AGIOLAX GRANULES 1 PAPER/AL CONTAINER OF 250 G WITH MEASURING SPOON

Name
AGIOLAX granules
Ispaghula seed, Ispaghula cuticle and Senna fruit


What is it and what is it 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.
Contact 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 to any of the other ingredients of this medicine (listed in section 6)
- if you suffer from abdominal pain, even 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 esophagus (the food pipe that leads from your throat to your stomach) or of the gastrointestinal tract (stomach and intestines),
- if you have rectal bleeding of unknown origin,
- if you suffer from a severe state of 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 the risk of regurgitation (for example if you are confined to bed),
- if you suffer from a loss of normal bowel function (colonic atony) or have a hard, bulky lump of stool in your intestine caused by constipation (faecal impaction),
- if you are pregnant or breast-feeding (see section Pregnancy and breast-feeding),
- if you suffer from inflammatory bowel diseases (Crohn's disease, ulcerative colitis or appendicitis),
- if the subject to be treated is under 12 years old


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

Health education notes
First of all, it must be kept in mind that, in most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can permanently solve the problem of constipation.
Many people think they are constipated if they are unable to have a bowel movement every day.
This is a misconception as this situation is completely normal for a large number of individuals.
Consider, however, that constipation occurs when bowel movements are reduced compared to your personal habits and are associated with the emission of hard stools.
If episodes of constipation occur repeatedly, a doctor should be consulted.
Laxative abuse (frequent or prolonged use or excessive doses) can cause persistent diarrhea resulting in loss of water, mineral salts (especially potassium) and other essential nutrients.
In more serious 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).
Laxative abuse can cause dependence (and, therefore, the possible need to gradually increase the dosage), chronic constipation and intestinal atony (loss of normal intestinal function).
During treatment with Agiolax it is necessary to drink plenty of water (6-8 glasses a day) to prevent the onset of intestinal obstruction.
Agiolax should be used only if a therapeutic effect cannot be achieved by modifying the diet or administering bulk laxatives.
Tell your doctor if you are taking thyroid medicines.
After oral intake or contact with the skin, Agiolax may cause hypersensitivity reactions (allergies), see "Possible side effects".
Abdominal pain, spasms and diarrhoea may occur, especially in case of pre-existing irritable bowel syndrome (altered intestinal motility), see "Possible side effects".
Some symptoms may also arise following an overdose; in this circumstance it is necessary to reduce the dose (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, STOP using Agiolax immediately 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 colic (painful contractions of the visceral muscles) may occur. This occurs more frequently in cases of severe constipation or irritable bowel syndrome (a condition of altered intestinal motility).
The following side effects may also occur:
Rare (may affect up to 1 in 1,000 people):
- Flatulence (emission of intestinal gas from the anus)
- Abdominal distension (swollen belly)
- Chromaturia (abnormal coloration of urine), due to the presence of senna components
Very rare (may affect up to 1 in 10,000 people):
- Obstruction of the esophagus (the food pipe that leads from the throat to the stomach)
Not known (frequency cannot be estimated from the available data)
- Nausea
- Vomit
- Diarrhea
- Albuminuria [loss of albumin (a protein) in the urine], from prolonged use
- Hematuria (blood in the urine), from prolonged use.
In addition, colonic melanosis (staining of the intestinal mucosa) has been reported, which recedes after discontinuation of the drug.

Reporting of side effects
If you experience 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.