Glycerin suppositories Viti

Patient Information Leaflet: Information for the User

VITI GLYCERIN SUPPOSITORIES ADULTS 2250 mg suppositories

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 you experience worsening of symptoms after 7 days.

Contents of this leaflet:

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

1. What SUPPOSTE DI GLICERINA VITI ADULTI is and what it is used for

SUPPOSTE DI GLICERINA VITI ADULTI 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 constipation.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

2. What you need to know before using SUPPOSTE DI GLICERINA VITI ADULTI

Do not use SUPPOSTE DI GLICERINA VITI ADULTI

• 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 suffer from swollen blood vessels around the anus (hemorrhoidal inflammation);
• if you are severely dehydrated;
• if you have intestinal inflammation associated with bleeding lesions (haemorrhagic rectocolitis).

Warnings and precautions
Talk to your doctor or pharmacist before taking SUPPOSTE DI GLICERINA VITI ADULTI.
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 in any case for no longer than 7 days. The use of laxatives for longer periods requires a prescription from your doctor, following an adequate assessment of your condition.
If you suffer from constipation that lasts for long periods (chronic) or that is frequent, 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 your previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks, or when the 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 (hypokalaemia) may occur, which can cause heart problems or muscle dysfunction, especially if you are taking cardiac glycosides, diuretics, or corticosteroids during treatment with this medicine.
Abuse of laxatives, especially 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).

Children
In children under 12 years of age, use SUPPOSTE DI GLICERINA VITI ADULTI only after consulting a doctor.

Other medicines and SUPPOSTE DI GLICERINA VITI ADULTI
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking medicines used to treat stomach problems (antacids), use SUPPOSTE DI GLICERINA VITI ADULTI at least one hour after.
Use this medicine at least two hours after taking any other medicine.

SUPPOSTE DI GLICERINA VITI ADULTI with drinks
Milk may alter the effect of this medicine. Wait at least one hour before using SUPPOSTE DI GLICERINA VITI ADULTI.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, 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 affect the ability to drive vehicles or operate machinery.

3. How to use VITI ADULT GYCERIN SUPPOSITORIES

Use this medicine exactly as stated 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 smallest amount needed to produce easy bowel evacuation. Initially use the lowest recommended dose.
The recommended dose for adults and adolescents over 12 years of age is 1 suppository as needed or as prescribed by a doctor.
It is preferable to use this medicine in the evening.
If the suppositories seem too soft, place the containers in cold water before opening them.
Use laxatives as infrequently as possible and for no longer than seven days (see section Warnings and precautions).

If you use more VITI ADULT GLYCERIN SUPPOSITORIES 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 need to be replaced (see section Warnings and precautions).
In case of accidental ingestion/overdose of VITI ADULT GLYCERIN SUPPOSITORIES, 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 will experience them.
The following side effects may occur:

• Isolated cramp-like pains or more frequent abdominal colic, particularly in cases of severe constipation.

Reporting of side effects
If you experience any side effects, 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
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 VITI ADULT 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.
This medicine does not require any special storage conditions.
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 SUPPOSTE DI GLICERINA VITI ADULTI contains

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

Description of the appearance of SUPPOSTE DI GLICERINA VITI ADULTI and contents of the pack
SUPPOSTE DI GLICERINA VITI ADULTI 2250 mg suppositories. Carton containing 6, 12 or 18 suppositories.
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.