Glycerol Pietrasanta

Package leaflet: Information for the patient

GLYCEROL PIETRASANTA Adults 2250 mg suppositories

Please read this leaflet carefully before using 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 those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

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

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

GLICEROLO PIETRASANTA contains the active substance glycerol, which belongs to the category of laxative medicines.
GLICEROLO PIETRASANTA is used for the short-term treatment of occasional constipation.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using GLYCEROL PIETRASANTA

Do not use GLYCEROL PIETRASANTA

• 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
• in case of nausea or vomiting
• intestinal obstruction or narrowing
• in case of rectal bleeding. Rectal bleeding of unknown origin
• in case of hemorrhoids with pain and bleeding
• in case of severe dehydration

Warnings and precautions
Talk to your doctor or pharmacist before using GLYCEROL PIETRASANTA.
Use laxatives as infrequently as possible and for no longer than seven days. Use for longer periods
requires a doctor's prescription following adequate assessment of the individual case.
The treatment of chronic or recurrent constipation always requires medical supervision for
diagnosis, prescription of medications, and monitoring during therapy.
Abuse of laxatives may cause persistent diarrhea, resulting in loss of water, mineral salts
(especially potassium), and other essential nutrients. In more severe cases of abuse, dehydration or
hypokalaemia may occur, which can lead to cardiac or neuromuscular dysfunction, especially if you
are also taking cardiac glycosides, diuretics, or corticosteroids.
Abuse of laxatives, particularly stimulant laxatives (contact laxatives), may lead to dependence
(and therefore a possible need to progressively increase the dose), chronic constipation, and
loss of normal intestinal function (intestinal atony).
If you suffer from episodes of constipation, first correct your dietary habits by increasing your daily
dietary intake of adequate fiber and water.
If you take laxatives, drink at least 6–8 glasses of water or other fluids daily to help soften stools.
Children and adolescents: Do not administer GLYCEROL PIETRASANTA to children under
12 years of age without first consulting a doctor.
If you are elderly or if your general health condition is poor, consult your doctor before taking
this medicine.
Other medicines and GLYCEROL PIETRASANTA
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, think you may be pregnant, planning a pregnancy, or breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Although there are no evident contraindications to the use of this medicine during pregnancy and
breastfeeding, take this medicine only when necessary and under medical supervision.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery. However, it is possible that
undesired effects may occur during treatment; therefore, it is advisable to become aware of your
reaction to the medicine before driving or operating machinery.
Health education notes
You should keep in mind that, in most cases, a balanced diet rich in water and fiber (bran, vegetables,
and fruit) can permanently resolve constipation problems.
Many people believe they suffer from constipation if they do not have a bowel movement every day.
This belief is incorrect, as not having a daily bowel movement is perfectly normal for many
individuals.
Consider that you have constipation only when bowel movements are reduced compared to your
usual pattern and are associated with the passage of hard stools.
If episodes of constipation occur repeatedly, consult your doctor.

3. How to use GLYCEROL PIETRASANTA

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 recommended dose is the lowest dose sufficient to produce easy bowel evacuation.
Initially use the minimum recommended doses.
Adults and adolescents (12–18 years): 1 adult suppository as needed, up to a maximum of 1 or 2
administrations per day.

Instructions for use
Remove the suppository from its container and, if necessary, moisten it slightly to facilitate rectal insertion.
If the suppositories appear soft, immerse the containers in cold water before opening them.
A diet rich in fluids helps enhance the effect of the medicine.

If you use more GLYCEROL PIETRASANTA than you should
Excessive doses of laxatives, or frequent or prolonged use, or use in excessive doses, may cause abdominal pain, persistent diarrhoea leading to loss of water, electrolytes (especially potassium), and other essential nutrients. Fluid and electrolyte losses should be replaced.
Loss of mineral salts (electrolyte imbalances) is characterized by the following symptoms: thirst, vomiting, weakness, oedema, bone pain (osteomalacia), and hypoalbuminemia.
In more severe cases, dehydration or hypokalaemia may occur, which can lead to cardiac or neuromuscular dysfunction, especially if concomitantly taking cardiac glycosides, diuretics, or corticosteroids.
Abuse of laxatives, particularly stimulant laxatives (contact laxatives), may lead to dependence (and thus a possible need to progressively increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).
In case of accidental ingestion/overdose of glycerol, contact your doctor immediately or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following are adverse reactions associated with glycerol:
Gastrointestinal disorders Isolated cramp-like pains or abdominal colic and diarrhoea, with loss of fluids and electrolytes, more frequent in cases of severe constipation, as well as 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 can also report side effects directly via the national reporting system at
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 GLYCEROL PIETRASANTA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Store in the original container to protect the medicine from moisture and keep it 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 GLICEROLO PIETRASANTA contains

• The active substance is glycerol. Glycerol 2250 mg.
• The other components are: Sodium stearate, sodium bicarbonate.

Description of the appearance of GLICEROLO PIETRASANTA and package contents
Suppositories.
Pack containing 18 suppositories.

Marketing Authorization Holder
Pietrasanta Pharma S.p.A.
Via San Francesco, 67 - Viareggio (LU)

Manufacturer
NOVA ARGENTIA S.p.A. - Via Pascoli 1 - 20064 GORGONZOLA (MI)