Laxipeg

Package leaflet: Information for the patient

Laxipeg 97% oral solution powder

Macrogol 4000
Please read this leaflet carefully before taking this medicine because 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 to do.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If any of the side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement 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 taking 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 Laxipeg is and what it is used for

Laxipeg contains the active substance macrogol 4000, which belongs to a group of medicines called osmotic laxatives that 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 increased or decreased intestinal motility (peristalsis) or rectal bleeding;
• if you have intestinal blockage (intestinal obstruction, symptomatic stenosis, paralytic ileus);
• if you have or are at risk of gastrointestinal perforation;
• if you have a severe inflammatory bowel disease (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 medical supervision for diagnosis, prescription of medicines and monitoring during therapy.
Consult your doctor when the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks, or when the use of a laxative fails to produce an effect.

Children
Data on efficacy in children under 2 years of age are limited.
The treatment of constipation with any medicine should only be an adjunct to a healthy lifestyle and proper diet, for example:

• increasing fluid and dietary fibre intake;
• appropriate physical activity and restoration of intestinal motility. Before starting treatment, any organic disorders must be ruled out. After three months of treatment, a full clinical evaluation of constipation should be performed.

Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause persistent diarrhoea, resulting in loss of water, mineral salts (especially potassium) and other essential nutrients.
In more severe cases, dehydration or potassium deficiency (hypokalaemia) may occur, which can lead to cardiac or neuromuscular disorders, especially if you are also taking medicines for the heart (cardiac glycosides), medicines that increase urine production (diuretics), or medicines for inflammation (corticosteroids).
Exercise particular caution during treatment with Laxipeg if you are prone to imbalances in blood electrolyte levels, which are commonly seen in elderly patients, or if you have kidney (renal insufficiency), liver (hepatic insufficiency) or heart (cardiac insufficiency) problems. In these cases, you should regularly monitor your blood electrolyte levels.
Abuse of laxatives, especially stimulant laxatives (contact laxatives), may lead to dependence (and thus a possible need to progressively increase the dose), chronic constipation and loss of normal intestinal function (intestinal atony).
Very rare cases of hypersensitivity reactions (skin rash, urticaria, oedema) and exceptional cases of anaphylactic shock have been reported with medicines containing macrogol.
Laxipeg contains no sugars or polyols and can therefore be taken by diabetic patients or by those on 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: wait at least two hours after taking another medicine before taking the laxative.
If you need to thicken liquids to help you swallow them safely, Laxipeg may counteract the effect of the thickening agent.

Laxipeg with food and drink
Do not take Laxipeg together with liquorice.
The use of liquorice increases the risk of potassium deficiency (hypokalaemia).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Laxipeg should be used during pregnancy and breastfeeding only if necessary, under direct medical supervision, after carefully evaluating with your doctor the benefit to the mother versus the potential risk to the fetus or infant.

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

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

3. How to take Laxipeg

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
The recommended doses are:
Children over 8 years of age and weighing more than 20 kg: 2–4 full measuring spoons per day (the measuring spoon holds 2.5 g at 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 table for dose calculation according to the child's body weight).
Dose calculation table for Laxipeg in children up to 20 kg

The daily dose can be taken away from meals, preferably in the morning if one measuring spoon (5 g) is taken per day, or divided between morning and evening if the dose exceeds one measuring spoon per day.
Dissolve the contents of one measuring spoon (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 prolonged sipping.
The recommended dose should be adjusted according to individual response. Increments or reductions of half (½) or one measuring spoon from the dose indicated in the table are advisable.
The correct dose is the lowest amount sufficient to produce easy passage of soft stools.
Initially use the minimum recommended doses.
When necessary, the dose may be increased, but must never exceed the maximum dose indicated.
The effect occurs 24–48 hours after administration.
Treatment duration is limited to 3 months; in any case, follow your doctor's instructions.
A diet rich in fluids enhances the medicine's effect. The regulation of intestinal motility induced by treatment should be maintained through a healthy lifestyle and proper diet.

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

• abdominal pain;
• vomiting or diarrhoea. Excessive fluid loss due to diarrhoea or vomiting may require correction of imbalances in blood salt levels (electrolyte imbalance);
• cases of accidental inhalation of the preparation into the trachea during swallowing (aspiration), particularly when administering high volumes of macrogol and electrolyte solution via nasogastric tube;
• perianal inflammation and pain associated with administration of large volumes of macrogol solution (from 4 to 11 litres).

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 everyone experiences 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 (frequency cannot be estimated from the available data)

• hypersensitivity
• severe, rapidly progressing allergic reaction (anaphylactic shock)
• swelling of tissues in general (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 present as itching, skin rash, urticaria, swelling of the face (oedema) and of tissues in general (angioedema), difficulty in breathing (dyspnoea), severe, rapidly progressing allergic reaction (anaphylactic shock).

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 stated on the packaging after "Exp". The expiry date refers to the last day of that month. The expiry date applies to the product in its original sealed packaging, correctly stored.
Store Laxipeg in its original packaging to protect it from moisture.
After opening the bottle, the contents should be used within 90 days at most; after this period, any remaining medicine must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Laxipeg contains

• The active substance is macrogol 4000. 100 g of powder contain 97.36 g of macrogol 4000.
• The other components 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 a powder for oral solution.
The pack contains one 200 g bottle.
Marketing Authorization 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)

Patient Information Leaflet: Information for the patient

Laxipeg 9.7 g oral solution powder

Macrogol 4000
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement 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 taking 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 Laxipeg is and what it is used for

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

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 increased or decreased intestinal motility (peristalsis) or rectal bleeding;
• if you have intestinal blockage (intestinal obstruction, symptomatic stenosis, paralytic ileus);
• if you have or are at risk of perforation of the gastrointestinal tract;
• if you suffer from a severe inflammatory bowel disease (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 medical supervision for diagnosis, prescription of medicines and monitoring during therapy.
Consult your doctor if the need for a laxative arises from a sudden change in your previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks, or when the use of the laxative fails to produce an effect.
Consult your doctor before using this medicine, especially if you are elderly or in poor general health.
The treatment of constipation with any medicine should only be an adjunct to a healthy lifestyle and proper diet, for example:

• increasing fluid and dietary fibre intake;
• engaging in appropriate physical activity and restoring normal intestinal motility.

Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause persistent diarrhoea, resulting in loss of water, electrolytes (especially potassium) and other essential nutrients. In severe cases, dehydration or potassium deficiency (hypokalaemia) may occur, which can lead to cardiac or neuromuscular disorders, especially if you are also taking medicines for the heart (cardiac glycosides), medicines that increase urine production (diuretics), or anti-inflammatory medicines (corticosteroids).

Exercise particular caution during treatment with Laxipeg if you are prone to imbalances in blood electrolyte levels, which are more common in elderly patients or in those with kidney (renal insufficiency), liver (hepatic insufficiency) or heart (cardiac insufficiency) problems. In these cases, you should regularly monitor your blood electrolyte levels.
Abuse of laxatives, particularly stimulant laxatives (contact laxatives), may lead to dependence (and therefore a possible need to progressively increase the dose), chronic constipation and loss of normal intestinal function (intestinal atony).
Very rare cases of hypersensitivity reactions (skin rash, urticaria, oedema) and exceptional cases of anaphylactic shock have been reported with medicines containing macrogol.
Laxipeg contains no sugar or polyols and may therefore be taken by diabetic patients or by patients on a galactose-free diet.

Children
In children, this medicine should 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: wait at least two hours after taking any other medicine before taking the laxative.
If you need to thicken liquids to swallow them safely, Laxipeg may interfere with the thickening effect.

Laxipeg with food and drink
Do not take Laxipeg with liquorice.
Taking liquorice increases the risk of potassium deficiency (hypokalaemia).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or 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 carefully evaluating with them the balance between the expected benefit for the mother and the potential risk for the foetus or infant.

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

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 exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, 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 may be taken apart from meals, preferably in the morning, as a single dose (1 or 2 sachets), or divided into two doses.
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 slowly over a long period.
The indicated dose should be adjusted according to individual response and may vary from 1 sachet every other day (especially in children) up to 2 sachets per day.
The correct dose is the smallest dose that produces easy passage of soft stools.
Initially use the lowest recommended doses.
If necessary, the dose may then be increased, but never exceeding the maximum dose indicated.
The effect occurs within 24-48 hours after administration.
Keep in mind that laxatives should be used as infrequently as possible and for no longer than seven days.
Use beyond this period requires a doctor's prescription following an appropriate evaluation of the individual case. In children, treatment should not exceed three months.
A diet rich in fluids helps the medicine's effect. The normalization of intestinal motility induced by treatment should be maintained through a healthy lifestyle and proper diet.

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

• abdominal pain;
• vomiting or diarrhoea. Excessive fluid loss due to diarrhoea or vomiting may require correction of imbalances in blood salt levels (electrolyte imbalance);
• cases of the preparation entering the trachea during swallowing (aspiration), particularly when administering high volumes of macrogol and electrolyte solution via a nasogastric tube.

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.

• The following side effects may occur in children:

Common (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

• vomiting
• rectal irritation

Rare (may affect up to 1 in 10,000 patients)

• hypersensitivity

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

• severe, rapidly developing allergic reaction (anaphylactic shock)

• swelling of tissues in general (angioedema)

• skin irritation (urticaria, rashes), itching.

• The following side effects may occur in adults:

Common (may affect up to 1 in 10 patients)

• abdominal pain and/or distension
• diarrhoea
• nausea

Uncommon (may affect up to 1 in 100 patients)

• vomiting
• urgency to defecate
• faecal incontinence
• rectal irritation

Rare (may affect up to 1 in 10,000 patients)

• hypersensitivity reactions which may present as itching, skin rash, urticaria, facial swelling (oedema), generalised swelling of tissues (angioedema), difficulty in breathing (dyspnoea), severe, rapidly developing allergic reaction (anaphylactic shock).

Frequency not known (frequency cannot be estimated from 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 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 Laxipeg

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. The expiry date applies to the product in its original packaging, properly stored.
Store in the original packaging to protect the medicine from moisture.
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 Laxipeg contains

• The active substance is macrogol 4000. Each sachet contains 9.736 g of macrogol 4000.
• The other components are: potassium acesulfame, 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 a powder for oral solution.
Pack contents: 10 or 20 sachets.
Marketing Authorization 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)