Colirei - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life and Storage Other Information

Active ingredients: Macrogol, Sodium and Potassium salts

Colirei Powder for oral solution

Why is Colirei used? What is it for?

Colirei contains the active ingredients macrogol and sodium and potassium salts and belongs to the category of laxative drugs with osmotic action - macrogol, combinations.

Colirei is used for:

  • treatment of constipation
  • clinical conditions that require a complete emptying of the intestine (for example preparation before operations, diagnostic tests, etc.)

Contraindications When Colirei should not be used

Do not take Colirei:

  • if you are allergic to macrogol and sodium and potassium salts or any of the other ingredients of this medicine (listed in section 6);
  • if you have a hole in the wall of your stomach or intestines (gastrointestinal perforation);
  • if you suffer from severe inflammatory bowel diseases (such as ulcerative colitis, Crohn's disease and toxic megacolon);
  • in case of forms of blockage of the intestine (occlusive, subocclusive or stenotic);
  • case of blockage or slowdown of food in the gastric tract (gastric stasis, dynamic ileus, paralytic ileus);
  • if you suffer from abdominal pain of unknown origin;
  • if you suffer from painful inflammation of the colon (acute colitis);
  • if you suffer from nausea, vomiting;
  • in case of increased or reduced bowel 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.

Precautions for use What you need to know before taking Colirei

Talk to your doctor or pharmacist before using Colirei.

Take Colirei with particular caution

  • if you suffer from heart or kidney disease (heart or kidney disease).
  • if you have an inability to swallow and impaired mental status, due to the risk of aspiration of stomach contents into the lungs (regurgitation aspiration).
  • in elderly patients or subjects in poor health conditions. In this case the doctor will carefully evaluate the relationship between the expected benefit and the possible risk before prescribing Colirei.

Consult your doctor

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

Keep in mind that:

  • the repeated use of laxatives can give rise to addiction or damage of various kinds.
  • Prolonged use of a laxative for the treatment of constipation is not recommended.
  • should consider the intake of medicines as an added aid to the correction of the diet for the treatment of constipation (eg increase of vegetable fibers and fluids in the diet, physical activity and re-education of intestinal motility).

The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause:

  • persistent diarrhea with consequent loss of water, minerals (especially potassium) and other essential nutritional factors.
  • in severe cases: possibility of dehydration or low levels of potassium in the blood (hypokalaemia), which can lead to cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids.
  • dependence and therefore possible need to gradually increase the dosage
  • chronic constipation
  • loss of normal intestinal functions (intestinal atony).

Interactions Which drugs or foods can modify the effect of Colirei

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Avoid ingesting laxatives and other medications at the same time. After taking a medicine leave an interval of at least 2 hours before taking Colirei.

Colirei with food and drink

The use of licorice increases the risk of low blood potassium levels (hypokalaemia).

Warnings It is important to know that:

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Colirei should only be used when needed, under direct medical supervision, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.

Dose, Method and Time of Administration How to use Colirei: Posology

Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.

The recommended dose in case of intestinal cleansing is:

Adults:

4 liters (16 sachets of 17.50 g each dissolved in 250 ml of water) to be taken, in a single dose, the afternoon before the examination, or divided into two doses, 2 liters the evening before the examination and 2 liters the same morning of the exam.

The intake rate is 250 ml every 15 minutes, until the 4 liters are used up. It is preferable that each single dose is swallowed quickly.

The preparation should be ingested after a 3-4 hour fast. In any case, solid foods should not be ingested from 2 hours before the intake until the test is performed. You can instead drink the water.

The first evacuation usually occurs approximately 90 minutes after the start of administration. You should continue drinking until the stool is liquid and clear (clear rectal outflow).

Use in children (over 8 years of age and weighing over 20 kg) and adolescents:

The recommended dosage is 25-40 ml / kg / to be taken every hour until the stool is liquid and clear (clear rectal efflux).

Treatment of constipation:

Adults, adolescents and children (over 8 years of age and weighing more than 20 kg):

  • start the treatment with two sachets a day, one in the morning on an empty stomach and one in the evening before going to bed.
  • obtained the result of one evacuation per day, the dose can be reduced to one sachet per day, even in two administrations of half a sachet each or one sachet every other day.
  • the correct dose is the minimum sufficient to produce an easy evacuation of soft faeces.
  • evacuation occurs 24 to 48 hours after administration.
  • does not exceed three months of treatment; in any case, follow the doctor's prescription.
Method of 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 other ingredients to the solution.
  • if it is not swallowed immediately, keep the solution in the refrigerator and, in any case, use the solution within 48 hours of its preparation.
  • the solution is more pleasant if cooled

Overdose What to do if you have taken too much Colirei

In case of accidental ingestion / intake of an excessive dose of Colirei, notify your doctor immediately or go to the nearest hospital.

Too high doses can cause abdominal pain and diarrhea which disappears in 24-48 hours. The resulting loss of fluids and electrolytes must be replaced. It is generally sufficient to drink / give a lot of fluids, especially fruit juices. Thereafter, therapy can be resumed at lower doses.

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

Side Effects What are the side effects of Colirei

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 (hypersensitivity) reactions such as:

  • itch
  • skin rashes
  • localized swelling especially of the face or hands, swelling or itching of the lips or throat (hives, edema)
  • 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
  • feeling of full stomach (epigastric fullness)
  • bloating (abdominal distension)

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

  • pain in the abdomen (stomach cramps)
  • He retched
  • rectal irritation

Rare side effects (may affect up to 1 in 1000 people):

  • severe diarrhea
  • rectal bleeding or black stools (melena)

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

  • hypersensitivity reactions. They can occur with: itching, rash, hives or edema (swelling, especially in the face or hands; swelling or itching of the lips or throat), difficulty in breathing.

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

  • heart rhythm changes (hypo-hyperkinetic cardiac arrhythmias)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Keep this medicine out of the sight and reach of children.

The reconstituted solution must be stored in a refrigerator (between 2 ° C and 8 ° C) and used within 48 hours of preparation. The residual solution must be discarded.

Store in the original packaging to protect the product from moisture.

Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Deadline "> Other information

What Colirei contains

A bipartite sachet of 17.5 contains:

  • The active ingredients are:
    • macrogol 4000 14,580 g
    • sodium sulfate anhydrous 1,422 g
    • sodium bicarbonate 0.422 g
    • sodium chloride 0.365 g
    • potassium chloride 0.185 g
  • The other ingredients are: sodium cyclamate, acesulfame K, sodium saccharinate, maltodextrin, orange flavor.

Description of what Colirei looks like and contents of the pack

Colirei comes in the form of a powder for oral solution.

Each pack contains 8 or 16 bipartite sachets of 17.5 g.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Colirei is available in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

COLIREI POWDER FOR ORAL SOLUTION

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

Each bipartite sachet contains:

active ingredients: 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.

For the complete list of excipients see section 6.1

03.0 PHARMACEUTICAL FORM -

Powder for oral solution

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

Treatment of constipation

Clinical conditions that require complete emptying of the large intestine (for example preoperative preparation, diagnostic investigations, etc.)

04.2 Posology and method of administration -

Intestinal cleansing

Adults

The recommended dose is 4 liters (16 sachets of 17.50 g each dissolved in 250 ml of water) to be taken, in a single dose, the afternoon before the examination, or divided into two doses, 2 liters the evening before the " examination and 2 liters the same morning of the examination. The rate of intake is 250 ml every 15 minutes, until the 4 liters are exhausted. It is preferable that each single dose is swallowed quickly. The first evacuation usually occurs approximately 90 minutes after the start of administration. You must continue to drink until the rectal outflow is clear. The preparation should be ingested after a 3-4 hour fast. In any case, solid foods should not be ingested from 2 hours before the intake until the examination . The water supply is instead free. The solution is more pleasant if cooled. The medicine is usually taken orally, but can be administered by nasogastric tube in continuous infusion. In this case, the quantity to be administered should be from 20 to 30 ml per minute.

Children (older than 8 years and weighing more than 20 kg) and adolescents

The recommended dosage is 25-40 ml / kg / hour until a clear rectal outflow is obtained.

Treatment of constipation

Adults, adolescents and children (over 8 years of age and weighing more than 20 kg)

Start the treatment with two sachets a day, one in the morning on an empty stomach and one in the evening before going to bed. Having obtained the result of one evacuation per day, the dose can be reduced to one sachet per day, even in two administrations of half a sachet each or one sachet every other day. The laxative effect of the preparation occurs 24 to 48 hours after administration. The correct dose is the minimum sufficient to produce an easy evacuation of soft faeces. The duration of treatment is limited to three months; in any case the patient must comply to the prescription of the Doctor.

Method of 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. If it is not swallowed immediately, the solution should be kept in the refrigerator and, in any case, used within 48 hours of its preparation.

Do not add other ingredients to the reconstituted solution.

04.3 Contraindications -

Hypersensitivity to the active ingredients or to any of the excipients;

Gastrointestinal perforation;

Serious inflammatory bowel diseases (such as ulcerative colitis, Crohn's disease and toxic megacolon);

Occlusive or subocclusive or stenotic forms of the intestine, gastric stasis, dynamic ileus, paralytic ileus;

Abdominal pain of unknown origin, acute colitis, nausea, vomiting, marked accentuation or reduction of peristalsis, rectal bleeding (the presence of one or more of these signs and symptoms requires adequate medical attention in order to exclude the presence of pathological conditions that they contraindicate the use of laxatives (see previous points);

Severe state of dehydration;

Children under the age of 8 and weighing less than 20 kg;

Generally contraindicated in pregnancy (see section 4.6)

04.4 Special warnings and appropriate precautions for use -

The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors.

In severe cases, the onset of dehydration or hypokalemia is possible, which can cause cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids.

The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).

The repeated use of laxatives can give rise to addiction or damage of various kinds.

The medicine should be administered with particular caution in cardiopathic or renal patients, in patients with impaired swallowing reflex and mental status, due to the risk of regurgitation aspiration.

In elderly subjects or in poor health conditions, the prescription must be preceded by a careful assessment of the risk / benefit ratio.

The prolonged use of a laxative for the treatment of constipation is not recommended. The pharmacological treatment of constipation must be considered an adjuvant to the hygienic-dietetic treatment (eg increase of vegetable fibers and fluids in the diet, physical activity and rehabilitation of motility intestinal).

The treatment of chronic or recurrent constipation always requires the intervention of the physician for the diagnosis, the prescription of the drugs and the surveillance during the therapy.

A careful evaluation by the doctor is essential when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasted for more than two weeks or when the use of the laxative fails to produce effects.

A diet rich in liquids promotes the action of the medicine.

04.5 Interactions with other medicinal products and other forms of interaction -

Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid ingesting other drugs at the same time: after taking a medicine, leave an interval of at least 2 hours before taking the laxative.

The use of licorice increases the risk of hypokalemia.

04.6 Pregnancy and breastfeeding -

There are no adequate and well-controlled studies on the use of the drug in pregnancy or lactation. Therefore, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.

04.7 Effects on ability to drive and use machines -

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

04.8 Undesirable effects -

Too high doses can cause diarrhea which disappears within 24-48 hours after stopping treatment.Thereafter, therapy can be resumed at lower doses. The most frequently observed side effects are: nausea, epigastric fullness and abdominal swelling; less frequently: abdominal cramps, vomiting and rectal irritation. No significant alterations have been reported in controlled studies regarding objective (body weight) vital (blood pressure) biochemical parameters (hematocrit, hemoglobin, sodium, potassium, chloremia, bicarbonates and pCO2). There have been reports of hypo-hyperkinetic cardiac arrhythmias probably secondary to altered vagal or sympathetic tone following luminal distension, accelerated transit, frequent defecation.

Alterations of the gastrointestinal system

Common: abdominal distension, nausea

Uncommon: abdominal pain, rectal irritation, vomiting.

Rare: severe diarrhea, rectal bleeding or melaena (black stools).

General unrest

Very rare: hypersensitivity reactions.

They can occur with: itching, rash, hives or edema (swelling, especially in the face or hands; swelling or itching of the lips or throat), difficulty in breathing.

04.9 Overdose -

Excessive doses can cause abdominal pain and diarrhea; consequent losses of fluids and electrolytes must be replaced. Conservative measures are generally sufficient; a lot of fluids should be given, especially fruit juices.

See also what is reported in section 4.4 about laxative abuse.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

ATC A06AD65: Therapeutic drug category: Laxatives with osmotic action - Macrogol, combinations.

The formulation is such as to allow the blocking of the absorption of water and sodium by the small intestine, and to keep the intraluminal isoosmotic content in the extracellular environment in order to prevent further hydroelectrolytic exchanges along the entire intestinal tract. The result is therefore the passage into the colon, in a relatively short time, of a volume of liquid such as to saturate the absorption capacity of the bowel (from 2 to 4 liters in normal subjects) and determine a progressive increase in the water content of the stool until obtaining, with appropriate dosages, a liquid and clear rectal efflux. This effect results from the combined action of mainly two molecules: sodium sulfate and macrogol (or polyethylene glycol-PEG) 4000. The sulphate ion is poorly absorbable and is able to drastically reduce the absorption of sodium (and secondarily of water) through two mechanisms: 1) inhibition of the neutral NaCl pump by substitution of the Cl ion; 2) induction of a negative transmucosal potential by the addition of an inert, non-absorbable solute (macrogol with a molecular weight between 3250 and 4000) which, with a dose dependent action, prevents, with an osmotic mechanism, the absorption of water and hence the contraction of the intraluminal volume. Although macromolecules the size of macrogol 4000 can theoretically be partially absorbed from the gastrointestinal tract, there is currently compelling evidence that this event is clinically irrelevant. Pharmacokinetic tests carried out through the fecal recovery (or in the ileal efflux in ileostomates) of Macrogol 3350 administered to healthy volunteers, a systemic absorption of the product ranging from 0.06% to a maximum of 2.5%.

05.2 "Pharmacokinetic properties -

The kinetics are not influenced by the presence of inflammatory phenomena of the intestinal mucosa. In fact, it has been observed that, in patients with ulcerative colitis or Crohn's disease, systemic absorption increases only negligibly from 0.06% to 0.09%.

05.3 Preclinical safety data -

In animal toxicology studies it has been documented, after acute oral administration of Macrogol 4000, LD 50 of 59 and 76 g / kg respectively in rats and rabbits with the appearance of renal and hepatic lesions, in rats, with doses of 20 g / kg , significantly higher than those used in humans 23 g / kg. In other pharmacological studies of the dose / response type with doses of macrogol ranging from 500 to 8000 mg / kg orally, they were documented in rats within 2 weeks of administration, only mild tremors and diarrhea and rare cases of seizures, but no deaths.

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

Sodium cyclamate, acesulfame K, sodium saccharinate, maltodextrin, orange flavor.

06.2 Incompatibility "-

Not applicable

06.3 Period of validity "-

5 years

06.4 Special precautions for storage -

Store the medicine in the original package to protect the product from moisture. The reconstituted solution should be stored at 2-8 ° C (in the refrigerator) and used within 48 hours of preparation. The residual solution should be discarded.

06.5 Nature of the immediate packaging and contents of the package -

Cardboard box containing 8 or 16 bipartite sachets of 17.5 g.

06.6 Instructions for use and handling -

None in particular.

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

Sofar S.p.A. - Via Firenze 40, Trezzano Rosa (MI).

08.0 MARKETING AUTHORIZATION NUMBER -

COLIREI powder for oral solution - 16 bipartite sachets of 17.5 g AIC 035704016

COLIREI powder for oral solution - 8 bipartite sachets of 17.5 g AIC 035704028

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

03/05/2004 (first authorization)

10.0 DATE OF REVISION OF THE TEXT -

September 2010

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -

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