GLICEROLO 1375 mg Suppository

Зміст інструкції

1. GLICEROLO AFOM bambini 1375 mg suppositories
   1. What is GLICEROLO AFOM and what is it used for
   2. What you need to know before using GLICEROLO AFOM
   3. How to use GLICEROLO AFOM
   4. Possible side effects
   5. How to store GLICEROLO AFOM
   6. Contents of the pack and other information
2. GLICEROLO AFOM early childhood 2.25 g rectal solution
   1. What is GLICEROLO AFOM and what is it used for
   2. What you need to know before using GLICEROLO AFOM
   3. How to use GLICEROLO AFOM
   4. Possible side effects
   5. How to store GLICEROLO AFOM
   6. Package Contents and Other Information

GLICEROLO AFOM bambini 1375 mg suppositories

GLICEROLO AFOM adulti 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 after 7 days.

Contents of this leaflet:

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

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

GLICEROLO AFOM 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 you notice a worsening of symptoms after
7 days.

2. What you need to know before using GLICEROLO AFOM

Do not use GLICEROLO AFOM

• 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 AFOM.
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 of time
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. Consult your doctor when the need for a laxative derives from
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.
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
develop persistent diarrhea with consequent loss of water, minerals (especially
potassium) and other essential nutrients. In the most severe cases of abuse, you may experience
excessive fluid loss (dehydration) or a decrease in 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 the
treatment with this medicine.
The abuse of laxatives, especially stimulant laxatives (contact 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 AFOM only after consulting the
doctor.

Other medicines and GLICEROLO AFOM
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 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 AFOM

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 recommended 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 between 2 and 11 years of age, the recommended dose is 1 children's suppository as needed, up to a maximum of 1 or 2 administrations per day.
Use laxatives as infrequently as possible and for no more than seven days (see section Warnings and precautions).
Method of use
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.

If you use more GLICEROLO AFOM 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).
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 the most severe cases, dehydration or a decrease in potassium levels may occur
in the blood (hypokalemia), which can cause heart problems and muscle activity, especially if you are taking medications for the heart (cardiac glycosides), medications
used to lower blood pressure (diuretics) or anti-inflammatory drugs
(corticosteroids).
.
If you abuse this medicine you may develop dependence (with a need to
progressively increase the dosage), chronic constipation and loss of normal
intestinal functions..
In case of accidental ingestion/intake of an excessive dose of GLICEROLO AFOM
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
• 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
https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . Reporting side effects can help provide more information
on the safety of this medicine.

5. How to store GLICEROLO AFOM

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 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 AFOM contains
GLICEROLO AFOM 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 AFOM 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 AFOM and contents of the pack
GLICEROLO AFOM children 1375 mg suppositories. Pack of 6 suppositories.
GLICEROLO AFOM adults 2250 mg suppositories. Pack of 18 suppositories.

Marketing Authorisation Holder
AEFFE FARMACEUTICI S.r.l. –
Via Carlo Porta, 49 – Gorgonzola (Mi)

Manufacturer
Industria Farmaceutica NOVA ARGENTIA S.p.A. - Via Pascoli, 1 - Gorgonzola (MI)
AEFFE FARMACEUTICI S.r.l. – Via Torino, 448 – Brandizzo (TO)

Sales Concessionaire:
Montefarmaco OTC Spa
Via IV Novembre, 92 – 20021 Bollate (MI)

Health education notes
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. 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 AFOM early childhood 2.25 g rectal solution

GLICEROLO AFOM children 4.5 g rectal solution
GLICEROLO AFOM 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 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 AFOM is and what it is used for
• 2. What you need to know before you use GLICEROLO AFOM
• 3. How to use GLICEROLO AFOM
• 4. Possible side effects
• 5. How to store GLICEROLO AFOM
• 6. Contents of the pack and other information

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

GLICEROLO AFOM 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 AFOM

Do not use GLICEROLO AFOM

• 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 in a severe state of dehydration.

Warnings and precautions
Consult your doctor or pharmacist before taking GLICEROLO AFOM.
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 of time
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. Consult your doctor when the need for a laxative arises from
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.
Drink at least 6-8 glasses of water or other liquids a day to help soften
the stool when using laxatives.
If you use laxatives excessively, frequently or incorrectly, you may
develop prolonged diarrhea with consequent loss of water, minerals (especially
potassium) and other essential nutrients. In the most severe cases of abuse, you may experience
excessive fluid loss (dehydration) or a decrease in potassium levels in
the blood (hypokalaemia) which can cause heart problems or muscle activity, especially if you are taking cardiac glycosides, diuretics or corticosteroids during the
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 AFOM only after consulting a
doctor.

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

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is the minimum sufficient to produce easy evacuation. Initially use the minimum doses provided.
The recommended dose in adults and adolescents (12-18 years) 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 6 years and 11 years, the recommended dose is 1 child single-dose container of 4.5 g as needed, up to a maximum of 1 or 2 administrations per day.
In children aged between 2 years and 6 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.
Remove the cap from the single-dose container without ever gripping the bellows, otherwise you would cause the medicine to leak before use.
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).

If you use more GLICEROLO AFOM 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).
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 present in the blood, albumin (hypoalbuminemia).
In the most severe cases, dehydration or a decrease in potassium levels in the blood (hypokalemia) may occur, which can cause heart problems and muscle activity, especially if you are taking heart medications (cardiac glycosides), medications used to lower blood pressure (diuretics) or anti-inflammatory drugs (corticosteroids) at the same time.
If you abuse this medicine, you may develop dependence (with the need to gradually increase the dosage), chronic constipation and loss of normal bowel function.
In case of accidental ingestion/administration of an excessive dose of GLICEROLO AFOM, 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,

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
https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . Reporting side effects can help provide more information
on the safety of this medicine.

5. How to store GLICEROLO AFOM

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. Package Contents and Other Information

What GLICEROLO AFOM contains
GLICEROLO AFOM 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, potato starch, purified water.

GLICEROLO AFOM children 4.5 g rectal solution

• The active ingredient is glycerol. Each single-dose container contains 4.5 g of glycerol
• The other ingredients are: chamomile fluid extract, mallow fluid extract, potato starch, purified water.

GLICEROLO AFOM 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 AFOM and package contents
Pack of 6 single-dose containers of rectal solution.

Marketing Authorisation Holder
AEFFE FARMACEUTICI S.r.l. – Via Carlo Porta, 49- Gorgonzola (Mi)

Manufacturers
AEFFE FARMACEUTICI S.r.l. – Via Torino, 448 – Brandizzo (TO)

Sales distributor:
Montefarmaco OTC Spa
Via IV Novembre, 92 – 20021 Bollate (MI)

Health education notes
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. 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.