Glycerol Polifarma Benessere: detailed information

GLYCEROL Polifarma Benessere “6.75 g rectal solution for adults”
Glycerol
Please read this leaflet carefully before using 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 instructed.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

What GLYCEROL Polifarma Benessere is and what it is used for
What you need to know before using GLYCEROL Polifarma Benessere
How to use GLYCEROL Polifarma Benessere
Possible side effects
How to store GLYCEROL Polifarma Benessere
Package contents and other information

1. What GLYCEROL Polifarma Benessere is and what it is used for

GLYCEROL Polifarma Benessere belongs to a group of medicines called laxatives.
GLYCEROL Polifarma Benessere works by stimulating intestinal movements and accelerating the passage of intestinal contents.
GLYCEROL Polifarma Benessere is used in adults and adolescents aged 12 to 18 years for the treatment of constipation.
Contact your doctor if you do not feel better or if you feel worse after 7 days.

Health education notes
First of all, remember that in most cases, a balanced diet rich in water and fibre (bran, vegetables, and fruit) can permanently resolve constipation.
Many people believe they suffer from constipation if they do not have a bowel movement every day.
This is a mistaken belief, as going less than daily is perfectly normal for many individuals. Instead, consider that constipation occurs when bowel movements are reduced compared to your usual habits and are associated with the passage of hard stools.
If episodes of constipation recur frequently, consult your doctor.
Combine pharmacological treatment of constipation with increased dietary intake of vegetable fibres and fluids (6–8 glasses of water per day), physical activity, and re-education of intestinal motility.

2. What you need to know before using GLICEROLO Polifarma Benessere

Do not use GLICEROLO Polifarma Benessere

if you are allergic to glycerol or to any of the other ingredients of this medicine (listed in section 6),
if you have severe abdominal pain of unknown cause,
if you have nausea or vomiting,
if you suffer from intestinal obstruction or narrowing of the intestine (intestinal stenosis),
if you are experiencing rectal bleeding of unknown cause,
if you have haemorrhoids that bleed,
if you have lost a significant amount of fluids.

Warnings and precautions
Talk to your doctor or pharmacist before using GLICEROLO Polifarma Benessere.
Like all laxatives, do not use GLICEROLO Polifarma Benessere daily or for prolonged periods
without first having your doctor evaluate the cause of constipation. The treatment of
chronic or recurrent constipation always requires medical supervision for diagnosis,
prescription of medications, and monitoring during therapy.
In particular, 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 use of the laxative fails to produce an effect,
if you are elderly or in poor general health.

If you abuse laxatives (frequent or prolonged use, or excessive doses), you may experience:

persistent diarrhoea leading to loss of water, mineral salts (especially potassium), and other essential nutrients. As a result, you may develop heart or muscle problems, especially if you are taking medicines for high blood pressure or inflammation (cardiac glycosides, diuretics, or corticosteroids),
dependence (and therefore the need to increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).

Children
Do not give GLICEROLO Polifarma Benessere for adults to children under 12 years of age without
first consulting a doctor.

Other medicines and GLICEROLO Polifarma Benessere
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
If you are pregnant, use GLICEROLO Polifarma Benessere only if necessary and after consulting your doctor.

Breastfeeding
If you are breastfeeding, use GLICEROLO Polifarma Benessere only if necessary and after consulting your doctor.

Driving and using machines
GLICEROLO Polifarma Benessere does not affect the ability to drive or operate machinery.
However, adverse effects may occur. Keep this in mind before driving or operating machinery.

3. How to use GLICEROLO Polifarma Benessere

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is as follows:
Adults and adolescents (12–18 years): 1 single-dose container for adults of 6.75 g as needed, with a maximum of 1 or 2 administrations per day.
Only give GLICEROLO Polifarma Benessere for adults to children under 12 years of age after consulting a doctor.

Instructions for use

Remove the protective cap from the rectal cannula.
Hold the squeezable container and gently insert the cannula into the rectum, after lubricating it with a drop of the solution itself; then squeeze the bulb.
At the end of administration, remove the cannula while continuing to squeeze the bulb.

If you use more GLICEROLO Polifarma Benessere than you should
If you accidentally ingest/absorb an excessive dose of GLICEROLO Polifarma Benessere, contact your doctor immediately or go to the nearest hospital.
If you use excessive doses, you may experience abdominal pain, diarrhoea, and significant loss of water and substances present in the blood (potassium and other electrolytes). These losses may cause thirst, vomiting, weakness, swelling (edema), bone pain (osteomalacia), and low levels of albumin in the blood (hypoalbuminemia). Drink plenty of fluids to replace fluid losses.
In more severe cases, you may develop dehydration and low potassium levels in the blood (hypokalaemia). This may lead to heart or muscle problems, especially if you are taking medicines for high blood pressure and inflammation (cardiac glycosides, diuretics or corticosteroids).
If you forget to use GLICEROLO Polifarma Benessere
Do not use a double dose to make up for the missed dose.
If you stop using GLICEROLO Polifarma Benessere
If you have any doubts about using 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 following side effects may occur:
Effects related to stomach and intestine, more frequent in cases of severe constipation and rectal irritation:

Pain and cramps
Abdominal colic
Diarrhoea
Loss of fluids and electrolytes
Rectal irritation

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GLYCEROL Polifarma Benessere

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.
This medicine does not require any special storage temperature.
Store in the original container tightly closed to protect the medicine from light.
Do not dispose of medicines 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 GLICEROLO Polifarma Benessere contains

The active substance is: glycerol 6.75 g.
The other components are: pregelatinized starch; chamomile liquid extract; mallow liquid extract; purified water.

Description of the appearance of GLICEROLO Polifarma Benessere and contents of the package
GLICEROLO Polifarma Benessere is a rectal solution contained in single-dose containers.
The package contains 6 single-dose containers.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
POLIFARMA BENESSERE S.r.l. Via Laurentina 289 – 00142 Rome
Zeta Farmaceutici S.p.A. Via Galvani 10 - 36066 Sandrigo (VI)

Package leaflet: information for the user

GLYCEROL Polifarma Benessere "early infancy 2.25 g rectal solution"

Glycerol
Please read this leaflet carefully before giving this medicine to your child, as it contains
important information for you.
Give this medicine to your child exactly as described in this leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If any side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if symptoms worsen after 7 days.

Contents of this leaflet:

What GLYCEROL Polifarma Benessere is and what it is used for
What you need to know before giving GLYCEROL Polifarma Benessere to your child
How to give GLYCEROL Polifarma Benessere to your child
Possible side effects
How to store GLYCEROL Polifarma Benessere
Package contents and other information

1. What GLICEROLO Polifarma Benessere is and what it is used for

GLICEROLO Polifarma Benessere belongs to a group of medicines called laxatives.
GLICEROLO Polifarma Benessere works by stimulating intestinal movements, accelerating the passage of intestinal contents.
GLICEROLO Polifarma Benessere is used in children from 2 to 6 years of age for the treatment of constipation.
Consult your doctor if the child does not feel better or feels worse after 7 days.

Health education notes
First of all, keep in mind that, in most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can provide a long-term solution to constipation.
Many people believe they suffer from constipation if they cannot defecate every day.
This is a mistaken belief, as going less than daily is completely normal for many individuals. Instead, consider constipation to be present when bowel movements are reduced compared to one's usual pattern and are associated with the passage of hard stools.
If episodes of constipation recur frequently in the child, consult your doctor.
Combine pharmacological treatment of constipation with an increased intake of dietary fiber and fluids (6–8 glasses of water per day), physical activity, and re-education of intestinal motility.

2. What you should know before giving GLYCEROL Polifarma Benessere to the child

Do not give GLYCEROL Polifarma Benessere to the child

if he/she is allergic to glycerol or to any of the other ingredients of this medicine (listed in section 6),
if he/she has severe abdominal pain of unknown cause,
if he/she has nausea or vomiting,
if he/she suffers from intestinal obstruction or narrowing of the intestine (intestinal stenosis),
if he/she is bleeding from the rectum and the cause is unknown,
if he/she has haemorrhoids that are bleeding,
if he/she has lost a lot of fluids.

Warnings and precautions
Consult your doctor or pharmacist before giving GLYCEROL Polifarma Benessere to the child.
Like all laxatives, do not give GLYCEROL Polifarma Benessere to the child daily or for prolonged periods without prior medical evaluation of the cause of constipation. The treatment of chronic or recurrent constipation always requires medical supervision for diagnosis, prescription of medicines and monitoring during therapy.
In particular, 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 use of the laxative fails to produce an effect,
if the child is not in good general health.

If you administer laxatives frequently or for prolonged periods, or in excessive doses, the child may experience:

persistent diarrhoea, resulting in loss of water, mineral salts (especially potassium) and other essential nutrients. This may lead to heart or muscle problems, especially if the child is taking medicines to treat high blood pressure or inflammation (cardiac glycosides, diuretics or corticosteroids).
dependence (and therefore the need to increase the dose), chronic constipation and loss of normal intestinal function (intestinal atony).

Children
Do not give GLYCEROL Polifarma Benessere Infant to children under 2 years of age.
Other medicines and GLYCEROL Polifarma Benessere
Inform your doctor or pharmacist if the child is taking, has recently taken or might take any other medicines.
Driving and using machines
GLYCEROL Polifarma Benessere does not affect the ability to drive vehicles (e.g. bicycle). However, adverse effects may occur. Take this into account before allowing the child to drive vehicles.

3. How to administer GLICEROLO Polifarma Benessere to the child

Administer this medicine to the child exactly as stated in this leaflet or as directed by the doctor or pharmacist.
If you have any doubts, consult the doctor or pharmacist.
The recommended dose is as follows:
Children aged 2–6 years: 1 single-dose container early infancy of 2.25 g as needed,
up to a maximum of 1 or 2 administrations per day.
Each container must be used for a single administration only; any unused medicine must be discarded.

Instructions for use

Remove the protective cap from the rectal cannula.
Hold the squeezable container and gently insert the cannula into the child’s rectum, after lubricating it with a drop of the solution itself, then squeeze the bulb.
After administration, remove the cannula while continuing to squeeze the bulb.

If you give the child more GLICEROLO Polifarma Benessere than you should
In case of accidental ingestion/overdose of GLICEROLO Polifarma Benessere, contact the doctor immediately or go to the nearest hospital.
If excessive doses are given, the child may experience abdominal pain, diarrhoea, and significant loss of water and substances present in the blood (potassium and other electrolytes). These losses may cause thirst, vomiting, weakness, swelling (oedema), bone pain (osteomalacia), and low levels of albumin in the blood (hypoalbuminaemia). Make the child drink plenty of fluids to replace fluid losses.
In more severe cases, the child may develop dehydration and low potassium levels in the blood (hypokalaemia). As a result, the child may experience heart or muscle problems, especially if taking medicines for high blood pressure and inflammation (cardiac glycosides, diuretics, or corticosteroids).

If you forget to give the child GLICEROLO Polifarma Benessere
Do not give the child a double dose to make up for the forgotten dose.

If you stop treatment with GLICEROLO Polifarma Benessere
If you have any doubts about the use of this medicine, consult the 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:
Effects related to stomach and intestine, more frequent in cases of severe constipation and rectal irritation.

Pain and cramps
Abdominal colic
Diarrhoea
Loss of fluids and electrolytes
Rectal irritation

Reporting of side effects
If the child experiences any side effect, including those not listed in this leaflet, consult a doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following address:
http://www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GLYCEROL Polifarma Benessere

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.
This medicine does not require any special storage temperature.
Store in the original container tightly closed to protect the medicine from light.
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 GLICEROLO Polifarma Benessere contains

The active substance is: glycerol 2.25 g.
The other components are: pregelatinized starch; chamomile fluid extract; mallow fluid extract; purified water.

Description of the appearance of GLICEROLO Polifarma Benessere and package contents
GLICEROLO Polifarma Benessere is a rectal solution contained in single-dose containers.
The package contains 6 single-dose containers.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Polifarma Benessere S.r.l., Via Laurentina 289 – 00142 Rome
Zeta Farmaceutici S.p.A., Via Galvani 10 - 36066 Sandrigo (VI)