GLICEROLO 1375 mg Suppository

Зміст інструкції

1. GLICEROLO NOVA ARGENTIA children 1375 mg suppositories, adults 2250 mg suppositories
   1. What is GLICEROLO NOVA ARGENTIA and what is it used for?
   2. What you need to know before using GLICEROLO NOVA ARGENTIA
   3. How to use GLICEROLO NOVA ARGENTIA
   4. Possible side effects
   5. How to store GLICEROLO NOVA ARGENTIA
   6. Contents of the pack and other information
2. GLICEROLO NOVA ARGENTIA early childhood 2.25 g rectal solution, adults 6.75 g rectal solution
   1. What is GLICEROLO NOVA ARGENTIA and what is it used for?
   2. What you need to know before using GLICEROLO NOVA ARGENTIA
   3. How to use GLICEROLO NOVA ARGENTIA
   4. Possible side effects
   5. How to store GLICEROLO NOVA ARGENTIA
   6. Contents of the pack and other information

GLICEROLO NOVA ARGENTIA children 1375 mg suppositories, 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 do.

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

1. What is GLICEROLO NOVA ARGENTIA and what is it used for?

GLICEROLO NOVA ARGENTIA contains the active ingredient glycerol, which belongs to the category
of laxatives, which are medicines used to facilitate the expulsion of stool. 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 NOVA ARGENTIA

Do not use GLICEROLO NOVA ARGENTIA

• 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 NOVA ARGENTIA.
If you are elderly and/or not in good health, inform your doctor before using this
medicine.
Use medicines that stimulate bowel evacuation (laxatives) as infrequently as possible and
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 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
(dehydration) or a decrease in blood potassium levels (hypokalemia) may occur, which can
cause heart or muscle problems, 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, consuming 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 NOVA ARGENTIA
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 a pregnancy, 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 alter 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 NOVA ARGENTIA

Use this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, ask 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.
In children aged between 2 and 11 years, the recommended dose is 1 children's 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 NOVA ARGENTIA than you should
If you use this medicine too often, for too long or in excessive quantities, abdominal pain and persistent diarrhoea 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/administration of an excessive dose of GLICEROLO NOVA ARGENTIA, immediately inform your doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, ask 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:

Not known frequency(frequency cannot be estimated from available data):

• Pain in the form of isolated cramps or abdominal colic and diarrhea, 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/
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 NOVA ARGENTIA

Keep this medicine out of 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 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 NOVA ARGENTIA contains
GLICEROLO NOVA ARGENTIA children 1375 mg suppositories

• The active ingredient is glycerol. Each suppository contains 1375 mg of glycerol.
• The other ingredients are: sodium stearate, sodium bicarbonate.

GLICEROLO NOVA ARGENTIA 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 NOVA ARGENTIA and contents of the pack
GLICEROLO NOVA ARGENTIA children 1375 mg suppositories. Pack of 6, 12, 18 suppositories.
GLICEROLO NOVA ARGENTIA adults 2250 mg suppositories. Pack of 12, 18, 48 suppositories.

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

Manufacturer
Industria Farmaceutica NOVA ARGENTIA S.r.l.. - Via Pascoli, 1 - Gorgonzola (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
perfectly 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.

GLICEROLO NOVA ARGENTIA early childhood 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.

• 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 get worse.

Contents of this leaflet:

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

1. What is GLICEROLO NOVA ARGENTIA and what is it used for?

GLICEROLO NOVA ARGENTIA contains the active ingredient glycerol, which belongs to the category
of laxatives, which are medicines used to facilitate the expulsion of stool. 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 NOVA ARGENTIA

Do not use GLICEROLO NOVA ARGENTIA

• 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 NOVA ARGENTIA.
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
for no more than 7 days. The use of laxatives for longer periods requires a
prescription from your doctor, 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 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
(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 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 NOVA ARGENTIA
Inform your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
There is no information on interactions with other medicines.

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.
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 undesirable effects may occur that alter the ability
to drive and use machinery.

3. How to use GLICEROLO NOVA ARGENTIA

Use this medicine following exactly as described 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 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 early childhood 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 remaining medicine.
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 NOVA ARGENTIA 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 need to 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/administration of an excessive dose of GLICEROLO NOVA ARGENTIA, 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 (the 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
• Rectal irritation

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 NOVA ARGENTIA

Keep this medicine out of 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, tightly closed, 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 NOVA ARGENTIA contains
GLICEROLO NOVA ARGENTIA infants 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, potato starch, purified water.

GLICEROLO NOVA ARGENTIA 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, potato starch, purified water.

Description of the appearance of GLICEROLO NOVA ARGENTIA and contents of the pack
Pack of 6 single-dose containers of rectal solution.

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

Manufacturers Responsible for Batch Release
Industria Farmaceutica NOVA ARGENTIA S.r.l. - Via G. Pascoli, 1 - Gorgonzola (MI)
AEFFE FARMACEUTICI S.r.l. – Via Torino, 448 – Brandizzo (TO)

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
entirely 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.