PORTOLAC 200 G Oral powder

Зміст інструкції

1. Portolac 5 g powder for oral solution
   1. What is Portolac and what is it used for
   2. What you need to know before taking/giving Portolac to the child
   3. How to take/give Portolac to the child
   4. Possible side effects
   5. How to store Portolac
   6. Contents of the pack and other information
2. Portolac 66.67 g/100 ml syrup
   1. What is Portolac and what is it used for
   2. What you need to know before taking/giving Portolac to the child
   3. How to take/give Portolac to the child
   4. Possible side effects
   5. How to store Portolac
   6. Contents of the pack and other information

Portolac 5 g powder for oral solution

Portolac 10 g powder for oral solution
Portolac 200 g powder for oral solution
Lactitol monohydrate

Read this leaflet carefully before taking/giving this medicine to the child
because it contains important information for you.
Take/give this medicine to the child always as exactly described in this leaflet or
as the 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 you or the child experiences any side effects, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms get worse after 7 days of treatment.

Contents of this leaflet:

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

1. What is Portolac and what is it used for

Portolac contains the active ingredient lactitol monohydrate, which belongs to a group of
medicines called osmotic laxatives. This medicine works by increasing the water content in the
intestine, thus promoting the evacuation of soft and bulky stools.
Portolac is indicated in adultsand childrenfor the short-term treatment of
occasional constipation.
Consult a doctor if you or the child do not feel better or if you feel worse after 7 days of
treatment.

2. What you need to know before taking/giving Portolac to the child

Do not take/give Portolac to the child

• if you or the child are allergic to mannitol monohydrate or to any of the other ingredients of this medicine (listed in section 6)
• if you or the child suffers from reduced intestinal transit (for example, bowel obstruction due to an occlusion)
• if you or the child has or may have an injury to the intestine
• if you or the child has any abdominal pain of unknown cause
• if you or the child has bleeding from the rectum
• if you or the child suffers from hydro-electrolytic imbalance (alteration of the concentrations of liquids and salts present in the body);
• if you or the child suffers from galactose intolerance (a type of sugar).

Do not give Portolac to breast-fed children and children with fructose intolerance (another type of
sugar).
If you or your child suffers from fecaloma (a hard and bulky mass of stool in the intestine
caused by constipation), this condition must be treated differently before using
laxatives.

Warnings and precautions
Consult your doctor or pharmacist before taking/giving Portolac to the child.
The treatment of chronic or recurrent constipation always requires the intervention of a doctor for
diagnosis, prescription of drugs and monitoring during therapy.
Consult your doctor:

• when the constipation you or the child suffers from is chronic or particularly stubborn. In this case, the doctor will advise you to treat the constipation first with a diet rich in fiber, sufficient fluid intake or physical activity;
• if you are going to undergo electrocauterization procedures (a medical procedure used to remove parts of tissue) of the intestine;
• if you experience nausea or bloating (gas in the stomach);
• if you or the child have undergone an ileostomy or colostomy (surgical techniques that allow an opening at the level of the abdomen that allows the elimination of feces externally);
• if the doctor has diagnosed you or the child with intolerance to certain sugars;
• when the need for a laxative is due to 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;
• if you are elderly and/or debilitated, as the doctor may want to regularly check the levels of salts in the blood.

It is important to treat any hydro-electrolytic imbalance (alteration of the concentrations of
liquids and salts present in the body) before starting treatment with a laxative.

Laxative abuse
If you or the child abuse (frequent or prolonged use or with excessive doses) of laxatives:

• you may experience persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients;
• in the most severe cases, you may experience a serious loss of water from the body (dehydration) or a decrease in potassium in the blood. You may therefore have problems with the heart or muscles, especially if you are also taking medications such as cardiac glycosides, diuretics or corticosteroids, to treat heart disease or inflammation;
• you may develop dependence (and therefore a possible need to gradually increase the dosage), chronic constipation and loss of normal bowel function (intestinal atony).

For these reasons, prolonged use of laxatives without interruption should be avoided and the doctor
must try to determine the optimal dosage at the beginning of treatment.

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

Other medicines and Portolac
Tell your doctor or pharmacist if you/the child are taking, have recently taken or
may take any other medicine.
Laxatives can reduce the time of stay in the intestine, and therefore the absorption, of other
medicines taken simultaneously by mouth.
Avoid taking/giving the child laxatives and other medicines at the same time: after having
taken/given the child a medicine, allow at least 2 hours to pass before
taking/giving the child the laxative.
Tell your doctor if you or the child are taking:

• neomycin(a medicine used to treat infections) and antacids(to treat stomach acidity). In particular, these medicines should not be taken with Portolac in case of severe liver disease (cirrhosis with hepatic encephalopathy);
• cardiac glycosides(medicines used to treat heart disease), as they may increase the toxic effects of these medicines;
• antibacterial agents(medicines used to treat infections) and oral antacids, as they reduce the effect of Portolac on the intestinal bacterial flora;
• medicines that, when taken together with Portolac, increase potassium loss, for example:
• thiazide diuretics (medicines that determine an increase in urine production);
• corticosteroids (anti-inflammatory drugs);
• carbenoxolone (a medicine used to treat ulcers);
• amphotericin B (medicines used against fungal infections).

Portolac with food and drink
If you feel nauseous, take Portolac during meals.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
In the first 3 months of pregnancy, take Portolac only if absolutely necessary and under
medical supervision.

Breastfeeding
If you are breastfeeding, consult your doctor before taking Portolac.

Driving and operating machinery
Portolac does not impair the ability to drive vehicles or operate machinery.

Health education notes
In most cases, a balanced diet rich in water and fiber (bran, vegetables and fruit)
can 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 is a completely normal situation for a large number of
individuals. Instead, consider that constipation occurs when bowel movements are reduced
compared to one's personal habits and are associated with the passage of hard stools.
If episodes of constipation occur repeatedly, you should consult a doctor.

3. How to take/give Portolac to the child

Take/give this medicine to the child following exactly as reported in this leaflet or the instructions of the doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.

Adults
The recommended dose is 10-15 g of Portolac per day, equivalent to 2-3 measuring scoops of 5 g of powder for oral solution or 2-3 sachets of 5 g or 1 sachet of 10 g.
Take Portolac preferably in the evening, before going to bed, in a single administration. If you experience nausea, it is advisable to take Portolac during meals

Use in children

Children
➢ from 2 to 6 years: 5 g per day equivalent to 1 measuring scoop of 5 g of powder for oral solution or 1 sachet of 5 g.
➢ over 6 years: 5-10 g per day, equivalent to 1-2 measuring scoops of 5 g powder for oral solution, 1-2 sachets of 5 g or 1 sachet of 10 g.
Give Portolac to the child in a single administration, in the morning with breakfast.

Infants
On average 1-2 g per day, equivalent to 1-2 measuring scoops of 1 g of powder for oral solution.
In general, the optimal effect can be achieved with dosage adjustments of 5 g per day (more or less) in adults and 1 g per day in pediatric age.
The correct dose is the minimum sufficient to produce an easy evacuation of soft stools. Use/give the child initially the minimum foreseen doses. When necessary, the dose can then be increased, but never exceeding the maximum indicated.
Dissolve the powder in water or other beverages (milk, tea, coffee, fruit juices) or add it to other foods such as: yogurt, cooked fruit, etc.
Ingest/give Portolac to the child together with an adequate amount of water (a generous glass). A diet rich in fluids promotes the effect of the medicine.
Take/give the child laxatives as infrequently as possible and for no more than 7 days. Use for longer periods requires a prescription from the doctor after adequate evaluation of the individual case.
Avoid prolonged use of laxatives without interruption.

If you take/give the child too much Portolac
In case of accidental ingestion/intake of an excessive dose of Portolac, immediately warn the doctor or go to the nearest hospital.
In case of accidental ingestion/intake of an excessive dose, you or the child may experience stomach pain and diarrhea. In these cases, treatment should be discontinued, drink fluids and consult a doctor.
See also what is reported in the “Warnings and Precautions” section regarding the abuse of laxatives.

If you forget to take/give Portolac to the child
Do not take/give the child a double dose to compensate for the 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.
At the beginning of treatment, Portolac may cause abdominal discomfort, especially with emission of
gas from the intestine, and rarely abdominal pain or sometimes abdominal bloating. These effects
tend to decrease or disappear after a few days of regular intake of Portolac.
The following side effects may occur with the following frequency:

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

• vomiting
• diarrhea
• abdominal pain
• abdominal bloating
• production of gas from the intestine (flatulence).

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

• nausea
• abnormal sounds from the stomach and intestines
• anal itching.

Reporting of side effects
If you or the child experiences any side effect, including those not listed in
this leaflet, please inform your doctor or pharmacist. You can also report side effects
directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Portolac

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 Expiry.
The expiry date refers to the last day of that month.

Portolac 5 g and 10 g powder for oral solution: this medicine does not require any special
storage conditions.

Portolac 200 g powder for oral solution: do not store at a temperature above 25°C.
Store in the original packaging to protect the medicine from humidity.
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 Portolac contains

Portolac 5g or 10 g powder for oral solution

• the active ingredient is: lactitolmonohydrate (each sachet contains 5 g or 10 g of lactitol monohydrate).

Portolac 200 g powder for oral solution

• the active ingredient is: lactitolmonohydrate (each jar contains 200 g of lactitol monohydrate).

There are no other components.

Description of the appearance of Portolac and contents of the pack
Portolac is a powder for oral solution, available in a pack of 10 sachets of 5 g or
a pack of 20 sachets of 10 g or a jar of 200 g with a measuring spoon.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70
00181 ROMA

Manufacturer
Lamp San Prospero S.p.A., Via della Pace 25/A – 41030 San Prospero (MO)
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio 22 - 60131 Ancona
April 2024

Portolac 66.67 g/100 ml syrup

Lactitol monohydrate

Read this leaflet carefully before you take/give this medicine to the child
as it contains important information for you.
Always take/give this medicine to the child 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 you or the child experiences any side effects, 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 7 days of treatment.

Contents of this leaflet:

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

1. What is Portolac and what is it used for

Portolac contains the active ingredient lactitol monohydrate, which belongs to a group of
medicines called osmotic laxatives. This medicine works by increasing the water content in the
intestine, thus promoting the evacuation of soft and bulky stools.
Portolac is indicated in adultsand childrenfor the short-term treatment of
occasional constipation.
See a doctor if you or the child do not feel better or if you feel worse after 7 days of
treatment.

2. What you need to know before taking/giving Portolac to the child

Do not take/give Portolac to the child

• if you or the child is allergic to mannitol monohydrate or to any of the other ingredients of this medicine (listed in section 6)
• if you or the child suffers from reduced intestinal transit (for example, bowel obstruction due to an occlusion)
• if you or the child has or may have an intestinal lesion
• if you or the child has any abdominal pain of unknown cause
• if you or the child has bleeding from the rectum
• if you or the child suffers from hydro-electrolytic imbalance (alteration of the concentrations of fluids and salts present in the body);
• if you or the child suffers from galactose intolerance (a type of sugar).

Do not give Portolac to breastfed children and children with fructose intolerance (another type of
sugar).
If you or your child suffers from fecaloma (a hard and bulky mass of stool in the intestine
caused by constipation), this condition must be treated differently before using
laxatives.

Warnings and precautions
Consult your doctor or pharmacist before taking/giving Portolac to the child.
The treatment of chronic or recurrent constipation always requires the intervention of a doctor for
diagnosis, prescription of medications and monitoring during therapy.
Consult your doctor:

• when the constipation you, or the child, suffer from is chronic or particularly stubborn. In this case, the doctor will advise you to treat the constipation first with a diet rich in fiber, sufficient fluid intake or physical activity
• if you are to undergo electrocauterization procedures (a medical procedure used to remove parts of tissue) of the intestine.
• if you experience nausea or bloating (air in the stomach)
• if you, or the child, have undergone an ileostomy or colostomy (surgical techniques that allow an opening at the level of the abdomen that allows the elimination of feces externally)
• if the doctor has diagnosed you or the child with intolerance to certain sugars
• when the need for a laxative derives from a sudden change in previous bowel habits (frequency and characteristics of evacuations) that lasts for more than two weeks or when the use of the laxative fails to produce effects.
• if you are elderly and/or debilitated, as the doctor may want to regularly check the levels of salts in the blood.

It is important to treat any hydro-electrolytic imbalance (alteration of the concentrations of
fluids and salts present in the body) before starting treatment with a laxative.

Laxative abuse
If you, or the child, abuse (frequent or prolonged use or with excessive doses) of laxatives:

• you may experience persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients;
• in the most severe cases, you may experience a severe loss of water from the body (dehydration) or a decrease in potassium in the blood. You may therefore have problems with the heart or muscles, especially if you are also taking medications such as cardiac glycosides, diuretics or corticosteroids, to treat heart disease or inflammation;
• you may develop dependence (and, therefore, a possible need to gradually increase the dosage), chronic constipation and loss of normal bowel function (intestinal atony).

For these reasons, prolonged use of laxatives without interruption should be avoided and the doctor
must try to determine the optimal dosage at the beginning of treatment.

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

Other medicines and Portolac
Tell your doctor or pharmacist if you/the child is taking, has recently taken or
may take any other medicine.
Laxatives can reduce the time of stay in the intestine, and therefore the absorption, of other
medicines taken simultaneously by mouth.
Avoid taking/giving the child laxatives and other medicines at the same time: after taking/giving the child a medicine, allow at least 2 hours to pass before
taking/giving the child the laxative.
Tell your doctor if you or the child is taking:

• neomycin(a medicine used to treat infections) and antacids(to treat stomach acidity). In particular, these medicines should not be taken with Portolac in case of severe liver disease (cirrhosis with hepatic encephalopathy);
• cardiac glycosides(medicines used to treat heart disease), as they may increase the toxic effects of these medicines;
• antibacterial agents(medicines used to treat infections) and oral antacids, as they reduce the effect of Portolac on the intestinal bacterial flora;
• medicines that, when taken with Portolac, increase potassium loss, for example: thiazide diuretics (medicines that determine an increase in urine production); corticosteroids (anti-inflammatory drugs);
• carbenoxolone (a medicine used to treat ulcers);
• amphotericin B (medicines used against fungal infections).

Portolac with food and drink
If you feel nauseous, take Portolac during meals.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
In the first 3 months of pregnancy, take Portolac only if absolutely necessary and under
medical supervision

Breastfeeding
If you are breastfeeding, consult your doctor before taking Portolac

Driving and operating machinery
Portolac does not impair the ability to drive vehicles or operate machinery.

Health education notes
In most cases, a balanced diet rich in water and fiber (bran, vegetables and fruit)
can 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 is a perfectly normal situation for a large number of
individuals. Instead, consider that constipation occurs when evacuations are reduced
compared to one's personal habits and are associated with the emission of hard stools.
If episodes of constipation occur repeatedly, you should consult a doctor.

Portolac contains:

• benzoic acid:This medicine contains 30 mg of benzoic acid per dose (37.5 ml) equivalent to 10 mg/37.5 ml. Benzoic acid can increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age;
• sodium:This medicine contains less than 1 mmol (23 mg) of sodium per dose and per maximum daily dose, i.e. essentially ‘sodium-free’.

3. How to take/give Portolac to the child

Take/give this medicine to the child following the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults
The recommended dose is 15-30 ml of Portolac per day, equivalent to 1-2 measuring cups filled up to the 15 ml mark.
In general, depending on the needs, you can increase or decrease the dose by taking 7.5 ml of syrup (7.5 ml measuring cup mark) more or less per day.
Take Portolac preferably in the evening, before going to bed, in a single administration. If you experience nausea, it is recommended to take Portolac during meals.

Use in children

Children

• from 2 to 6 years: 10 ml per day, equivalent to 1 measuring cup filled up to the 10 ml mark.
• over 6 years: 10-15 ml per day, equivalent to 1 measuring cup filled up to the 10 ml or 15 ml mark. Give Portolac to the child in a single administration, in the morning with breakfast.

Infants
On average 5 ml of syrup per day, equivalent to 1 measuring cup filled up to the 5 ml mark.
The correct dose is the minimum sufficient to produce easy evacuation of soft stools. Use/give the child initially the minimum doses provided. When necessary, the dose can then be increased, but never exceeding the maximum indicated.
Use the appropriate measuring cup filled up to the mark corresponding to the indicated dose.
Clean the measuring cup thoroughly after each use before storing it back in the packaging.
Swallow/give Portolac to the child together with an adequate amount of water (a large glass). A diet rich in fluids promotes the effect of the medicine.
Take/give laxatives to the child as infrequently as possible and for no more than 7 days. Use for longer periods requires a doctor's prescription after adequate evaluation of the individual case.
Avoid prolonged use of laxatives without interruption.

If you take/give the child more Portolac than you should
In case of accidental ingestion/intake of an excessive dose of Portolac, immediately notify your doctor or go to the nearest hospital.
In case of accidental ingestion/intake of an excessive dose, you or the child may experience stomach pain and diarrhea. In these cases, treatment should be discontinued, drink fluids and consult a doctor.
See also what is reported in the “Warnings and Precautions” section regarding the abuse of laxatives.

If you forget to take/give Portolac to the child
Do not take/give the child a double dose to compensate for the 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.
At the beginning of treatment, Portolac may cause abdominal discomfort, especially with emission of
gas from the intestine, and rarely abdominal pain or sometimes abdominal bloating. These effects
tend to decrease or disappear after a few days of regular intake of Portolac.
The following side effects may occur with the following frequency:

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

• vomiting
• diarrhoea
• abdominal pain
• abdominal bloating
• production of gas from the intestine (flatulence).

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

• nausea
• abnormal sounds from the stomach and intestines
• anal itching.

Reporting of side effects
If you or your child experiences any side effect, including those not listed in
this leaflet, please inform your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Portolac

Keep this medicine out of the sight and reach of children.
After first opening, use the medicine within 12 months.
Do not use this medicine after the expiry date which is stated on the bottle after Scad. The expiry
date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 Portolac contains

• the active ingredient is: lactitolmonohydrate (100 ml of syrup contains 66.67 g of lactitol monohydrate)
• the other ingredients are: benzoic acid; sodium hydroxide; purified water.

Description of the appearance of Portolac and contents of the pack
Portolac is a syrup and is presented as a clear, colorless and odorless solution. It is available in
200 ml bottle with a closing cap and equipped with a measuring cup.

Marketing Authorisation Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70
00181 ROMA

Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)

or
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio 22 - 60131 ANCONA