SORBICLIS 36.00 G/0.24 G Ректальный раствор

Содержание инструкции

1. Sorbiclis Adulti 36 g + 0,24 g rectal solution, Sorbiclis Bambini 12 g + 0,0096 g rectal solution
   1. What is Sorbiclis 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. Package contents and other information
2. Sorbiclis Adulti 36 g + 0,24 g rectal solution
   1. What is Sorbiclis and what is it 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

Sorbiclis Adulti 36 g + 0,24 g rectal solution, Sorbiclis Bambini 12 g + 0,0096 g rectal solution

sorbitol liquid non-crystallizable + docusate sodium

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.
• Talk to your doctor if you do not feel better 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 is Sorbiclis and what it is used for

Sorbiclis is a rectal solution containing two active ingredients: non-crystallizable liquid sorbitol and
docusate sodium.
These two substances belong to the class of laxatives and work by softening the stool and
stimulating the intestine to eliminate it.
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 ingredients or to any of the other ingredients of this medicine (listed in section 6);
• if you have problems with the anus or the last part of the intestine called the “rectum” (ano-rectal conditions with mucosal lesions, rectal bleeding of unknown origin);
• if you have liver problems (hepatic insufficiency, obstruction of the bile ducts, gallstones);
• if you have abdominal pain, nausea and vomiting;
• if you have problems with the intestine (obstruction or intestinal stenosis);
• if you are severely dehydrated.

Warnings and precautions
Talk to your doctor before using Sorbiclis:

• if constipation is persistent. Treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of drugs and monitoring during therapy;
• if you have noticed a sudden change in your bowel habits (frequency and characteristics of bowel movements) that lasts for more than two weeks;
• if you are pregnant or breastfeeding (see also “Pregnancy and breastfeeding”);
• if you are elderly or your health conditions are not good.

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

• dependence and therefore a possible need to gradually increase the dose;
• chronic constipation;
• loss of the normal capabilities of the intestine (intestinal atony);
• persistent diarrhea which can lead to loss of water, mineral salts (especially potassium) and other essential nutrients. In the most severe cases, dehydration or a decrease in potassium in the blood (hypokalemia) may occur, which can determine heart or nerve dysfunction that control the muscles. The risk is increased if you are simultaneously treated with drugs for the heart (cardiac glycosides), drugs used against high blood pressure (diuretics) or drugs used against allergies and inflammation (corticosteroids).

Children
Sorbiclis Adulti 36 g + 0.24 g rectal solution is not indicated in children
In children under 12 years of age Sorbiclis Bambini 12 g + 0.0096 g rectal solutioncan be
used only after consulting a doctor.

Other medicines and Sorbiclis
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, do not use Sorbiclis if you are taking medicines based on liquid paraffin or mineral oil,
used for constipation.
Sorbiclis may reduce the time of stay in the intestine of other drugs administered
simultaneously orally, and therefore the absorption. Therefore, avoid taking
laxatives and other drugs at the same time: after taking a medicine, allow at least 2 hours to pass
before taking the laxative.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
There are no adequate studies on the use of this medicine in pregnancy or breastfeeding.
During pregnancy and breastfeeding, use this medicine only if your doctor has considered it
necessary, after evaluating the risk/benefit ratio with him and under his direct control

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

Sorbiclis contains sodium methyl parahydroxybenzoate
It may cause allergic reactions (including delayed reactions).

3. How to use Sorbiclis

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 recommended dose for an enema is the entire contents of the bottle, preferably taken in the
evening.
Use the minimum dose sufficient to produce 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 promotes the effect of the medicine.

Method of use
For correct use of the product, it is recommended to use Sorbiclis by inserting it into the rectum in
a lying position on your side (see below).

Duration of treatment
This medicine, like all laxatives, should be used as infrequently as possible and for no more than
seven days. Use for longer periods requires adequate evaluation and prescription by your doctor.

If you use more Sorbiclis than you should
Excessive doses can cause abdominal pain and diarrhea, which can lead to loss of water and mineral
salts (see the section “Warnings and precautions” regarding the abuse of laxatives). Drink plenty of fluids if you experience diarrhea.
In case of accidental ingestion or taking an excessive amount of Sorbiclis, immediately warn
your doctor or go to the nearest hospital. Bring this leaflet with you.

4. Possible side effects

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

Additional side effects in children
Occasionally, children have experienced difficulty controlling bowel movements and the rectal solution
has been rapidly expelled immediately after introduction.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili.By reporting side effects you can help
to provide more information on the safety of this medicine.

5. How to store Sorbiclis

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the pack after “Exp.”. The expiry
date refers to the last day of that month.
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. Package contents and other information

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

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

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

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

Description of the appearance of Sorbiclis and contents of the pack
Sorbiclis Adults and Sorbiclis Children are presented as a rectal solution in 1 bottle of 120
ml in polyethylene with a bellows and with a cannula already inserted.

Marketing Authorisation 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 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, however, is defined as a situation in which evacuations are reduced compared to one's
personal habits and are associated with the passage of hard stools.
In most cases, a balanced diet rich in water and fiber (bran, vegetables and fruit) can
durably resolve the problem of constipation.
If episodes of constipation occur repeatedly, a doctor should be consulted.

Sorbiclis Adulti 36 g + 0,24 g rectal solution

sorbitol liquid non-crystallizing + docusate sodium

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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, ask 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 is Sorbiclis and what is it used for

Sorbiclis is a rectal solution containing two active ingredients: non-crystallizable liquid sorbitol and
sodium docusate.
These two substances belong to the class of laxatives and work by softening the stool and
stimulating the intestine to eliminate it.
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 ingredients or to any of the other ingredients of this medicine (listed in section 6);
• if you have problems with the anus or the last part of the intestine called the “rectum” (ano-rectal conditions with mucosal lesions, rectal bleeding of unknown origin);
• if you have liver problems (hepatic insufficiency, obstruction of the bile ducts, gallstones);
• if you have abdominal pain, nausea and vomiting;
• if you have problems with the intestine (intestinal obstruction or stenosis);
• if you are severely dehydrated;
• in children

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

• the constipation is persistent. The treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of drugs and monitoring during therapy;
• you have noticed a sudden change in your bowel habits (frequency and characteristics of bowel movements) that lasts for more than two weeks;
• you are pregnant or breastfeeding (see also “Pregnancy and breastfeeding”);
• you are elderly or your health conditions are not good;
• after a short period of treatment with this medicine, you do not obtain appreciable results.

Do not use this medicine for prolonged treatments and follow the doctor's instructions.
The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause:

• dependence and therefore a possible need to progressively increase the dose;
• chronic constipation;
• loss of the normal capabilities of the intestine (intestinal atony);
• persistent diarrhea which can lead to loss of water, mineral salts (especially potassium) and other essential nutrients. In the most severe cases, dehydration or a decrease in potassium in the blood (hypokalemia) may occur, which can cause heart or nerve dysfunction that control muscles. The risk is increased if you are simultaneously treated with drugs for the heart (cardiac glycosides), drugs used against high blood pressure (diuretics) or drugs used against allergies and inflammation (corticosteroids).

Other medicines and Sorbiclis
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
In particular, tell your doctor if you are taking medicines based on liquid paraffin or mineral
oil, used for constipation.
Sorbiclis may reduce the time of stay in the intestine of other drugs administered
simultaneously orally, and therefore the absorption. Therefore, avoid taking
laxatives and other drugs at the same time: after taking a medicine, allow at least 2 hours to pass before taking the laxative.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor for advice before using this medicine.
There are no adequate studies on the use of this medicine in pregnancy or breastfeeding.
During pregnancy and breastfeeding, use this medicine only if your doctor has considered it
necessary, after evaluating the risk/benefit ratio with him and under his direct control

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

Sorbiclis contains sodium methyl parahydroxybenzoate
It may cause allergic reactions (including delayed reactions).

3. How to use Sorbiclis

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor.
The recommended dose for an enema is the entire contents of the bottle, preferably taken in the
evening.
Use the minimum dose sufficient to produce easy evacuation of soft stools.
Do not exceed the recommended dose.
A diet rich in fluids promotes the effect of the medicine.

Method of use
For correct use of the product, it is recommended to use Sorbiclis by inserting it into the rectum in a
lying position on your side (see below).

D
Duration of treatment
This medicine, like all laxatives, should be used as infrequently as possible and for no more than
seven days. Use for longer periods requires adequate evaluation by your
doctor.

If you use more Sorbiclis than you should
Excessive doses can cause abdominal pain and diarrhea, which can lead to loss of water and salts
minerals (see what is reported in the “Warnings and precautions” section regarding the abuse of
laxatives). If you experience diarrhea, drink plenty of fluids.
In case of accidental ingestion or taking an excessive amount of Sorbiclis, immediately notify your
doctor

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Occasionally, cramp-like or abdominal colic pains may occur, which are more
frequent in cases of severe constipation. No cases of intolerance or discomfort
have been reported with application.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact
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 medicine does not require any particular storage conditions.
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 pack 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 Adulti rectal solution 36 g + 0.24 g:

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

Description of the appearance of Sorbiclis and contents of the pack
Sorbiclis is presented as a rectal solution in packs of 20 vials of 120 ml in
polyethylene with a bellows and with a cannula already inserted.

Marketing Authorisation 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)