Selg Esse
Italy
Table of Contents
Patient Information Leaflet
SELG ESSE powder for oral solution
macrogol and sodium and potassium salts
Please read this leaflet carefully before using 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, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What SELG ESSE is and what it is used for
- What you need to know before taking SELG ESSE
- How to take SELG ESSE
- Possible side effects
- How to store SELG ESSE
- Package contents and other information
1. What SELG ESSE is and what it is used for
SELG ESSE contains the active ingredients macrogol, sodium and potassium salts (anhydrous sodium sulfate, sodium bicarbonate, sodium chloride, potassium chloride) and simethicone.
SELG ESSE is a medicine belonging to the class of osmotic laxatives, which work by drawing water into the intestine, thus promoting the formation of soft stools.
SELG ESSE is used in clinical conditions requiring complete bowel evacuation (e.g. 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 bowel diseases (such as ulcerative colitis, Crohn's disease) or colon dilation (toxic megacolon associated with symptomatic stenosis)
- in case of blockage or slowing down 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
Talk to your doctor or pharmacist before using SELG ESSE.
Use SELG ESSE with particular caution:
- if you suffer from heart or kidney diseases (cardiopathy or nephropathy)
- if you experience abdominal distension or pain. In this case, you should reduce the frequency of administration or temporarily stop treatment until these symptoms disappear
- if you suffer from inflammation of the esophagus due to backflow of acidic stomach fluids (reflux esophagitis)
- acute colitis, nausea, vomiting, marked increase or decrease in intestinal motility, rectal bleeding. In such cases, it is advisable to consult your doctor before using this medicine
- if after taking the medicine you feel like vomiting (retching)
- if you experience sudden abdominal pain or rectal bleeding during administration of SELG ESSE for bowel preparation, contact a doctor immediately.
Due to the risk of aspiration of gastric contents into the lungs (aspiration from regurgitation), this medicine should be administered with particular caution in patients with swallowing difficulties or impaired mental status.
Patients who are unconscious or semi-conscious, or patients in whom aspiration from regurgitation or regurgitation itself may occur, must be closely monitored during administration, especially if administered via nasogastric route.
Very rare cases of hypersensitivity reactions (rash, urticaria, edema) have been reported with medicines containing macrogol (polyethylene glycol). Anaphylactic shock has been reported exceptionally rarely.
Children
SELG ESSE must not be used in children under 8 years of age and weighing less than 20 kg.
Other medicines and SELG ESSE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
SELG ESSE, like other laxatives, may reduce intestinal transit time, and thus the absorption, of other medicines taken concomitantly by oral route, including in particular:
- antiepileptic drugs (used for epilepsy)
- digoxin (used for cardiac arrhythmias and other heart conditions)
- immunosuppressive agents (used to prevent transplant rejection)
Therefore, do not take other medicines immediately before or during administration of SELG ESSE.
Wait at least 2 hours after taking any medicine before taking SELG ESSE.
SELG ESSE with food and drinks
Do not take SELG ESSE together with liquorice. Taking liquorice increases the risk of low potassium levels in the blood (hypokalaemia).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Since adequate studies on the use of this medicine during pregnancy or breastfeeding are lacking, SELG ESSE should only be used when strictly necessary, under direct medical supervision, after carefully evaluating with your doctor the benefit expected for the mother against the potential risk for the fetus or breastfed infant (see section "DO NOT use SELG ESSE").
Driving and using machines
No studies have been conducted on the ability to drive vehicles or operate machinery.
SELG ESSE contains sodium and potassium
This medicine contains 722 mg of sodium (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 recommended daily dietary intake for an adult. This should be taken into account in individuals with reduced kidney function or those 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. This should be taken into account in patients with reduced kidney function or those following a low-potassium diet.
3. How to use SELG ESSE
Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose in adults is:
4 litres (16 sachets, each dissolved in 250 ml of water) to be taken as a single dose, preferably consumed within a time interval of 4 to 6 hours, 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.
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 per hour until stools become liquid and clear (clear rectal effluent).
Instructions for preparation and use
Take the preparation after a 3–4 hour fast. In any case, do not eat solid foods within 2 hours before taking the medicine and until the examination is completed. You may drink water freely.
The medicine is normally taken orally, but it may also be administered via a nasogastric tube by continuous infusion under the supervision of a doctor or nurse. In this case, the recommended administration rate should be 20 to 30 ml per minute.
- Empty the contents of one 17.5 g sachet into 250 ml of lukewarm water and stir until the powder is completely dissolved. The solution may be more palatable if cooled.
- Drink the entire prepared solution (250 ml). It is preferable to ingest each individual dose rapidly.
- Continue this procedure with each sachet, one after another, every 10–15 minutes, until the entire solution has been consumed or until liquid stools become clear. The first bowel movement usually occurs approximately 90 minutes after starting administration.
- Store the reconstituted solution in the refrigerator.
- Use the reconstituted solution within 48 hours of 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/overdose of SELG ESSE.
Excessively high doses may cause abdominal pain, diarrhoea, and vomiting, which resolve within 24–48 hours after discontinuation of treatment. Resulting losses of fluids and electrolytes should be replaced. In general, it is sufficient to administer plenty of fluids, especially fruit juices. After this, treatment may be resumed at lower doses.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
During treatment, allergic reactions, even severe ones (anaphylactic shock), may occur in adults, although very rarely (may affect up to 1 in 10,000 people), such as itching, skin rashes, urticaria or oedema (swelling, particularly localized to the face or hands; swelling or tingling of the lips or throat), difficulty breathing.
In such 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 full stomach
- abdominal pain and/or abdominal bloating
- diarrhoea
Uncommon side effects (may affect up to 1 in 100 people):
- vomiting
- rectal irritation
- urgent need to empty the bowel
- uncontrolled loss of faeces (faecal incontinence)
Rare side effects (may affect up to 1 in 1,000 people):
- blood loss in faeces or presence of blood in faeces (melaena)
Side effects with unknown frequency (frequency cannot be estimated from the available data):
- electrolyte imbalances (reduced 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 adolescents following the use of SELG ESSE:
Common side effects (may affect up to 1 in 10 people):
- abdominal pain
- diarrhoea, possibly accompanied by skin irritation around the anus
Uncommon side effects (may affect up to 1 in 100 people):
- vomiting
- abdominal swelling
- nausea
Side effects with unknown frequency (frequency cannot be estimated from the available data):
- allergic reactions (anaphylactic shock, angioedema, urticaria, skin rash, itching)
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the 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 SELG ESSE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the product from moisture.
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.
Do not use this medicine if the packaging is open or damaged.
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 SELG ESSE contains
One 17.5 g sachet contains:
- Active substances: 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
- Other components: sodium cyclamate, acesulfame K, sodium saccharin, mandarin flavour, maltodextrin.
Description of the appearance of SELG ESSE and contents of the pack
SELG ESSE is a powder for oral solution. 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)
Patient Information Leaflet
SELG ESSE powder for oral solution
macrogol and sodium and potassium salts
Please read this leaflet carefully before using 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 personally. 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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What SELG ESSE is and what it is used for
- What you need to know before taking SELG ESSE
- How to take SELG ESSE
- Possible side effects
- How to store SELG ESSE
- Contents of the pack and other information
1. What SELG ESSE is and what it is 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 belonging to the class of osmotic laxatives, which act by drawing water into the intestine, thereby promoting the formation of soft stools.
SELG ESSE is used in clinical conditions requiring complete bowel evacuation (e.g. preoperative preparation, diagnostic examinations, 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 bowel diseases (such as ulcerative colitis, Crohn's disease) or colon dilation (toxic megacolon associated with symptomatic stenosis)
- in case of blockage or slowing down 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
Talk to 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 discontinue treatment until these symptoms disappear
- if you have inflammation of the esophagus due to backflow of acidic stomach fluids (reflux esophagitis)
- if you have acute colitis, nausea, vomiting, markedly increased or decreased intestinal movements, or rectal bleeding. In such cases, it is advisable to consult your doctor before using the medicine
- if after taking the medicine you feel nauseous (urge to vomit)
- if you experience sudden abdominal pain or rectal bleeding during administration of SELG ESSE for bowel preparation, contact a doctor immediately. Due to the risk of aspiration of gastric contents into the lungs (aspiration from regurgitation), this medicine should be administered with particular caution in patients with difficulty swallowing or impaired mental status. Patients who are unconscious or semi-conscious, or patients in whom regurgitation or aspiration may occur, must be closely monitored during administration, especially if administered via nasogastric tube. Hypersensitivity reactions (rash, urticaria, edema) have been reported very rarely with medicines containing macrogol (polyethylene glycol). Anaphylactic shock has been reported exceptionally.
Children
SELG ESSE must not be used in children under 8 years of age and weighing less than 20 kg.
Other medicines and SELG ESSE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
SELG ESSE, like other laxatives, may reduce intestinal transit time, and thus the absorption, of other medicines taken simultaneously by oral route, including in particular:
- antiepileptics (used for epilepsy)
- digoxin (used for heart rhythm irregularities and other cardiac conditions)
- immunosuppressive agents (used to prevent transplant rejection).
Therefore, do not take other medicines immediately before or during administration of SELG ESSE.
Wait at least 2 hours after taking any medicine before taking SELG ESSE.
SELG ESSE with food and drinks
Do not take SELG ESSE together with liquorice. The use of liquorice increases the risk of reduced potassium levels in the blood (hypokalaemia).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Since adequate studies on the use of this medicine during pregnancy or breastfeeding are lacking, SELG ESSE should be used only if necessary, under the direct supervision of a doctor, after evaluating with him the benefit expected for the mother against the potential risk for the fetus or infant (see section "DO NOT use SELG ESSE").
Driving and using machines
No studies on the ability to drive vehicles or use machinery have been conducted.
SELG ESSE contains sodium and potassium
This medicine contains 2.88 g of sodium (main component of table salt) per sachet and 11.54 g of sodium in the recommended dose of 4 litres of solution, equivalent to 577% of the maximum daily dietary intake recommended for an adult. This should be taken into account in individuals with reduced kidney function or those on 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 litres of solution. This should be taken into account in patients with reduced kidney function or those on a low-potassium diet.
3. How to use SELG ESSE
Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose in adults is:
4 litres (4 sachets of 70 g each dissolved in one litre of water) to be taken as a single dose, preferably
drunk within a time interval of 4 to 6 hours, 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.
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, taken every hour until stools become liquid and clear (clear rectal effluent).
Instructions for preparation and use
Take the preparation after a 3–4 hour fast. In any case, do not eat solid food within the 2 hours before
taking the medicine and until completion of the examination. You may drink water freely.
Normally, the medicine is taken orally, but it may also be administered via a nasogastric tube by continuous
infusion under the supervision of a doctor or nurse. In this case, the recommended administration rate
should be 20 to 30 ml per minute.
- Pour the contents of one 70 g sachet into one litre of lukewarm water and mix until the powder is completely dissolved. The solution may be more palatable if cooled.
- Drink one full glass (250 ml) of the solution every 10–15 minutes until the entire solution has been consumed. It is preferable to ingest each dose rapidly.
- Continue this procedure with each sachet, one after the other, until the entire solution has been taken or until the liquid stools become clear. The first bowel movement usually occurs about 90 minutes after starting administration.
- Store the reconstituted solution in the refrigerator.
- Use the reconstituted solution within 48 hours of preparation.
- Do not add any other ingredients to the reconstituted solution.
If you take more SELG ESSE than you should
Inform your doctor immediately or go to the nearest hospital in case of accidental ingestion/overdose of SELG ESSE.
Excessively high doses may cause abdominal pain, diarrhoea, and vomiting, which resolve within 24–48 hours
after discontinuation of treatment. Resulting losses of fluids and electrolytes should be replaced.
In most cases, it is sufficient to administer plenty of fluids, especially fruit juices. Afterwards, treatment may be
resumed at a lower dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
During treatment, allergic reactions, even severe ones (anaphylactic shock), may occur in adults, although very rarely (may affect up to 1 in 10,000 people), such as itching, skin rashes, urticaria or oedema (swelling, localized especially on the face or hands; swelling or tingling of the lips or throat), difficulty breathing.
In such 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 full stomach
- abdominal pain and/or abdominal bloating
- diarrhoea
Uncommon side effects (may affect up to 1 in 100 people):
- vomiting
- rectal irritation
- urgent need to empty the bowel
- uncontrolled loss of faeces (faecal incontinence)
Rare side effects (may affect up to 1 in 1,000 people):
- rectal bleeding or presence of blood in the stools (melena)
Side effects with unknown frequency (frequency cannot be estimated from the available data):
- electrolyte imbalances (reduced levels of sodium and potassium in the blood) and/or dehydration, especially in the elderly
- erythema
Cases of changes in heart rhythm (hypo-hyperkinetic cardiac arrhythmias) have been reported.
Possible side effects that may occur in children and adolescents following the use of SELG ESSE:
Common side effects (may affect up to 1 in 10 people):
- abdominal pain
- diarrhoea, possibly accompanied by skin irritation around the anus
Uncommon side effects (may affect up to 1 in 100 people):
- vomiting
- abdominal distension
- nausea
Side effects with unknown frequency (frequency cannot be estimated from the available data):
- allergic reactions (anaphylactic shock, angioedema, urticaria, skin rash, itching)
Reporting of side effects
If you experience any side effect, including those 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/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 stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the product from moisture.
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.
Do not use this medicine if the packaging is open or damaged.
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 SELG ESSE contains
One 70 g sachet contains:
- Active substances: macrogol 4000 58.30 g simeticone 0.08 g anhydrous sodium sulfate 5.68 g sodium bicarbonate 1.68 g sodium chloride 1.46 g potassium chloride 0.74 g
- Other components: sodium cyclamate, acesulfame K, sodium saccharin, mandarin flavour, maltodextrin.
Description of SELG ESSE and contents of the pack
SELG ESSE is a powder for oral solution. Each pack contains 4 sachets of 70 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)