SELG 70 G Powder

Зміст інструкції

1. SELG ESSE powder for oral solution
   1. What is SELG ESSE and what is it used for
   2. What you need to know before using SELG ESSE
   3. How to use SELG ESSE
   4. Possible side effects
   5. How to store SELG ESSE
   6. Contents of the pack and other information
2. SELG ESSE powder for oral solution
   1. What is SELG ESSE and what is it used for
   2. What you need to know before using SELG ESSE
   3. How to use SELG ESSE
   4. Possible side effects
   5. How to store SELG ESSE
   6. Contents of the pack and other information

SELG ESSE powder for oral solution

macrogol and sodium and potassium salts
Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is SELG ESSE and what is it used for

SELG ESSE contains the active ingredients macrogol, sodium and potassium salts (anhydrous sodium sulfate, sodium bicarbonate, sodium chloride, potassium chloride) and simeticone.
SELG ESSE is a medicine that belongs to the class of osmotic laxatives which work
by drawing water into the intestine, promoting the formation of soft stools.
SELG ESSE is used in clinical conditions that require complete emptying
of the intestine (for example: pre-operative preparation, diagnostic investigations etc.).

2. What you need to know before using SELG ESSE

DO NOT use SELG ESSE

• if you are allergic to macrogol, sodium and potassium salts, simethicone or any of the other ingredients of this medicine (listed in section 6)
• in case of gastrointestinal perforation or risk of gastrointestinal perforation
• if you suffer from severe inflammatory diseases of the intestine (such as ulcerative colitis, Crohn's disease) or colon dilation (toxic megacolon associated with symptomatic stenosis)
• in case of blockage or slowing of food in the gastrointestinal tract (ileus, occlusive, sub-occlusive or stenotic forms of the intestine, gastric stasis)
• in case of abdominal pain of unknown origin
• in case of severe dehydration
• in children under 8 years of age and weighing less than 20 kg

Warnings and precautions
Consult your doctor or pharmacist before using SELG ESSE
Use SELG ESSE with particular caution:

• if you suffer from heart or kidney diseases (cardiopathies or nephropathies)
• if you experience abdominal distension or pain. In this case, you should reduce the frequency of administration or temporarily interrupt the administration until these symptoms disappear
• if you suffer from inflammation of the esophagus due to reflux of acidic liquids from the stomach (reflux esophagitis)
• acute colitis, nausea, vomiting, marked increase or decrease in bowel movements, rectal bleeding. In such cases, it is advisable to consult a doctor before using the medicine
• if, after taking the medicine, you should feel the urge to vomit (nausea)
• if you experience sudden abdominal pain or rectal bleeding during the use of SELG ESSE for bowel preparation, seek immediate medical attention.

Due to the risk of aspiration of gastric contents into the lungs (aspiration from regurgitation), the
medicine should be administered with particular caution in patients with difficulty swallowing or with impaired
mental status.
Patients who are unconscious or semi-conscious, or patients for whom aspiration from regurgitation or
regurgitation is possible, should be monitored during administration, especially if administered via nasogastric
tube.
Very rare cases of hypersensitivity reactions (skin rash, urticaria,
edema) with medicines containing macrogol (polyethylene glycol) have been reported. Exceptionally, cases of
anaphylactic shock have been reported.

Children
SELG ESSE should not be used in children under 8 years of age and weighing less than 20 kg.

Other medicines and SELG ESSE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
SELG ESSE, like other laxatives, can reduce the time of stay in the intestine, and therefore
the absorption, of other drugs administered simultaneously orally, including in
particular:

• antiepileptics (used for epilepsy)
• digoxin (used for irregular heartbeat and other heart problems)
• immunosuppressants (used to prevent rejection in transplants);

Do not therefore take other medicines immediately before or during the administration of SELG
ESSE.
Allow an interval of at least 2 hours after taking a medicine before taking SELG
ESSE.

SELG ESSE with food and drink
Do not take SELG ESSE together with licorice. The use of licorice increases the risk of reducing
blood potassium levels (hypokalemia).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Since there are no adequate studies on the use of the medicine during pregnancy or breastfeeding, SELG
ESSE should only be used if necessary, under the direct control of the doctor, after
assessing with him the benefit expected for the mother and the possible risk to the fetus or to the
infant (see section “DO NOT use SELG ESSE”).

Driving and using machines
No studies have been conducted on the ability to drive vehicles and operate machinery.

SELG ESSE contains sodium and potassium
This medicine contains 722 mg of sodium (the main component of table salt) per sachet and
11.54 g of sodium in the recommended dose of 4 liters of solution, equivalent to 576% of the maximum
daily intake recommended with the diet of an adult. To be taken into consideration in people
with impaired kidney function or who are following a low-sodium diet.
This medicine contains 2.6 mmol (100 mg) of potassium per sachet and 42 mmol in the recommended
dose of 4 liters of solution. To be taken into consideration in patients with impaired kidney function or in patients
following a low-potassium diet.

3. How to use SELG ESSE

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose in adults is:
4 liters (16 sachets each dissolved in 250 ml of water) to be taken, as a single dose, to drink
preferably within a time interval of 4 to 6 hours, the afternoon before the examination, or
divided into two doses, 2 liters the evening before the examination and 2 liters on the morning of the examination.

Use in children and adolescents
In children over 8 years of age and weighing more than 20 kg, and in adolescents, the recommended
dosage is 25-40 ml/kg to be taken every hour until the stool is liquid and clear (limpid
rectal effluent).

Method of preparation and use
Take the preparation after a fast of 3-4 hours. In any case, do not ingest solid foods in the 2 hours
preceding the intake and until the examination is performed. You can drink water freely.
Normally the medicine is taken orally, but it can also be administered via naso-
gastric tube in continuous infusion under the control of the doctor or nurse. In this case, the
amount to be administered should be from 20 to 30 ml per minute.

• Pour the contents of a 17.5 g sachet into 250 ml of lukewarm water and mix until the powder is completely dissolved. The solution is more palatable if cooled.
• Drink all the prepared solution (250 ml). It is preferable that each single dose is ingested quickly.
• Continue this procedure with each sachet, one after the other, every 10-15 minutes, until you have taken all the solution or until the liquid stool becomes clear. The first evacuation occurs, as a rule, about 90 minutes after the start of administration.
• Keep the reconstituted solution in the refrigerator.
• Use the reconstituted solution within 48 hours of its preparation.
• Do not add any other ingredients to the reconstituted solution.

If you take more SELG ESSE than you should
Immediately inform your doctor or go to the nearest hospital in case of accidental ingestion/intake
of an excessive dose of SELG ESSE.
Too high doses can cause abdominal pain, diarrhea and vomiting that disappear within 24-48 hours
after discontinuation of treatment. The resulting fluid and electrolyte losses must be
reintegrated. Generally, it is sufficient to administer plenty of fluids, especially fruit juices. In
following, the therapy can be resumed at lower doses.
If you have any doubts 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.
During treatment, the following may occur in adults, although very rarely (may affect up to 1 in 10,000 people): severe allergic reactions (anaphylactic shock) such as
itching, skin rashes, urticaria or edema (swelling, especially of the face or hands; swelling or tingling of the lips or throat), difficulty breathing.
In these cases, stop taking the medicine and consult a doctor immediately.
Other side effects that may occur in adults are:

Common side effects (may affect up to 1 in 10 people):

• nausea
• feeling of fullness
• abdominal pain and/or abdominal bloating
• diarrhea

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

• vomiting
• rectal irritation
• urgent need to empty the bowels
• uncontrolled loss of stool (faecal incontinence)

Rare side effects (may affect up to 1 in 1,000 people):

• blood in the stool or presence of blood in the stool (melena)

Side effects with unknown frequency (frequency cannot be estimated based on available data):

• electrolyte imbalances (reduction of sodium and potassium levels in the blood) and/or dehydration, especially in the elderly
• erythema

Cases of altered heart rhythm (hypo-hyperkinetic cardiac arrhythmias) have been reported.
Possible side effects that may occur in children and adolescentsafter use of SELG
ESSE:

Common side effects (may affect up to 1 in 10 people):

• abdominal pain
• diarrhea, possibly accompanied by irritation of the skin around the anus

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

• vomiting
• abdominal bloating
• nausea

Side effects with unknown frequency (frequency cannot be estimated based on available data):

• allergic reactions (anaphylactic shock, angioedema, urticaria, skin rash, itching)

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 through
the national reporting system at 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 SELG ESSE

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

6. Contents of the pack and other information

What SELG ESSE contains
One 17.5 g sachet contains:

• The active ingredients are: macrogol 4000 14.57 g simeticone 0.02 g anhydrous sodium sulfate 1.42 g sodium bicarbonate 0.42 g sodium chloride 0.37 g potassium chloride 0.19 g
• The other ingredients are: sodium cyclamate, acesulfame K, sodium saccharin, mandarin aroma, maltodextrin.

Description of the appearance of SELG ESSE and contents of the pack
SELG ESSE is presented in the form of an oral solution powder. Each pack contains 16 sachets
of 17.5 g.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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)

SELG ESSE powder for oral solution

macrogol and sodium and potassium salts
Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if they have the same symptoms as you, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What SELG ESSE is and what it is used for
• 2. What you need to know before using SELG ESSE
• 3. How to use SELG ESSE
• 4. Possible side effects
• 5. How to store SELG ESSE
• 6. Contents of the pack and other information

1. What is SELG ESSE and what is it used for

SELG ESSE contains the active ingredients macrogol, sodium and potassium salts (anhydrous sodium sulfate, sodium bicarbonate, sodium chloride, potassium chloride) and simeticone.
SELG ESSE is a medicine that belongs to the class of osmotic laxatives which work
by drawing water into the intestine, promoting the formation of soft stools.
SELG ESSE is used in clinical conditions that require complete emptying
of the intestine (for example: pre-operative preparation, diagnostic investigations etc.).

2. What you need to know before using SELG ESSE

DO NOT use SELG ESSE

• if you are allergic to macrogol, sodium and potassium salts and simeticone or to any of the other ingredients of this medicine (listed in section 6)
• in case of gastrointestinal perforation or risk of gastrointestinal perforation
• if you suffer from severe inflammatory diseases of the intestine (such as ulcerative colitis, Crohn's disease) or colon dilation (toxic megacolon associated with symptomatic stenosis)
• in case of blockage or slowing of food in the gastrointestinal tract (ileus, occlusive or sub-occlusive forms of the intestine, gastric stasis)
• in case of abdominal pain of unknown origin
• in case of severe dehydration
• in children under 8 years of age and weighing less than 20 kg.

Warnings and precautions
Consult your doctor or pharmacist before using SELG ESSE.
Use SELG ESSE with particular caution:

• if you suffer from heart or kidney diseases (cardiopathies or nephropathies)
• if you experience abdominal distension or pain. In this case, you should reduce the frequency of administration or temporarily interrupt the administration until these symptoms disappear
• if you suffer from inflammation of the esophagus due to reflux of acidic liquids from the stomach (reflux esophagitis)
• if you experience acute colitis, nausea, vomiting, marked increase or decrease in bowel movements, rectal bleeding. In such cases, it is advisable to consult your doctor before using the medicine
• if, after taking the medicine, you should feel the urge to vomit (nausea)
• if you experience sudden abdominal pain or rectal bleeding during the administration of SELG ESSE for bowel preparation, consult a doctor immediately. Due to the risk of aspiration of gastric contents into the lungs (aspiration from regurgitation), the medicine should be administered with particular caution in patients with difficulty swallowing or with impaired mental status. Patients who are unconscious or semi-conscious, or patients for whom aspiration from regurgitation or vomiting is possible, should be monitored during administration, especially if administered via nasogastric tube. Very rare cases of hypersensitivity reactions (skin rash, urticaria, edema) with medicines containing macrogol (polyethylene glycol) have been reported. Exceptionally, cases of anaphylactic shock have been reported.

Children
SELG ESSE should not be used in children under 8 years of age and weighing less than 20 kg.

Other medicines and SELG ESSE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
SELG ESSE, like other laxatives, can reduce the time of stay in the intestine, and therefore
the absorption of other drugs administered simultaneously orally, including in particular

• antiepileptics (used for epilepsy)
• digoxin (used for irregular heartbeat and other heart problems)
• immunosuppressants (used to prevent rejection in transplants);

Do not therefore take other medicines immediately before or during the administration of SELG
ESSE.
Allow an interval of at least 2 hours after taking a medicine before taking SELG
ESSE.

SELG ESSE with food and drink
Do not take SELG ESSE together with licorice. The use of licorice increases the risk of reducing
blood potassium levels (hypokalemia).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Since there are no adequate studies on the use of the medicine during pregnancy or breastfeeding, SELG
ESSE should only be used if necessary, under the direct control of the doctor, after
assessing with him the benefit expected for the mother and the possible risk to the fetus or to the
infant (see section “DO NOT use SELG ESSE”).

Driving and using machines
No studies have been conducted on the ability to drive vehicles and use machines.

SELG ESSE contains sodium and potassium
This medicine contains 2.88 g of sodium (the main component of table salt) per sachet and
11.54 g of sodium in the recommended dose of 4 liters of solution, equivalent to 577% of the maximum
recommended daily intake with the diet of an adult. To be taken into consideration in people
with reduced kidney function or who are following a low-sodium diet.
This medicine contains 10.3 mmol (402 mg) of potassium per sachet and 42 mmol in the recommended
dose of 4 liters of solution. To be taken into consideration in patients with reduced kidney function or in patients who are following a low-potassium diet.

3. How to use SELG ESSE

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose in adults is:
4 liters (4 sachets of 70 g dissolved each in one liter of water) to be taken, in a single dose, to be drunk
preferably within a time interval of 4 to 6 hours, the afternoon before the examination, or
divided into two doses, 2 liters the evening before the examination and 2 liters on the morning of the examination.

Use in children and adolescents
In children over 8 years of age and weighing more than 20 kg and in adolescents, the recommended
dosage is 25-40 ml/kg to be taken every hour until the stool is liquid and clear (clear
rectal effluent).

Method of preparation and use
Take the preparation after a fast of 3-4 hours. In any case, do not ingest solid foods in the 2 hours
preceding the intake and until the examination is performed. You may drink water freely.
Normally the medicine is taken by mouth, but it can also be administered by naso-
gastric tube in continuous infusion under the control of the doctor or nurse. In this case, the
quantity to be administered should be from 20 to 30 ml per minute.

• Pour the contents of one 70 g sachet into one liter of lukewarm water and mix until the powder is completely dissolved. The solution is more palatable if cooled.
• Drink a full glass (250 ml) of the solution every 10-15 minutes until the entire solution is consumed. It is preferable that each single dose is ingested quickly.
• Continue this procedure with each sachet, one after the other, until the entire solution is taken or until the liquid stool becomes clear. The first evacuation occurs, as a rule, about 90 minutes after the start of administration.
• Keep the reconstituted solution in the refrigerator.
• Use the reconstituted solution within 48 hours of its preparation.
• Do not add any other ingredients to the reconstituted solution.

If you take more SELG ESSE than you should
Immediately inform your doctor or go to the nearest hospital in case of accidental ingestion/intake
of an excessive dose of SELG ESSE.
Too high doses can cause abdominal pain, diarrhea and vomiting that disappear within 24-48 hours
after discontinuation of treatment. The resulting loss of fluids and electrolytes must be
reintegrated. Generally, administering plenty of fluids, especially fruit juices, is sufficient. The therapy can then be resumed at lower doses.
If you have any doubts 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.
During treatment, the following may occur in adults, although very rarely (may affect up to 1 in 10,000 people): serious allergic reactions (anaphylactic shock) such as
itching, skin rashes, urticaria or edema (swelling, especially of the face or hands; swelling or tingling of the lips or throat), difficulty breathing.
In these cases, stop taking the medicine and consult a doctor immediately.
Other side effects that may occur in adults are:

Common side effects (may affect up to 1 in 10 people):

• nausea
• feeling of fullness
• abdominal pain and/or abdominal bloating
• diarrhea

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

• vomiting
• rectal irritation
• urgent need to empty the bowels
• uncontrolled loss of stool (faecal incontinence)

Rare side effects (may affect up to 1 in 1,000 people):

• rectal bleeding or blood in the stool (melena)

Side effects with unknown frequency (frequency cannot be estimated based on available data):

• electrolyte imbalances (decreased levels of sodium and potassium in the blood) and/or dehydration, especially in the elderly
• erythema

Cases of heart rhythm disturbances (hypo-hyperkinetic cardiac arrhythmias) have been reported.
Possible side effects that may occur in children and adolescentsafter use of SELG
ESSE:

Common side effects (may affect up to 1 in 10 people):

• abdominal pain
• diarrhea, possibly accompanied by irritation of the skin around the anus

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

• vomiting
• abdominal bloating
• nausea

Side effects with unknown frequency (frequency cannot be estimated based on available data):

• allergic reactions (anaphylactic shock, angioedema, urticaria, skin rash, itching)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the
national reporting system at 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 SELG ESSE

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

6. Contents of the pack and other information

What SELG ESSE contains
One 70 g sachet contains:

• The active ingredients are: macrogol 4000 58.30 g simethicone 0.08 g anhydrous sodium sulfate 5.68 g sodium bicarbonate 1.68 g sodium chloride 1.46 g potassium chloride 0.74 g
• The other ingredients are: sodium cyclamate, acesulfame K, sodium saccharin, mandarin aroma, maltodextrin.

Description of the appearance of SELG ESSE and contents of the pack
SELG ESSE is presented in the form of an oral solution powder. Each pack contains 4 sachets
of 70 g.

Marketing authorisation holder and manufacturer
Marketing authorisation 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)