Glycerol Nova Argentia

Patient Information Leaflet: Information for the User

GLYCEROL NOVA ARGENTIA children 1375 mg suppositories, adults 2250 mg suppositories

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 side effects, including those not listed in this leaflet, consult 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 GLYCEROL NOVA ARGENTIA is and what it is used for
2. What you need to know before using GLYCEROL NOVA ARGENTIA
3. How to use GLYCEROL NOVA ARGENTIA
4. Possible side effects
5. How to store GLYCEROL NOVA ARGENTIA
6. Package contents and other information

1. What GLICEROLO NOVA ARGENTIA is and what it is used for

GLICEROLO NOVA ARGENTIA 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 notice any improvement or if your symptoms worsen.

2. What you need to know before using GLICEROLO NOVA ARGENTIA

Do not use GLICEROLO NOVA ARGENTIA

• 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 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 NOVA ARGENTIA.
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 the patient's 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 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 blood potassium levels (hypokalemia) may occur, which can lead to 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 continuously increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).
In case of 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 NOVA ARGENTIA only after consulting a doctor.

Other medicines and GLICEROLO NOVA ARGENTIA
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 use of 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 NOVA ARGENTIA

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 that produces easy bowel evacuation. Initially use the lowest recommended doses.
The recommended dose in adults and adolescents aged over 12 years is 1 adult suppository 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 paediatric suppository as needed, up to a maximum of 1 or 2 administrations 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 the effect of this medicine.

If you use more GLICEROLO NOVA ARGENTIA 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, loss of minerals (especially potassium), and other essential nutrients that need to be replaced (see section Warnings and precautions).
Symptoms of electrolyte imbalance in the body include: thirst, vomiting, weakness, swelling (oedema), bone problems (osteomalacia), and low levels of a protein in the blood called albumin (hypoalbuminaemia).
In case of accidental ingestion/overdose of GLICEROLO NOVA ARGENTIA, 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 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 the following website: www.agenziafarmaco.gov.it/it/ 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 NOVA ARGENTIA

Keep this medicine out of 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 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 NOVA ARGENTIA contains
GLICEROLO NOVA ARGENTIA children 1375 mg suppositories

• The active substance is glycerol. Each suppository contains 1375 mg of glycerol.
• The other components are: sodium stearate, sodium bicarbonate.

GLICEROLO NOVA ARGENTIA 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 NOVA ARGENTIA and contents of the pack
GLICEROLO NOVA ARGENTIA children 1375 mg suppositories. Box containing 6, 12, 18 suppositories.
GLICEROLO NOVA ARGENTIA adults 2250 mg suppositories. Box containing 12, 18, 48 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 fibre (bran, vegetables and fruit) can
provide a long-term solution to constipation. Many people believe they are constipated
if they do not have a bowel movement every day. This is a mistaken belief, as going less than daily is
perfectly normal for many individuals. True constipation occurs when bowel movements are less frequent than usual and are associated with the passage of hard stools. If episodes of constipation recur frequently, a doctor should be consulted.

Package leaflet: information for the user

GLYCEROL NOVA ARGENTIA pediatric 2.25 g rectal solution, adult 6.75 g rectal solution

Glycerol
Please read this leaflet carefully before using this medicine as 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 further information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, inform 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 GLYCEROL NOVA ARGENTIA is and what it is used for
2. What you need to know before using GLYCEROL NOVA ARGENTIA
3. How to use GLYCEROL NOVA ARGENTIA
4. Possible side effects
5. How to store GLYCEROL NOVA ARGENTIA
6. Contents of the pack and other information

1. What GLICEROLO NOVA ARGENTIA is and what it is used for

GLICEROLO NOVA ARGENTIA 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 notice any improvement or if you experience worsening of symptoms.

2. What you need to know before using GLICEROLO NOVA ARGENTIA

Do not use GLICEROLO NOVA ARGENTIA

• 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 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 NOVA ARGENTIA.
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 more than 7 days. Using laxatives for longer periods requires a doctor's prescription following an adequate assessment of the patient's 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 liquids daily to help soften stools when using laxatives.
If you use laxatives excessively, frequently, or incorrectly, you may develop persistent diarrhea leading to 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 cause heart problems or muscle dysfunction, especially if you are taking cardiac glycosides, diuretics, or corticosteroids during treatment with this medicine.
Abuse of laxatives, particularly stimulant (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 fluids in your daily diet.

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

Other medicines and GLICEROLO NOVA ARGENTIA
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, monitor your response to the medicine, as adverse effects may occur that could affect your ability to drive or operate machinery.

3. How to use GLYCEROL NOVA ARGENTIA

Use this medicine exactly as stated 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 dose that produces easy evacuation. Initially use the lowest recommended doses.
The recommended dose in adults and adolescents is 1 single-dose container for adults containing 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 containing 2.25 g as needed, up to a maximum of 1 or 2 administrations per day.
If necessary, use a 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 compressed.
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 helps enhance the effect of the medicine.
If you use more GLYCEROL NOVA ARGENTIA than you should
If you use this medicine too often, for too long, or in excessive amounts, you may experience abdominal pain and persistent diarrhoea, leading to fluid loss, loss of minerals (especially potassium), and other essential nutrients that need to be replaced (see section Warnings and precautions).
Symptoms of disturbance in the body's electrolyte balance (electrolyte imbalance) include: thirst, vomiting, weakness, swelling (oedema), bone problems (osteomalacia), and decreased levels of the protein albumin in the blood (hypoalbuminaemia).
In case of accidental ingestion/overdose of GLYCEROL NOVA ARGENTIA, 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 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 the following website: 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 NOVA ARGENTIA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the pack 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 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 no longer required. This will help protect the environment.

6. Package contents and other information

What GLICEROLO NOVA ARGENTIA contains
GLICEROLO NOVA ARGENTIA 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, potato starch, purified water.

GLICEROLO NOVA ARGENTIA 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, potato starch, purified water.

Description of the appearance of GLICEROLO NOVA ARGENTIA 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 Manufacturers for Batch Release
Industria Farmaceutica NOVA ARGENTIA S.r.l. - Via G. Pascoli, 1 - Gorgonzola (MI)
AEFFE FARMACEUTICI S.r.l. – Via Torino, 448 – Brandizzo (TO)
Health education notes
In most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can
provide a long-term solution to 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
perfectly normal for a large number of individuals. True constipation occurs when bowel movements are reduced in frequency compared to an individual's usual pattern and are associated with the passage of hard stools. If episodes of constipation occur repeatedly, a doctor should be consulted.