Zetalax

Package leaflet: Information for the patient

ZETALAX Glycerin Micro-enemas for adults 6.75 g, Glycerin Micro-enemas for children 2.25 g

glycerol
Please read all of this leaflet carefully before you use this medicine because it contains important information for you.
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 you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What ZETALAX Glycerin Micro-enemas Is and What It Is Used For

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

2. What you need to know before using ZETALAX Glycerin Micro-enemas

Do not use ZETALAX Glycerin Micro-enemas 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, intestinal obstruction or narrowing (stenosis), or any abdominal pain of unknown cause;
• you have pain and/or rectal bleeding (for example, due to haemorrhoids);
• you are in a severe state of dehydration, characterized by dry and sticky mouth, thirst, reduced urine output, absence or reduction of tears, 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 medical 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 bowel function (intestinal atony). Moreover, abuse may cause persistent diarrhoea, 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, oedema, bone pain (osteomalacia), and hypoalbuminaemia. More serious adverse effects include heart and muscle dysfunction, particularly if you are concurrently taking certain heart medications (cardiac glycosides), diuretics, or corticosteroids.
Consult your doctor before using ZETALAX Glycerin Micro-enemas:

• 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 an effect after a short period of treatment, consult your doctor.

Other medicines and ZETALAX Glycerin Micro-enemas
No interactions with other medicines or other types have been reported; however, 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 to become pregnant, or are 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 ZETALAX Glycerin Micro-enemas

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

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

Use in children (6 - 11 years)
The recommended dose is 1-2 children's micro-enemas, 1 or 2 times daily.

Use in children (2 - 6 years)
The recommended dose is 1 children's micro-enema, 1 or 2 times daily.
Use ZETALAX Glycerin Micro-enemas only after consulting your doctor.
Do not use in children under 2 years of age.

Method of administration
Remove the cap, lubricate the cannula with a drop of the solution, then insert the cannula into the rectum and squeeze the bulb. Remove the cannula while continuing to squeeze the bulb.
Use the container for a single administration only; discard any remaining medicine.

If you use more ZETALAX Glycerin Micro-enemas 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 diarrhoea, with loss of fluids and electrolytes. These losses should be replenished by drinking water or other fluids.
In case of accidental ingestion/absorption of an excessive dose of glycerol, notify your doctor immediately or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Usually, the side effects of ZETALAX Glycerin Micro-enemas affect the stomach and intestine (gastrointestinal). Inform your doctor if you experience any of the following symptoms:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at https://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 ZETALAX Glycerin Micro-enemas

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 ZETALAX Glycerin Micro-enemas contains

• The active substance is: glycerol. ZETALAX Glycerin Micro-enemas for children contains 2.25 g of glycerol. ZETALAX Glycerin Micro-enemas for adults 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 ZETALAX Glycerin Micro-enemas and contents of the pack
ZETALAX Glycerin Micro-enemas for adults and for children are available in packs containing
6 single-dose containers.
Marketing Authorization Holder
Zeta Farmaceutici S.p.A. - Via Mentana No. 38 - 36100 Vicenza
Manufacturer
Zeta Farmaceutici S.p.A., Via Galvani No. 10, 36066 Sandrigo (VI).

Patient Information Leaflet: Information for the patient

ZETALAX Glycerin Suppositories

for adults, children and infants
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 want 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 after a short period of time.

Contents of this leaflet:

1. What ZETALAX Glycerin Suppositories are and what they are used for
2. What you need to know before using ZETALAX Glycerin Suppositories
3. How to use ZETALAX Glycerin Suppositories
4. Possible side effects
5. How to store ZETALAX Glycerin Suppositories
6. Contents of the pack and other information

1. What ZETALAX Glycerin Suppositories is and what it is used for

ZETALAX Glycerin Suppositories 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 and transient constipation.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after a short period of time.

2. What you need to know before using ZETALAX Glycerin Suppositories

Do not use ZETALAX Glycerin Suppositories

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have nausea, vomiting, or an obstruction or narrowing (stenosis) of the intestine, or any condition causing abdominal pain of unknown origin;
• if you have pain and/or rectal bleeding (for example, due to hemorrhoids);
• if you are suffering from severe 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 fluids to help soften the stools.
Abuse of laxatives may cause dependence (possibly requiring progressively higher doses) and other disorders such as chronic constipation and loss of normal intestinal function (intestinal atony).
Furthermore, excessive use may cause persistent diarrhea, leading to loss of water (dehydration), mineral salts—especially potassium (hypokalemia)—and other essential nutrients. Loss of mineral salts may alter blood ion levels (electrolyte imbalances), characterized by symptoms such as thirst, vomiting, weakness, edema, bone pain (osteomalacia), and hypoalbuminemia. More serious side effects include heart and muscle dysfunction, particularly if used concurrently with certain heart medications (cardiac glycosides), diuretics, or corticosteroids.
Consult your doctor before using ZETALAX Glycerin Suppositories:

• 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 the use of the laxative fails to produce an effect after a short period of treatment, consult your doctor.
Other medicines and ZETALAX Glycerin Suppositories
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 may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use ZETALAX Glycerin Suppositories

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 dose needed 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 helps enhance the effect of the 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 ZETALAX only after consulting a doctor.

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

If you use more ZETALAX Glycerin Suppositories than you should
No cases of overdose have been reported.
However, excessive doses (laxative abuse, frequent or prolonged use, or high doses) may cause abdominal pain and diarrhea, leading to loss of fluids and electrolytes. These losses should be compensated by drinking water or other fluids.
In case of accidental ingestion/overdose of glycerol, immediately inform a doctor or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Usually, side effects due to ZETALAX affect the stomach and intestine (gastrointestinal).
Contact your doctor if you experience the following symptoms:

• Cramping pain (localized or widespread in the abdomen);
• Intermittent abdominal pain (colic);
• Diarrea;
• 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 may also report side effects directly through 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 ZETALAX Glycerin Suppositories

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 no longer in use. This will help protect the environment.

6. Package contents and other information

What ZETALAX Glycerin Suppositories contain
ZETALAX Glycerin Suppositories for adults

• The active substance is glycerol. Each adult suppository contains 2.250 g of glycerol.
• The other components are: sodium stearate, anhydrous sodium carbonate.

ZETALAX Glycerin Suppositories for children

• The active substance is glycerol. Each children's suppository contains 1.375 g of glycerol.
• The other components are: sodium stearate, anhydrous sodium carbonate.

ZETALAX Glycerin Suppositories for infants

• The active substance is glycerol. Each infant suppository contains 0.908 g of glycerol.
• The other components are: sodium stearate, anhydrous sodium carbonate.

Description of the appearance of ZETALAX Glycerin Suppositories and contents of the pack
ZETALAX Glycerin Suppositories for adults
Pack of 18 suppositories.
ZETALAX Glycerin Suppositories for children
Pack of 18 suppositories.
ZETALAX Glycerin Suppositories for infants
Pack of 12 suppositories.

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