or liquorice root, cortisone-containing or diuretic drugs (thiazide diuretics) are taken at the same time, this can lead to a decrease in the potassium level in the blood (hypokalaemia), which can e.g. the effect of cardiac glycosides is increased and that of agents against cardiac arrhythmias is influenced.

The absorption of medicines taken at the same time, such as minerals, vitamins (B12), cardiac glycosides, coumarin derivatives, carbamazepine and lithium, through the intestine can be delayed. Therefore, Agiolax should be taken at least ½ to 1 hour before or after taking other medicines.

In insulin-dependent diabetics, it may be necessary to adjust the amount of insulin. This also applies to the intake of thyroid hormones. In these cases, medical supervision is required.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

As a precaution, Agiolax should be avoided during the first three months of pregnancy. Otherwise, Agiolax should only be used temporarily
if constipation cannot be relieved by a change in behavior or diet or by taking bulking agents. Please ask your doctor for advice.

Agiolax should not be used during breast-feeding.

Driving and operating machinery

No studies on the effects on the ability to drive and use machines have been performed.

Agiolax contains sucrose (sugar)

Only take Agiolax after consulting your doctor if you are known to suffer from sugar intolerance.

Note for diabetics:
1 measuring spoon of Agiolax (approx. 5 g granules) contains approx. 1.04 g sugar = 0.09 BE.

How is the medication to be taken?

How is Agiolax to be taken?

Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults and adolescents aged 12 years and over:
1 measuring spoon in the evening after meals (additionally in the morning before breakfast if necessary).
The single dose can also be reduced individually. The lowest effective dose should always be used.

Type of application
For oral use.
Take the granules without chewing with plenty of liquid (at least 1/4 liter), preferably in the evening, but not immediately before going to bed.

Duration of application
The intake should only take place when necessary, whereby an application 2-3 times a week should usually be sufficient. Taking it for a period longer than 1-2 weeks requires medical supervision.

If you do not feel better or even worse after 7 days, contact your doctor. Application in children

Children under 12 years of age must not take Agiolax.

If you have taken more Agiolax than you should

please contact your doctor.

As main symptoms in case of overdose or abuse, abdominal discomfort, painful intestinal cramps, flatulence, intestinal obstruction and severe diarrhea can occur, with the result of water and electrolyte losses, which should be replaced.

Diarrhea can cause potassium deficiency in particular. Potassium deficiency can lead to heart dysfunction and muscle weakness, especially when taken together with heart medication (cardiac glycosides), diuretics (diuretics), a certain group of drugs with anti-inflammatory effects (corticosteroids) and liquorice root.

As a supportive treatment, larger amounts of fluid should be taken. The electrolyte level, especially the potassium level, should be monitored. This is particularly important in elderly patients.

Long-term overdose can lead to liver inflammation (toxic hepatitis).

If you forget to take Agiolax

Do not take double the amount if you have forgotten the previous dose.

If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.

What side effects are possible?

How is Agiolax to be stored?

Do not store above 25 °C.
Always keep the can tightly closed.
Keep this medicine out of the reach of children.
You must not use the medicinal product after the expiry date which is stated on the bottom of the can. The expiry date refers to the last day of the month.
Shelf life after first opening: 6 months
Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special storage instructions

5. How is Agiolax-Granulat to be stored?

Do not store above 30 °C. Do not store above 25° after first opening.
Always keep the can tightly closed.
Keep this medicine out of the reach of children.
You must not use the medicinal product after the expiry date which is stated on the bottom of the can. The expiry date refers to the last day of the month.
Shelf life after first opening: 6 months
Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special notes on the content

Contents of the pack and further information

What Agiolax contains

• The active ingredients based on 100 g granules are:
  Indian flea seeds 52.0 g,
  Indian flea seed coats 2.2 g,
  Tinnevelly senna fruits 6.74 – 13.5 g corresponding to 300 mg sennosides.
• The other ingredients are:
  Talcum, gum arabic, black, red, yellow iron oxides (E 172), liquid paraffin, flavorings, sucrose.
  1 measuring spoon corresponds to 5 g granules.

What Agiolax looks like and contents of the pack


Brown granules in a container (cardboard composite can coated with Alu/PET with screw cap (polystyrene, PP), membrane (Alu/PP)).
Pack sizes: 100 g, 250 g, 400 g and 1000 g.
Measuring spoon included.