Colirei

Package leaflet: Information for the patient

Colirei Powder for oral solution

macrogol and sodium and potassium salts
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Colirei is and what it is used for
2. What you need to know before taking Colirei
3. How to take Colirei
4. Possible side effects
5. How to store Colirei
6. Contents of the pack and other information

1. What Colirei is and what it is used for

Colirei contains the active substances macrogol and sodium and potassium salts and belongs to the category of osmotic laxatives – macrogol combinations.
Colirei is used for:

• treatment of constipation
• clinical conditions requiring complete bowel evacuation (for example, preparation prior to surgery, diagnostic examinations, etc.)

2. What you should know before taking Colirei

Do not take Colirei:

• if you are allergic to macrogol or to sodium and potassium salts, or to any of the other ingredients of this medicine (listed in section 6);
• if you have a hole in the wall of the stomach or intestine (gastrointestinal perforation) or are at risk of developing one;
• if you suffer from severe inflammatory bowel diseases (such as ulcerative colitis, Crohn's disease), or toxic megacolon (severe dilation of the colon) associated with symptomatic stenosis (narrowing);
• in case of intestinal blockage (obstructive, subobstructive or stenotic forms);
• in case of blockage or slowing down of food in the gastric tract (gastric stasis, dynamic ileus, paralytic ileus);
• if you have abdominal pain of unknown origin;
• if you suffer from painful inflammation of the colon (acute colitis);
• if you have nausea or vomiting;
• in case of increased or decreased intestinal movements (peristalsis);
• in case of rectal bleeding;
• in case of severe dehydration;
• in children under 8 years of age and weighing less than 20 kg.
  The use of Colirei is not recommended during pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using Colirei.
Do not use this medicine if you suspect having lesions blocking the intestinal cavity and/or if you have abdominal pain, nausea and/or vomiting.
If you experience sudden abdominal pain or rectal bleeding while taking Colirei for bowel preparation, contact a doctor immediately.
Take Colirei with particular caution:

• if you suffer from heart or kidney diseases (cardiac or renal patients);
• if you have difficulty swallowing or impaired mental status, due to the risk of aspiration of stomach contents into the lungs (regurgitation aspiration);
• in case of diarrhea, if you are predisposed to disturbances in water and electrolyte balance (for example, if you suffer from severe liver or kidney dysfunction, if you are taking diuretics, or if you are elderly); in such cases, frequent electrolyte monitoring is recommended;
• in elderly patients or individuals with poor health status. In these cases, the doctor will carefully evaluate the benefit-risk ratio before prescribing Colirei.

Consult your doctor:

• if you are treating chronic or periodic constipation;
• when the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of stools) lasting more than two weeks;
• when the use of a laxative fails to produce effects.

Please bear in mind that:

• repeated use of laxatives may lead to dependence or various types of harm;
• prolonged use of a laxative for the treatment of constipation is not recommended;
• you should consider taking medicines as an additional aid to correcting your diet for treating constipation (e.g. increasing dietary fiber and fluid intake, physical activity, and re-education of intestinal motility).

Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause:

• persistent diarrhea, leading to loss of water, mineral salts (especially potassium), and other essential nutrients;
• in more severe cases: risk of dehydration or low blood potassium levels (hypokalemia), which may result in cardiac or neuromuscular dysfunction, especially if you are also taking cardiac glycosides, diuretics, or corticosteroids;
• dependence, possibly requiring progressive dose increases;
• chronic constipation;
• loss of normal intestinal function (intestinal atony).

You may take COLIREI if you have diabetes or are on a galactose-free diet, as the medicine does not contain sugar or polyalcohols.
Children and adolescents
The use of COLIREI is not recommended in children under 8 years of age and weighing less than 20 kg (see "Do not take COLIREI"). In children over 8 years of age and weighing more than 20 kg, the medicine may be used only after consulting a doctor, and treatment should not exceed 3 months (due to lack of clinical data for treatments longer than 3 months).
Other medicines and Colirei
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking laxatives and other medicines at the same time. After taking any medicine, wait at least 2 hours before taking Colirei.
Indeed, laxatives may reduce intestinal transit time, and thus the absorption, of other medicines taken simultaneously by oral route.
In severe cases of laxative abuse, dehydration or hypokalemia (reduced potassium levels in the blood) may occur, which can lead to cardiac or neuromuscular dysfunction, especially if you are also taking cardiac glycosides (medicines that stimulate heart function), diuretics (medicines that increase urine production), or corticosteroids (anti-inflammatory medicines).
If you need to thicken liquids for safe swallowing, Colirei may counteract the thickening agent's effect.
Colirei with food and drinks
Consumption of liquorice increases the risk of reduced potassium levels in the blood (hypokalemia).
Driving and using machines
COLIREI does not affect the ability to drive or operate machinery.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Colirei should be used only when necessary, under direct medical supervision, after carefully weighing the expected benefit for the mother against the potential risk for the fetus or nursing infant.

3. How to take Colirei

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Recommended dose for bowel cleansing:
Adults:
4 litres (16 sachets of 17.50 g each, dissolved in 250 ml of water) to be taken as a single dose on
the afternoon before the examination, or divided into two doses: 2 litres the evening before the examination and 2 litres on the morning of the examination. The recommended rate of intake is 250 ml every 15 minutes, until the full 4 litres are consumed. It is preferable to drink each portion quickly.

The preparation should be taken after a 3-4 hour fast. In any case, no solid food should be consumed from 2 hours before administration until after the examination. You may drink water.

The first bowel movement usually occurs approximately 90 minutes after starting administration. Continue drinking until the stools become liquid and clear (clear rectal effluent).

Treatment of constipation:
Adults:

• Start treatment with two sachets per day, one in the morning on an empty stomach and one in the evening before bedtime.
• Once daily bowel movement is achieved, the dose may be reduced to one sachet per day, either as a single dose or split into two half-sachets, or one full sachet every other day.
• The correct dose is the lowest dose sufficient to produce easy passage of soft stools.
• Bowel movement typically occurs 24 to 48 hours after administration.
• Do not exceed a treatment duration of three months; in any case, follow your doctor’s instructions.

Use in children (over 8 years of age and weighing more than 20 kg) and adolescents:
In children, treatment should not exceed 3 months due to lack of clinical data on longer-term use. Recommended doses should be proportionally reduced, using half-sachets of 8.7 g dissolved in 125 ml of water or full sachets of 17.5 g dissolved in 250 ml of water. Depending on the individual case and only under medical supervision, a second dose may be administered 12 hours apart, or according to a regimen established by the doctor based on the desired effect and individual sensitivity.

Instructions for preparation:

• Dissolve the contents of one sachet in 250 ml of tap water. The reduced dose of half a sachet should be dissolved in a glass of water.
• Do not add any other ingredients to the solution.
• If not taken immediately, store the solution in the refrigerator and use it within 48 hours of preparation.
• The solution may be more palatable when cooled.

If you take more Colirei than you should
In case of accidental ingestion/overdose of Colirei, contact your doctor immediately or go to the nearest hospital.
Excessively high doses may cause abdominal pain and diarrhoea, which usually resolve within 24–48 hours. Resulting losses of fluids and electrolytes should be replaced. In most cases, drinking or administering large amounts of fluids, especially fruit juices, is sufficient. Treatment may then be resumed at a lower dose.
Cases of aspiration have been reported when large volumes of macrogol (polyethylene glycol) and electrolytes are administered via nasogastric tubes (medical devices used for artificial nutrition in patients unable or unwilling to eat normally).
Children with neurological impairments and oromotor dysfunction (difficulty with motor control and coordination of lips, tongue, cheeks, and pharynx) are at particular risk of aspiration.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Colirei immediately and consult your doctor if you experience allergic reactions (hypersensitivity) such as:

• itching
• skin rash
• localized swelling, especially of the face or hands, swelling or tingling of the lips or throat (urticaria, oedema)
• breathing difficulties

Other side effects that may occur with the use of Colirei.
Common side effects (may affect up to 1 in 10 people):

• nausea
• diarrhoea
• abdominal pain and/or abdominal distension (bloating)

Uncommon side effects (may affect up to 1 in 100 people):

• vomiting
• urgency to defecate (expulsion of faeces)
• faecal incontinence (involuntary and uncontrolled loss of faeces and intestinal gas)

Very rare side effects (may affect up to 1 in 10,000 people):

• hypersensitivity reactions. These may manifest as: itching, skin rash, urticaria or oedema (swelling, particularly of the face or hands; swelling or tingling of the lips or throat), breathing difficulties, anaphylactic shock.

Frequency not known (frequency cannot be estimated from the available data):

• changes in heart rhythm (hypo-hyperkinetic cardiac arrhythmias), probably secondary to altered vagal or sympathetic tone due to intestinal distension, accelerated transit, frequent defecation.
• electrolyte imbalances such as hyponatraemia (decreased sodium levels in the blood) and hypokalaemia (decreased potassium levels in the blood) and/or dehydration, especially in elderly patients, skin redness (erythema).

Side effects in children and adolescents
As in the adult population, side effects have generally been mild and transient and mainly involved the gastrointestinal system.
Common side effects (may affect less than 1 in 10 patients):

• Abdominal pain.
• Diarrhoea (may cause perianal inflammation).

Uncommon side effects (may affect less than 1 in 100 patients):

• vomiting
• bloating
• nausea

Side effects with unknown frequency (frequency cannot be determined from the available data):

• Hypersensitivity reactions (anaphylactic shock, angioedema, urticaria, rash, pruritus).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Colirei

Keep this medicine out of the sight and reach of children.
The reconstituted solution must be stored in the refrigerator (between 2°C and 8°C) and used within 48 hours of preparation. Any remaining solution must be discarded.
Store in the original packaging to protect the product from moisture.
Do not use this medicine after the expiry date stated on the container after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Colirei contains
One dual-chamber sachet of 17.5 g contains:

• Active substances: macrogol 4000 14.580 g anhydrous sodium sulfate 1.422 g sodium bicarbonate 0.422 g sodium chloride 0.365 g potassium chloride 0.185 g
• Other components: sodium cyclamate, acesulfame K, sodium saccharin, maltodextrin, orange flavour.

Description of the appearance of Colirei and contents of the pack
Colirei is a powder for oral solution. Each pack contains 8 or 16 dual-chamber sachets of 17.5 g.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer
Sigmar Italia S.p.A. Via Sombreno, 11 - 24011 Almè (BG)