Glycerol Farmakopea

Patient Information Leaflet: Information for the User

GLYCEROL FARMAKOPEA Adults 2250 mg Suppositories

Glycerol
Please 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 instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

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

GLICEROLO FARMAKOPEA contains the active substance glycerol, which belongs to the category
of laxatives—medicines used to facilitate the expulsion of faeces. This
medicinal product 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 have acute abdominal pain or of unknown origin;
• if you have nausea or vomiting;
• if you suffer from intestinal obstruction or narrowing (stenosis);
• if you have rectal bleeding of unknown origin;
• if you have acute hemorrhoidal swelling (acute hemorrhoidal crisis) with pain and bleeding;
• if you are severely dehydrated.

Warnings and precautions
Talk to your doctor or pharmacist before using GLICEROLO FARMAKOPEA.
If you are elderly and/or in poor general health, consult your doctor before using this
medicine.
Use medicines that stimulate bowel evacuation (laxatives) as infrequently as
possible and in any case for no longer than 7 days. Using laxatives for longer periods
requires a doctor's prescription, following an appropriate assessment of the patient's
condition.
If you suffer from constipation that lasts for long periods (chronic) or is frequent, always
seek medical advice for diagnosis, prescription of medicines, and monitoring during
treatment. Consult your doctor when the need for a laxative arises from a sudden change in
your previous bowel habits (frequency and characteristics of bowel movements) lasting more
than two weeks, or when use of the laxative fails to produce an effect.
Drink at least 6–8 glasses of water or other fluids daily to help soften stools when using
laxatives.
If you use laxatives excessively, frequently, or incorrectly, you may develop prolonged
diarrhea, resulting in loss of water, minerals (especially potassium), and other essential
nutrients. In severe cases of abuse, excessive fluid loss (dehydration) or low blood potassium
levels (hypokalaemia) may occur, which can cause heart problems or affect muscle function,
especially if you are taking natural-origin drugs affecting the heart (cardiac glycosides),
drugs that increase urine production and excretion (diuretics), or drugs used to reduce
inflammation (corticosteroids) during treatment with this medicine.
Abuse of laxatives, particularly stimulant (contact) laxatives, may lead to dependence (the
need to continually increase the dose), chronic constipation, and loss of normal intestinal
function (intestinal atony).
If you suffer from constipation, first correct your dietary habits by consuming an adequate
amount of dietary fiber and fluids in your daily diet.
In most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can
permanently resolve constipation. Many people believe they are constipated if they do not
have a bowel movement every day. This is a misconception, as this condition is completely
normal for many individuals. True constipation occurs when bowel movements are reduced
compared to your usual pattern and are associated with hard stools. If episodes of
constipation recur frequently, you should consult your doctor.

Children
This medicine must not be administered to children under 12 years of age.

Other medicines and GLICEROLO FARMAKOPEA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
There is no information available on interactions with other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or 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 using machines
This medicine does not affect the ability to drive or operate machinery.
However, pay attention to your individual response to the medicine, as adverse effects may
occur that could impair your ability to drive or operate machinery.

3. How to use GLICEROLO FARMAKOPEA

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The correct dose is the lowest amount needed to produce easy bowel evacuation. Initially use the lowest recommended dose.
The recommended dose for 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 packaging and moisten it, if necessary, to facilitate rectal insertion.
If the suppositories seem too soft, place the containers in cold water before opening them.
Use laxatives as infrequently as possible and for no longer than seven days (see section Warnings and precautions). A diet rich in fluids enhances the effect of this medicine.

If you use more GLICEROLO FARMAKOPEA than you should
If you use this medicine too frequently, for too long, or in excessive amounts, abdominal pain and persistent diarrhea may occur, leading to loss of fluids, electrolytes (especially potassium), and other essential nutrients, which must be replaced (see section Warnings and precautions).
In more severe cases, excessive fluid loss (dehydration) or low blood potassium levels (hypokalaemia) may occur, potentially causing heart problems or muscle dysfunction, especially if you are taking natural-origin drugs affecting the heart (cardiac glycosides), drugs that increase urine production and excretion (diuretics), or drugs used to reduce inflammation (corticosteroids) during treatment with this medicine.
Laxative abuse, especially of stimulant (contact) laxatives, may lead to dependence (the need to continually increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).
Symptoms of electrolyte imbalance include: thirst, vomiting, weakness, fluid retention and swelling (oedema), bone disease (osteomalacia), and decreased levels of the blood protein albumin (hypoalbuminaemia).
In case of accidental ingestion/overdose of GLICEROLO FARMAKOPEA, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data)

• Isolated cramping pains or abdominal colic and diarrhoea, with loss of fluids and 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
via the national reporting system at the following website: 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 GLYCEROL PH. EUR.

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.
The expiry date applies to the medicine stored in its original, unopened packaging and
correctly stored.
Store in the original packaging to protect the medicine from moisture and keep it away from
direct sources of heat.
Do not dispose of any medicine via 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 FARMAKOPEA contains

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

Description of the appearance of GLICEROLO FARMAKOPEA and package contents
Box containing 6, 12 and 18 suppositories.
Marketing Authorization 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 -

Package leaflet: information for the user

GLYCEROL PHARMACOPOEIA for infants 2.25 g rectal solution, children 4.5 g rectal solution, adults 6.75 g rectal solution

Glycerol
Please 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 do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

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

GLICEROLO FARMAKOPEA contains the active substance glycerol, which belongs to the category
of laxatives—medicines used to facilitate the expulsion of faeces. 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 have acute abdominal pain or of unknown origin;
• if you have nausea or vomiting;
• if you have intestinal obstruction or narrowing (stenosis);
• if you have rectal bleeding of unknown origin;
• if you have acute hemorrhoidal crisis (swelling of blood vessels around the anus) with pain and bleeding;
• if you are severely dehydrated.

Warnings and precautions
Talk to your doctor or pharmacist before using GLICEROLO FARMAKOPEA.
If you are elderly and/or in poor health, inform your doctor before using this medicine.
Use medicines that stimulate bowel evacuation (laxatives) as infrequently as possible and never for longer than 7 days. Using laxatives for longer periods requires a doctor's prescription following adequate assessment of the patient's condition.
If you suffer from long-lasting (chronic) or frequent constipation, always seek medical advice for diagnosis, prescription of medicines, and monitoring during treatment. Consult your doctor when the need for a laxative arises from a sudden change in your previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks, or when the laxative fails to produce an effect.
Drink at least 6–8 glasses of water or other fluids daily to help soften stools while using laxatives.
If you use laxatives excessively, frequently, or incorrectly, you may develop prolonged diarrhea, resulting in loss of water, mineral salts (especially potassium), and other essential nutrients. In severe cases of abuse, excessive fluid loss (dehydration) or low potassium levels in the blood (hypokalemia) may occur, which can lead to heart problems or muscle dysfunction, especially if you are taking naturally derived medicines affecting the heart (cardiac glycosides), medicines that increase urine production and excretion (diuretics), or medicines used to reduce inflammation (corticosteroids) during treatment with this medicine.
Laxative abuse, particularly of stimulant laxatives (contact laxatives), may lead to dependence (the need to continuously increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).
If you suffer from constipation, first correct your dietary habits by consuming an adequate amount of dietary fiber and water in your daily diet.
In most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can permanently resolve constipation. Many people believe they are constipated if they do not have a bowel movement every day. This is a misconception, as this condition is completely normal for many individuals. True constipation occurs when bowel movements are less frequent than usual and are associated with hard stools. If episodes of constipation recur frequently, consult your doctor.
Children
Use GLICEROLO FARMAKOPEA in children under 12 years of age only after consulting a doctor.
Other medicines and GLICEROLO FARMAKOPEA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
There is no information available on interactions with other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Take this medicine during pregnancy and breastfeeding only if strictly necessary and always under direct medical supervision.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
However, observe your response to the medicine, as adverse effects may occur that could affect your ability to drive or use machinery.

3. How to use GLYCEROL FARMAKOPEA

Use this medicine exactly as stated in this leaflet or according to your doctor’s or pharmacist’s instructions. If you have any doubts, consult your doctor or pharmacist.
The correct dose is the lowest amount needed to produce easy bowel evacuation. Initially use the lowest recommended doses.
Adults: The recommended dose is 1 single-dose container for adults (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 single-dose container for adults (6.75 g) as needed, up to a maximum of 2 single-dose containers per day.
Children aged between 6 and 11 years: The recommended dose is 1 single-dose container for children (4.5 g) as needed, up to a maximum of 2 single-dose containers per day.
Children aged between 2 and 6 years: The recommended dose is 1 single-dose container for early infancy (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 nozzle before inserting it into the rectum, then squeeze the bulb. Withdraw the nozzle while keeping the bulb compressed.
Use each container only once; discard any remaining medicine after use.
Use laxatives as infrequently as possible and for no longer than seven days (see section Warnings and precautions). A diet rich in fluids helps enhance the effect of the medicine.
If you use more GLYCEROL FARMAKOPEA than you should
If you use this medicine too frequently, for too long, or in excessive amounts, abdominal pain and persistent diarrhoea may occur, leading to loss of fluids, electrolytes (especially potassium), and other essential nutrients, which must be replaced (see section Warnings and precautions).
In more severe cases, excessive fluid loss (dehydration) or low blood potassium levels (hypokalaemia) may occur, potentially causing heart problems or muscle dysfunction, especially if you are taking naturally derived medicines affecting the heart (cardiac glycosides), medicines that increase urine production and excretion (diuretics), or medicines used to reduce inflammation (corticosteroids) during treatment with this medicine.
Abuse of laxatives, particularly stimulant laxatives (contact laxatives), may lead to dependence (the need to continuously increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).
Symptoms of disturbance in the body's electrolyte balance (electrolyte imbalance) include: thirst, vomiting, weakness, swelling due to fluid accumulation (oedema), bone disease (osteomalacia), and reduced levels of the blood protein albumin (hypoalbuminaemia).
In case of accidental ingestion/overdose of GLYCEROL FARMAKOPEA, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use 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:
Not known (frequency cannot be estimated from the available data)

• Isolated cramping pains or abdominal colic and diarrhoea, with loss of fluids and 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, 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 GLYCEROL PHARMACOPEIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month. The expiry date applies to the medicine in its original, undamaged packaging, stored correctly.
Store in the original packaging to protect the medicine from moisture and keep it away from heat sources.
Do not dispose of any medicine via 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 pediatric 2.25 g rectal solution

• The active substance is glycerol. Each single-dose container for pediatric use contains 2.25 g of glycerol.
• The other components are: chamomile fluid extract, mallow fluid extract, pregelatinized starch, purified water.

GLICEROLO FARMAKOPEA children 4.5 g rectal solution

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

GLICEROLO FARMAKOPEA adults 6.75 g rectal solution

• The active substance is glycerol. Each single-dose container for adults contains 6.75 g of glycerol.
• The other components are: chamomile fluid extract, mallow fluid extract, pregelatinized starch, purified water.

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Farmakopea S.p.A., Via Aldo Moro, 11 – 20074 Carpiano (MI).
Manufacturer
AEFFE FARMACEUTICI S.R.L., Via Torino, 448, 10032 - Brandizzo (TO)