Felax

Package leaflet: Information for the user

FELAX Children 1375 mg suppositories, Adults 2250 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 you.

• 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, contact 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 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 FELAX is and what it is used for

FELAX 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 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 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 FELAX.
If you are elderly and/or in poor general health, inform your doctor before using this medicine.
Use medicines that stimulate bowel emptying (laxatives) as infrequently as possible and in any case for no 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 that 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 previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks, or when the 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 when using laxatives.
If you overuse, use frequently, or misuse laxatives, 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 (hypokalaemia) may occur, which can cause heart problems or muscle dysfunction, especially if you are taking cardiac glycosides, diuretics, or corticosteroids during treatment with this medicine.
Abuse of laxatives, particularly 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
In children under 12 years of age, use FELAX only after consulting a doctor.
Other medicines and FELAX
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 the ability to drive vehicles or operate machinery.
However, observe your response to the medicine, as adverse effects may occur that could affect your ability to drive or use machinery (see "Undesired effects").

3. How to use FELAX

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 amount needed to produce easy bowel movements. Start with the lowest recommended dose. If necessary, the dose may then 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 FELAX 2250 mg as needed, up to a maximum of 2 suppositories per day.

Use in children aged 2 to 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 longer than seven days (see "Warnings and precautions").

Method of administration
Remove the suppository from its packaging 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 FELAX than you should
If you use this medicine in excessive amounts, you may experience abdominal pain and persistent diarrhoea, leading to loss of fluids, electrolytes (especially potassium), and other essential nutrients, which need to be replaced.
Symptoms of electrolyte imbalance include thirst, vomiting, weakness, swelling (oedema), bone problems (osteomalacia), and low levels of the protein albumin in the blood (hypoalbuminaemia).
In case of accidental overdose or ingestion of FELAX, 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 gets them.
The following side effects have been observed with FELAX, with a frequency not known (the
frequency cannot be estimated from the available data):

• Cramp-like pains (isolated or spreading to 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, talk to your doctor, pharmacist, or nurse. You can also report side effects directly
through the national reporting system at the website
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 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 keep 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 no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What FELAX contains
The active substance is glycerol.
FELAX Bambini 1375 mg suppositories contain 1375 mg of glycerol.
FELAX Adulti 2250 mg suppositories contain 2250 mg of glycerol.
The other components 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 Authorization Holder and Manufacturer
Marketing Authorization 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 fiber (bran, vegetables, and fruit) can permanently resolve the problem of constipation.
Many people believe they suffer from constipation if they are unable to defecate every day. This is a mistaken belief, as going less than daily is perfectly normal for a large number of 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 adequate amounts of fiber and water.
If the condition is persistent (chronic constipation) or recurrent, it is appropriate to consult a doctor.

Package leaflet: Information for the user

FELAX 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.

• 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, contact 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 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 FELAX is and what it is used for

FELAX contains the active substance glycerol, which belongs to the category 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 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 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 FELAX.
If you are elderly and/or in poor general 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 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 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 persistent 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 potassium levels in the blood (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 (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 FELAX in children under 12 years of age only after consulting a doctor.

Other medicines and FELAX
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 to become pregnant, or are 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 FELAX

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 amount needed to produce easy bowel evacuation. Start with the lowest recommended dose. When necessary, the dose may then 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 FELAX 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 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 longer than seven days (see "Warnings and precautions").

Method of administration
Remove the cap from the single-dose container without ever grasping 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 press the bulb. Withdraw the cannula while keeping the bulb pressed.
Use the container for a single administration only; discard any remaining medicine.

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

If you have any questions 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.
The following side effects have been observed with FELAX at an unknown frequency (the 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, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the website
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 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 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What FELAX contains
The active substance is glycerol.
FELAX Bambini 2.25 g rectal solution contains 2.25 g of glycerol.
FELAX 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 FELAX and the contents of the pack
FELAX 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
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 permanently resolve the problem of constipation.
Many people believe they suffer from constipation if they are unable to have a bowel movement every day. This is a mistaken belief, as this condition is completely normal for many individuals.
Constipation is instead defined as a reduction in bowel movements compared to one's personal usual pattern, associated with the passage of hard stools. Before using laxatives, it is advisable to correct dietary habits by ensuring an adequate daily intake of fibre and water.
If the condition is persistent (chronic constipation) or recurrent, it is appropriate to consult a doctor.