Sorbiclis

Package leaflet: Information for the user

Sorbiclis Adults 36 g + 0.24 g rectal solution, Children 12 g + 0.0096 g rectal solution

liquid non-crystallizable sorbitol + sodium docusate
Please read all of this leaflet carefully before you start using 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 advice or information, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What Sorbiclis is and what it is used for

Sorbiclis is a rectal solution containing two active substances: liquid non-crystallizable sorbitol and sodium docusate.
These two substances belong to the class of laxatives and work by softening the stools and stimulating the intestine to expel them.
This medicine is used for the short-term treatment of occasional constipation.
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using Sorbiclis

Do not use Sorbiclis

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have problems affecting the anus or the final portion of the intestine called the "rectum" (anorectal disorders with mucosal lesions, rectal bleeding of unknown origin);
• if you have liver problems (hepatic insufficiency, biliary obstruction, biliary calculi);
• if you have abdominal pain, nausea, and vomiting;
• if you have intestinal problems (intestinal obstruction or stenosis);
• if you are severely dehydrated.

Warnings and precautions
Consult your doctor before using Sorbiclis:

• if you have persistent constipation. Treatment of chronic or recurrent constipation always requires medical supervision for diagnosis, prescription of medications, and monitoring during therapy;
• if you have noticed a sudden change in your bowel habits (frequency and characteristics of bowel movements) lasting for more than two weeks;
• if you are pregnant or breastfeeding (see also "Pregnancy and breastfeeding");
• if you are elderly or your general health condition is poor.

Consult your doctor also if, after a short period of treatment with this medicine, you do not achieve noticeable results.
Do not use this medicine for prolonged treatments.
Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause:

• dependence, leading to the possible need to progressively increase the dose;
• chronic constipation;
• loss of normal intestinal function (intestinal atony);
• persistent diarrhea, which may result in loss of water, electrolytes (especially potassium), and other essential nutrients. In more severe cases, dehydration or low blood potassium levels (hypokalaemia) may occur, which can lead to heart or nerve dysfunction affecting muscle control. The risk is increased if you are simultaneously taking medications for heart conditions (cardiac glycosides), medications for high blood pressure (diuretics), or medications used for allergies and inflammation (corticosteroids).

Children
Sorbiclis Adults 36 g + 0.24 g rectal solution is not indicated for children.
In children under 12 years of age, Sorbiclis Children 12 g + 0.0096 g rectal solution may be used only after consulting a doctor.

Other medicines and Sorbiclis
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, do not use Sorbiclis if you are taking medicines containing liquid paraffin or mineral oil, used for constipation.
Sorbiclis may reduce the intestinal transit time of other orally administered medicines taken simultaneously, thereby reducing their absorption. Therefore, avoid taking laxatives together with other medicines: after taking any medicine, wait at least 2 hours before taking the laxative.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
There are no adequate studies on the use of this medicine during pregnancy or breastfeeding.
During pregnancy and breastfeeding, use this medicine only if your doctor considers it necessary, after evaluating the risk/benefit ratio with you and under their direct supervision.

Driving and using machines
This medicine does not affect the ability to drive vehicles or operate machinery.

Sorbiclis contains sodium methyl para-hydroxybenzoate
It may cause allergic reactions (including delayed reactions).

3. How to use Sorbiclis

Use this medicine 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 recommended dose for an enema is the entire contents of the bottle, preferably administered in the evening.
Use the smallest effective dose necessary to produce an easy evacuation of soft stools.
Do not exceed the recommended dose.
If you have any doubts, consult your doctor or pharmacist.
A diet rich in fluids helps enhance the effect of the medicine.

Instructions for use
For correct use of the product, it is recommended to administer Sorbiclis by inserting it into the rectum while lying on your side (see below).

Duration of treatment
This medicine, like all laxatives, should be used as infrequently as possible and for no longer than seven days. Use for longer periods requires appropriate medical evaluation and a prescription.

If you use more Sorbiclis than you should
Excessive doses may cause abdominal pain and diarrhoea, which can lead to loss of water and electrolytes (see the section "Warnings and precautions" regarding laxative abuse). If diarrhoea occurs, drink plenty of fluids.
In case of accidental ingestion or overdose of Sorbiclis, contact your doctor immediately or go to the nearest hospital. Take this leaflet with you.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Occasionally, abdominal cramp-like or colicky pains may occur, which are more frequent in cases of severe constipation. No intolerance phenomena or discomfort at application site have been reported.
Additional adverse reactions in children
Occasionally, children have experienced difficulty controlling bowel movements, and the rectal solution has been rapidly expelled immediately after insertion.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at the website
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. How to store Sorbiclis

This medicine does not require any special storage conditions.
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.
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 Sorbiclis contains
In 120 ml of rectal solution of Sorbiclis Adulti 36 g + 0.24 g:

• The active substances are liquid non-crystallizable sorbitol 36 g and sodium docusate 0.24 g.
• The other components are sodium methyl parahydroxybenzoate, purified water.

In 120 ml of rectal solution of Sorbiclis Bambini 12 g + 0.0096 g:

• The active substances are liquid non-crystallizable sorbitol 12 g and sodium docusate 0.0096 g.
• The other components are sodium methyl parahydroxybenzoate, purified water.

Description of the appearance of Sorbiclis and contents of the pack
Sorbiclis Adulti and Sorbiclis Bambini are presented as rectal solution in a 120 ml polyethylene bottle with collar and with an attached cannula.
Marketing Authorization Holder
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
DMS Farmaceutici S.p.A. - Via Provinciale per Lecco, 78 - 22038 Tavernerio (CO)
Health education notes:
Many people believe they suffer from constipation if they cannot defecate every day.
This is a mistaken belief, as this condition is completely normal for a large number of individuals.
Constipation instead refers to the condition in which bowel movements are reduced compared to one's usual habits and are associated with the passage of hard stools.
In most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit) can permanently resolve constipation.
If episodes of constipation occur repeatedly, a doctor should be consulted.
Package leaflet: information for the user

Sorbiclis Adulti 36 g + 0.24 g rectal solution

liquid non-crystallizable sorbitol + sodium docusate
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What Sorbiclis is and what it is used for

Sorbiclis is a rectal solution containing two active substances: liquid non-crystallizable sorbitol and sodium docusate.
These two substances belong to the class of laxatives and work by softening the stools and stimulating the bowel to eliminate them.
This medicine is used in adults for the short-term treatment of occasional constipation.

2. What you need to know before using Sorbiclis

Do not use Sorbiclis

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have problems affecting the anus or the final part of the intestine called the "rectum" (anorectal conditions with mucosal lesions, unexplained rectal bleeding);
• if you have liver problems (hepatic insufficiency, biliary obstruction, gallstones);
• if you have abdominal pain, nausea, and vomiting;
• if you have intestinal problems (intestinal obstruction or stenosis);
• if you are severely dehydrated;
• in children

Warnings and precautions
Talk to your doctor or nurse before using Sorbiclis if:

• your constipation is persistent. Treatment of chronic or recurrent constipation always requires medical supervision for diagnosis, prescription of medication, and monitoring during therapy;
• you have noticed a sudden change in your bowel habits (frequency and characteristics of bowel movements) lasting for more than two weeks;
• you are pregnant or breastfeeding (see also “Pregnancy and breastfeeding”);
• you are elderly or your general health condition is poor;
• after a short period of treatment with this medicine, you do not achieve noticeable results.

Do not use this medicine for prolonged treatments and follow your doctor's instructions.
Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause:

• dependency, leading to a possible need for progressively increasing doses;
• chronic constipation;
• loss of normal intestinal function (intestinal atony);
• persistent diarrhea, which may result in loss of water, mineral salts (especially potassium), and other essential nutrients. In more severe cases, dehydration or low blood potassium levels (hypokalemia) may occur, potentially causing heart or nerve problems affecting muscle control. The risk is increased if you are simultaneously being treated with heart medications (cardiac glycosides), drugs used for high blood pressure (diuretics), or drugs used for allergies and inflammation (corticosteroids).

Other medicines and Sorbiclis
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
In particular, inform your doctor if you are taking medicines containing liquid paraffin or mineral oil, used for constipation.
Sorbiclis may reduce the intestinal transit time of other medicines taken simultaneously by mouth, thereby affecting their absorption. Therefore, avoid taking laxatives together with other medicines: after taking a medicine, wait at least 2 hours before taking the laxative.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
There are no adequate studies on the use of this medicine during pregnancy or breastfeeding.
During pregnancy and breastfeeding, use this medicine only if your doctor considers it necessary, after evaluating with you the risk/benefit ratio, and under his or her direct supervision.

Driving and operating machinery
This medicine does not impair the ability to drive or operate machinery.

Sorbiclis contains sodium methyl para-hydroxybenzoate
It may cause allergic reactions (including delayed reactions).

3. How to use Sorbiclis

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor.
The recommended dose for an enema is the entire contents of the bottle, preferably administered in the
evening.
Use the smallest dose sufficient to produce easy evacuation of soft stools.
Do not exceed the recommended dose.
A diet rich in fluids helps enhance the effect of the medicine.
Instructions for use
For proper use of the product, it is recommended to administer Sorbiclis by rectal administration while lying on your side (see below).

D
Duration of treatment
This medicine, like all laxatives, should be used as infrequently as possible and for no
longer than seven days. Use for longer periods requires appropriate medical evaluation.
If you use more Sorbiclis than you should
Excessive doses may cause abdominal pain and diarrhoea, which can lead to loss of water and mineral salts (see information in section “Warnings and precautions” regarding laxative abuse). If diarrhoea occurs, drink plenty of fluids.
In case of accidental ingestion or overdose of Sorbiclis, contact your doctor immediately

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Occasionally, abdominal cramps or colic-like pains may occur, which are more frequent in cases of severe constipation. No intolerance reactions or discomfort at the application site have been reported.

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 website: http://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 Sorbiclis

This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.

6. Contents of the pack and other information

What Sorbiclis contains
In 120 ml of Sorbiclis Adults rectal solution 36 g + 0.24 g:

• The active substances are liquid non-crystallizable sorbitol 36 g and sodium docusate 0.24 g.
• The other components are sodium methyl para-hydroxybenzoate, purified water.

Description of the appearance of Sorbiclis and contents of the pack
Sorbiclis is a rectal solution supplied in a pack containing 20 120 ml polyethylene vials with neck and with an attached cannula.
Marketing Authorization Holder
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
DMS Farmaceutici S.p.A. - Via Provinciale per Lecco, 78 - 22038 Tavernerio (CO)