Glycerol Zeta

Package leaflet: Information for the user

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

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

GLICEROLO Zeta 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 short-term treatment of occasional constipation.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

2. What you should know before using GLICEROLO Zeta

Do not use GLICEROLO Zeta

• 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 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 taking GLICEROLO Zeta.
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 adequate 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. 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 cause heart or muscle problems, especially if you are taking cardiac glycosides, diuretics, or corticosteroids during treatment with this medicine.
Abuse of laxatives, particularly stimulant laxatives (contact laxatives), may lead to dependence (the need to continually increase the dose), chronic constipation, and loss of normal bowel function (intestinal atony).
In cases of constipation, first correct your dietary habits by consuming an adequate amount of 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 such a pattern is completely normal for many individuals. True constipation occurs when bowel movements are reduced compared to your usual pattern and are associated with passage of hard stools. If episodes of constipation recur frequently, you should consult your doctor.

Children
Use GLICEROLO Zeta in children under 12 years of age only after consulting a doctor.

Other medicines and GLICEROLO Zeta
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, ask your doctor or pharmacist for advice 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, 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 GLICEROLO Zeta

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.

Use in adults and adolescents
The recommended dose for adults and adolescents is 1 single-dose container for adults containing 6.75 g as needed, up to a maximum of 2 single-dose containers per day.
Remove the cap from the single-dose container without touching the bulb, otherwise the medicine may be expelled before use.
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 still squeezing the bulb.
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.

Use in children
Children aged between 6 and 11 years: the recommended dose is 1 single-dose container for children containing 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 childhood containing 2.25 g as needed, up to a maximum of 2 single-dose containers per day.

If you use more GLICEROLO Zeta 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 loss of fluids, electrolytes (especially potassium), and other essential nutrients, which must be replaced (see section Warnings and precautions).
Symptoms of altered electrolyte balance in the body (electrolyte imbalance) include: thirst, vomiting, weakness, swelling (oedema), bone problems (osteomalacia), and decreased levels of the blood protein albumin (hypoalbuminaemia).
In case of accidental ingestion/overdose of GLICEROLO Zeta, 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 cramp-like pains or abdominal colic and diarrhoea, with loss of fluids and electrolytes, occurring more frequently 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 through the national reporting system at the following 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 GLICEROLO Zeta

Keep this medicine out of the 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.
Store in the original packaging to protect the medicine from light.
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 Zeta contains
GLICEROLO Zeta for infants 2.25 g rectal solution

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

GLICEROLO Zeta for 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 liquid extract, mallow liquid extract, pregelatinized starch, purified water.

GLICEROLO Zeta for 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 liquid extract, mallow liquid extract, pregelatinized starch, purified water.

Description of the appearance of GLICEROLO Zeta and contents of the package
GLICEROLO Zeta for infants 2.25 g rectal solution. Carton containing 6 single-dose containers with chamomile and mallow.
GLICEROLO Zeta for children 4.5 g rectal solution. Carton containing 6 single-dose containers with chamomile and mallow.
GLICEROLO Zeta for adults 6.75 g rectal solution. Carton containing 6 single-dose containers with chamomile and mallow.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zeta Farmaceutici S.p.A. - Via Mentana, 38 - 36100 Vicenza
Manufacturer
Zeta Farmaceutici S.p.A. - Via Galvani, 10 - 36066 Sandrigo (VI) - Italy.