Glycerol Pharma Trenta

PACKAGE LEAFLET

GLYCEROL PHARMA TRENTA SUPPOSITORIES

Children 1375 mg - 18 suppositories.
Adults 2250 mg – 18 suppositories
PHARMACOTHERAPEUTIC CATEGORY
Other laxatives - ATC Code: A06AX01 .

THERAPEUTIC INDICATIONS
Short-term treatment of occasional constipation.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients;
acute abdominal pain or of unknown origin;
nausea or vomiting;
intestinal obstruction or stenosis;
rectal bleeding of unknown origin;
acute hemorrhoidal crisis with pain and bleeding;
severe dehydration.
PRECAUTIONS FOR USE
Laxatives should be used as infrequently as possible and for no longer than
seven days. Use for longer periods requires medical prescription following
adequate assessment of the individual case.
The treatment of chronic or recurrent constipation always requires medical
intervention for diagnosis, prescription of medications, and monitoring during
therapy.
Abuse of laxatives may cause persistent diarrhoea, 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, particularly if the patient is
concurrently being treated with cardiac glycosides, diuretics, or corticosteroids.
Abuse of laxatives, especially stimulant laxatives (contact laxatives), may
lead to dependence (and thus a possible need for progressive dose increase),
chronic constipation, and loss of normal intestinal function (intestinal atony).
In episodes of constipation, it is advisable first to correct dietary habits by
increasing daily intake of adequate fibre and water. When using laxatives, it is
recommended to drink at least 6–8 glasses of water or other fluids per day to
promote softening of stools.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other
medicines, including those without a prescription.
No specific interaction studies have been conducted.
SPECIAL WARNINGS
Consult your doctor if 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 if use of the laxative fails to produce an effect.
In children under twelve years of age, this medicine should be used only after
consulting a doctor.

Elderly patients or those in poor general health should also consult a doctor
before using this medicine.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Adequate and well-controlled studies on the use of this medicine during
pregnancy or breastfeeding have not been conducted. Although there are no
obvious contraindications to its use during pregnancy and breastfeeding, it is
recommended that the medicine be taken only when necessary and under
medical supervision.
Effects on the ability to drive and use machines
This medicine does not impair the ability to drive vehicles or operate machinery.
However, undesirable effects may occur during treatment; therefore, it is
advisable to be aware of your response to the medicine before driving or
operating machinery.
Important information about certain excipients
No significant information is known, even with regard to the characteristics and
concentration of the excipients used.
Health education notes
It should first be emphasized that, in most cases, a balanced diet rich in water and
fibre (bran, vegetables, and fruit) can provide a lasting solution to constipation.
Many people believe they suffer from constipation if they do not defecate every
day. This is a mistaken belief, as such a pattern is entirely normal for many
individuals. Constipation should instead be considered when bowel movements
are reduced compared to one's usual habits and are associated with the passage
of hard stools.
If episodes of constipation occur repeatedly, a doctor should be consulted.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The correct dose is the smallest amount sufficient to produce an easy bowel
movement. It is advisable to start with the lowest recommended doses.
Adults and adolescents (12–18 years of age): 1 adult suppository as needed,
up to a maximum of 1 or 2 administrations per day.
Children aged 2–11 years: 1 children's 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 softened, immerse the
containers in cold water before opening them. This medicine may be used in children under
twelve years of age only after consulting a doctor. Laxatives should be used as infrequently as
possible and for no longer than seven days (see precautions for use). A diet rich in fluids
enhances the effect of the medicine.

OVERDOSE
No cases of overdose have been reported. However, excessive doses
(abuse of laxatives: frequent or prolonged use, or use of excessive doses) may
cause abdominal pain, persistent diarrhoea leading to loss of water, mineral salts
(especially potassium), and other essential nutrients. Fluid and electrolyte losses
must be replaced.
Electrolyte imbalances are characterized by the following symptoms: thirst, vomiting,
weakness, oedema, bone pain (osteomalacia), and hypoalbuminaemia. In more
severe cases, dehydration or hypokalaemia may occur, which can lead to cardiac or
neuromuscular dysfunction, particularly if the patient is concurrently being treated with
cardiac glycosides, diuretics, or corticosteroids.
Abuse of laxatives, especially stimulant laxatives (contact laxatives), may lead to dependence
(necessitating progressive dose increases), chronic constipation, and loss of normal
intestinal function (intestinal atony).
In case of accidental ingestion/overdose of Glycerol Pharma Trenta, contact a doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Glycerol Pharma Trenta suppositories,
consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, Glycerol Pharma Trenta can cause undesirable effects, although not everyone experiences them.
The table below lists the undesirable effects of GLYCEROL. There are insufficient data available to determine the frequency of the individual effects listed.
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.
Following the instructions in this leaflet reduces the risk of undesirable effects.
If any of the undesirable effects worsen, or if you notice any undesirable effects not listed in this leaflet, inform your doctor or pharmacist.
EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging.
The expiry date refers to the product in its original, unopened packaging, stored correctly.
WARNING: Do not use the medicine after the expiry date stated on the packaging.
Store in the original packaging to protect the medicine from moisture and keep away from direct sources of heat.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment. Keep the medicine out of the sight and reach of children.
COMPOSITION
Glycerol Pharma Trenta - Children 1375 mg suppositories
Each 1500 mg suppository contains:
active substance: Glycerol 1375 mg
excipients: sodium bicarbonate 30 mg; sodium stearate 95 mg.
Glycerol Pharma Trenta - Adults 2250 mg Suppositories
Each 2500 mg suppository contains:
active substance: Glycerol 2250 mg
excipients: sodium bicarbonate 60 mg; sodium stearate 190 mg.
PHARMACEUTICAL FORM AND CONTENT
Suppositories. Glycerol Pharma Trenta
A.I.C. No. 030497046 - Children 1375 mg - 18 Glycerol suppositories
A.I.C. No. 030497073 - Adults 2250 mg - 18 Glycerol suppositories
MARKETING AUTHORISATION HOLDER
NEW FA.DEM S.r.l. – Viale Ferrovia dello Stato – zona ASI - 80014 Giugliano in
Campania (NA) – Italy
MANUFACTURER
New,Fa.Dem. srl with registered office and manufacturing site at Viale Ferrovia dello Stato, Zona ASI, 80014, Giugliano in Campania (NA)
REVISION OF THE PACKAGE LEAFLET BY THE
ITALIAN MEDICINES AGENCY
AIFA Determination of ……………………..

PACKAGE LEAFLET

GLYCEROL PHARMA TRENTA RECTAL SOLUTION

Early infancy 2.25 g rectal solution with chamomile and mallow.
Adults 6.75 g rectal solution with chamomile and mallow.
THERAPEUTIC PHARMACOLOGICAL CATEGORY
Laxatives, enemas
THERAPEUTIC INDICATIONS
Short-term treatment of occasional constipation
CONTRAINDICATIONS

• Hypersensitivity to the active substance or to any of the excipients,
• acute abdominal pain or of unknown origin,
• nausea or vomiting,
• intestinal obstruction or stenosis,
• rectal bleeding of unknown origin,
• acute hemorrhoidal crisis with pain and bleeding,
• severe state of dehydration.

PRECAUTIONS FOR USE
Laxatives should be used as infrequently as possible and for no longer than seven days. Use beyond this period requires medical prescription following adequate evaluation of the individual case.
The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, drug prescription, and monitoring during therapy.
Abuse of laxatives may cause persistent diarrhea leading to loss of water, mineral salts (especially potassium), and other essential nutrients.
In more severe cases of abuse, dehydration or

hypokalemia may occur, which can lead to cardiac or neuromuscular dysfunction, especially if concomitant treatment with cardiac glycosides, diuretics, or corticosteroids is being administered.
Abuse of laxatives, particularly contact laxatives (stimulant laxatives), may lead to dependence (and thus possible need for progressive dose increases), chronic constipation, and loss of normal intestinal function (intestinal atony).
In episodes of constipation, it is first recommended to correct dietary habits by supplementing the daily diet with adequate intake of fiber and water.
When using laxatives, it is advisable to drink at least 6–8 glasses of water or other liquids per day to help soften stools.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
No specific interaction studies have been conducted.
SPECIAL WARNINGS
Consult a 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. In children under twelve years of age, the medicine should only be used after consulting a doctor. It is also advisable for elderly individuals or those in poor health to consult a doctor before using the medicine.
Pregnancy and breastfeeding
Seek advice from your doctor or pharmacist before taking any medicine.
Adequate and well-controlled studies on the use of this medicine during pregnancy or breastfeeding have not been conducted.
Although there are no apparent contraindications for the use of this medicine during pregnancy and breastfeeding, it is recommended to take the medicine only when necessary and under medical supervision.
Effects on ability to drive vehicles and operate machinery
This medicine does not alter the ability to drive vehicles or operate machinery.
However, undesirable effects may occur during treatment; therefore, it is advisable to be aware of your individual response to the medicine before driving or operating machinery.
Important information about certain excipients: none.
Health education notes
First and foremost, it must be recognized that in most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can provide lasting relief from constipation. Many people believe they suffer from constipation if they do not have a bowel movement every day. This is a misconception, as such a pattern is entirely normal for many individuals. Constipation should instead be considered when bowel movements are reduced compared to one's usual habits and are associated with the passage of hard stools.
If episodes of constipation recur frequently, a doctor should be consulted.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The correct dose is the smallest amount sufficient to produce easy evacuation. It is advisable to start with the lowest recommended doses.
Adults and adolescents (12–18 years): 1 single-dose adult container as needed, up to a maximum of 1 or 2 administrations per day.
Children aged 6–11 years: 1–2 single-dose early infancy containers as needed, up to a maximum of 1 or 2 administrations per day.
Children aged 2–6 years: 1 single-dose early infancy container as needed, up to a maximum of 1 or 2 administrations per day.
Instructions for use
To remove the safety cannula cap from the single-dose container, place index finger and thumb on the round ring located above the bulb and, with the other hand, bend the cannula cap until it detaches from the body of the container.
During this operation, never grasp the bulb, otherwise the medicine may be expelled before use.
It may be helpful to lubricate the cannula with a drop of the solution itself before inserting it into the rectum and squeezing the bulb. Withdraw the cannula while keeping pressure on the bulb.
Each container must be used for a single administration only; any residual medicine should be discarded.
In children under twelve years of age, the medicine should only be used after consulting a doctor.
Laxatives should be used as infrequently as possible and for no more than seven days (see Precautions for Use). A diet rich in fluids enhances the effect of the medicine.
OVERDOSE
No cases of overdose have been reported. However, excessive doses (laxative abuse – frequent or prolonged use or excessive doses) may cause abdominal pain, persistent diarrhea with consequent loss of water, mineral salts (especially potassium), and other essential nutrients. Fluid and electrolyte losses must be replaced. Electrolyte imbalances are characterized by the following symptoms: thirst, vomiting, weakness, edema, bone pain (osteomalacia), and hypoalbuminemia.
In more severe cases, dehydration or hypokalemia may occur, which can lead to cardiac or neuromuscular dysfunction, especially if concomitant treatment with cardiac glycosides, diuretics, or corticosteroids is being administered. Abuse of laxatives, particularly contact laxatives (stimulant laxatives),

may cause dependence (and thus possible need for progressive dose increases), chronic constipation, and loss of normal intestinal function (intestinal atony).
In case of accidental ingestion/absorption of an excessive dose of glycerol, contact a doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Glycerol Pharma Trenta, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, glycerol may cause undesirable effects, although not everyone experiences them.
The following undesirable effects of glycerol are reported. Sufficient data are not available to determine the frequency of the individual effects listed.
Gastrointestinal disorders
Isolated cramping pains or abdominal colic and diarrhea, with loss of fluids and electrolytes, more frequent in cases of severe constipation, as well as rectal irritation.
Following the instructions contained in this leaflet reduces the risk of
undesirable effects.
If any of the undesirable effects worsens, or if you notice any undesirable
effect not listed in this leaflet, inform your doctor or pharmacist.
EXPIRY DATE AND STORAGE
Expiry date: see the date indicated on the packaging.
The expiry date refers to the medicine in its original, unopened packaging, correctly stored.
CAUTION: do not use the medicine after the expiry date stated on the packaging.
Store below 30 °C.
Keep in the original packaging to protect the medicine from moisture and away from direct sources of heat.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Keep the medicine out of the sight and reach of children.
COMPOSITION
GLYCEROL PHARMA TRENTA – early infancy 2.25 g rectal solution with
chamomile and mallow.
Each single-dose container contains:
active substance: Glycerol 2.25 g
excipients: wheat starch 0.02 g; chamomile fluid extract 0.10 g; mallow fluid extract 0.10 g; purified water q.s. to 3 g.
GLYCEROL PHARMA TRENTA – adults 6.75 g rectal solution with
chamomile and mallow.
Each single-dose container contains:

active substance: Glycerol 6.75 g
excipients: wheat starch 0.06 g; chamomile fluid extract 0.30 g; mallow fluid extract 0.30 g; purified water q.s. to 9 g.
PHARMACEUTICAL FORM AND CONTENT
Rectal solution

• early infancy 2.25 g rectal solution with chamomile and mallow. – six micro-enemas in PE with cannula, 3 g each
• adults 6.75 g rectal solution with chamomile and mallow. – six micro-enemas in PE with cannula, 9 g each

MARKETING AUTHORIZATION HOLDER
NEW FA.DEM S.r.l. – Viale Ferrovia dello Stato – zona ASI - 80014 Giugliano in Campania (NA) – Italy
MANUFACTURER
New,Fa.Dem. srl with registered office and production site at Viale Ferrovia dello Stato, Zona ASI, 80014, Giugliano in Campania (NA)
REVISION OF THE PACKAGE LEAFLET BY THE
ITALIAN MEDICINES AGENCY (AIFA)
AIFA Determination of ……………………….