GLYCEROL MONTEFARMACO OTC

Package leaflet: Information for the user

Glycerol Montefarmaco OTC adults 2250 mg suppositories, children 1375 mg suppositories

glycerol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use 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, please contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What Glicerolo Montefarmaco is and what it is used for

Glicerolo Montefarmaco is a laxative.
Glicerolo Montefarmaco is used for the short-term treatment of occasional constipation.

Health education notes
First of all, it should be borne in mind that, in most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit) can provide a long-lasting solution to constipation.
Many people believe they suffer from constipation if they are unable to defecate every day.
This is a mistaken belief, as this situation is completely normal for a large number of individuals.
Instead, consider that constipation occurs when bowel movements are reduced compared to one's own personal habits and are associated with the passage of hard stools.
If episodes of constipation occur repeatedly, a doctor should be consulted.

2. What you need to know before using Glycerol Montefarmaco

Do not use Glycerol Montefarmaco

• 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, nausea or vomiting, intestinal obstruction or stenosis (complete or partial blockage of the small or large intestine), rectal bleeding of unknown origin, or severe dehydration.

Warnings and precautions
Talk to your doctor or pharmacist before using Glycerol Montefarmaco.
The treatment of chronic or recurrent constipation always requires medical supervision for diagnosis,
prescription of medication, and monitoring during therapy.
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.
Elderly patients or those in poor health should also consult a doctor before using this medicine.
It is important to know that
Laxative abuse (frequent or prolonged use with excessive doses) may cause persistent diarrhoea, resulting in loss of water, mineral salts (especially potassium), and other essential nutrients.
In more severe cases, dehydration or hypokalaemia (reduced potassium levels in the blood) may occur, which could lead to heart or nerve dysfunction affecting muscle control, particularly if you are also being treated with cardiac glycosides (medicines used to treat heart problems or arrhythmias), diuretics, or corticosteroids.
Abuse of laxatives, especially 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 no improvement is seen after a short period of treatment, consult your doctor.
In episodes of constipation, it is recommended first to correct dietary habits by increasing daily intake of dietary fibre and water.

Other medicines and Glycerol Montefarmaco
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines or of any other kind have been reported.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

3. How to use Glycerol Montefarmaco

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.
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.

Recommended dose
Adults and adolescents (12–18 years): 1 adult suppository as needed or as prescribed by the doctor.
Children aged 2 to 11 years: 1 children's suppository as needed or as prescribed by the doctor.

Warning: Do not exceed the recommended doses without medical advice.
Laxatives should be used as infrequently as possible and for no longer than 7 days.
Use beyond this period requires a doctor's prescription following appropriate individual assessment.
Consult your doctor if the condition recurs frequently or if you have noticed any recent changes in its pattern.

If you use more Glycerol Montefarmaco than you should
Excessive doses may cause abdominal pain and diarrhoea; the resulting loss of fluids and electrolytes should be replaced.
See also the information in the section 'Important to know' regarding laxative abuse.
In case of accidental overdose of Glycerol Montefarmaco, contact 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.
Occasionally: pain occurring as isolated cramps or abdominal colic, more frequent in cases of severe constipation.
Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, 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 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 Montefarmaco

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. This date refers to the product
in its original packaging, correctly stored and unopened.

6. Package contents and other information

What Glicerolo Montefarmaco contains
Glicerolo Montefarmaco OTC Bambini suppositories:

• The active substance is glycerol. Each suppository contains 1375 mg of glycerol.
• The other components are sodium stearate, sodium bicarbonate.

Glicerolo Montefarmaco OTC Adulti suppositories:

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

Description of the appearance of Glicerolo Montefarmaco and contents of the pack
Pharmaceutical form: suppositories.
Pack: carton containing 18 adult suppositories and 18 pediatric suppositories.
Marketing Authorization Holder
MONTEFARMACO OTC S.p.A. - Via IV Novembre, 92 – 20021 Bollate (MI)
Manufacturer
INDUSTRIA FARMACEUTICA NOVA ARGENTIA S.p.A – Via G. Pascoli n. 1 – 20064 Gorgonzola (MI)