LATTULAC 66,7 G/100ML Syrup

Зміст інструкції

1. Lattulac EPS 10 g granules for oral solution
   1. What is Lattulac EPS and what is it used for
   2. What you need to know before taking Lattulac EPS
   3. How to take Lattulac EPS
   4. Possible side effects
   5. How to store Lattulac EPS
   6. Contents of the pack and other information
2. Lattulac EPS 200 g granules for rectal solution
   1. What is Lattulac EPS and what is it used for
   2. What you need to know before using Lattulac EPS
   3. How to use Lattulac EPS
   4. Possible side effects
   5. How to store Lattulac EPS
   6. Contents of the pack and other information
3. Lattulac EPS 66.7 g/100 ml syrup
   1. What is Lattulac EPS and what is it used for
   2. What you need to know before taking Lattulac EPS
   3. How to take Lattulac EPS
   4. Possible side effects
   5. How to store Lattulac EPS
   6. Contents of the pack and other information

Lattulac EPS 10 g granules for oral solution

Lactulose

Read this leaflet carefully before taking 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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Lattulac EPS and what is it used for

Lattulac EPS contains the active ingredient lactulose which belongs to a class of medicines called
anti-hyperammonemic agents.
Lactulose is a sugar that, not finding in the small intestine the specific enzyme for its
metabolism, reaches the colon unchanged where it is transformed by the bacterial flora into short-chain
fatty acids. This determines a decrease in production and an increase in excretion with feces of ammonia,
thus favoring the reduction of its level in the blood.
Lattulac EPS is used in the treatment of:

• conditions of mental confusion, altered level of consciousness and coma, due to liver failure (hepatic porto-systemic encephalopathy). These conditions are correlated with the accumulation of toxic substances, such as ammonia, in the brain following serious liver problems;
• a chronic and degenerative disease of the liver, defined as hepatic cirrhosis.

2. What you need to know before taking Lattulac EPS

Do not take Lattulac EPSif:

• you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
• you suffer from a hereditary disease that does not allow you to metabolize a sugar called galactose (galactosemia);
• you suffer from disorders that lead to intestinal obstruction.

Warnings and precautions
Consult your doctor or pharmacist before taking Lattulac EPS if you suffer from excessive production and
accumulation of gas in the intestinal tract (flatulence). In this case, treatment will begin with minimal doses that
may be gradually increased depending on your response to the medicine.
If you suffer from carbohydrate metabolism disorders (diabetes mellitus) you can take Lattulac EPS as it
contains sugars that are not absorbed at the intestinal level.
If you take Lattulac EPS for long periods, in exceptional cases, you may experience a loss of electrolytes.

Other medicines and Lattulac EPS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Pay particular attention if you are taking:

• medicines taken by mouth used in the treatment of infections caused by bacteria as they may reduce the response to treatment with Lattulac EPS;
• medicines taken by mouth used to counteract stomach acidity (antacids) as they may reduce the response to treatment with Lattulac EPS;
• medicines for the heart called digitalis, as Lattulac EPS may increase the toxicity of these medicines;
• neomycin, an antibiotic used to treat bacterial infections, as it increases the activity of Lattulac EPS.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Lattulac EPS does not affect the ability to drive vehicles and operate machinery.

3. How to take Lattulac EPS

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Dissolve the granules contained in the sachet of Lattulac EPS in water, milk or other beverages.

Use in adults
The recommended dose of Lattulac EPS is 10-15 g per day, divided into two administrations.
If necessary, depending on your response to the medicine, your doctor may double or halve the
dose.
If you suffer from chronic disorders (chronic hepatic encephalopathy) the recommended dose of Lattulac EPS is 60-120
g per day, divided into two or three administrations.

Use in children
The recommended dose of Lattulac EPS is 2.5-10 g per day, even in a single administration
depending on the severity of the condition or the child's age.

Use in infants
The recommended dose of Lattulac EPS is 2.5 g per day.

If you take more Lattulac EPS than you should
In case of ingestion/accidental intake of an excessive dose of Lattulac EPS, immediately
inform your doctor or go to the nearest hospital.
Accidental intake of very high doses of Lattulac EPS may cause diarrhea and abdominal cramps, which
disappear with discontinuation of treatment.

If you forget to take Lattulac EPS
Do not take a double dose to make up for a missed dose.

If you stop taking Lattulac EPS
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.
In rare cases Lattulac EPS may cause:

• excessive production and accumulation of gas in the intestinal tract or stomach (flatulence);
• abdominal cramps. These side effects are mild and disappear spontaneously after the first few days of treatment. If this does not happen, the doctor will assess the possibility of reducing the dose.

Reactions with unknown frequency: frequency cannot be estimated based on available data:
allergic reactions, skin rash, itching, hives.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://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 Lattulac EPS

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.
This medicine does not require any particular storage conditions.
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 Lattulac EPS contains

• The active ingredient is lactulose. Each sachet contains 10 g of lactulose crystals.
• The other component is lemon flavour.

Description of the appearance of Lattulac EPS and contents of the pack
Lattulac EPS is a free-flowing crystalline powder, white in colour, contained in heat-sealed sachets made of paper-aluminium-polyethylene.
Each pack of Lattulac EPS contains 20 sachets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
SOFAR S.p.A.
Via Firenze 40,
20060 Trezzano Rosa (MI)
Italy

Lattulac EPS 200 g granules for rectal solution

Lattulose

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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Lattulac EPS and what is it used for

Lattulac EPS contains the active ingredient lactulose, which belongs to a class of medicines called
anti-hyperammonemic agents.
Lactulose is a sugar that, not finding the specific enzyme for its
metabolism in the small intestine, reaches the colon unchanged where it is transformed by the bacterial flora into short-chain fatty acids.
This determines a decrease in production and an increase in excretion with the faeces of ammonia,
thus favouring the reduction of its level in the blood.
Lattulac EPS is used in the treatment of:

• conditions of mental confusion, altered level of consciousness and coma, due to liver failure (hepato-portal systemic encephalopathy). These conditions are correlated to the accumulation of toxic substances, such as ammonia, at the brain level following serious liver problems;
• a chronic and degenerative disease of the liver, defined as hepatic cirrhosis.

Lattulac EPS, 200 g granules for rectal solution, is used when the patient is unable to take
Lattulac EPS orally, due to the following impediments:

• state of impaired vigilance, coma, pre-coma, semi-consciousness;
• difficulty in taking Lattulac EPS orally due to high doses or taste;
• risk of tracheal aspiration of the product when taken orally;
• impossibility of oral administration for medical reasons (endoscopic procedures or intubation).

2. What you need to know before using Lattulac EPS

Do not use Lattulac EPSif:

• you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• you suffer from a hereditary disease that prevents you from metabolizing a sugar called galactose (galactosemia);
• you suffer from disorders that lead to an obstruction of the intestine.

Warnings and precautions
Consult your doctor or pharmacist before taking Lattulac EPS if you suffer from excessive production and
accumulation of gas in the intestinal tract (flatulence). In such cases, treatment should begin with minimal doses that
may be gradually increased depending on your response to the medicine.
If you suffer from carbohydrate metabolism disorders (diabetes mellitus) you can take Lattulac EPS because
it contains sugars that are not absorbed at the intestinal level.
If you take Lattulac EPS for long periods, in exceptional cases, you may experience a loss of electrolytes.

Children and adolescents
Lattulac EPS, 200 g granules for rectal solution, is not recommended for use in children and adolescents.

Other medicines and Lattulac EPS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Pay particular attention if you are taking:

• medicines taken by mouth used in the treatment of infections caused by bacteria as they may reduce the response to treatment with Lattulac EPS;
• medicines taken by mouth used to counteract stomach acidity (antacids) as they may reduce the response to treatment with Lattulac EPS;
• medicines for the heart called digitalis, as Lattulac EPS may increase the toxicity of these medicines;
• neomycin, an antibiotic used to treat bacterial infections, as it increases the activity of Lattulac EPS.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Lattulac EPS does not affect the ability to drive vehicles and operate machinery.

4. How to use Lattulac EPS

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
The lactulose crystals contained in the graduated bag must be dissolved with lukewarm water (37°C) bringing the
volume up to 1 liter, immediately before use.

Instructions for use
To facilitate the use of the medicine, quickly and hygienically, it is recommended to use the following accessories
present in the package together with the Lattulac EPS bag, ready for use, which has the dual function of container
for the active ingredient and administration device:

• atraumatic rectal cannula, protected in a heat-sealed sachet;
• lubricant for the rectal cannula, in a heat-sealed sachet.

The preparation and administration of Lattulac EPS 200 g granules for rectal solution (1 liter bag) must
be carried out as follows:

• 1. remove the cap and bring the bag to a volume of 1 liter, adding lukewarm tap water at 37°C;

• 2. close the bag and shake until a homogeneous solution is obtained. Add more water if necessary, to bring it back to a volume of 1 liter and shake briefly again;

• 3. suspend the bag about 1 meter above the bed, using the ring provided on the bag cap;

• 4. block the clamp near the cone attached to the end of the drain tube;

• 5. Break the seal at the beginning of the drain tube, inside the bag, by bending it alternately to the right and to the left. The solution is thus free to flow from the bag;

• 6. drain any air from the flow tube, briefly opening the clamp and closing it immediately after the solution appears;

• 7. remove the rectal cannula from its packaging, inserting it, with firm pressure, onto the conical fitting attached to the end of the drain tube;
• 8. if appropriate, the rectal cannula can be lubricated before introduction into the rectum, using the lubricant contained in the sachet attached to the package;
• 9. position the patient on their left side, with the right leg slightly bent. Gently insert the cannula into the rectum in the direction of the navel. To facilitate retention of the enema, raise the pelvis with one or two pillows;

• 10. unblock the clamp on the drain tube to allow the solution to flow into the intestine. It is important to regulate the flow rate, acting on the clamp, in order to avoid any unpleasant sensations or abdominal cramps for the patient. The enema should be retained for at least 30-40 minutes;

In case of immediate evacuation, the enema must be repeated immediately, possibly using
a balloon catheter, available at the pharmacy, to ensure retention for the required time. The catheter
must be attached to the cone of the drain tube, replacing the rectal cannula.

Use in adults
The recommended dose is 1 liter of Lattulac EPS every 8-12 hours, to be retained in the intestine for at least 30-40 minutes.
In case of persistent inability to retain the enema, for the necessary time of at least 30-40 minutes, or in
the presence of any subjective intolerance problems (abdominal pain or serious discomfort), the 1 liter dose can
be divided into two half doses of 500 ml, every 3-4 hours. Rectal administration should still continue
for 3-4 days, during which time full and vigilant awareness is usually restored, with the possibility of switching
to taking Lattulac EPS orally or other medicines.

If you take more Lattulac EPS than you should
No effects from an overdose are expected. In case of accidental ingestion/administration of an excessive dose of Lattulac EPS, immediately inform your doctor or go to the nearest hospital.

If you forget to take Lattulac EPS
Do not take a double dose to make up for a missed dose.

If you stop taking Lattulac EPS
If you have any doubts about using 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.
In rare cases Lattulac EPS may cause:

• excessive production and accumulation of gas in the intestinal tract or stomach (flatulence);
• abdominal cramps. These side effects are mild and disappear spontaneously after the first few days of treatment. If this does not happen, the doctor will assess the possibility of reducing the dose.

Reactions with unknown frequency (frequency cannot be estimated based on available data):
allergic reactions, rash, itching, hives.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://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 Lattulac EPS

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C.
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.
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 Lattulac EPS contains

• The active ingredient is lactulose. Each 1 liter graduated bag contains 200 g of lactulose crystals.
• There are no other components.

Description of the appearance of Lattulac EPS and contents of the pack
Lattulac EPS is a granular powder for rectal solution, contained in a 1 liter graduated bag made of medical grade PVC.
Each pack contains one bag of Lattulac EPS and the following accessories for administration:

• atraumatic rectal cannula, protected in a heat-sealed sachet;
• lubricant for the rectal cannula, in a heat-sealed sachet.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
SOFAR S.p.A.
Via Firenze 40,
20060 Trezzano Rosa (MI)
Italy

Lattulac EPS 66.7 g/100 ml syrup

Lactulose

Read this leaflet carefully before taking 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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Lattulac EPS and what is it used for

Lattulac EPS contains the active ingredient lactulose, which belongs to a class of medicines called
anti-hyperammonemic agents.
Lactulose is a sugar that, not finding in the small intestine the specific enzyme for its
metabolism, reaches the colon unchanged where it is transformed by the bacterial flora into short-chain
fatty acids. This determines a lower production and a greater excretion with the feces of ammonia,
thus favoring its reduction in the blood.
Lattulac EPS is used in the treatment of:

• conditions of mental confusion, altered level of consciousness and coma, due to liver failure (hepatic porto-systemic encephalopathy). These conditions are correlated with the accumulation of toxic substances, such as ammonia, in the brain following serious liver problems;
• a chronic and degenerative disease of the liver, defined as hepatic cirrhosis.

2. What you need to know before taking Lattulac EPS

Do not take Lattulac EPSif:

• you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
• you suffer from a hereditary disease that does not allow you to metabolize a sugar called galactose (galactosemia);
• you suffer from disorders that lead to an obstruction of the intestine.

Warnings and precautions
Consult your doctor or pharmacist before taking Lattulac EPS if you suffer from excessive production and
accumulation of gas in the intestinal tract (flatulence). In such cases, treatment will begin with minimal doses that
may be gradually increased depending on your response to the medicine.
If you suffer from carbohydrate metabolism disorders (diabetes mellitus) you can take Lattulac EPS as it
contains sugars that are not absorbed at the intestinal level.
If you take Lattulac EPS for long periods, in exceptional cases, you may experience a loss of electrolytes.

Other medicines and Lattulac EPS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Pay particular attention if you are taking:

• medicines taken by mouth used in the treatment of infections caused by bacteria as they may reduce the response to treatment with Lattulac EPS;
• medicines taken by mouth used to counteract stomach acidity (antacids) as they may reduce the response to treatment with Lattulac EPS;
• medicines for the heart called digitalis, as Lattulac EPS may increase the toxicity of these medicines;
• neomycin, an antibiotic used to treat bacterial infections, as it increases the activity of Lattulac EPS.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Lattulac EPS does not affect the ability to drive vehicles and use machines.

5. How to take Lattulac EPS

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Use in adults
The recommended dose of Lattulac EPS is 15-45 ml per day, depending on the severity of the condition and
your response to the medicine.
If you suffer from chronic disorders (chronic hepatic encephalopathy) the recommended dose of Lattulac EPS is 90-190
ml per day, to be divided into two or three administrations.

Use in children
The recommended dose of Lattulac EPS is 5-15 ml per day, even in a single administration in
relation to the severity of the condition or the child's age.

Use in infants
The recommended dose of Lattulac EPS is 5 ml per day.

If you take more Lattulac EPS than you should
In case of accidental ingestion/intake of an excessive dose of Lattulac EPS, immediately
inform your doctor or go to the nearest hospital.
Accidental intake of very high doses of Lattulac EPS can cause diarrhea and abdominal cramps, which
disappear with discontinuation of treatment.

If you forget to take Lattulac EPS
Do not take a double dose to make up for a missed dose.

If you stop taking Lattulac EPS
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.
In rare cases Lattulac EPS may cause:

• excessive production and accumulation of gas in the intestinal tract or stomach (flatulence);
• abdominal cramps. These side effects are mild and disappear spontaneously after the first few days of treatment. If this does not happen, the doctor will assess the possibility of reducing the dose.

Reactions with unknown frequency: frequency cannot be estimated based on available data:
allergic reactions, rash, itching, hives.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://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 Lattulac EPS

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.
This medicine does not require any particular storage conditions.
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 Lattulac EPS contains

• The active ingredient is lactulose. 100 ml of syrup contains 66.7 g of lactulose.
• The other ingredients are sorbic acid (E200) and purified water.

Description of the appearance of Lattulac EPS and contents of the pack
Lattulac EPS is a clear, dense syrup, of a slightly brownish-yellow color contained in a
180 ml bottle, made of amber PET, with a screw cap, and sealed with an aluminum capsule.
The pack contains 1 bottle of 180 ml and a measuring cup.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
SOFAR S.p.A.
Via Firenze 40,
20060 Trezzano Rosa (MI)
Italy