Glycerol AN

Package leaflet: Information for the user

GLICEROLO NA 2250 mg adult suppositories

Glycerol
Read this entire leaflet carefully before using this medicine because it contains important information for you.
Always take 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 improvement or if your symptoms worsen.

Contents of this leaflet:

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

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

GLICEROLO NA contains the active substance glycerol, which belongs to the class 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 notice any improvement or if your symptoms worsen.

2. What you need to know before using GLICEROLO NA

Do not use GLICEROLO NA

• 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 taking GLICEROLO NA.
If you are elderly and/or in poor general 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 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 occurs frequently, always seek medical advice for diagnosis, prescription of medicines, and monitoring during treatment.
Drink at least 6–8 glasses of water or other fluids per day 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 (hypokalemia) may occur, which can cause heart problems or muscle dysfunction, particularly if you are taking cardiac glycosides, diuretics, or corticosteroids during treatment with this medicine.
Abuse of laxatives, especially stimulant laxatives (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 fiber and fluids in your daily diet.

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

Other medicines and GLICEROLO NA
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 necessary and always under direct medical supervision.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery. However, pay attention to your individual response to the medicine, as adverse effects may occur that could affect your ability to drive or use machinery.

3. How to use GLICEROLO NA

Use this medicine exactly as described 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 dose required to produce easy bowel movement. Initially use the lowest recommended doses.
The recommended dose for adults and adolescents over 12 years of age is 1 adult suppository as needed, up to a maximum of 1 or 2 doses per day.
Remove the suppository from its container 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 helps enhance the effect of the medicine.
If you use more GLICEROLO NA than you should
If you use this medicine too often, for too long, or in excessive amounts, you may experience abdominal pain and persistent diarrhea, leading to loss of fluids, electrolytes (especially potassium), and other essential nutrients, which must be replaced (see section Warnings and precautions).
Symptoms of disturbance in the body's electrolyte balance (electrolyte imbalance) include: thirst, vomiting, weakness, swelling (edema), bone problems (osteomalacia), and decreased levels of albumin, a protein in the blood (hypoalbuminemia).
In case of accidental ingestion/overdose of GLICEROLO NA, contact your doctor immediately or go to the nearest hospital.
If you have any questions 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 will experience them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

• Isolated cramping pains or abdominal colic and diarrhoea, with loss of fluids and mineral salts (electrolytes), more frequent in cases of severe constipation
• Rectal irritation

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/it/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GLYCEROL NA

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.
Store in the original packaging to protect the medicine from moisture and keep 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 NA contains
GLICEROLO NA adults 2250 mg suppositories

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

Description of the appearance of GLICEROLO NA and contents of the pack
GLICEROLO NA adults 2250 mg suppositories. Carton containing 18 suppositories.
Marketing Authorization Holder
Industria Farmaceutica NOVA ARGENTIA S.r.l. - Via Carlo Porta, 49 – Gorgonzola (MI).
Manufacturer
Industria Farmaceutica NOVA ARGENTIA S.r.l. - Via Pascoli, 1 - Gorgonzola (MI)
Health education notes
In most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can permanently resolve constipation. Many people believe they suffer from constipation if they are unable to defecate every day. This is a mistaken belief, as this condition is completely normal for many individuals. True constipation occurs when bowel movements are reduced compared to one's usual habits and are associated with the passage of hard stools. If episodes of constipation recur, a doctor should be consulted.

Package leaflet: information for the user

GLYCEROL NA Paediatric 2.25 g Rectal Solution

GLYCEROL NA Adult 6.75 g Rectal Solution
Glycerol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

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

Contents of this leaflet:

1. What GLICEROLO NA is and what it is used for
2. What you need to know before using GLICEROLO NA
3. How to use GLICEROLO NA
4. Possible side effects
5. How to store GLICEROLO NA
6. Package contents and other information

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

GLICEROLO NA contains the active substance glycerol, which belongs to the class 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 notice any improvement or if you experience a worsening of symptoms.

2. What you need to know before using GLYCEROL NA

Do not use GLYCEROL NA

• 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 taking GLYCEROL NA.
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 an appropriate assessment of your condition.
If you suffer from constipation that lasts for long periods (chronic) or occurs frequently, always consult your doctor for diagnosis, prescription of medicines, and monitoring during treatment.
Drink at least 6–8 glasses of water or other fluids daily to help soften stools when using laxatives.
If you overuse laxatives, use them 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 potassium levels in the blood (hypokalemia) may occur, which can cause heart problems or affect muscle function, particularly if you are taking cardiac glycosides, diuretics, or corticosteroids during treatment with this medicine.
Abuse of laxatives, especially stimulant laxatives (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 including an adequate amount of fiber and fluids in your daily diet.
Children
In children under 12 years of age, use GLYCEROL NA only after consulting a doctor.
Other medicines and GLYCEROL NA
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, think you might 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 necessary and always under direct medical supervision.
Driving and using machines
This medicine does not impair your ability to drive or operate machinery. However, monitor your response to the medicine, as adverse effects may occur that could affect your ability to drive or use machinery.

3. How to use GLICEROLO NA

Use this medicine 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 lowest amount needed to produce an easy bowel movement. Initially use the lowest recommended doses.
The recommended dose in adults and adolescents over 12 years of age is 1 single-dose container for adults (6.75 g) as needed, up to a maximum of 1 or 2 administrations per day.
In children aged between 2 and 11 years, the recommended dose is 1 single-dose container for early childhood (2.25 g) as needed, up to a maximum of 1 or 2 administrations per day.
If necessary, use one drop of the medicinal solution to moisten (lubricate) the cannula before inserting it into the rectum, then squeeze the bulb. Withdraw the cannula while keeping the bulb squeezed.
Use each container for a single administration only; discard any remaining medicine.
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 the medicine.

If you use more GLICEROLO NA than you should
If you use this medicine too frequently, for too long, or in excessive amounts, you may experience abdominal pain and persistent diarrhoea, leading to fluid loss, minerals (especially potassium), and other essential nutrients that need to be replaced (see section Warnings and precautions).
Symptoms of imbalance in the body's electrolyte levels (electrolyte imbalance) include: thirst, vomiting, weakness, swelling (oedema), bone problems (osteomalacia), and decreased levels of albumin, a protein in the blood (hypoalbuminaemia).
In case of accidental ingestion/overdose of GLICEROLO NA, 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:
Frequency not known ( frequency cannot be estimated from the available data):

• Isolated cramp-like 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address: www.agenziafarmaco.gov.it/it/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GLICEROLO NA

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.
Store in the original container tightly closed to protect the medicine from moisture and keep 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 NA contains
GLICEROLO NA first infancy 2.25 g rectal solution

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

GLICEROLO NA adults 6.75 g rectal solution

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

Description of the appearance of GLICEROLO NA and contents of the pack
Pack containing 6 single-dose containers of rectal solution.
Marketing Authorization Holder
Industria Farmaceutica NOVA ARGENTIA S.r.l. - Via Carlo Porta, 49 –
Gorgonzola (MI).
Responsible Lot Release Manufacturer
Industria Farmaceutica NOVA ARGENTIA S.r.l. - Via G. Pascoli, 1 - Gorgonzola (MI)
Health education notes
In most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit) can provide long-term relief from constipation. Many people believe they suffer from constipation if they are unable to defecate every day. This is a mistaken belief, as this condition is completely normal for many individuals. True constipation occurs when bowel movements are reduced compared to one's usual pattern and are associated with the passage of hard stools. If episodes of constipation occur repeatedly, a doctor should be consulted.