GLICEROLO 6.75 G Rectal solution

Зміст інструкції

1. GLICEROLO COOP Bambini 1375 mg suppositories
   1. What is GLICEROLO COOP and what is it used for
   2. What you need to know before using GLICEROLO COOP
   3. How to use GLICEROLO COOP
   4. Possible side effects
   5. How to store GLICEROLO COOP
   6. Package contents and other information
2. GLICEROLO COOP Children 2.25 g rectal solution, Adults 6.75 g rectal solution
   1. What is GLICEROLO COOP and what is it used for
   2. What you need to know before using GLICEROLO COOP
   3. How to use GLICEROLO COOP
   4. Possible side effects
   5. How to store GLICEROLO COOP
   6. Contents of the pack and other information

GLICEROLO COOP Bambini 1375 mg suppositories

GLICEROLO COOP Adulti 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 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.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

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

GLICEROLO COOP contains the active ingredient glycerol, which belongs to the category of
laxatives, which are medicines used to facilitate the elimination 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 your symptoms worsen
after 7 days.

2. What you need to know before using GLICEROLO COOP

Do not use GLICEROLO COOP

• 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 COOP.
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 of time
requires a doctor's prescription, after adequate assessment of the patient's conditions.
If you suffer from constipation that lasts for a long time (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 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 loss of fluids (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.
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 intestinal functions (intestinal atony).

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

Other medicines and GLICEROLO COOP
Inform your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
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 using
this medicine.
Use 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 (see “Side effects”).

3. How to use GLICEROLO COOP

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist. The correct dose is the minimum sufficient to produce easy evacuation. Use initially the minimum doses provided. When necessary, the dose can then be increased, but never exceeding the maximum indicated.

Use in adults and adolescents (12-18 years)
The recommended dose is 1 suppository of GLICEROLO COOP 2250 mg as needed, up to a maximum of 2 suppositories per day.

Use in children aged between 2 years and 11 years
The recommended dose is 1 suppository of GLICEROLO COOP 1375 mg as needed, up to a maximum of 2 suppositories per day.
Use laxatives as infrequently as possible and for no more than seven days (see “Warnings and precautions”).

Method of administration
Remove the suppository from its container and moisten it, if necessary, to facilitate rectal introduction.
If they seem too soft, place the containers in cold water before opening them.

If you use more GLICEROLO COOP than you should
If you use this medicine 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.
The symptoms of an alteration of the balance of salts in the body (electrolyte imbalance) are: thirst, vomiting, weakness, swelling (edema), bone problems (osteomalacia) and lowering of a protein present in the blood, albumin (hypoalbuminemia).
In case of accidental ingestion/intake of an excessive dose of GLICEROLO COOP, 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 everyone will experience them.
With GLICEROLO COOP, the following side effects have been observed with an unknown frequency (frequency cannot be defined based on available data):

• cramping pains (isolated or widespread in the abdomen);
• non-continuous abdominal pain (colic);
• diarrhea (with loss of fluids and electrolytes);
• redness with burning or pain (irritation) at the level of the anus.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
http://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 COOP

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. Package contents and other information

What GLICEROLO COOP contains
The active ingredient is glycerol.
GLICEROLO COOP Children 1375 mg suppositories contain 1375 mg of glycerol .
The other ingredients are: sodium stearate, sodium carbonate decahydrate.
GLICEROLO COOP Adults 2250 mg suppositories contain 2250 mg of glycerol.
The other ingredients are: sodium stearate, sodium bicarbonate.

Description of the appearance of GLICEROLO COOP and package contents
GLICEROLO COOP 1375 mg and 2250 mg suppositories are available in packs
containing 18 suppositories.

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

Manufacturers
GLICEROLO COOP Children 1375 mg suppositories:
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)
GLICEROLO COOP Adults 2250 mg suppositories:
Industria Farmaceutica NOVA ARGENTIA S.r.l. – Via Pascoli, 1 – Gorgonzola – Milano.

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.
Constipation is considered instead when evacuations are reduced compared to one's
personal habits and are associated with the emission of hard stools. Before using laxatives,
it is good to correct eating habits, integrating the daily diet with an adequate
intake of fiber and water.
If the disorder is continuous (chronic constipation) or recurrent, it is advisable to contact
your doctor.

GLICEROLO COOP Children 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 use 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 worsen after 7 days.

Contents of this leaflet:

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

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

GLICEROLO COOP contains the active ingredient glycerol which belongs to the category of
laxatives, which are medicines used to facilitate the elimination 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 your symptoms worsen
after 7 days.

2. What you need to know before using GLICEROLO COOP

Do not use GLICEROLO COOP

• 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 or of unknown origin abdominal pain;
• 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 COOP.
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 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 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 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, 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
treatment with this medicine.
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).

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

Other medicines and GLICEROLO COOP
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 using
this medicine.
Use 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 (see “Side effects”).

3. How to use GLICEROLO COOP

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. Use initially the minimum doses provided. When necessary, the dose can then be increased, but never exceeding the maximum indicated.

Use in adults and adolescents (12-18 years)
The recommended dose is 1 single-dose container of GLICEROLO COOP 6.75 g as needed, up to a maximum of 2 single-dose containers per day.

Use in children aged between 2 years and 11 years
The recommended dose is 1 single-dose container of GLICEROLO COOP 2.25 g as needed, up to a maximum of 2 single-dose containers per day.
Use laxatives as infrequently as possible and for no more than seven days (see “Warnings and precautions”).

Method of administration
Remove the cap from the single-dose container without ever gripping the applicator tip, 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 applicator tip. Extract the cannula while keeping the applicator tip pressed.
Use the container for a single administration; discard any remaining medicine.

If you use more GLICEROLO COOP than you should
If you use this medicine 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.
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 case of accidental ingestion/administration of an excessive dose of GLICEROLO COOP, 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 everyone will experience them.
With GLICEROLO COOP, the following side effects have been observed with an unknown frequency (frequency cannot be defined based on available data):

• cramping pains (isolated or widespread in the abdomen);
• non-continuous abdominal pain (colic);
• diarrhea (with loss of fluids and electrolytes);
• redness with burning or pain (irritation) at the level of the anus.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
http://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 COOP

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 COOP contains
The active ingredient is glycerol.
GLICEROLO COOP Children 2.25 g rectal solution contains 2.25 g of glycerol
GLICEROLO COOP Adults 6.75 g rectal solution contains 6.75 g of glycerol.
The other ingredients are: chamomile fluid extract, mallow fluid extract, wheat starch, purified water.

Description of the appearance of GLICEROLO COOP and contents of the pack
GLICEROLO COOP 2.25 g and 6.75 g rectal solution is available in packs
containing 6 single-dose containers.

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

Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)

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.
Constipation is considered instead when evacuations are reduced compared to one's
personal habits and are associated with the emission of hard stools. Before using laxatives,
it is good to correct eating habits, integrating the daily diet with an adequate
intake of fiber and water.
If the disorder is continuous (chronic constipation) or recurrent, it is advisable to contact
your doctor.