Glycerol Coop
Italy
Table of Contents
Package leaflet: Information for the user
GLICEROLO COOP 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 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 you notice worsening of symptoms after 7 days.
Contents of this leaflet:
- What GLICEROLO COOP is and what it is used for
- What you need to know before using GLICEROLO COOP
- How to use GLICEROLO COOP
- Possible side effects
- How to store GLICEROLO COOP
- Contents of the pack and other information
1. What GLICEROLO COOP is and what it is used for
GLICEROLO COOP contains the active substance glycerol, which belongs to the category of
laxatives, 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 you notice a worsening of symptoms
after 7 days.
2. What you need to know before using GLYCEROL COOP
Do not use GLYCEROL COOP
- 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 swelling (acute hemorrhoidal crisis) with pain and bleeding;
- if you are severely dehydrated.
Warnings and precautions
Talk to your doctor or pharmacist before using GLYCEROL COOP.
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 consult your doctor for diagnosis, prescription of medicines, and monitoring during treatment. Consult your doctor when the need for a laxative arises from a sudden change in 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 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 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 (contact) laxatives, may lead to dependence (the need to continually increase the dose), chronic constipation, and loss of normal bowel function (intestinal atony).
Children
In children under 12 years of age, use GLYCEROL COOP only after consulting a doctor.
Other medicines and GLYCEROL COOP
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 pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Use 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 use machinery (see “Side effects”).
3. How to use GLICEROLO COOP
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 one that produces easy bowel evacuation. Initially use the lowest recommended doses. If necessary, the dose may be increased later, but never exceed the maximum indicated dose.
Use in adults and adolescents (12–18 years of age)
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 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 longer 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 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 amounts, abdominal pain and persistent diarrhoea may occur, leading to loss of fluids, mineral salts (especially potassium), and other essential nutrients, which must be replaced.
Symptoms of altered body salt 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 GLICEROLO COOP, 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 everyone experiences them.
The following adverse reactions have been observed with GLYCEROL COOP at an unknown frequency (frequency cannot be estimated from the available data):
- Cramp-like pains (localized or widespread in the abdomen);
- Intermittent abdominal pain (colic);
- Diarrhoea (with loss of fluids and electrolytes);
- Redness with burning or pain (irritation) around the anus.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You may also report side effects directly via the national reporting system at the following website: 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 GLYCEROL COOP
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 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 COOP contains
The active substance is glycerol.
GLICEROLO COOP Bambini 1375 mg suppositories contain 1375 mg of glycerol.
The other components are: sodium stearate, sodium carbonate decahydrate.
GLICEROLO COOP Adulti 2250 mg suppositories contain 2250 mg of glycerol.
The other components are: sodium stearate, sodium bicarbonate.
Description of the appearance of GLICEROLO COOP and contents of the pack
GLICEROLO COOP 1375 mg and 2250 mg suppositories are available in packs containing 18 suppositories.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Industria Farmaceutica NOVA ARGENTIA S.r.l. – Via Carlo Porta, 49 – Gorgonzola (MI)
Manufacturers
GLICEROLO COOP Bambini 1375 mg suppositories:
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)
GLICEROLO COOP Adulti 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 permanently resolve constipation.
Many people believe they suffer from constipation if they do not have a bowel movement every day. This belief is incorrect, as going less frequently is perfectly normal for many individuals.
Constipation is instead defined as a reduction in bowel movements compared to one's usual pattern, associated with the passage of hard stools. Before using laxatives, it is advisable to correct dietary habits by increasing daily intake of fiber and water.
If the condition is persistent (chronic constipation) or recurrent, it is recommended to consult a doctor.
Package leaflet: information for the user
GLICEROLO COOP Children 2.25 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 instructed.
- Keep this leaflet. You may need to read it again.
- If you would like more information or advice, please 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:
- What GLICEROLO COOP is and what it is used for
- What you need to know before using GLICEROLO COOP
- How to use GLICEROLO COOP
- Possible side effects
- How to store GLICEROLO COOP
- Contents of the pack and other information
1. What GLICEROLO COOP is and what it is used for
GLICEROLO COOP contains the active substance glicerolo, which belongs to the category of
laxatives—medicinal products 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 improvement or if your symptoms worsen after 7 days.
2. What you need to know before using GLYCEROL COOP
Do not use GLYCEROL COOP
- 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 swelling of the blood vessels around the anus (acute hemorrhoidal crisis) with pain and bleeding;
- if you are severely dehydrated.
Warnings and precautions
Talk to your doctor or pharmacist before using GLYCEROL COOP.
If you are elderly and/or in poor health, inform your doctor before using this medicine.
Use 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 consult your doctor for diagnosis, prescription of medicines, and monitoring during treatment. Consult your doctor when the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks, or when the 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 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 blood potassium levels (hypokalaemia) may occur, which can cause heart problems or affect muscle function, 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 continually increase the dose), chronic constipation, and loss of normal bowel function (intestinal atony).
Children
In children under 12 years of age, use GLYCEROL COOP only after consulting a doctor.
Other medicines and GLYCEROL COOP
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 using this medicine.
Use 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 operate machinery (see "Side effects").
3. How to use GLICEROLO COOP
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 an easy bowel movement. Initially use the lowest recommended doses. If necessary, the dose may then be increased, but never exceed the maximum recommended dose.
Use in adults and adolescents (12-18 years of age)
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 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 longer than seven days (see "Warnings and precautions").
Method of administration
Remove the cap from the single-dose container without ever touching the bulb, otherwise the medicine may be expelled before use.
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 still squeezing the bulb.
Use each container only once; discard any remaining medicine after administration.
If you use more GLICEROLO COOP than you should
If you use excessive amounts of this medicine, abdominal pain and persistent diarrhoea may occur, leading to loss of fluids, mineral salts (especially potassium), and other essential nutrients that need to be replaced.
Symptoms of imbalance of salts in the body (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 GLICEROLO COOP, 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 have been observed with GLICEROLO COOP at an unknown frequency (the frequency cannot be estimated from the available data):
- Cramp-like pains (localized or widespread in the abdomen);
- Intermittent abdominal pain (colic);
- Diarrhoea (with loss of fluids and electrolytes);
- Redness with burning or pain (irritation) at the anal area.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the website 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 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What GLICEROLO COOP contains
The active substance is glycerol.
GLICEROLO COOP Bambini 2.25 g rectal solution contains 2.25 g of glycerol.
GLICEROLO COOP Adulti 6.75 g rectal solution contains 6.75 g of glycerol.
The other components are: chamomile fluid extract, mallow fluid extract, wheat starch, purified water.
Description of the appearance of GLICEROLO COOP and pack contents
GLICEROLO COOP 2.25 g and 6.75 g rectal solution are available in packs containing 6 single-dose containers.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 permanently resolve constipation problems.
Many people believe they suffer from constipation if they do not have a bowel movement every day. This is a mistaken belief, as going less frequently is completely normal for many individuals.
Constipation is instead defined by a reduction in bowel movements compared to one's usual pattern, associated with the passage of hard stools. Before using laxatives, it is advisable to correct dietary habits by increasing daily intake of fiber and water.
If the condition is persistent (chronic constipation) or recurrent, it is appropriate to consult a doctor.