ZETALAX Suppository

Зміст інструкції

1. ZETALAX Glycerin Enemas for Adults 6.75 g, Glycerin Enemas for Children 2.25 g
   1. What is ZETALAX Glycerin Enemas and what it is 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
2. ZETALAX Glycerin Suppositories
   1. What is ZETALAX Glycerin Suppositories and what are they 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

ZETALAX Glycerin Enemas for Adults 6.75 g, Glycerin Enemas for Children 2.25 g

glycerol

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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in
• this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

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

Glycerol, the active ingredient of this medicine, serves to facilitate the elimination of feces.
The laxative effect is obtained thanks to glycerol's ability to soften the feces and to
provoke a slight 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 ZETALAX Glycerin Suppositories

Do not use ZETALAX Glycerin Suppositories if:

• you are allergic to the active ingredient or 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 situation of abdominal pain of which you do not know the cause;
• you have pain and/or bleeding from the rectum (for example in case of haemorrhoids);
• you are in a severe state of dehydration which manifests with a dry and sticky mouth, thirst, scarcity of urine, absence or scarcity of tears and dry skin.

Warnings and precautions
Laxatives should be used as infrequently as possible and for no more 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, in order to favor the softening of the stools.
Abuse of laxatives can cause dependence (with possible need to progressively increase the
dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). Furthermore
abuse could cause persistent diarrhoea with consequent loss of water (dehydration), mineral
salts, especially potassium (hypokalaemia) and other essential nutritional factors. Loss of mineral
salts causes alterations of the ions present in the blood (electrolytic) characterized by the following
symptoms: thirst, vomiting, weakness, edema, bone pain (osteomalacia) and hypoalbuminaemia. More
serious adverse effects are heart and muscle dysfunctions especially in case of concomitant treatment
with some drugs for the heart (cardiac glycosides), with drugs that increase
diuresis (diuretics) or corticosteroids.
Consult your doctor before using ZETALAX Glycerin Suppositories:

• if you are elderly or not in good health;
• if the need for a laxative derives from a sudden change in previous bowel habits (frequency and characteristics of evacuations) that lasts for more than two weeks;
• in children under 12 years of age. If the use of the laxative fails to produce effects after a short period of treatment, consult your doctor.

Other medicines and ZETALAX Glycerin Suppositoriesof glycerin
No interactions with other medicines or of any other kind have been reported, however inform your
doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
This medicine does not alter the ability to drive vehicles or operate machinery.

3. How to use ZETALAX Glycerin Suppositories

Use this medicine following exactly as described 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 minimum sufficient to produce an easy evacuation of soft stools. It is
advisable to initially use the minimum doses provided.
Laxatives should be used as infrequently as possible and for no more than 7 days. A diet
rich in fluids promotes the effect of the medicine.

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

Use in children(6 - 11 years)
The recommended dose is 1-2 children's suppositories, 1 or 2 times a day.

Use in children(2 - 6 years)
The recommended dose is 1 children's suppository, 1 or 2 times a day.
Use ZETALAX Glycerin Suppositories only after consulting a 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 same solution then insert the
cannula into the rectum and squeeze the bulb. Finally, remove the cannula, always keeping the bulb pressed.
Use the container for a single administration; discard any remaining medicine.

If you use more ZETALAX Glycerin Suppositories than you should
No cases of overdose have been reported. In any case, excessive doses (laxative abuse, frequent or prolonged use or with high doses) can cause abdominal pain and diarrhea with loss of
fluids and electrolytes. These losses should be replenished with water or other fluids.
In case of accidental ingestion/intake of an excessive dose of glycerol, immediately notify your 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, the side effects due to ZETALAX Glycerin Enemas affect the stomach and
intestines (gastrointestinal). Inform your doctor if you experience the following symptoms:

• cramping pains (isolated or widespread in the abdomen);
• abdominal pain that is not constant (colic);
• diarrhea;
• redness with burning or pain (irritation) at the rectal level.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, please tell your doctor or pharmacist. You can 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 Suppositories

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect the medicine from moisture and away from direct
sources of heat. Do not use this medicine after the expiry date which is stated on the packaging.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ZETALAX Glycerin Enemas contain

• The active ingredient is: glycerol. ZETALAX Glycerin Enemas for children contains 2.25 g of glycerol. ZETALAX Glycerin Enemas for adults contains 6.75 g of glycerol.
• The other ingredients are: chamomile fluid extract; mallow fluid extract; wheat starch; purified water.

Description of the appearance of ZETALAX Glycerin Enemas and pack contents
ZETALAX Glycerin Enemas for adults and children are available in packs containing
6 single-dose containers.

Marketing Authorisation Holder
Zeta Farmaceutici S.p.A. - Via Mentana n° 38 - 36100 Vicenza

Manufacturer
Zeta Farmaceutici S.p.A., Via Galvani n°10, 36066 Sandrigo (VI).

ZETALAX Glycerin Suppositories

for adults, children and infants
glycerol

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 told you to.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if you feel worse after a short time.

Contents of this leaflet:

• 1. What ZETALAX Glycerin Suppositories is and what it is used for
• 2. What you need to know before you use 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 is ZETALAX Glycerin Suppositories and what are they for?

ZETALAX Glycerin Suppositories contain the active ingredient glycerol, which belongs to the category of
laxatives, which are medicines used to facilitate the expulsion of feces. 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 your symptoms worsen 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 ingredient or 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 situation of abdominal pain whose cause you do not know;
• if you have pain and/or bleeding from the rectum (e.g. in case of hemorrhoids);
• if you are in a severe state of dehydration which manifests with a dry and sticky mouth, thirst, scarcity of urine, absence or scarcity of tears and dry skin.

Warnings and precautions
Laxatives should be used as infrequently as possible and for no more 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 stool.
Abuse of laxatives can cause dependence (with a possible need to progressively increase the
dose) and other disorders such as chronic constipation and loss of normal bowel function (intestinal atony).
Furthermore, abuse could cause persistent diarrhea with consequent loss of water (dehydration),
mineral salts especially potassium (hypokalemia) and other essential nutrients. Loss of mineral
salts causes alterations of the ions present in the blood (electrolytic) characterized by the following
symptoms: thirst, vomiting, weakness, edema, bone pain (osteomalacia) and hypoalbuminemia. More
serious adverse effects are heart and muscle dysfunction, especially in case of concomitant treatment with certain drugs for the heart (cardiac glycosides), with drugs that increase
diuresis (diuretics) or corticosteroids.
Consult your doctor before using ZETALAX Glycerin Suppositories:

• if you are elderly or not in good health;
• if the need for a laxative derives from a sudden change in previous bowel habits (frequency and characteristics of evacuations) that lasts more than two weeks;
• in children under 12 years of age.

If the use of the laxative fails to produce effects after a short period of treatment, consult your
doctor.

Other medicines and ZETALAX Glycerin Suppositories
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
This medicine does not impair the ability to drive vehicles and operate machinery.

3. How to use ZETALAX Glycerin Suppositories

Use this medicine following exactly the instructions in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The correct dose is the minimum sufficient to produce easy evacuation of soft stools. It is
advisable to initially use the minimum doses provided.
Laxatives should be used as infrequently as possible and for no more than 7 days. A diet
rich in fluids promotes the effect of the medicine.

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

Use in children(under 12 years)
Children aged 2 - 11 years: 1 children's suppository, 1 or 2 times a day.
Children aged 1 month - 2 years: 1 infant suppository, 1 or 2 times a day.
Use ZETALAX only after consulting a doctor.
Method of administration:
Remove the suppository from its container and, if necessary, moisten it to facilitate its rectal
introduction. If the suppositories appear very soft, immerse the containers, before opening them, in
cold water.

If you use more ZETALAX Glycerin Suppositories than you should
No cases of overdose have been reported.
In any case, excessive doses (abuse of laxatives, frequent or prolonged use or with high doses) can
cause abdominal pain and diarrhea with loss of fluids and electrolytes. These losses must be
replenished by drinking water or other fluids.
In case of accidental ingestion/intake of an excessive dose of glycerol, immediately notify your
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, the side effects due to ZETALAX affect the stomach and intestines
(gastrointestinal). Tell your doctor if you experience the following symptoms:

• cramping pains (isolated or widespread in the abdomen);
• abdominal pain that is not constant (colic);
• diarrhea;
• redness with burning or pain (irritation) at the rectal level.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help to 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 which is stated on the packaging after “Scad.”. The
expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture and away from direct
sources of heat. Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ZETALAX Glycerin Suppositories contains
ZETALAX Glycerin Suppositories adults

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

ZETALAX Glycerin Suppositories children

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

ZETALAX Glycerin Suppositories infants

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

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