REGOLINT 9.7 G Proszek do sporządzania roztworu

Treść ulotki

1. REGOLINT 9.7 g powder for oral solution
   1. What is REGOLINT and what is it used for
   2. What you need to know before you take REGOLINT
   3. How to take REGOLINT
   4. Possible side effects
   5. How to store REGOLINT
   6. Contents of the pack and other information
2. REGOLINT 973.6 mg/g powder for oral solution
   1. What is REGOLINT and what is it used for
   2. What you need to know before you take REGOLINT
   3. How to take REGOLINT
   4. Possible side effects
   5. How to store REGOLINT
   6. Contents of the pack and other information

REGOLINT 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 take 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 want more information or advice, ask your pharmacist.
• If any of the side effects become serious, or if you notice any side 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 you feel worse after a few days.

Contents of this leaflet

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

1. What is REGOLINT and what is it used for

REGOLINT contains the active ingredient macrogol 4000 which belongs to a group of medicines called
osmotic laxatives, which work by drawing water into the intestine and facilitating the formation of
soft stools.
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 a few days.

2. What you need to know before you take REGOLINT

Do not use REGOLINT if:

• you are allergic to macrogol 4000 or to any of the other ingredients of this medicine (listed in section 6);
• you suffer from severe inflammatory diseases of the intestine (such as ulcerative colitis, Crohn's disease or toxic megacolon associated with symptomatic stenosis);
• you experience acute or of unknown origin abdominal pain;
• you present a marked increase or decrease in intestinal activity (peristalsis), nausea or vomiting, bleeding from the lower part of the intestine (rectal bleeding);
• you present an obstruction (ileus) or suspected obstruction, a narrowing (stenosis) or a perforation, or risk of perforation of the intestine;
• you are in a condition characterized by excessive fluid loss (severe dehydration).

Warnings and precautions
Talk to your doctor or pharmacist before taking REGOLINT.
Before starting treatment, talk to your doctor who will need to make sure that your constipation is not
due to other diseases. If you suffer from chronic or recurrent constipation, see your doctor who will advise
you on appropriate therapy and monitor you.
Also consult your doctor if the need for a laxative stems from any of the following conditions:

• your bowel habits (frequency and characteristics of bowel movements) have changed suddenly for more than 2 weeks;
• the laxative fails to produce effects.

If you suffer from constipation, first correct your eating habits and adopt a healthy lifestyle,
following a balanced diet, rich in water and fiber and engaging in physical activity.
Immediately stop treatment and inform your doctor if you experience allergic reactions such as
skin irritation (rash, hives), swelling of the face, lips, throat and/or tongue
(edema) and severe allergic reactions (anaphylactic shock).
Do not use laxative medicines if you suffer from acute or of unknown origin abdominal pain, nausea or
vomiting, marked increase or decrease in peristalsis, rectal bleeding. In these cases, consult your
doctor who will indicate whether you suffer from diseases in which the use of laxatives is contraindicated (for example:
intestinal obstruction or suspected obstruction, stenosis or perforation of the intestine, paralytic ileus, severe diseases
inflammatory diseases of the intestine).
After about 3 months of treatment, it is recommended to consult your doctor who, as it is necessary
to perform specific checks and establish an appropriate therapy.
If you take laxatives frequently, for a long time or in high doses, you may experience prolonged diarrhea
resulting in loss of water, minerals (especially potassium) and other essential nutrients. In
the most severe cases, excessive fluid loss (dehydration) may occur, accompanied by
low levels of potassium in the blood (hypokalaemia), which can cause problems with the functioning of the heart,
nerves and muscles (cardiac or neuromuscular dysfunction). These effects can occur
especially if you are taking medicines at the same time that increase the force of heart contraction
(cardiac glycosides), which facilitate the elimination of urine (diuretics) or for the treatment of allergies and
inflammation (corticosteroids).
Use caution and inform your doctor if:

• you suffer from liver problems (hepatic insufficiency);
• you suffer from kidney problems (renal insufficiency);
• you have heart problems (heart failure);
• you are elderly. In these cases, the doctor must periodically check the levels of salts in the blood (serum electrolytes).

If you take laxatives excessively or incorrectly (abuse), especially some types of laxatives (stimulant laxatives), you may develop dependence (possible need to progressively increase the dose of
medicine), chronic constipation and loss of normal bowel function (intestinal atony).

Health education notes
First of all, it must be kept in mind that, in most cases, a balanced diet rich in
water and fiber (bran, vegetables and fruit) can durably solve the problem of constipation.
Many people think they suffer from constipation if they cannot evacuate every day.
This is a mistaken belief as this situation is perfectly normal for a large number of
individuals.
Instead, consider that constipation occurs when bowel movements are reduced compared to your own
personal habits and are associated with the passage of hard stools.
If episodes of constipation occur repeatedly, you should consult your doctor.

Children
Treatment with REGOLINT in children can only be started after consulting a doctor.

Other medicines and REGOLINT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including over-the-counter medicines.
Avoid taking this medicine at the same time as other laxatives or together with other medicines
taken by mouth (orally) because REGOLINT may reduce their effects. Take REGOLINT at least 2 hours after taking another medicine.
Use REGOLINT with caution if you are taking medicines for the treatment of epilepsy (antiepileptics), for
the treatment of irregular heartbeat and other heart problems (digoxin) or
medicines used to treat immune system disorders (immunosuppressants).
If you need to thicken liquids to be able to swallow them without problems, Regolint may counteract
the effect of the thickener.

REGOLINT with food
Avoid consuming licorice during treatment with REGOLINT, as it increases the risk of
a reduction in potassium levels in the blood (hypokalaemia).

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.
If you are pregnant or breastfeeding, take REGOLINT only when absolutely necessary and
under the direct supervision of your doctor.

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

3. How to take REGOLINT

Take this medicine following exactly what is reported in this leaflet or the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults and children over 8 years of age and weighing more than 20 kg
The recommended dose ranges from 1 sachet, to be taken on alternate days (especially in children) up to 2 sachets per day.
Do not exceed the maximum dose of 20 g of macrogol per day.
The correct dose is the minimum sufficient to produce easy expulsion of soft stools.
It is advisable to initially use the minimum doses provided.

Method of administration
The recommended dose is 1-2 sachets per day.
Based on your response to treatment, the doctor will adjust the dose, which ranges from 1 sachet, on alternate days, up to 2 sachets per day.
The daily dose of REGOLINT can be taken in 1 or 2 administrations, away from meals. If it is necessary to take 1 dose per day, it is recommended to take it in the morning.
In the case of multiple doses per day, it is advisable to divide them between morning and evening.
Dissolve the contents of one sachet in a glass of water (125 ml), without adding other ingredients.
Drink the resulting solution quickly (within a few minutes), avoiding sipping it for a long time.
Usually the effect of REGOLINT manifests within 1-2 days of taking the medicine, although it may take 2 days or more before obtaining the desired effect. In the latter case, proceed with the treatment with this medicine always keeping in mind that laxatives should be taken as infrequently as possible and for no more than 7 days. If necessary, the indicated dose may be increased, but without ever exceeding the maximum recommended dose.
Use for longer periods requires a doctor's prescription after adequate evaluation of the individual case. In children, treatment should not exceed 3 months and always under close medical supervision.
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 REGOLINT than you should
In case of accidental intake/ingestion of an excessive dose of REGOLINT, immediately inform your doctor or go to the nearest hospital.
If you take this medicine too often, for too long or in excessive quantities, abdominal pain, vomiting and diarrhea may occur, which cause loss of fluids and mineral salts (electrolytes). Diarrhea disappears with temporary interruption of treatment or with dose reduction.
Cases of aspiration have been reported on the occasion of administration with a nasogastric tube of large volumes of polyethylene glycol and electrolytes. This can happen especially in children who have brain damage, who cannot take this medicine orally (oromotor dysfunction) and who are at risk of aspiration of the medicine.

If you forget to take REGOLINT
Do not take a double dose to make up for a missed dose.
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.
The side effects that may occur are generally mild and temporary and mainly affect
the gastrointestinal system. In case of hypersensitivity reactions, stop taking
the medicine and consult a doctor immediately:

Common(may affect up to 1 in 10 people)

• abdominal pain;
• abdominal bloating (abdominal distension);
• diarrhea;
• nausea.

Uncommon(may affect up to 1 in 100 people)

• vomiting;
• urgency to defecate;
• difficulty in retaining bowel movements (fecal incontinence);
• irritation of the last part of the intestine (rectal irritation).

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

• allergic (hypersensitivity) reactions such as itching, skin irritation (skin rashes, urticaria), swelling due to fluid accumulation (edema) localized especially to the face, lips and the

throat or hands (edema, facial edema, angioedema), difficulty breathing, severe allergic
reaction that can lead to death (anaphylactic shock).

Frequency not known(frequency cannot be estimated based on available data)

• alteration of the levels of salts in the body, such as reduction of sodium and potassium levels in the blood (hyponatremia, hypokalemia);
• excessive fluid loss (dehydration), especially in the elderly.

Additional side effects in children
As in the case of adults, the reported adverse reactions are generally mild and temporary and
mainly affect the gastrointestinal system. In case of hypersensitivity reactions, stop
taking the medicine and consult a doctor immediately:

Common(may affect up to 1 in 10 people)

• abdominal pain;
• diarrhea, which may cause pain in the area near the anus (perianal);

Uncommon(may affect up to 1 in 100 people)

• vomiting;
• abdominal bloating (abdominal distension);
• nausea;
• irritation of the last part of the intestine (rectum).

Frequency not known(frequency cannot be estimated based on available data)

• allergic (hypersensitivity) reactions.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at 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 REGOLINT

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.
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 REGOLINT contains

• The active ingredient is macrogol 4000. One sachet contains 9.736 g of macrogol 4000.
• The other ingredients are: acesulfame potassium, banana flavour.

Description of the appearance of REGOLINT and contents of the pack
Powder for oral solution.
Pack of 10 or 20 sachets.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Laboratori Baldacci S.p.A. – Via S. Michele degli Scalzi 73 – 56124 Pisa – Italy
Manufacturer
Sigmar Italia S.r.l. – Via Sombreno, 11 – 24011 Almè (BG) – Italy

REGOLINT 973.6 mg/g powder for oral solution

Macrogol 4000

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

• 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 after a few days.

Contents of this leaflet

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

1. What is REGOLINT and what is it used for

REGOLINT contains the active ingredient macrogol 4000 which belongs to a group of medicines called
osmotic laxatives, which work by drawing water into the intestine and facilitating the formation of
soft stools.
This medicine is indicated for the treatment of constipation in children.
Consult your doctor if the condition does not resolve or worsens after a few days.

2. What you need to know before you take REGOLINT

Do not use REGOLINT if:

• you are allergic to macrogol 4000 or to any of the other ingredients of this medicine (listed in section 6);
• you suffer from severe inflammatory diseases of the intestine (such as ulcerative colitis, Crohn's disease) or toxic megacolon;
• you experience acute abdominal pain or of unknown origin;
• you present a marked increase or decrease in intestinal activity (peristalsis), nausea or vomiting, bleeding from the lower part of the intestine (rectal bleeding);
• you present an obstruction (ileus) or suspected obstruction, a narrowing (stenosis) or a perforation, or risk of perforation of the intestine;
• you are in a condition characterized by excessive fluid loss (severe dehydration).

Warnings and precautions
Consult your doctor or pharmacist before using REGOLINT.
Before starting treatment, consult your doctor who must ensure that your constipation is not
due to other diseases. If you suffer from chronic or recurrent constipation, consult your doctor who will advise you
adequate therapy and keep you under control.
Also consult your doctor if the need for a laxative derives from any of the following conditions:

• your bowel habits (frequency and characteristics of evacuations) have changed suddenly for more than 2 weeks;
• the laxative fails to produce effects.

If you suffer from constipation, first correct your eating habits and adopt a healthy lifestyle,
following a balanced diet, rich in water and fiber and practicing physical activity.
Immediately stop treatment and inform your doctor if you experience allergic reactions such as
skin irritation (rash, hives), swelling of the face, lips, throat and/or tongue
(edema) and severe allergic reactions (anaphylactic shock).
Do not use laxative medicines if you suffer from acute abdominal pain or of unknown origin, nausea or
vomiting, marked increase or decrease in peristalsis, rectal bleeding. In these cases, consult your
doctor who will indicate if you suffer from diseases in which the use of laxatives is contraindicated (for example:
intestinal or suspected intestinal obstruction, stenosis or perforation of the intestine, paralytic ileus, severe diseases
inflammatory diseases of the intestine).
After about 3 months of treatment, it is recommended to consult your doctor, as specific checks are necessary
and establish an appropriate therapy.
If you take laxatives frequently, for a long time or in high doses, you may experience prolonged diarrhea
resulting in loss of water, minerals (especially potassium) and other essential nutrients. In the
most severe cases, excessive fluid loss (dehydration) may occur, accompanied by
low levels of potassium in the blood (hypokalemia), which can cause problems with the functioning of the heart,
nerves and muscles (cardiac or neuromuscular dysfunction). These effects can occur
especially if you are taking medicines that increase the force of heart contraction at the same time
(cardiac glycosides), which facilitate the elimination of urine (diuretics) or for the treatment of allergies and
inflammation (corticosteroids).
Use caution and inform your doctor if:

• you suffer from liver problems (hepatic insufficiency)
• you suffer from kidney problems (renal insufficiency);
• you have heart problems (heart failure);
• you are elderly. In these cases, the doctor must periodically check the levels of salts in the blood (serum electrolytes).

If you take laxatives excessively or incorrectly (abuse), especially some types of laxatives (stimulant laxatives), you may develop dependence (possible need to gradually increase the dose of
medicine), chronic constipation and loss of normal bowel function (intestinal atony).

Children under 2 years of age
There is no information available on the effectiveness of this medicine in children under 2 years of age.

Other medicines and REGOLINT
Tell your doctor or pharmacist if you are taking, have recently taken or may take any
other medicines, including over-the-counter medicines.
Avoid taking this medicine at the same time as other laxatives or together with other medicines.
Take REGOLINT at least 2 hours after taking another medicine.
Use REGOLINT with caution if you are taking medicines for the treatment of epilepsy (antiepileptics), for
the treatment of irregular heartbeat and other heart problems (digoxin) or
medicines used to treat immune system disorders (immunosuppressants).
If you need to thicken liquids to be able to swallow them without problems, Regolint may counteract
the effect of the thickener.

REGOLINT with food
Avoid consuming licorice during treatment with REGOLINT, as it increases the risk of
excessive reduction of potassium levels in the blood (hypokalemia).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with milk
mother, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, take REGOLINT only when absolutely necessary and
under the direct supervision of a doctor.

Driving and operating machinery
No studies have been conducted on the ability to drive vehicles and operate machinery.
Regolint can be taken by patients with diabetes or undergoing a galactose-free diet, as it does not
contains any sugar or polyols.

3. How to take REGOLINT

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

Method of administration

• Children over 2 years of age and weighing less than 20 kgThe recommended initial dose is 0.7 g per kg of body weight per day. The measuring cup delivers 2.5 g to the mark and 5 g when full. In particular, the dose can be calculated as indicated in the following table: Table for calculating the dose of Regolint in children up to 20 kg.

The correct dose is the minimum sufficient to produce easy expulsion of soft stools.
It is advisable to initially use the minimum doses provided.
The indicated dose can be adjusted according to the individual response to the medicine, reducing or increasing the dose (½ or 1 measuring cup at a time), without ever exceeding the maximum recommended dose.

• Children over 8 years of age and weighing more than 20 kgThe recommended dose is 2-4 full measuring cups per day.

The measuring cup delivers 2.5 g to the mark and 5 g when full.
Do not exceed the maximum dose of 20 g of macrogol per day.

Method of administration
The daily dose of REGOLINT can be taken in 1 or 2 administrations, away from meals. If it is necessary to take 1 dose per day, it is recommended to administer it in the morning.
In the case of multiple doses per day, it is advisable to divide them between morning and evening.
Dissolve the contents of a measuring cup (5 g) in at least half a glass of water (about 60 ml), without adding any other ingredients.
Take the resulting solution quickly (within a few minutes), avoiding sipping it for a long time.
The effect of REGOLINT manifests within 1-2 days of taking the medicine, sometimes it may take 2 days or more before the desired effect is obtained.
Treatment in children should not exceed 3 months and, in any case, always according to the doctor's prescription.
A diet rich in fluids promotes the effect of the medicine. The regularization of intestinal motility induced by the treatment should be maintained with a healthy lifestyle and a correct diet.

If you take more REGOLINT than you should
In case of accidental ingestion of an excessive dose of REGOLINT, immediately inform your doctor or go to the nearest hospital.
If you take this medicine too often, for too long or in excessive quantities, abdominal pain, vomiting and diarrhea may occur, which cause loss of fluids and mineral salts (electrolytes). Diarrhea disappears with temporary interruption of treatment or with dose reduction.
Cases of aspiration have been reported during the administration of large volumes of polyethylene glycol and electrolytes with a nasogastric tube. This can happen especially in children who have brain damage, who cannot take this medicine by mouth (oromotor dysfunction) and who are at risk of aspiration of the medicine.
Furthermore, if REGOLINT is administered in large quantities (from 4 to 11 liters) for bowel cleansing (colon), before performing a specific examination of the intestine (colonoscopy) or in case of a disorder characterized by involuntary stool elimination (removal of fecal retention in case of encopresis), inflammation and pain may occur in the area near the anus (perianal pain).

If you forget to take REGOLINT
Do not take a double dose to make up for a missed dose.
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.
The side effects that may occur are generally mild and temporary and mainly affect
the gastrointestinal system. In case of hypersensitivity reactions, stop taking
the medicine and consult a doctor immediately:

Common(may affect up to 1 in 10 people)

• abdominal pain;
• diarrhea, which may cause pain in the area near the anus (perianal).

Uncommon(may affect up to 1 in 100 people)

• vomiting;
• abdominal bloating (abdominal distension);
• nausea;
• irritation of the last part of the intestine (rectal irritation).

Frequency not known(the frequency cannot be estimated on the basis of the available data)
allergic (hypersensitivity) reactions.
In addition, in adults, the following side effects have been reported:

Common(may affect up to 1 in 10 people)

• abdominal bloating (abdominal distension);
• nausea.

Uncommon(may affect up to 1 in 100 people)

• urgency to defecate;
• difficulty in retaining bowel movements (fecal incontinence).

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

• allergic (hypersensitivity) reactions such as itching, skin irritation (skin rashes, urticaria), swelling due to fluid accumulation (edema) localized especially to the face, lips and throat or hands (edema, facial edema, angioedema), difficulty breathing (dyspnea), severe allergic reaction that can lead to death (anaphylactic shock).

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

• alteration of the levels of salts in the body, such as reduction of sodium and potassium levels in the blood (hyponatremia, hypokalemia);
• excessive fluid loss (dehydration), especially in elderly people.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at 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 REGOLINT

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.
Store in the original packaging to protect the medicine from moisture.
Use the medicine within 90 days of first opening the bottle. Remember to write on the packaging the
date of first opening.
The excess product after the 90 days expiry 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 REGOLINT contains

• The active ingredient is macrogol 4000. 100 g of powder contain 97.36 g of macrogol 4000.
• The other ingredients are: acesulfame potassium, banana flavour.

Description of the appearance of REGOLINT and contents of the pack
Powder for oral solution.
Bottle containing 200 g.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Laboratori Baldacci S.p.A. – Via S. Michele degli Scalzi 73 – 56124 Pisa – Italy
Manufacturer
Sigmar Italia S.r.l. – Via Sombreno, 11 – 24011 Almè (BG) – Italy