GLICEROLO 6.75 G Rectal solution

Содержание инструкции

1. GLICEROLO FG Children 1375 mg suppositories, Adults 2250 mg suppositories
   1. What is GLICEROLO FG and what is it used for?
   2. What you need to know before using GLICEROLO FG
   3. How to use GLICEROLO FG
   4. Possible side effects
   5. How to store GLICEROLO FG
   6. Package Contents and Other Information
2. GLICEROLO FG Children 2.25 g rectal solution, Adults 6.75 g rectal solution
   1. What is GLICEROLO FG and what is it used for
   2. What you need to know before using GLICEROLO FG
   3. How to use GLICEROLO FG
   4. Possible side effects
   5. How to store GLICEROLO FG
   6. Contents of the pack and other information

GLICEROLO FG Children 1375 mg suppositories, Adults 2250 mg suppositories

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 would like more information or advice, ask your pharmacist.
• If any undesirable effects occur, including any 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 FG is and what it is used for
• 2. What you need to know before you use GLICEROLO FG
• 3. How to use GLICEROLO FG
• 4. Possible side effects
• 5. How to store GLICEROLO FG
• 6. Contents of the pack and other information

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

GLICEROLO FG contains the active ingredient glycerol which belongs to the category of
laxatives, which are medicines used to facilitate the elimination of faeces.
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 FG

Do not use GLICEROLO FG

• 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 haemorrhoidal 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 FG.
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 that 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 experience
prolonged diarrhoea 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
(hypokalaemia) may occur, 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 always increase the dosage), chronic constipation and loss
of normal bowel function (intestinal atony).

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

Other medicines and GLICEROLO FG
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 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 impair the ability to drive and use machinery (see “Side effects”).

3. How to use GLICEROLO FG

Use this medicine following exactly as indicated 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. When necessary, the dose may 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 FG 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 FG 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 insertion.
If the suppositories appear too soft, place the containers in cold water before
opening them.

If you use more GLICEROLO FG 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 replenished.
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/intake of an excessive dose of GLICEROLO FG
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.
With GLICEROLO FG the following side effects have been observed with an unknown frequency (the frequency cannot be defined based on available data):

• cramping pains (isolated or widespread in the abdomen);
• abdominal pain that is not continuous (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 or 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 FG

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

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
FG S.r.l.
Via San Rocco, 6
85033 Episcopia (PZ)

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 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, however, when bowel movements are reduced compared to one's personal
habits and are associated with the passage 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 appropriate to contact the doctor.

GLICEROLO FG Children 2.25 g rectal solution, Adults 6.75 g rectal solution

Read this leaflet carefully before using this medicine because 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 FG is and what it is used for
• 2. What you need to know before using GLICEROLO FG
• 3. How to use GLICEROLO FG
• 4. Possible side effects
• 5. How to store GLICEROLO FG
• 6. Contents of the pack and other information

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

GLICEROLO FG contains the active ingredient glycerol, which belongs to the category of
laxatives, which are medicines used to facilitate the elimination of faeces.
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 FG

Do not use GLICEROLO FG

• 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 haemorrhoidal 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 FG.
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 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 help soften
the stool when using laxatives.
If you use laxatives excessively, frequently or incorrectly, you may experience
prolonged diarrhoea 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 blood potassium levels
(hypokalaemia) may occur, which can cause heart or muscle problems,
especially if you are taking cardiac glycosides, diuretics or corticosteroids during the
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 FG only after consulting a
doctor.

Other medicines and GLICEROLO FG
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
with breast milk, 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 impair the ability to drive and operate machinery (see “Side effects”).

3. How to use GLICEROLO FG

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 single-dose container of GLICEROLO FG 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 FG 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 it 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 FG than you should
If you use this medicine in excessive quantities, abdominal pain and persistent diarrhea may occur, causing loss of fluids, minerals (especially potassium) and other essential nutrients that must be replenished.
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/intake of an excessive dose of GLICEROLO FG, 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 FG the following side effects have been observed with an unknown frequency
(the 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
consult 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 contribute to providing more information on the safety of this
medicine

5. How to store GLICEROLO FG

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 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 FG contains
The active ingredient is glycerol.
GLICEROLO FG Children 2.25 g rectal solution contains 2.25 g of glycerol
GLICEROLO FG 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 FG and contents of the pack
GLICEROLO FG 2.25 g and 6.75 g rectal solution are available in packs containing 6
single-dose containers.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
FG S.r.l.
Via San Rocco, 6
85033 Episcopia (PZ)

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 fibre (bran, vegetables and fruit)
can durably resolve 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.
Constipation is considered instead when bowel movements are reduced compared to one's personal
habits and are associated with the passage of hard stools. Before using laxatives, it is advisable to correct
dietary habits, supplementing the daily diet with an adequate intake of fibre and water.
If the disorder is continuous (chronic constipation) or recurrent, it is appropriate to contact your doctor.