MACROGOL AURO*20SACHETS 10G

Macrogol Aurobindo 10 g powder for oral solution in sachets
Macrogol 4000

What it is and what it is used for
Macrogol Aurobindo contains the active substance macrogol 4000, which belongs to a group of medicines called osmotic laxatives. It works by adding water to the stools, which helps to overcome problems caused by very slow bowel movements. Macrogol Aurobindo is not absorbed into the bloodstream or metabolised by the body.

Macrogol Aurobindo is used for the treatment of constipation in adults and children aged 8 years and older.

This medicine consists of a powder to be dissolved in a glass of water (at least 50 ml) and drunk.

It usually works within 24-48 hours after administration.

The treatment of constipation with any medicinal product should be considered an adjunct to an appropriate lifestyle and a healthy diet.

What you need to know before taking the medicine
Do not take Macrogol Aurobindo:
• If you are allergic to macrogol (polyethylene glycol) or any of the other ingredients of this medicine (listed in section 6).
• If you have an existing serious intestinal disease, such as:
• inflammatory bowel disease (such as ulcerative colitis, Crohn's disease, abnormal dilation of the intestine);
• perforation or risk of intestinal perforation;
• ileus or suspected intestinal obstruction;
• abdominal pain of unknown cause.

Do not use this medicine if you suffer from any of the conditions listed above. If you are not sure, talk to your pharmacist or doctor before taking the medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Macrogol Aurobindo.

Cases of allergic reactions such as rash and swelling of the face or throat (angioedema) have been reported in adults after taking products containing macrogol (polyethylene glycol). Isolated cases of severe allergic reactions characterised by weakness, collapse or difficulty breathing and general malaise have been reported. If you experience any of these symptoms, stop taking Macrogol Aurobindo and seek immediate medical attention.

If you experience sudden abdominal pain or rectal bleeding while taking Macrogol Aurobindo for bowel preparation, contact a doctor immediately.

As this medicine can sometimes cause diarrhoea, check with your doctor or pharmacist before taking the medicine if:
• you suffer from impaired liver or kidney function;
• you are taking diuretics (water pills) or are elderly because there is a risk of a reduction in sodium (salt) or potassium in the blood.

Before taking Macrogol Aurobindo, talk to your doctor or pharmacist if you know you have a swallowing disorder. If you have difficulty swallowing, avoid mixing Macrogol Aurobindo and starch-based food thickeners. This can result in a watery liquid that could enter the lungs and cause pneumonia if you are unable to swallow correctly.

Possible side effects
Like all medicines, Macrogol Aurobindo can cause side effects, although not everybody gets them.

Side effects are generally mild and temporary and include:

In children:
Common (may affect up to 1 in 10 people)
• Abdominal pain (stomach ache).
• Diarrhoea which may cause rectal (anus) cramps.

Uncommon (may affect up to 1 in 100 people)
• Nausea (feeling sick) or vomiting.
• Abdominal bloating (in the stomach).

Not known (frequency cannot be estimated from the available data)
• Allergic reactions (hypersensitivity) (skin rash (hives), swelling of the face and throat, difficulty breathing, weakness or collapse).

In adults:
Common (may affect up to 1 in 10 people)
• Abdominal pain (stomach ache).
• Abdominal bloating (in the stomach).
• Nausea (feeling sick).
• Diarrhoea.

Uncommon (may affect up to 1 in 100 people)
• Vomiting.
• Urgent need to go to the toilet.
• Faecal incontinence.

Not known (frequency cannot be estimated from the available data)
• Low potassium levels in the blood, which can cause muscle weakness, tremors and altered heart rhythm.
• Low sodium levels, which can lead to tiredness and confusion, muscle spasms, convulsions and coma.
• Dehydration caused by severe diarrhoea, especially in the elderly.
• Symptoms of an allergic reaction, such as skin redness, rash, (hives), swelling of the face and throat, difficulty breathing, weakness and collapse.

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.