AGIOLAX*ORAL GRANULES BAR 400G

AGIOLAX granules
Ispaghula seed, Ispaghula husk and Senna fruit

What it is and what it is used for
This medicine contains Ispaghula seed, Ispaghula husk and Senna fruit, and belongs to a group of medicines called laxatives. Agiolax is used for the short-term treatment of occasional constipation in adults and adolescents over 12 years of age.
Consult your doctor if you do not feel better or if you feel worse after 7 days.

What you need to know before taking the medicine
Do not use AGIOLAX
- if you are allergic to Ispaghula seed, Ispaghula husk and Senna fruit or any of the other ingredients of this medicine (listed in section 6)
- if you suffer from abdominal pain, including pain of unknown origin,
- if you have episodes of nausea or vomiting,
- if you have an intestinal obstruction,
- if you have a stenosis (narrowing) of the oesophagus (the food pipe that goes from the throat to the stomach) or of the gastrointestinal tract (stomach and intestines),
- if you have unexplained rectal bleeding,
- if you suffer from severe dehydration (excessive loss of water from the body),
- if you suffer from dysphagia (difficulty swallowing), hiatal hernia (protrusion of a portion of the stomach that moves upwards) or conditions that involve a risk of regurgitation (for example, if you are bedridden),
- if you suffer from a loss of normal bowel function (colonic atony) or have a hard, bulky mass of faeces in the intestine caused by constipation (faecal impaction),
- if you are pregnant or breastfeeding (see section Pregnancy and breastfeeding),
- if you suffer from inflammatory bowel diseases (Crohn's disease, ulcerative colitis or appendicitis),
- if the person to be treated is under 12 years of age

Warnings and precautions
Talk to your doctor or pharmacist before using Agiolax.

Health education notes
First of all, it should be noted that, in most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit) can permanently solve the problem of constipation.
Many people think they suffer from constipation if they cannot have a bowel movement every day.
This is a mistaken belief, as this situation is completely normal for a large number of individuals.
Instead, consider that constipation occurs when bowel movements are reduced compared to your personal habits and are associated with the passage of hard stools.
If episodes of constipation occur repeatedly, a doctor should be consulted.
The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhoea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients.
In the most severe cases, dehydration (excessive loss of water from the body) or hypokalaemia (decrease in potassium in the blood) may occur, which can cause heart or muscle problems, especially if you are taking certain medicines at the same time (see Other medicines and Agiolax).
The abuse of laxatives can cause dependence (and, therefore, a possible need to progressively increase the dosage), chronic constipation and intestinal atony (loss of normal bowel function).
During treatment with Agiolax, it is necessary to drink plenty of water (6-8 glasses a day) to prevent intestinal obstruction.
Agiolax should only be used if a therapeutic effect cannot be achieved by modifying the diet or administering bulk laxatives.
Inform your doctor if you are taking medicines for the thyroid.
After oral intake or skin contact, Agiolax can cause hypersensitivity reactions (allergies), see Possible side effects.
Abdominal pain, spasms and diarrhoea may occur, especially in cases of pre-existing irritable bowel (altered bowel motility), see Possible side effects.
Some symptoms may also occur following an overdose; in this circumstance, the dose should be reduced (see If you take more AGIOLAX than you should).

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, IMMEDIATELY STOP using Agiolax and contact your doctor or the nearest hospital where you will be given appropriate and specific treatment:
- Hypersensitivity reactions (allergic reactions)
- Anaphylactic reactions (severe allergic reactions)
- Skin rash and itching.
Abdominal cramps (painful contractions of the visceral muscles) may occur. These occur more frequently in cases of severe constipation or irritable bowel (a condition of altered bowel motility).
The following side effects may also occur:
Rare (may affect up to 1 in 1000 people):
- Flatulence (emission of intestinal gas from the anus)
- Abdominal distension (bloated belly)
- Chromaturia (abnormal urine colour), due to the presence of senna components
Very rare (may affect up to 1 in 10,000 people):
- Oesophageal obstruction (the food pipe that goes from the throat to the stomach)
Not known (frequency cannot be estimated from the available data)
- Nausea
- Vomiting
- Diarrhoea
- Albuminuria [loss of albumin (a protein) in the urine], from prolonged use
- Haematuria (blood in the urine), from prolonged use.
In addition, melanosis coli (discoloration of the intestinal mucosa) has been reported, which subsides after discontinuation of the medicine.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.