Epilax

Package leaflet: Information for the user

EPILAX Children 1375 mg suppositories, Adults 2250 mg suppositories

Glycerol
Please read all of this leaflet carefully before you use 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 told you to.

• 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement 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 EPILAX is and what it is used for

EPILAX contains the active substance glycerol, which belongs to the group of laxatives – 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 you experience worsening of symptoms 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 medicine (listed in section 6);
• if you have acute abdominal pain or of unknown origin;
• if you have nausea or vomiting;
• if you have intestinal obstruction or narrowing (stenosis);
• if you have rectal bleeding of unknown origin;
• if you have acute hemorrhoidal crisis (swelling of blood vessels around the anus) with pain and bleeding;
• if you are severely dehydrated.

Warnings and precautions
Talk to your doctor or pharmacist before using EPILAX.
If you are elderly and/or in poor health, inform your doctor before using this medicine.
Use laxatives (medicines that stimulate bowel evacuation) as infrequently as possible and never for longer than 7 days. Using laxatives for longer periods requires a doctor’s prescription following an appropriate assessment of the patient’s condition.
If you suffer from constipation that lasts for long periods (chronic) or occurs frequently, always seek medical advice for diagnosis, prescription of medicines, and monitoring during treatment. 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 the laxative fails to produce an effect.
Drink at least 6–8 glasses daily of water or other fluids to help soften stools when using laxatives.
If you overuse, use too frequently, or misuse laxatives, you may develop prolonged diarrhea, resulting in loss of water, minerals (especially potassium), and other essential nutrients. In severe cases of abuse, excessive fluid loss (dehydration) or low blood potassium levels (hypokalaemia) may occur, which can cause heart problems or affect muscle function, particularly if you are taking cardiac glycosides, diuretics, or corticosteroids during treatment with this medicine.
Abuse of laxatives, especially stimulant laxatives (contact laxatives), may lead to dependence (increasing need for higher doses), chronic constipation, and loss of normal intestinal function (intestinal atony).

Children
Use EPILAX in children under 12 years of age only after consulting a doctor.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Use this medicine during pregnancy and breastfeeding only if necessary and always under direct medical supervision.

Driving and using machines
This medicine does not impair your ability to drive or operate machinery. However, pay attention to your individual response to the medicine, as adverse effects may occur that could affect your ability to drive or use machinery (see “Side effects”).

3. How to use EPILAX

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.
The correct dose is the lowest dose required to produce easy bowel movement. Initially use the minimum recommended doses. When necessary, the dose may be increased, but never exceed the maximum indicated dose.

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

Use in children aged between 2 and 11 years
The recommended dose is 1 suppository of EPILAX 1375 mg as needed, up to a maximum of 2 suppositories per day.

Use laxatives as infrequently as possible and for no longer 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 seem 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 amounts, you may experience abdominal pain and persistent diarrhoea, leading to loss of fluids, mineral salts (especially potassium), and other essential nutrients, which must be replaced.
Symptoms of disturbance in the body's salt balance (electrolyte imbalance) include: thirst, vomiting, weakness, swelling (oedema), bone problems (osteomalacia), and decreased levels of a protein in the blood called albumin (hypoalbuminaemia).
In case of accidental ingestion/overdose of EPILAX, contact your doctor immediately or go to the nearest hospital.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects have been observed with EPILAX at an unknown frequency (frequency cannot be estimated from the available data):

• Cramping pains (localized or widespread in the abdomen);
• Intermittent abdominal pain (colic);
• Diarrhoea (with loss of fluids and electrolytes);
• Redness with burning or pain (irritation) around the anus.

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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EPILAX contains
The active substance is glycerol.
EPILAX Bambini 1375 mg suppositories contain 1375 mg of glycerol.
EPILAX Adulti 2250 mg suppositories contain 2250 mg of glycerol.
The other components are: sodium stearate, sodium carbonate decahydrate.

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Epifarma S.r.l.
Via San Rocco, 6
85033 Episcopia (PZ)

Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)

Health Education Notes
In most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can provide a lasting solution to constipation.
Many people believe they suffer from constipation if they do not have a bowel movement every day. This is a mistaken belief, as such a pattern is completely normal for many individuals.
Constipation is instead defined by having fewer bowel movements than usual for the individual, associated with the passage of hard stools. Before using laxatives, it is advisable to correct dietary habits by increasing daily intake of adequate amounts of fiber and water.
If the condition is persistent (chronic constipation) or recurrent, it is advisable to consult a doctor.

Package leaflet: Information for the user

EPILAX Children 2.25 g rectal solution, Adults 6.75 g rectal solution

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 you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any of the side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms 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 EPILAX is and what it is used for

EPILAX contains the active substance glycerol, which belongs to a group of medicines called laxatives. Laxatives are medicines used to facilitate the evacuation 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 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 have acute abdominal pain or of unknown origin;
• if you have nausea or vomiting;
• if you suffer from intestinal obstruction or narrowing (stenosis);
• if you have rectal bleeding of unknown origin;
• if you have acute swelling of blood vessels around the anus (acute hemorrhoidal crisis) with pain and bleeding;
• if you are severely dehydrated.

Warnings and precautions
Talk to your doctor or pharmacist before using EPILAX.
If you are elderly and/or in poor health, inform your doctor before using this medicine.
Use laxatives (medicines that stimulate bowel evacuation) as infrequently as possible and never for longer than 7 days. Using laxatives for longer periods requires a doctor's prescription following an adequate assessment of your condition.
If you suffer from constipation that lasts for long periods (chronic) or occurs frequently, always consult your doctor for diagnosis, prescription of medicines, and monitoring during treatment. 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) lasting more than two weeks, or when use of the laxative fails to produce an effect.
Drink at least 6–8 glasses of water or other fluids daily to help soften stools while using laxatives.
If you use laxatives excessively, frequently, or incorrectly, you may develop prolonged diarrhea, resulting in loss of water, mineral salts (especially potassium), and other essential nutrients. In severe cases of abuse, excessive fluid loss (dehydration) or low blood potassium levels (hypokalemia) may occur, which can cause heart problems or muscle dysfunction, particularly if you are taking cardiac glycosides, diuretics, or corticosteroids during treatment with this medicine.
Abuse of laxatives, especially stimulant laxatives (contact laxatives), may lead to dependence (the need to continually increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).

Children
Use EPILAX in children under 12 years of age only after consulting a doctor.

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

Pregnancy and breastfeeding
If you are pregnant, think 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 using machines
This medicine does not impair the ability to drive or operate machinery. However, observe your individual response to the medicine, as adverse effects may occur that could affect your ability to drive and use machinery (see “Side effects”).

3. How to use EPILAX

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The correct dose is the lowest amount needed to produce easy bowel evacuation. Initially use the lowest recommended doses. When necessary, the dose may be increased, but must never exceed the maximum indicated dose.

Use in adults and adolescents (12–18 years of age)
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 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 longer than seven days (see "Warnings and precautions").

Method of administration
Remove the cap from the single-dose container without ever touching the bulb, otherwise the medicine may be expelled before use.
If necessary, use a drop of the medicinal solution to moisten (lubricate) the cannula before inserting it into the rectum, then squeeze the bulb. Withdraw the cannula while still pressing the bulb.
Use each container for a single administration only; discard any remaining medicine.

If you use more EPILAX than you should
If you use this medicine in excessive amounts, abdominal pain and persistent diarrhoea may occur, leading to loss of fluids, minerals (especially potassium), and other essential nutrients that need to be replaced.
Symptoms of altered body electrolyte balance (electrolyte imbalance) include: thirst, vomiting, weakness, swelling (oedema), bone problems (osteomalacia), and decreased levels of the protein albumin in the blood (hypoalbuminaemia).
In case of accidental ingestion/overdose of EPILAX, contact your doctor immediately or go to the nearest hospital.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects have been observed with EPILAX, with a frequency not known (frequency cannot be estimated based on the available data):

• Cramping pains (isolated or widespread in the abdomen);
• Intermittent abdominal pain (colic);
• Diarrhoea (with loss of fluids and electrolytes);
• Redness with burning or pain (irritation) around the anus.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may 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 EPILAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What EPILAX contains
The active substance is glycerol.
EPILAX Bambini 2.25 g rectal solution contains 2.25 g of glycerol.
EPILAX Adulti 6.75 g rectal solution contains 6.75 g of glycerol.
The other components 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 Authorization Holder and Manufacturer
Marketing Authorization Holder
Epifarma S.r.l.
Via San Rocco, 6
85033 Episcopia (PZ)

Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)

Health Education Notes
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 are unable to defecate every day. This is a mistaken belief, as such a pattern is completely normal for many individuals.
Constipation is instead defined as a reduction in bowel movements compared to one's usual habits, associated with the passage of hard stools. Before using laxatives, it is advisable to correct dietary habits by increasing daily intake of fibre and water.
If the condition is persistent (chronic constipation) or recurrent, it is advisable to consult a doctor.