GLICEROLO 2250 mg Суппозиторий

Содержание инструкции

1. GLICEROLO FARMAKOPEA Adults 2250 mg suppositories
   1. What is GLICEROLO FARMAKOPEA and what is it used for
   2. What you need to know before using GLICEROLO FARMAKOPEA
   3. How to use GLICEROLO FARMAKOPEA
   4. Possible side effects
   5. How to store GLICEROLO FARMAKOPEA
   6. Contents of the pack and other information
2. GLICEROLO FARMAKOPEA early childhood 2.25 g rectal solution, children 4.5 g rectal solution, adults 6.75 g rectal solution
   1. What is GLICEROLO FARMAKOPEA and what is it used for
   2. What you need to know before using GLICEROLO FARMAKOPEA
   3. How to use GLICEROLO FARMAKOPEA
   4. Possible side effects
   5. How to store GLICEROLO FARMAKOPEA
   6. Contents of the pack and other information

GLICEROLO FARMAKOPEA Adults 2250 mg suppositories

Glycerol

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 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 after 7 days.

Contents of this leaflet:

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

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

GLICEROLO FARMAKOPEA contains the active ingredient glycerol, which belongs to the category
of laxatives, which are medicines used to facilitate bowel movements. This
medicine is indicated for the short-term treatment of occasional constipation.
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using GLICEROLO FARMAKOPEA

Do not use GLICEROLO FARMAKOPEA

• 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 using GLICEROLO FARMAKOPEA.
If you are elderly and/or in poor health, consult your doctor before using this
medicine.
Use medicines that stimulate bowel movements (laxatives) as infrequently
as possible and 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 (hypokalemia) which can cause heart problems or muscle activity, especially if you are taking drugs of natural origin with effects on the heart (cardiac glycosides), drugs that increase the production and excretion of urine (diuretics) or drugs
used to reduce inflammation (corticosteroids) during treatment with this
medicine.
Abuse of laxatives, especially 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.
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 have a bowel movement 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 your habits and are associated with the passage of hard stools. If episodes of constipation occur
repeatedly, you should consult your doctor.

Children
This medicine should not be given to children under 12 years of age.

Other medicines and GLICEROLO FARMAKOPEA
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 strictly
necessary and always under direct medical supervision.

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

3. How to use GLICEROLO FARMAKOPEA

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 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 2 suppositories per day.
Remove the suppository from its container and moisten it, if necessary, to facilitate
rectal insertion.
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 the
Warnings and precautions section). A diet rich in fluids promotes the effect of the
medicine.

If you use more GLICEROLO FARMAKOPEA 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 the Warnings and precautions section).
In the most severe cases, excessive fluid loss (dehydration) or a decrease in blood potassium levels (hypokalemia) may occur, which can cause
problems with the heart or muscle activity, especially if you are taking medications of natural origin with effects on the heart (cardiac glycosides), medications that increase urine production and
excretion (diuretics) or medications used to reduce inflammation
(corticosteroids) during treatment with this medicine.
The abuse of laxatives, especially stimulant laxatives, can cause
dependence (the need to increase the dosage more and more), chronic constipation and
loss of normal bowel function (intestinal atony).
The symptoms of an imbalance of salts in the body (electrolyte imbalance) are: thirst, vomiting, weakness, swelling caused by fluid accumulation
(edema), bone disease (osteomalacia) and a decrease in the levels of a protein present
in the blood, albumin (hypoalbuminemia).
In case of accidental ingestion/intake of an excessive dose of GLICEROLO
FARMAKOPEA, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about using 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 cannot be estimated from available data)

• Pains 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 get any side effects, talk to 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 GLICEROLO FARMAKOPEA

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.
The expiry date refers to the medicine in intact packaging, correctly
stored.
Store in the original packaging 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. Contents of the pack and other information

What GLICEROLO FARMAKOPEA contains

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

Description of the appearance of GLICEROLO FARMAKOPEA and contents of the pack
Pack of 6, 12 and 18 suppositories.

Marketing authorisation holder and manufacturer
Farmakopea S.p.A., Via Aldo Moro, 11 – 20074 Carpiano (MI).

Manufacturer
Industria Farmaceutica NOVA ARGENTIA S.p.A. Via G. Pascoli, 1 20064 - Gorgonzola - MI –

GLICEROLO FARMAKOPEA early childhood 2.25 g rectal solution, children 4.5 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 use 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 FARMAKOPEA is and what it is used for
• 2. What you need to know before you use GLICEROLO FARMAKOPEA
• 3. How to use GLICEROLO FARMAKOPEA
• 4. Possible side effects
• 5. How to store GLICEROLO FARMAKOPEA
• 6. Contents of the pack and other information

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

GLICEROLO FARMAKOPEA 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 feel better or if you feel worse after 7 days.

2. What you need to know before using GLICEROLO FARMAKOPEA

Do not use GLICEROLO FARMAKOPEA

• 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 using GLICEROLO FARMAKOPEA.
If you are elderly and/or not in good health, inform your doctor before using this
medicine.
Use medicines that stimulate the expulsion of stools (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 conditions.
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 stems 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.
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
develop prolonged diarrhea with consequent loss of water, mineral salts (especially
potassium) and other essential nutrients. In the most severe cases of abuse, it may manifest
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 drugs of natural origin with effects on the heart (cardiac glycosides), drugs that increase the production and excretion of urine (diuretics) or drugs
used to reduce inflammation (corticosteroids) during treatment with this
medicine.
The abuse of laxatives, especially stimulant laxatives (contact laxatives), can cause
dependence (the need to always increase the dosage), 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.
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 because this situation is perfectly normal for a large number of individuals. True constipation occurs when evacuations are reduced in number compared to
their habits and are associated with the emission of hard stools. If episodes of constipation occur
repeatedly, you should consult your doctor.

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

Other medicines and GLICEROLO FARMAKOPEA
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 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 strictly
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 FARMAKOPEA

Use this medicine following exactly as stated in this leaflet or as instructed 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 prescribed doses.
Adults: the recommended dose is 1 adult single-dose container of 6.75 g as needed, up to a
maximum of 2 single-dose containers per day.

Use in children and adolescents
Adolescents: the recommended dose is 1 adult single-dose container of 6.75 g as needed
up to a maximum of 2 single-dose containers per day.
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 2 single-dose containers per
day.
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 2 single-dose containers
per day.
Remove the cap from the single-dose container
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 the
Warnings and precautions paragraph). A diet rich in fluids promotes the effect of the
medicine.

If you use more GLICEROLO FARMAKOPEA 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, minerals (especially potassium) and
other essential nutrients that must be replaced (see the Warnings and precautions
paragraph).
In the most severe cases, excessive fluid loss (dehydration) or a decrease in blood potassium
levels (hypokalaemia) may occur, which can cause problems with the heart or muscle activity,
especially if you are taking drugs of natural origin with effects on the heart (cardiac glycosides),
drugs that increase urine production and excretion (diuretics) or drugs used to reduce
inflammation (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).
The symptoms of an imbalance of salts in the body (electrolyte imbalance) are: thirst, vomiting,
weakness, swelling caused by fluid accumulation (edema), bone disease (osteomalacia) and a
decrease in the levels of a protein present in the blood, albumin (hypoalbuminemia).
In case of accidental ingestion/intake of an excessive dose of GLICEROLO
FARMAKOPEA, immediately inform your doctor or go to the nearest hospital.
If you have any doubts about using 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 cannot be estimated from available data)

• Pains 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
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 GLICEROLO FARMAKOPEA

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. The expiry date
refers to the medicine in intact packaging, correctly stored.
Store in the original packaging to protect the medicine from moisture and away from
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 FARMAKOPEA contains
GLICEROLO FARMAKOPEA infant 2.25 g rectal solution

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

GLICEROLO FARMAKOPEA children 4.5 g rectal solution

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

GLICEROLO FARMAKOPEA adults 6.75 g rectal solution

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

Description of the appearance of GLICEROLO FARMAKOPEA and contents of the pack
GLICEROLO FARMAKOPEA infant 2.25 g rectal solution. Pack of 6 single-dose containers of 3 g each.
GLICEROLO FARMAKOPEA children 4.5 g rectal solution. Pack of 6 single-dose containers of 6 g each.
GLICEROLO FARMAKOPEA adults 6.75 g rectal solution. Pack of 6 single-dose containers of 9 g each.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmakopea S.p.A., Via Aldo Moro, 11 – 20074 Carpiano (MI).

Manufacturer
AEFFE FARMACEUTICI S.R.L. Via Torino, 448 10032 - Brandizzo (TO)