FELAX 6.75 G Rectal solution

Зміст інструкції

1. FELAX Bambini 1375 mg suppositories, Adulti 2250 mg suppositories
   1. What is FELAX and what is it used for
   2. What you need to know before using FELAX
   3. How to use FELAX
   4. Possible side effects
   5. How to store FELAX
   6. Contents of the pack and other information
2. FELAX Bambini 2.25 g rectal solution, Adulti 6.75 g rectal solution
   1. What is FELAX and what is it used for
   2. What you need to know before using FELAX
   3. How to use FELAX
   4. Possible side effects
   5. How to store FELAX
   6. Contents of the pack and other information

FELAX Bambini 1375 mg suppositories, Adulti 2250 mg suppositories

Glycerol

Read this leaflet carefully before using this medicine as it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What is FELAX and what is it used for

FELAX contains the active ingredient glycerol which belongs to the category of laxatives which
are medicines used to facilitate the elimination 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 FELAX

Do not use FELAX

• if you are allergic to glycerol or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from acute abdominal pain of unknown origin;
• if you have nausea or vomiting;
• if you suffer from obstruction or narrowing (stenosis) of the intestine;
• if you suffer from rectal bleeding of unknown origin;
• if you suffer from swelling of the blood vessels around the anus (acute haemorrhoidal crisis) with pain and bleeding;
• if you are severely dehydrated.

Warnings and precautions
Consult your doctor or pharmacist before using FELAX.
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 more than 7 days. The use of laxatives for longer periods of time
requires a doctor's prescription, after adequate assessment of the patient's condition.
If you suffer from constipation that lasts for long periods (chronic) or is frequent, always seek
medical attention for diagnosis, prescription of medicines and
monitoring during therapy. 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) that lasts for more than two weeks or when the use of the laxative fails to
produce effects.
Drink at least 6-8 glasses of water or other liquids a day to help soften
the stool when using laxatives.
If you use laxatives excessively, frequently or incorrectly, you may experience
prolonged diarrhoea with consequent loss of water, mineral salts (especially potassium) and other
essential nutrients. In the most severe cases of abuse, excessive
loss of fluids (dehydration) or a decrease in blood potassium levels may occur
(hypokalaemia) which can cause heart or muscle problems,
especially if you are taking cardiac glycosides, diuretics or corticosteroids during the
treatment with this medicine.
The abuse of laxatives, especially stimulant laxatives (contact laxatives), can cause
dependence (the need to increase the dosage more and more), chronic constipation and loss
of normal bowel function (intestinal atony).

Children
In children under 12 years of age, use FELAX only after consulting a doctor.

Other medicines and FELAX
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
There is no information on interactions with other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Use this medicine during pregnancy and breastfeeding only if necessary and always
under direct medical supervision.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles and operate machinery.
However, observe your response to the medicine as undesirable effects may occur
that impair the ability to drive and use machinery (see “Side effects”).

3. How to use FELAX

Use this medicine following 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 minimum sufficient to produce easy evacuation. Initially use the minimum doses provided. When necessary, the dose can then be increased,
but never exceeding the maximum indicated.

Use in adults and adolescents (12-18 years)
The recommended dose is 1 suppository of FELAX 2250 mg as needed, up to a maximum of 2
suppositories per day.

Use in children aged between 2 years and 11 years
The recommended dose is 1 suppository of FELAX 1375 mg as needed, up to a maximum of 2
suppositories per day.
Use laxatives as infrequently as possible and for no more than seven days (see
“Warnings and precautions”).

Method of administration
Remove the suppository from its container and moisten it, if necessary, to facilitate
rectal insertion.
If the suppositories appear too soft, place the containers in cold water before
opening them.

If you use more FELAX than you should
If you use this medicine in excessive quantities, abdominal pain and
persistent diarrhea may occur, causing loss of fluids, mineral salts (especially potassium) and other
essential nutrients that need to be replenished.
The symptoms of an imbalance of salts in the body (electrolyte imbalance) are: thirst, vomiting, weakness, swelling (edema), bone problems
(osteomalacia) and a decrease in a protein in the blood, albumin
(hypoalbuminemia).
In case of accidental ingestion/intake of an excessive dose of FELAX, immediately inform your doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With FELAX, the following side effects have been observed with an unknown frequency (the
frequency cannot be defined based on available data):

• cramping pains (isolated or widespread in the abdomen);
• non-continuous abdominal pain (colic);
• diarrhea (with loss of fluids and electrolytes);
• redness with burning or pain (irritation) at the level of the anus.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult your doctor, pharmacist or nurse. You can also report side effects
directly
through the national reporting system at
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the
safety of this medicine.

5. How to store FELAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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 moisture and away from
direct sources of heat.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FELAX contains
The active ingredient is glycerol.
FELAX Bambini 1375 mg suppositories contain 1375 mg of glycerol .
FELAX Adulti 2250 mg suppositories contain 2250 mg of glycerol.
The other ingredients are: sodium stearate, sodium carbonate decahydrate.

Description of the appearance of FELAX and contents of the pack
FELAX 1375 mg and 2250 mg suppositories are available in packs containing 18 suppositories.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmeg S.r.l.
Via dei Giardini, 34
85033 Episcopia (PZ)

Manufacturer
Special Product’s Line S.p.A. - Strada Paduni, 240 - 03012 Anagni (FR)

Health Education Notes
In most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit)
can durably resolve the problem of constipation.
Many people think they suffer from constipation if they cannot evacuate every day. This is
a mistaken belief, as this situation is perfectly normal for a large number of
individuals.
Constipation is considered when evacuations are reduced compared to one's personal
habits and are associated with the passage of hard stools. Before using laxatives, it is advisable to correct
dietary habits, supplementing the daily diet with an adequate intake of fibre and water.
If the disorder is continuous (chronic constipation) or recurrent, it is appropriate to contact your doctor.

FELAX Bambini 2.25 g rectal solution, Adulti 6.75 g rectal solution

Glycerol

Read this leaflet carefully before using this medicine as it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What is FELAX and what is it used for

FELAX contains the active ingredient glycerol which belongs to the category of laxatives which
are medicines used to facilitate the elimination of stools.
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 FELAX

Do not use FELAX

• if you are allergic to glycerol or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from acute abdominal pain or of unknown origin;
• if you have nausea or vomiting;
• if you suffer from obstruction or narrowing (stenosis) of the intestine;
• if you suffer from rectal bleeding of unknown origin;
• if you suffer from swelling of the blood vessels around the anus (acute hemorrhoidal crisis) with pain and bleeding;
• if you are in a severe state of dehydration.

Warnings and precautions
Consult your doctor or pharmacist before using FELAX.
If you are elderly and/or are not in good 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 more than 7 days. The use of laxatives for longer periods of time
requires a doctor's prescription, after adequate assessment of the patient's conditions.
If you suffer from constipation that lasts for long periods (chronic) or is frequent, always seek
medical attention for diagnosis, prescription of medicines 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) that lasts for more than two weeks or when the use of the laxative fails to
produce effects.
Drink at least 6-8 glasses of water or other liquids a day to help soften
stools when using laxatives.
If you use laxatives excessively, frequently or incorrectly, you may experience
prolonged diarrhea with consequent loss of water, mineral salts (especially potassium) and other
essential nutrients. In the most severe cases of abuse, excessive
loss of fluids (dehydration) or a decrease in blood potassium levels
(hypokalaemia) may occur, which can cause heart or muscle problems,
especially if you are taking cardiac glycosides, diuretics or corticosteroids during the
treatment with this medicine.
The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause
dependence (the need to always increase the dosage), chronic constipation and loss
of normal intestinal functions (intestinal atony).

Children
In children under 12 years of age, use FELAX only after consulting a doctor.

Other medicines and FELAX
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
There is no information on interactions with other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Use this medicine during pregnancy and breastfeeding only if necessary and always
under direct medical supervision.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles and operate machinery.
However, observe your response to the medicine as undesirable effects may occur
that impair the ability to drive and use machinery (see “Side effects”).

3. How to use FELAX

Use this medicine following 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 minimum sufficient to produce easy evacuation. Initially use the minimum doses provided. When necessary, the dose can then be increased,
but never exceeding the maximum indicated.

Use in adults and adolescents (12-18 years)
The recommended dose is 1 single-dose container of FELAX 6.75 g as needed, up to a
maximum of 2 single-dose containers per day.

Use in children aged 2 years and over to 11 years
The recommended dose is 1 single-dose container of FELAX 2.25 g as needed, up to a
maximum of 2 single-dose containers per day.
Use laxatives as infrequently as possible and for no more than seven days (see
“Warnings and precautions”).

Method of administration
Remove the cap from the single-dose container without ever gripping the applicator, otherwise you may 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 and press the applicator. Extract the cannula while keeping
the applicator pressed.
Use the container for a single administration; discard any remaining medicine.

If you use more FELAX than you should
If you use this medicine in excessive quantities, abdominal pain and
persistent diarrhea may occur, causing loss of fluids, mineral salts (especially potassium) and other
essential nutrients that must be replenished.
The symptoms of an imbalance of salts in the body (electrolyte imbalance) are: thirst, vomiting, weakness, swelling (edema), bone
problems (osteomalacia) and a decrease in a protein in the blood, albumin
(hypoalbuminemia).
In case of accidental ingestion/intake of an excessive dose of FELAX, immediately notify
your doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With FELAX, the following side effects have been observed with an unknown frequency (the
frequency cannot be defined based on available data):

• cramping pains (isolated or widespread in the abdomen);
• non-continuous abdominal pain (colic);
• diarrhea (with loss of fluids and electrolytes);
• redness with burning or pain (irritation) at the level of the anus.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult your doctor or pharmacist or nurse. You can also report side effects
directly through the national reporting system at
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine

5. How to store FELAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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 moisture and away from
direct sources of heat.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FELAX contains
The active ingredient is glycerol.
FELAX Children 2.25 g rectal solution contains 2.25 g of glycerol
FELAX Adults 6.75 g rectal solution contains 6.75 g of glycerol.
The other ingredients are: chamomile fluid extract, mallow fluid extract, wheat starch,
purified water.

Description of the appearance of FELAX and contents of the pack
FELAX 2.25 g and 6.75 g rectal solution is available in packs containing 6
single-dose containers.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmeg S.r.l.
Via dei Giardini, 34
85033 Episcopia (PZ)

Manufacturer
Special Product’s Line S.p.A. - Strada Paduni, 240 - 03012 Anagni (FR)

Health Education Notes
In most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit)
can durably resolve the problem of constipation.
Many people think they suffer from constipation if they cannot evacuate every day. This is
a mistaken belief as this situation is perfectly normal for a large number of
individuals.
Constipation is considered instead when evacuations are reduced compared to one's personal
habits and are associated with the passage of hard stools. Before using laxatives, it is advisable to correct
eating habits, integrating the daily diet with an adequate intake of fibre and water.
If the disorder is continuous (chronic constipation) or recurrent, it is appropriate to contact your doctor.