GLICEROLO 225 mg Czopek

Treść ulotki

1. GLICEROLO EG adults 2250 mg suppositories
   1. What is GLICEROLO EG and what is it used for
   2. What you need to know before using GLICEROLO EG
   3. How to use GLICEROLO EG
   4. Possible side effects
   5. How to store GLICEROLO EG
   6. Contents of the pack and other information
2. GLICEROLO EG early infancy 2.25 g rectal solution, adults 6.75 g rectal solution
   1. What is GLICEROLO EG and what is it used for?
   2. What you need to know before using GLICEROLO EG
   3. How to use GLICEROLO EG
   4. Possible side effects
   5. How to store GLICEROLO EG
   6. Package Contents and Other Information

GLICEROLO EG adults 2250 mg suppositories

Glycerol

Read this leaflet carefully before using 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.

Contents of this leaflet:

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

1. What is GLICEROLO EG and what is it used for

GLICEROLO EG contains the active ingredient glycerol which belongs to the category of laxatives which
are medicines used to facilitate the expulsion of feces. This medicine is indicated for the
short-term treatment of occasional constipation.
Consult your doctor if you do not notice any improvement or if you notice a worsening of the symptoms.

2. What you need to know before using GLICEROLO EG

Do not use GLICEROLO EG

• if you are allergic to glycerol or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from acute abdominal pain or of unknown origin;
• if you have nausea or vomiting;
• if you suffer from obstruction or narrowing (stenosis) of the intestine;
• if you suffer from rectal bleeding of unknown origin;
• if you suffer from swelling of the blood vessels around the anus (acute hemorrhoidal crisis) with pain and bleeding;
• if you are in a severe state of dehydration.

Warnings and precautions
Consult your doctor or pharmacist before taking GLICEROLO EG.
If you are elderly and/or are not in good health, inform your doctor before using this
medicine.
Use medicines that stimulate bowel evacuation (laxatives) as infrequently as possible and
in any case for no more than 7 days. The use of laxatives for longer periods requires a
doctor's prescription, after adequate assessment of the patient's condition.
If you suffer from constipation that lasts for long periods (chronic) or that is frequent, always seek
medical attention for diagnosis, prescription of medicines and monitoring during
therapy.
Drink at least 6-8 glasses of water or other liquids a day to promote softening of the stool
when using laxatives.
If you use laxatives excessively, frequently or incorrectly, you may experience
prolonged diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential
nutrients. In the most severe cases of abuse, excessive fluid loss may occur
(dehydration) or a lowering of potassium levels in the blood (hypokalemia) which can
cause heart problems or muscle activity, especially if you are taking cardiac glycosides,
diuretics or corticosteroids during treatment with this medicine.
The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (the
need to increase the dosage more and more), chronic constipation and loss of normal functions
intestine (intestinal atony).
In case of constipation, first correct your eating habits, taking an adequate
amount of fiber and water with your daily diet.

Children
In children under 12 years of age, use GLICEROLO NOVA ARGENTIA only after
consulting a doctor.

Other medicines and GLICEROLO EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
There is no information on interaction with other medicines.

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.
Take this medicine during pregnancy and breastfeeding only if necessary and always under
direct medical supervision.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles and operate machinery. However, observe
your response to the medicine as side effects may occur that alter the ability to
drive and use machinery.

3. How to use GLICEROLO EG

Use this medicine following the instructions provided in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The correct dose is the minimum sufficient to produce easy evacuation. Initially use the minimum doses provided.
The recommended dose in adults and adolescents over 12 years of age is 1 adult suppository as needed, up to a maximum of 1 or 2 administrations per day.
Remove the suppository from its container and moisten it, if necessary, to facilitate rectal introduction.
If the suppositories appear too soft, place the containers in cold water before opening them.
Use laxatives as infrequently as possible and for no more than seven days (see section Warnings and precautions).
A diet rich in fluids promotes the effect of the medicine.

If you use more GLICEROLO EG than you should
If you use this medicine too often, for too long, or in excessive quantities, abdominal pain and persistent diarrhea may occur, causing loss of fluids, mineral salts
(especially potassium) and other essential nutrients that must be replaced (see section Warnings and precautions).
Symptoms of an imbalance of salts in the body (electrolyte imbalance) are: thirst, vomiting, weakness, swelling (edema), bone problems (osteomalacia) and a decrease in
a protein in the blood, albumin (hypoalbuminemia).
In case of accidental ingestion/intake of an excessive dose of GLICEROLO EG, immediately inform your doctor or go to the nearest hospital.
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 following side effects may occur:

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

• Pain in the form of isolated cramps or abdominal colic and diarrhoea, with loss of fluids and mineral salts (electrolytes) more frequent in cases of severe constipation
• Irritation at the rectal level

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.agenziafarmaco.gov.it/it/segnalazioni-reazioni-
avverse.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store GLICEROLO EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.”. The
expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture and away from direct
sources of heat.
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 GLICEROLO EG contains
GLICEROLO EG adults 2250 mg suppositories

• The active ingredient is glycerol. Each suppository contains 2250 mg of glycerol.
• The other ingredients are: sodium stearate, sodium bicarbonate.

Description of the appearance of GLICEROLO EG and contents of the pack
GLICEROLO EG adults 2250 mg suppositories. Pack of 18 suppositories.

Marketing Authorisation Holder
Industria Farmaceutica NOVA ARGENTIA S.p.A. - Via Carlo Porta, 49 –
Gorgonzola (MI).
.

Manufacturer
Industria Farmaceutica NOVA ARGENTIA S.p.A. - Via Pascoli, 1 - Gorgonzola (MI)

Sales concessionaire:
EG S.p.A. – Via Pavia, 6 – 20136 Milano (MI)

Health education notes
In most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit) can
permanently resolve 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
entirely normal for a large number of individuals. True constipation occurs when
bowel movements are reduced in number compared to one's habits and are associated with the passage of
hard stools. If episodes of constipation occur repeatedly, a doctor should be consulted.

GLICEROLO EG early infancy 2.25 g rectal solution, adults 6.75 g rectal solution

Glycerol

Read this leaflet carefully before using 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 would like 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 your doctor if you do not feel better or if your symptoms worsen.

Contents of this leaflet:

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

1. What is GLICEROLO EG and what is it used for?

GLICEROLO EG contains the active ingredient glycerol, which belongs to the category of laxatives, which are medicines used to facilitate the expulsion of stools. This medicine is indicated for the short-term treatment of occasional constipation.
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

2. What you need to know before using GLICEROLO EG

Do not use GLICEROLO EG

• if you are allergic to glycerol or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from acute abdominal pain of unknown origin;
• if you have nausea or vomiting;
• if you suffer from obstruction or narrowing (stenosis) of the intestine;
• if you suffer from rectal bleeding of unknown origin;
• if you suffer from swelling of the blood vessels around the anus (acute hemorrhoidal crisis) with pain and bleeding;
• if you are severely dehydrated.

Warnings and precautions
Consult your doctor or pharmacist before taking GLICEROLO EG.
If you are elderly and/or are not in good health, inform your doctor before using this medicine.
Use medicines that stimulate bowel evacuation (laxatives) as infrequently as possible and in any case for no more than 7 days. The use of laxatives for longer periods requires a doctor's prescription, after adequate assessment of the patient's condition.
If you suffer from constipation that lasts for long periods (chronic) or is frequent, always seek medical attention for diagnosis, prescription of medicines and monitoring during therapy.
Drink at least 6-8 glasses of water or other liquids a day to promote softening of the stools when using laxatives.
If you use laxatives excessively, frequently or incorrectly, you may experience prolonged diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients. In the most severe cases of abuse, excessive fluid loss (dehydration) or a decrease in potassium levels in the blood (hypokalemia) may occur, which can cause heart problems or muscle activity, especially if you are taking cardiac glycosides, diuretics or corticosteroids during treatment with this medicine.
The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (the need to increase the dosage more and more), chronic constipation and loss of normal bowel function (intestinal atony).
In case of constipation, first correct your eating habits, taking an adequate amount of fiber and water with your daily diet.

Children
In children under 12 years of age, use GLICEROLO EG only after consulting a doctor.

Other medicines and GLICEROLO EG
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
There is no information on interaction with other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Take this medicine during pregnancy and breastfeeding only if necessary and always under direct medical supervision.

Driving and operating machinery
This medicine does not alter the ability to drive vehicles and operate machinery. However, observe your response to the medicine as undesirable effects may occur that alter the ability to drive and use machinery.

3. How to use GLICEROLO EG

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.
The correct dose is the minimum sufficient to produce easy evacuation. Initially use the minimum doses provided.
The recommended dose in adults and adolescents over 12 years of age is 1 adult single-dose container of 6.75 g as needed, up to a maximum of 1 or 2 administrations per day.
In children aged between 2 and 11 years, the recommended dose is 1 infant single-dose container of 2.25 g as needed, up to a maximum of 1 or 2 administrations per day.
If necessary, use a drop of the medicinal solution to moisten (lubricate) the cannula before inserting it into the rectum and press the bellows. Extract the cannula while keeping the bellows pressed.
Use the container for a single administration; discard any residual medicine.
Use laxatives as infrequently as possible and for no more than seven days (see the Warnings and precautions section).
A diet rich in fluids promotes the effect of the medicine.

If you use more GLICEROLO EG than you should
If you use this medicine too often, for too long or in excessive quantities, abdominal pain and persistent diarrhea may occur, which causes loss of fluids, mineral salts (especially potassium) and other essential nutrients that must be replaced (see the Warnings and precautions section).
The symptoms of an imbalance of salts in the body (electrolyte imbalance) are: thirst, vomiting, weakness, swelling (edema), bone problems (osteomalacia) and a decrease in a protein in the blood, albumin (hypoalbuminemia).
In case of accidental ingestion/administration of an excessive dose of GLICEROLO EG, immediately notify your doctor or go to the nearest hospital.
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 following side effects may occur,

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

• Pains in the form of isolated cramps or abdominal colic and diarrhoea, with loss of fluids and mineral salts (electrolytes) more frequent in cases of severe constipation
• Irritation at the rectal level

Reporting of side effects
If you experience any side effects, 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: www.agenziafarmaco.gov.it/it/segnalazioni-reazioni-
avverse.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store GLICEROLO EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.”. The
expiry date refers to the last day of that month.
Store in the original packaging, tightly closed, to protect the medicine from humidity and away
from direct sources of heat.
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. Package Contents and Other Information

What GLICEROLO EG contains
GLICEROLO EG early childhood 2.25 g rectal solution

• The active ingredient is glycerol. Each single-dose container contains 2.25 g of glycerol
• The other ingredients are: chamomile fluid extract, mallow fluid extract, pregelatinized potato starch, purified water.

GLICEROLO EG adults 6.75 g rectal solution

• The active ingredient is glycerol. Each single-dose container contains 6.75 g of glycerol.
• The other ingredients are: chamomile fluid extract, mallow fluid extract, pregelatinized potato starch, purified water.

Description of the appearance of GLICEROLO EG and package contents
Pack of 6 single-dose containers of rectal solution.

Marketing Authorisation Holder
Industria Farmaceutica NOVA ARGENTIA S.p.A. - Via Carlo Porta, 49 –
Gorgonzola (MI).

Responsible Manufacturer for Batch Release
Industria Farmaceutica NOVA ARGENTIA S.p.A. - Via G. Pascoli, 1 - Gorgonzola (MI)

Sales Concessionaire:
EG S.p.A. – Via Pavia, 6 – 20136 Milano (MI)

Health Education Notes
In most cases, a balanced diet rich in water and fiber (bran, vegetables and fruit) can
durably resolve 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
completely normal for a large number of individuals. True constipation occurs when
evacuations are reduced in number compared to one's habits and are associated with the passage of
hard stools. If episodes of constipation occur repeatedly, a doctor should be consulted.