Glycerol Carlo Erba

OK for variation VN2/2014/215

Patient Information Leaflet: Information for the patient

GLYCEROL CARLO ERBA Pediatric 900 mg suppositories, 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 instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, 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 you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What GLICEROLO CARLO ERBA is and what it is used for

Glycerol, the active ingredient of this medicinal product, is used to facilitate the elimination of faeces.
The laxative effect is achieved due to glycerol's ability to soften the faeces and to cause a slight local irritant action that stimulates intestinal movements.
This medicinal product is indicated for the symptomatic relief of occasional and transient constipation.
Consult a physician if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using GLICEROLO CARLO ERBA

Do not use GLICEROLO CARLO ERBA if:

• you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• you have nausea or vomiting, an obstruction or narrowing (stenosis) of the intestine, or any abdominal pain of unknown cause;
• you have rectal pain and/or bleeding (e.g. in case of hemorrhoids);
• you are in a severe state of dehydration characterized by dry and sticky mouth, thirst, reduced urine output, absence or reduced tear production, and dry skin.

Warnings and precautions
Laxatives should be used as infrequently as possible and for no longer than 7 days; use for longer periods requires a doctor's prescription. During treatment, drink at least 6–8 glasses of water or other liquids to help soften the stools.
Abuse of laxatives may lead to dependence (with possible need for progressively increasing doses), chronic constipation, and loss of normal bowel function (intestinal atony). Furthermore, abuse may cause persistent diarrhea, resulting in loss of water (dehydration), minerals—especially potassium (hypokalemia)—and other essential nutrients. Loss of minerals may cause imbalances in blood ions (electrolyte disturbances), characterized by symptoms such as thirst, vomiting, weakness, edema, bone pain (osteomalacia), and hypoalbuminemia. More serious adverse effects include heart and muscle dysfunction, particularly if used concomitantly with certain heart medications (cardiac glycosides), diuretics, or corticosteroids.
Consult your doctor before using GLICEROLO CARLO ERBA:

• if you are elderly or in poor general health;
• if the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting for more than two weeks;
• in children under 12 years of age.

If use of the laxative fails to produce an effect after a short period of treatment, consult your doctor.
Other medicines and GLICEROLO CARLO ERBA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any 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 using this medicine.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use GLICEROLO CARLO ERBA

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 dose required to produce an easy evacuation of soft stools. It is advisable to initially use the lowest recommended doses.
Laxatives should be used as infrequently as possible and for no longer than 7 days. A diet rich in fluids enhances the effect of this medicine.

Use in adults and adolescents (12 - 18 years)
The recommended dose is 1 adult suppository, 1 or 2 times daily.

Use in children (under 12 years)
Children aged 2 - 11 years: 1 children's suppository, 1 or 2 times daily.
Children aged 1 month - 2 years: 1 infant suppository, 1 or 2 times daily.
Use GLICEROLO CARLO ERBA only after consulting a doctor.

Method of administration:
Remove the suppository from its container and, if necessary, moisten it slightly to facilitate rectal insertion.
If the suppositories appear very soft, immerse the containers in cold water before opening them.

If you use more GLICEROLO CARLO ERBA than you should
Cases of overdose have not been reported. However, excessive doses (laxative abuse, frequent or prolonged use, or high doses) may cause abdominal pain and diarrhea, with loss of fluids and electrolytes. These losses should be replenished by drinking water or other fluids.
In case of accidental ingestion/overdose of glycerol, contact your doctor immediately or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
Side effects due to GLICEROLO CARLO ERBA usually affect the stomach and intestine (gastrointestinal).
Inform your doctor if you experience the following symptoms:

• cramping pains (localized or widespread in the abdomen);
• intermittent abdominal pain (colic);
• diarrhoea;
• redness with burning or pain (irritation) in the rectal area.

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 website "www.agenziafarmaco.gov.it/it/responsabili". By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GLYCEROL CARLO ERBA

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from moisture and keep it away from direct sources of heat.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
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 CARLO ERBA Contains
The active substance is: glycerol.
GLICEROLO CARLO ERBA Suppositories for Early Infancy contains 900 mg of glycerol.
GLICEROLO CARLO ERBA Children contains 1375 mg of glycerol.
GLICEROLO CARLO ERBA Adults contains 2250 mg of glycerol.
The other components are: sodium stearate, sodium carbonate.

Description of the Appearance of GLICEROLO CARLO ERBA and Package Contents
GLICEROLO CARLO ERBA Suppositories for Early Infancy is available in a pack containing 12 suppositories.
GLICEROLO CARLO ERBA Children is available in a pack containing 18 suppositories.
GLICEROLO CARLO ERBA Adults is available in a pack containing 18 suppositories.

Marketing Authorization Holder
Carlo Erba OTC S.r.l. – Via Ardeatina Km 23, 500-00040 Santa Palomba Pomezia (Rome).

Manufacturer
FARMEA – 10 Rue Bouchè Thomas Zac – Sud d’Orgemont 49007 ANGERS FRANCE.

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 is a mistaken belief, as such a condition is completely normal for many individuals.
Constipation is instead defined by bowel movements that are reduced compared to one's usual habits and are associated with the passage of hard stools. Before using laxatives, it is advisable to correct dietary habits by increasing daily intake of adequate amounts of fiber and water.
If the condition is persistent (chronic constipation) or recurrent, it is appropriate to consult a doctor.
OK for variation VN2/2014/215

Patient Information Leaflet

GLICEROLO CARLO ERBA Children 2.25 g rectal solution, Adults 6.75 g rectal solution

Glycerol
Please 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 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.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What GLICEROLO CARLO ERBA is and what it is used for

Glycerol, the active ingredient of this medicine, helps facilitate the elimination of stools.
The laxative effect is achieved due to glycerol's ability to soften the stools and produce a mild local irritant action that stimulates intestinal movements.
This medicine is indicated for the symptomatic relief of occasional and transient constipation.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using GLICEROLO CARLO ERBA

Do not use GLICEROLO CARLO ERBA if:

• you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• you have nausea or vomiting, an obstruction or narrowing (stenosis) of the intestine, or any condition causing abdominal pain of unknown cause;
• you have pain and/or rectal bleeding (for example, in case of hemorrhoids);
• you are in a severe state of dehydration characterized by dry and sticky mouth, thirst, low urine output, absence or reduced tear production, and dry skin.

Warnings and precautions
Laxatives should be used as infrequently as possible and for no longer than 7 days; use for longer periods requires a doctor's prescription. During treatment, drink at least 6–8 glasses of water or other fluids to help soften the stools.
Abuse of laxatives may lead to dependence (possibly requiring progressively higher doses), chronic constipation, and loss of normal intestinal function (intestinal atony). Furthermore, abuse may cause persistent diarrhea resulting in loss of water (dehydration), mineral salts—especially potassium (hypokalaemia)—and other essential nutrients. Loss of mineral salts causes imbalances in blood ions (electrolyte disturbances), characterized by symptoms such as thirst, vomiting, weakness, edema, bone pain (osteomalacia), and hypoalbuminemia. More serious adverse effects include heart and muscle dysfunction, especially if used concomitantly with certain heart medications (cardiac glycosides), diuretics, or corticosteroids.
Consult your doctor before using GLICEROLO CARLO ERBA:

• if you are elderly or in poor general health;
• if 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;
• in children under 12 years of age.

If use of the laxative fails to produce results after a short period of treatment, consult your doctor.
Other medicines and GLICEROLO CARLO ERBA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any 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 using this medicine.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

3. How to use GLYCEROL CARLO ERBA

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 evacuation of soft stools. It is advisable to start with the lowest recommended doses.
Laxatives should be used as infrequently as possible and for no longer than 7 days. A diet rich in fluids helps enhance the effect of the medicine.

Use in adults and adolescents (12 - 18 years)
The recommended dose is 1 single-dose container, 1 or 2 times daily.

Use in children (6 - 11 years)
The recommended dose is 1-2 single-dose containers for children, 1 or 2 times daily.

Use in children (2 - 6 years)
The recommended dose is 1 single-dose container for children, 1 or 2 times daily.
Use GLYCEROL CARLO ERBA only after consulting a doctor.

Do not use in children under 2 years of age.

Method of administration

1. Remove the safety cannula cap from the single-dose container by placing your index finger and thumb on the circular ring located above the bulb and, with the other hand, bending the cap until it detaches from the body of the container.

During this operation, never squeeze the bulb, otherwise the medicine may leak out before use;

2. Lubricate the cannula with a drop of the solution itself before inserting it into the rectum, then squeeze the bulb;
3. Remove the cannula while keeping the bulb squeezed.

If you use more GLYCEROL CARLO ERBA than you should
Cases of overdose have not been reported. However, excessive doses (laxative abuse, frequent or prolonged use, or high doses) may cause abdominal pain and diarrhea with loss of fluids and electrolytes. Such losses should be compensated by drinking water or other fluids.
In case of accidental ingestion/overdose of glycerol, contact your doctor immediately or go to the nearest hospital.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
Usually, adverse reactions due to GLICEROLO CARLO ERBA affect the stomach and intestine (gastrointestinal).
Inform your doctor if you experience the following symptoms:

• Cramping pains (localized or widespread in the abdomen);
• Intermittent abdominal pain (colic);
• Diarrhea;
• Redness with burning or pain (irritation) in the rectal area.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor or pharmacist.
You may also report adverse reactions directly through the national reporting system at the website "www.agenziafarmaco.gov.it/it/responsabili".
By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. How to store GLICEROLO CARLO ERBA

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect the medicine from moisture and keep it away from direct sources of heat.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
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 CARLO ERBA contains
The active substance is: glycerol.
GLICEROLO CARLO ERBA Bambini contains 2.25 g of glycerol.
GLICEROLO CARLO ERBA Adulti 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 CARLO ERBA and package contents
GLICEROLO CARLO ERBA Adulti and Bambini are available in packages containing 6 single-dose containers.

Marketing Authorization Holder
Carlo Erba OTC S.r.l. – Via Ardeatina Km 23.500-00040 Santa Palomba Pomezia (Rome).

Manufacturer
C.O.C. Farmaceutici S.r.l. – S. Agata Bolognese 40019 (BO).

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 completely 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 adequate amounts of fiber and water.
If the condition is persistent (chronic constipation) or recurrent, it is appropriate to consult a doctor.