EPILAX 6.75 G Ректальный раствор

Содержание инструкции

1. EPILAX Bambini 1,375 g supposte, Adulti 2,250 g supposte
   1. What is EPILAX and what is it used for
   2. What you need to know before using EPILAX
   3. How to use EPILAX
   4. Possible side effects
   5. How to store EPILAX
   6. Contents of the pack and other information
2. EPILAX Bambini 2,25 g rectal solution, Adulti 6,75 g rectal solution
   1. What is EPILAX and what is it used for
   2. What you need to know before you use EPILAX
   3. How to use EPILAX
   4. Possible side effects
   5. How to store EPILAX
   6. Contents of the pack and other information

EPILAX Bambini 1,375 g supposte, Adulti 2,250 g supposte

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

1. What is EPILAX and what is it used for

EPILAX contains the active ingredient glycerol which belongs to the category of laxatives which are
medicinal products used to facilitate the elimination of faeces.
This medicinal product 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 EPILAX

Do not use EPILAX

• if you are allergic to glycerol or to any of the other ingredients of this medicinal product (listed in section 6);
• if you suffer from acute or of unknown origin abdominal pain;
• 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 in a severe state of dehydration.

Warnings and precautions
Consult your doctor or pharmacist before using EPILAX.
If you are elderly and/or are not in good health, inform your doctor before using this
medicinal product.
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 requires a
prescription from your doctor, 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 is due to 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 stools
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 fluid loss
(dehydration) or a decrease in blood potassium levels (hypokalaemia) may occur, which can
cause heart problems or muscle activity, especially if you are taking cardiac glycosides,
diuretics or corticosteroids during treatment with this medicinal product.
Abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (the
need to constantly increase the dosage), chronic constipation and loss of normal functions
intestine (intestinal atony).

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

Other medicines and EPILAX
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 you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicinal product.
Use this medicinal product during pregnancy and breastfeeding only if necessary and always under
direct medical supervision.

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

3. How to use EPILAX

Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask 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 EPILAX 2.25 g suppository as needed, up to a maximum of 2 suppositories per
day.

Use in children aged 2 years and over to 11 years
The recommended dose is 1 EPILAX 1.375 g suppository 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
introduction.
If the suppositories appear too soft, place the containers in cold water before opening them.

If you use more EPILAX than you should
If you use this medicine in excessive quantities, abdominal pain and persistent diarrhea may occur, which cause loss of fluids, mineral salts (especially potassium) and other essential nutrients that must be replaced.
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 EPILAX, inform your
doctor immediately or go to the nearest hospital.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With EPILAX, 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 anus.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor, pharmacist or nurse. You can also report side effects directly
through 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 EPILAX

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 EPILAX contains
The active ingredient is glycerol.
EPILAX Children 1.375 g suppositories contain 1.375 g of glycerol .
EPILAX Adults 2.250 g suppositories contain 2.250 g of glycerol.
The other ingredients are: sodium stearate, decahydrate sodium carbonate.

Description of the appearance of EPILAX and contents of the pack
EPILAX 1.375 g and 2.250 g suppositories are available in packs containing 18 suppositories.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Epifarma S.r.l.
Via San Rocco, 6
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 fiber (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 emission of hard stools. Before using laxatives, it is good to correct dietary
habits, integrating the daily diet with an adequate intake of fiber and water.
If the disorder is continuous (chronic constipation) or recurrent, it is advisable to contact your doctor.

EPILAX 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.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What is EPILAX and what is it used for

EPILAX 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 you use EPILAX

Do not use EPILAX

• 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 EPILAX.
If you are elderly and/or 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 requires a
prescription from your doctor, 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 stems 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 stools
when using laxatives.
If you use laxatives excessively, frequently or incorrectly, you may experience prolonged diarrhoea
resulting in loss of water, mineral salts (especially potassium) and other essential nutrients.
In the most severe cases of abuse, excessive fluid loss
(dehydration) or a decrease in blood potassium levels (hypokalaemia) may occur, which can
cause heart problems or muscle activity, especially if you are taking cardiac glycosides,
diuretics or corticosteroids during treatment with this medicine.
Abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (the
need to increase the dosage more and more), chronic constipation and loss of normal functions
intestine (intestinal atony).

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

Other medicines and EPILAX
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 you may be pregnant, are planning a pregnancy, or are breastfeeding
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 alter your ability
to drive and use machinery (see "Side effects").

3. How to use EPILAX

Use this medicine following exactly as described 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 EPILAX 6.75 g as needed, up to a maximum of 2 single-dose containers per day.

Use in children aged 2 years and older up to 11 years
The recommended dose is 1 single-dose container of EPILAX 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 bellows, 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 bellows. Extract the cannula while keeping the bellows pressed.
Use the container for a single administration; discard any remaining medicine.

If you use more EPILAX than you should
If you use this medicine in excessive quantities, abdominal pain and persistent diarrhea may occur, causing loss of fluids, minerals (especially potassium) and other essential nutrients that must be replenished.
The symptoms of an alteration in the balance of salts in the body (electrolyte imbalance) are: thirst, vomiting, weakness, swelling (edema), bone problems (osteomalacia) and a decrease in a protein present in the blood, albumin (hypoalbuminemia).
In case of accidental ingestion/administration of an excessive dose of EPILAX, 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 EPILAX, 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 inform
your doctor or pharmacist or nurse. You can also report side effects directly
through 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 EPILAX

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 EPILAX contains
The active ingredient is glycerol.
EPILAX Children 2.25 g rectal solution contains 2.25 g of glycerol
EPILAX 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 EPILAX and contents of the pack
EPILAX 2.25 g and 6.75 g rectal solution are available in packs containing 6 single-dose containers.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Epifarma S.r.l.
Via San Rocco, 6
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 to occur when bowel movements 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 by 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 a doctor.