LAXIPEG 9,7 G Powder for oral solution

Зміст інструкції

1. Laxipeg 97% powder for oral solution
   1. What is Laxipeg and what is it used for
   2. What you need to know before taking Laxipeg
   3. How to take Laxipeg
   4. Possible side effects
   5. How to store Laxipeg
   6. Contents of the pack and other information
2. Laxipeg 9.7 g powder for oral solution
   1. What is Laxipeg and what is it used for
   2. What you need to know before you take Laxipeg
   3. How to take Laxipeg
   4. Possible side effects
   5. How to store Laxipeg
   6. Contents of the pack and other information

Laxipeg 97% powder for oral solution

Macrogol 4000

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen.

Contents of this leaflet:

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

1. What is Laxipeg and what is it used for

Laxipeg contains the active ingredient macrogol 4000 belonging to a group of medicines called osmotic laxatives which retain water in the intestine.
This medicine is indicated for the treatment of constipation in children.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Laxipeg

Do not take Laxipeg

• if you are allergic to macrogol 4000 or to any of the other ingredients of this medicine (listed in section 6);
• if you have acute abdominal pain of unknown origin, nausea or vomiting;
• if you have an exacerbation or reduction of intestinal movements (peristalsis) or rectal bleeding;
• if you suffer from an intestinal blockage (intestinal obstruction, symptomatic stenosis, paralytic ileus);
• if you suffer from or are at risk of a perforation of the digestive tract;
• if you suffer from a severe inflammatory disease of the intestine (ulcerative colitis, Crohn's disease) or toxic megacolon;
• if you are in a severe state of dehydration.

Warnings and precautions
Consult your doctor or pharmacist before taking Laxipeg.
The treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of medicines and monitoring during therapy.
Consult your doctor when the need for a laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasts for more than two weeks or when the use of the laxative fails to produce effects.
Children
Data on the effectiveness of treatment in children under 2 years of age are limited.
The treatment of constipation with any medicine is only an aid to a healthy lifestyle and a correct diet, for example:

• increased intake of fluids and plant fibers;
• appropriate physical activity and restoration of intestinal motility. Before starting treatment, any organic disorder must be excluded. After three months of treatment, a complete clinical evaluation of constipation should be performed.

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 nutrients.
In the most severe cases, dehydration or potassium deficiency (hypokalemia) may occur, which can determine cardiac or neuromuscular disorders, especially if you are taking medicines for the heart (cardiac glycosides), medicines that increase urine production (diuretics) or medicines for inflammation (corticosteroids) at the same time.
Take particular care during treatment with Laxipeg if you are subject to imbalances in the levels of salts present in the blood (electrolyte imbalances) easily found in elderly people, or if you have problems with the kidneys (renal insufficiency), liver (hepatic insufficiency) or heart (heart failure). In these cases, you should regularly check the levels of salts present in the blood.
The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (and therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).
Very rare cases of hypersensitivity reactions (skin rash, urticaria, edema) and exceptional cases of anaphylactic shock with medicines containing macrogol have been reported.
Laxipeg, not containing any sugar or polyol, can be taken by diabetic patients or those following a galactose-free diet.

Other medicines and Laxipeg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take laxatives and other medicines at the same time: after taking a medicine, allow at least two hours to pass before taking the laxative.
If you need to thicken liquids to be able to swallow them without problems, Laxipeg may counteract the effect of the thickener.

Laxipeg with food and drink
Laxipeg should not be taken with licorice.
The use of licorice increases the risk of potassium deficiency (hypokalemia).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Laxipeg should be used during pregnancy and breastfeeding only if necessary, under the direct control of the doctor, after evaluating with him the benefit expected for the mother and the possible risk to the fetus or infant.

Driving and operating machinery
No studies have been conducted on the ability to drive vehicles and operate machinery, therefore it is not known whether Laxipeg affects the ability to drive vehicles and use machinery.

Laxipeg contains propylene glycol
This medicine contains 13.75 mg of propylene glycol per heaped measuring spoon (5 g) equivalent to 2.75 mg/g.

3. How to take Laxipeg

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended doses are:
Children over 8 years of age and weighing over 20 kg: 2-4 full measuring scoops per day (the measuring scoop delivers 2.5 g to the mark and 5 g when full).
Do not exceed the maximum daily dose of 20 g of macrogol.

Children over 2 years of age and weighing less than 20 kg: the usual initial dose is 0.7 g/kg per day
(see the table for calculating the dose based on the child's body weight).
Table for calculating the dose of Laxipeg in children up to 20 kg
The daily dose can be taken away from meals, preferably in the morning if one scoop per day, or divided between morning and evening if it is higher than one scoop per day.
Dissolve the contents of one scoop (5 g) in at least half a glass of water (approximately 50 ml). Do not add any other ingredients.
Drink the entire amount fairly quickly (within a few minutes), avoiding sipping it for a long time.
The indicated dose should be adjusted according to individual response. Increases or decreases of half (½) or 1 scoop compared to the dose indicated in the table are recommended.
The correct dose is the minimum sufficient to produce easy evacuation of soft stools.
Initially use the minimum doses provided.
When necessary, the dose can then be increased, but never exceeding the maximum indicated.
The effect manifests itself 24-48 hours after administration.
The duration of treatment is limited to 3 months; in any case, follow your doctor's prescription.
A diet rich in fluids promotes the effect of the medicine. The regularization of intestinal motility induced by treatment should be maintained with a healthy lifestyle and a correct diet.

If you take more Laxipeg than you should
In case of accidental ingestion/intake of an excessive dose of Laxipeg, immediately inform your doctor
or go to the nearest hospital.
Excessive doses of Laxipeg can cause:

• abdominal pain;
• vomiting or diarrhea. Excessive fluid loss caused by diarrhea or vomiting may require correction of the imbalance of salt levels in the blood (electrolyte imbalance);
• cases of the preparation entering the trachea during swallowing (aspiration) during administration with a nasogastric tube of high volumes of macrogol and electrolytes solution;
• inflammation and perianal pain in conjunction with administrations of high volumes of macrogol solution (from 4 to 11 liters).

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.

Common(may affect up to 1 in 10 people)

• abdominal pain
• diarrhoea (diarrhoea may cause perianal pain)

Uncommon(may affect up to 1 in 100 people)

• vomiting
• abdominal distension
• nausea Frequency not known(the frequency cannot be estimated on the basis of the available data)
• hypersensitivity
• severe, rapidly evolving allergic reaction (anaphylactic shock)
• generalised tissue swelling (angioedema)
• skin irritation (urticaria, rash), itching.

Common(may affect up to 1 in 10 people)

• abdominal distension
• nausea

Uncommon(may affect up to 1 in 100 people)

• urgency to defecate
• faecal incontinence
• rectal irritation

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

• hypersensitivity reactions which may manifest with itching, skin rash, urticaria, facial swelling (oedema) and generalised tissue swelling (angioedema), difficulty breathing (dyspnoea), severe, rapidly evolving allergic reaction (anaphylactic shock).

Frequency not known(the frequency cannot be estimated on the basis of the available data)

• electrolyte imbalance (sodium deficiency, potassium deficiency) and/or dehydration, particularly in the elderly
• skin redness (erythema).

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 Laxipeg

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 “Exp”. The expiry date refers to the last day of that month. The expiry date refers to the product in
intact packaging, correctly stored.
Store Laxipeg in the original packaging to protect the product from humidity.
After opening the bottle, the contents must be used within a maximum of 90 days; after this period,
any remaining medicine must be discarded.
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 Laxipeg contains

• The active ingredient is macrogol 4000. 100 g of powder contains 97.36 g of macrogol 4000.
• The other ingredients are: acesulfame potassium, banana flavour containing: propylene glycol, waxy corn maltodextrins, modified waxy corn starch.

Description of the appearance of Laxipeg and contents of the pack
Laxipeg is presented as a powder for oral solution.
The pack contains a 200 g bottle.

Marketing authorisation holder
Zambon Italia s.r.l. - Via Lillo del Duca 10 - 20091 Bresso (MI)

Manufacturer
Sigmar Italia S.r.l. - Via Sombreno 11, 24011 - Almé (BG)

Laxipeg 9.7 g powder for oral solution

Macrogol 4000

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

• 7. What Laxipeg is and what it is used for
• 8. What you need to know before you take Laxipeg
• 9. How to take Laxipeg
• 10. Possible side effects
• 11. How to store Laxipeg
• 12. Contents of the pack and other information

1. What is Laxipeg and what is it used for

Laxipeg contains the active ingredient macrogol 4000 belonging to a group of medicines called osmotic laxatives which retain water in the intestine.
This medicine is indicated for the short-term treatment of occasional constipation.
See your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before you take Laxipeg

Do not take Laxipeg

• if you are allergic to macrogol 4000 or to any of the other ingredients of this medicine (listed in section 6);
• if you have acute abdominal pain of unknown origin, nausea or vomiting;
• if you have an exacerbation or reduction of intestinal movements (peristalsis) or rectal bleeding;
• if you suffer from an intestinal blockage (intestinal obstruction, symptomatic stenosis, paralytic ileus);
• if you suffer from or are at risk of a perforation of the digestive tract;
• if you suffer from a severe inflammatory disease of the intestine (ulcerative colitis, Crohn's disease) or toxic megacolon;
• if you are severely dehydrated.

Warnings and precautions
Talk to your doctor or pharmacist before taking Laxipeg.
The treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of medicines and monitoring during therapy.
Consult your doctor when the need for a laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasts for more than two weeks or when the use of the laxative fails to produce effects.
Consult your doctor before using the medicine especially if you are elderly or in poor health.
The treatment of constipation with any medicine is only an aid to a healthy lifestyle and a correct diet, for example:

• increased intake of fluids and vegetable fibers;
• appropriate physical activity and restoration of intestinal motility. 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 nutrients. In the most serious cases, dehydration or potassium deficiency (hypokalemia) may occur, which can cause heart or neuromuscular disorders, especially if you are taking heart medications (cardiac glycosides), medications that increase urine production (diuretics) or medications for inflammation (corticosteroids) at the same time.

Take particular care during treatment with Laxipeg if you are subject to imbalances in the levels of salts present in the blood (electrolyte imbalances) easily found if you are elderly or have kidney problems (renal insufficiency), liver (hepatic insufficiency) or heart (heart failure). In these cases, you should regularly check the levels of salts present in the blood.
Abuse of laxatives, especially stimulant laxatives, can cause dependence (and therefore a possible need to gradually increase the dosage), chronic constipation and loss of normal bowel function (intestinal atony).
Very rare cases of hypersensitivity reactions (skin rash, urticaria, edema) and exceptional cases of anaphylactic shock with medicines containing macrogol have been reported.
Laxipeg, not containing any sugar or polyol, can be taken by diabetic patients or those following a galactose-free diet.

Children
In children, the medicine can only be used after consulting a doctor.

Other medicines and Laxipeg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take laxatives and other medicines at the same time: after taking a medicine, allow at least two hours to pass before taking the laxative.
If you need to thicken liquids to be able to swallow them without problems, Laxipeg may counteract the effect of the thickener.

Laxipeg with food and drink
Do not take Laxipeg with licorice.
The use of licorice increases the risk of potassium deficiency (hypokalemia).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Laxipeg should be used during pregnancy and breastfeeding only if necessary, under the direct supervision of a doctor, after he has assessed the benefit expected for the mother and the possible risk to the fetus or infant.

Driving and using machines
No studies have been performed on the ability to drive vehicles and operate machinery, therefore it is not known whether Laxipeg affects the ability to drive vehicles and use machinery.

Laxipeg contains propylene glycol
This medicine contains 27.5 mg of propylene glycol per sachet equivalent to 2.75 mg/g.

3. How to take Laxipeg

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended doses are:
Adults and children over 8 years of age and weighing more than 20 Kg: 1-2 sachets per day.
Do not exceed the maximum daily dose of 20 g of macrogol.
The daily dose can be taken away from meals, preferably in the morning, in a single dose (1 or 2 sachets), or divided into two portions.
Dissolve the contents of one sachet in at least 125 ml (equivalent to a glass) of water. Do not add any other ingredients.
Drink the entire amount fairly quickly (within a few minutes) avoiding sipping it for a long time.
The indicated dose should be modified according to individual response and may vary from 1 sachet on alternate days (especially in children) up to 2 sachets per day.
The correct dose is the minimum sufficient to produce easy evacuation of soft stools.
Initially use the minimum doses provided.
When necessary, the dose can then be increased, but never exceeding the maximum indicated.
The effect manifests after 24-48 hours from administration.
Keep in mind that laxatives should be used as infrequently as possible and for no more than seven days.
Use for longer periods requires a doctor's prescription after adequate assessment of the individual case. In children, treatment should not exceed three months.
A diet rich in fluids promotes the effect of the medicine. The regularization of intestinal motility induced by treatment should be maintained with a healthy lifestyle and a correct diet.

If you take more Laxipeg than you should
In case of accidental ingestion/intake of an excessive dose of Laxipeg, immediately inform your doctor or go to the nearest hospital.
Excessive doses of Laxipeg may cause:

• abdominal pain;
• vomiting or diarrhea. Excessive fluid loss caused by diarrhea or vomiting may require correction of the imbalance of salt levels in the blood (electrolyte imbalance);
• cases of preparation ingestion into the trachea during swallowing (aspiration) on the occasion of administration with a nasogastric tube of high volumes of macrogol and electrolyte solution.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• The following side effects may occur in children:

Common(may affect up to 1 in 10 people)

• abdominal pain
• abdominal distension
• nausea
• diarrhea (diarrhea may cause perianal pain)

Uncommon(may affect up to 1 in 100 people)

• vomiting
• rectal irritation

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

• hypersensitivity

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

• severe, rapidly developing allergic reaction (anaphylactic shock)
• general swelling of the tissues (angioedema)
• skin irritation (urticaria, rash), itching.
• The following side effects may occur in adults:

Common(may affect up to 1 in 10 people)

• abdominal pain and/or distension
• diarrhea
• nausea Uncommon(may affect up to 1 in 100 people)
• vomiting
• urgency to defecate
• faecal incontinence
• rectal irritation Very rare(may affect up to 1 in 10,000 people)
• hypersensitivity reactions that may manifest with itching, skin rash, urticaria, swelling of the face (edema) and general tissues (angioedema), difficulty breathing (dyspnea), severe, rapidly developing allergic reaction (anaphylactic shock).

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

• electrolyte imbalance (sodium deficiency, potassium deficiency) and/or dehydration, particularly in the elderly
• redness of the skin (erythema).

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 Laxipeg

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. The expiry date refers to the product in intact packaging, correctly stored.
Store in the original packaging to protect the medicine from moisture.
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 Laxipeg contains

• The active ingredient is macrogol 4000. Each sachet contains 9.736 g of macrogol 4000.
• The other ingredients are: acesulfame potassium, banana flavour containing: propylene glycol, waxy maize maltodextrins, modified waxy maize starch.

Description of the appearance of Laxipeg and contents of the pack
Laxipeg is presented as a powder for oral solution.
The pack contains 10 or 20 sachets.

Marketing Authorisation Holder
Zambon Italia s.r.l. - Via Lillo del Duca 10 - 20091 Bresso (MI)

Manufacturer
Sigmar Italia S.r.l. - Via Sombreno 11, 24011 - Almé (BG)