Glycerol Marco Viti

PACKAGE LEAFLET

Package leaflet: Information for the user

GLYCEROL MARCO VITI 675 mg suppositories for infants, 1350 mg suppositories for children, 2250 mg suppositories for adults, 2.25 g rectal solution for infants, 4.5 g rectal solution for children, 6.75 g rectal solution for adults

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.

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

1. What GLICEROLO MARCO VITI is and what it is used for

GLICEROLO MARCO VITI contains the active substance glycerol, which belongs to the category of laxative medicines used to facilitate the expulsion 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 GLICEROLO MARCO VITI

Do not use GLICEROLO MARCO VITI

• 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 crisis (swelling of blood vessels around the anus) with pain and bleeding;
• if you are severely dehydrated.

Warnings and precautions
Talk to your doctor or pharmacist before taking GLICEROLO MARCO VITI.
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
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 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 overuse, use too frequently, or misuse laxatives, 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 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 laxatives (contact laxatives), may lead to dependence (the need to continually increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).
For 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 suffer from constipation if they do not have a bowel movement every day. This is a misconception, as it is perfectly normal for many individuals not to have daily bowel movements. True constipation occurs when bowel movements are less frequent than usual and are associated with hard stools. If episodes of constipation recur, you should consult your doctor.

Children
GLICEROLO MARCO VITI is recommended for children under 12 years of age only after medical consultation.

Other medicines and GLICEROLO MARCO VITI
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 between GLICEROLO MARCO VITI and 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 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; therefore, it is advisable to understand your reaction to the medicine before driving or operating machinery.

3. How to use GLYCEROL MARCO VITI

Use this medicine exactly as described 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 easy bowel evacuation. Initially use the lowest recommended doses.

GLYCEROL MARCO VITI suppositories
Adults and adolescents over 12 years of age: the recommended dose is 1 adult suppository as needed, up to a maximum of 2 suppositories per day.
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.

GLYCEROL MARCO VITI rectal solution
Adults and adolescents (12–18 years): the recommended dose is 1 single-dose adult container of 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, as this could cause the medicine to leak 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 keeping the bulb squeezed.
Use each container only once; discard any remaining medicine after use.
Use laxatives as infrequently as possible and for no longer than seven days (see section Warnings and precautions).

Use in children

GLYCEROL MARCO VITI suppositories
Children aged between 2 and 11 years: the recommended dose is 1 children’s suppository as needed, up to a maximum of 2 suppositories per day.
Children aged between 1 month and 2 years: the recommended dose is 1 infant suppository as needed, up to a maximum of 2 suppositories per day.

GLYCEROL MARCO VITI rectal solution
Children aged between 6 and 11 years: the recommended dose is 1 single-dose children’s container of 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 infant container of 2.25 g as needed, up to a maximum of 2 single-dose containers per day.

If you use more GLYCEROL MARCO VITI 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 fluid loss, loss of minerals (especially potassium), and other essential nutrients that must be replaced (see section Warnings and precautions).
Symptoms of electrolyte imbalance (disturbance in the body's salt balance) include: thirst, vomiting, weakness, swelling (oedema), bone problems (osteomalacia), and reduced levels of albumin, a protein in the blood (hypoalbuminemia).
In case of accidental ingestion/overdose of GLYCEROL MARCO VITI, 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 side effects may occur:

• Isolated cramping pains or abdominal colic and diarrhoea, with loss of fluids and electrolytes, more frequent 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, pharmacist or nurse. You may also report side effects directly through the national reporting system at the following website:
http://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 MARCO VITI

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 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 MARCO VITI contains
GLICEROLO MARCO VITI 675 mg suppositories for infants

• The active substance is glycerol. Each infant suppository contains 675 mg of glycerol.
• The other components are: sodium stearate, anhydrous sodium carbonate.

GLICEROLO MARCO VITI 1350 mg suppositories for children

• The active substance is glycerol. Each children's suppository contains 1350 mg of glycerol.
• The other components are: sodium stearate, anhydrous sodium carbonate.

GLICEROLO MARCO VITI 2250 mg suppositories for adults

• The active substance is glycerol. Each adult suppository contains 2250 mg of glycerol.
• The other components are: sodium stearate, anhydrous sodium carbonate.

GLICEROLO MARCO VITI 2.25 g rectal solution for infants

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

GLICEROLO MARCO VITI 4.5 g rectal solution for children

• The active substance is glycerol. Each single-dose container for children contains 4.5 g of glycerol.
• The other components are: chamomile fluid extract, mallow fluid extract, pregelatinized starch, purified water.

GLICEROLO MARCO VITI 6.75 g rectal solution for adults

• The active substance is glycerol. Each single-dose container for adults contains 6.75 g of glycerol.
• The other components are: chamomile fluid extract, mallow fluid extract, pregelatinized starch, purified water.

Description of the appearance of GLICEROLO MARCO VITI and package contents

GLICEROLO MARCO VITI 675 mg suppositories for infants. Box containing 6 suppositories.
GLICEROLO MARCO VITI 1350 mg suppositories for children. Box containing 6 suppositories.
GLICEROLO MARCO VITI 2250 mg suppositories for adults. Box containing 6, 12 or 18 suppositories.
GLICEROLO MARCO VITI 2.25 g rectal solution for infants. Box containing 6 single-dose containers.
GLICEROLO MARCO VITI 4.5 g rectal solution for children. Box containing 6 single-dose containers.
GLICEROLO MARCO VITI 6.75 g rectal solution for adults. Box containing 6 single-dose containers.

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