LAEVOLAC 66,7 G/100 ML Сироп

Содержание инструкции

1. Laevolac EPS 66.7 g/100 ml syrup
   1. What is LAEVOLAC EPS and what is it used for
   2. What you need to know before taking LAEVOLAC EPS
   3. How to take LAEVOLAC EPS
   4. Possible side effects
   5. How to store LAEVOLAC EPS
   6. Contents of the pack and other information
2. Laevolac EPS 66.7 g/100 ml syrup
   1. What is LAEVOLAC EPS and what is it used for
   2. What you need to know before taking LAEVOLAC EPS
   3. How to take LAEVOLAC EPS
   4. Possible side effects
   5. How to store LAEVOLAC EPS
   6. Contents of the pack and other information

Laevolac EPS 66.7 g/100 ml syrup

Lactulose

Read this leaflet carefully before you start 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 their symptoms are the same as yours, as it could 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 Laevolac EPS is and what it is used for
• 2. What you need to know before you take Laevolac EPS
• 3. How to take Laevolac EPS
• 4. Possible side effects
• 5. How to store Laevolac EPS
• 6. Contents of the pack and other information

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

Laevolac EPS contains lactulose, a sugar capable of facilitating the elimination of
ammonia, a toxic substance if produced in excess by the body
(anti-hyperammonemic).
Laevolac EPS is indicated in adultsfor the treatment of:

• hepatic encephalopathy (EPS), a disease caused by an alteration of liver function and characterized by mental confusion, drowsiness and disorientation;
• a severe liver disease (Cirrhosis).

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking LAEVOLAC EPS

Do not take LAEVOLAC EPS

• if you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from galactosemia, a genetic disease that prevents the digestion of certain sugars.

Warnings and precautions
Consult your doctor or pharmacist before taking Laevolac EPS.
If you suffer from a condition that makes it difficult or prevents you from taking
sugars, you can take Laevolac EPS.
Do not use Laevolac EPS if you have abdominal pain, nausea or vomiting.
This medicine may also contain other types of sugars, therefore contact
your doctor if you are intolerant to certain sugars such as lactose and galactose and consider
the intake of medicines containing fructose (or sorbitol) and
the intake of fructose (or sorbitol) with your diet.
Use in children and adolescents
The safety and efficacy of LAEVOLAC EPS in children and adolescents has not
yet been established.

Other medicines and LAEVOLAC EPS
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicine.
In particular, tell your doctor if:

• you are taking antibiotics, medicines used to treat infections, which if taken orally with lactulose, may reduce their effectiveness;
• you are taking antacids, medicines used to reduce stomach acidity which if taken orally with lactulose, may reduce their effectiveness;
• you are taking digitalis, medicines used to increase heart function, as LAEVOLAC EPS may increase the risk of side effects;
• you are taking neomycin, a medicine used to treat infections, due to a possible synergistic effect with LAEVOLAC EPS (greater activity for both drugs).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
However, there are no known contraindications to the use of Laevolac EPS in
pregnancy and during breastfeeding.

Driving and using machines
Laevolac EPS has no effect on the ability to drive and operate machines.

3. How to take LAEVOLAC EPS

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

Adults
The recommended dose may vary from 90 ml to 190 ml per day, to be taken in 2 or 3
administrations.
If you suffer from abdominal bloating (intestinal flatulence), your doctor will initially
prescribe treatment with the minimum doses indicated; you may then increase these doses
gradually in relation to your response to treatment.
Use in children and adolescents
The safety and efficacy of LAEVOLAC EPS in children and adolescents have not yet
been established.

If you take more LAEVOLAC EPS than you should
If you have taken an excessive dose of LAEVOLAC EPS or if you think a child may
have taken this medicine, immediately inform your doctor or go to the Emergency
Room of the nearest hospital.
In case of excessive dosage, you may experience diarrhea, abdominal cramps. If
you experience these symptoms, stop treatment.

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

If you stop taking LAEVOLAC 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.

Effects relating to the stomach and intestines

• abdominal cramps
• diarrhea
• gas in the stomach (flatulence)
• emission of gas (flatulence). These symptoms are generally mild; if they do not disappear spontaneously after the first few days of treatment, your doctor will reduce the dose.

Effects relating to blood tests
In exceptional cases, after prolonged treatment, you may experience loss of
electrolytes (substances contained in the blood).

Effects relating to the immune system
Allergic reactions (frequency not known)

Effects relating to the skin and subcutaneous tissue
Skin rash, itching, urticaria (frequency not known)

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 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 LAEVOLAC EPS

Store at a temperature below 25°C.
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.
Validity after first opening of the bottle: 30 days if stored at a temperature below
25°C.
Do not use this medicine if you notice any visible signs of damage or opening of the bottle
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 LAEVOLAC EPS contains
The active ingredient is lactulose. 100 ml of syrup contains 66.7 g of lactulose.

Description of the appearance of LAEVOLAC EPS and contents of the pack
Laevolac EPS is presented as a syrup.
It is available in 180 ml syrup bottles.

Marketing authorisation holder and manufacturer
Chiesi Italia S.p.A. – Via G. Chiesi, 1 – 43122 Parma

Manufacturer
Fresenius Kabi Austria GmbH - Estermannstraße 17 - 4020 Linz – Austria.

Laevolac EPS 66.7 g/100 ml syrup

Lactulose

Read this leaflet carefully before you start 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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Laevolac EPS contains purified lactulose, a sugar capable of facilitating the elimination
of ammonia, a toxic substance if produced in excess by the body
(anti-hyperammonemic).
Laevolac EPS is indicated in adultsfor the treatment of:

• hepatic encephalopathy (EPS), a disease caused by an alteration of liver function and characterized by mental confusion, drowsiness and disorientation; a serious liver disease (liver cirrhosis).

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking LAEVOLAC EPS

Do not take LAEVOLAC EPS

• if you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from galactosemia, a genetic disease that prevents the digestion of certain sugars.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking LAEVOLAC EPS.
If you suffer from a condition that makes it difficult or impossible for you to take
sugars, you can take Laevolac EPS.
Do not use Laevolac EPS if you have abdominal pain, nausea or vomiting.
This medicine may also contain other types of sugars, therefore your doctor should be contacted
if you are intolerant to certain sugars such as lactose and galactose and the intake of medicines containing fructose (or sorbitol) and
the intake of fructose (or sorbitol) with your diet should be considered.
Children and adolescents
The safety and efficacy of LAEVOLAC EPS in children and adolescents have not yet
been established.

Other medicines and LAEVOLAC EPS
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor if:

• you are taking antibiotics, medicines used to treat infections, which if taken orally with lactulose, may reduce their effectiveness;
• you are taking antacids, medicines used to reduce stomach acidity, which if taken orally with lactulose, may reduce their effectiveness; if taken orally with lactulose, may reduce their effectiveness;
• you are taking digitalis, medicines used to increase heart function, as LAEVOLAC EPS may increase the risk of side effects;
• you are taking neomycin, a medicine used to treat infections, due to a possible synergistic effect with LAEVOLAC EPS (greater activity for both drugs)

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
However, there are no known contraindications to the use of Laevolac EPS in
pregnancy and during breastfeeding.

Driving and operating machinery
LAEVOLAC EPS has no effects on the ability to drive and operate machinery.

LAEVOLAC EPS contains potassium
This medicine contains potassium, less than 1 mmol (39 mg) per 100 ml, i.e.
essentially ‘potassium-free’.

3. How to take LAEVOLAC EPS

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

Adults
The recommended dose may vary from 90 ml to 190 ml per day, to be taken in 2 or 3
administrations.
If you suffer from abdominal bloating (intestinal flatulence), your doctor will initially
prescribe treatment with the minimum doses indicated; you may then increase these doses
gradually in relation to your response to treatment.
Use in children and adolescents
The safety and efficacy of LAEVOLAC EPS in children and adolescents have not yet
been established.

If you take more LAEVOLAC EPS than you should
If you have taken an excessive dose of LAEVOLAC EPS or if you think a child may
have taken this medicine, immediately notify your doctor or go to the Emergency
Room of the nearest hospital.
In case of excessive dosage, you may experience diarrhea, abdominal cramps. If
you experience these symptoms, stop the treatment

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

If you stop taking LAEVOLAC EPS
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Effects involving the stomach and intestines

• abdominal cramps
• diarrhoea
• wind (flatulence)
• passage of gas (flatulence). These symptoms are generally mild; if they do not disappear spontaneously after the first few days of treatment, your doctor will reduce the dose.

Effects involving blood tests
In exceptional cases, after prolonged treatment, you may experience loss of
electrolytes (substances contained in the blood).

Effects involving the immune system
Allergic reactions (frequency not known)

Effects involving the skin and subcutaneous tissue
Skin rash, itching, urticaria (frequency not known)

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, tell 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 to provide more information on the
safety of this medicine.

5. How to store LAEVOLAC EPS

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 reported on the bottle after Scad.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice evident signs of damage or opening of the bottle
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 to protect the environment.

6. Contents of the pack and other information

What LAEVOLAC EPS contains

• The active ingredient is lactulose. 100 ml of syrup contains 66.7 mg of lactulose. The other ingredients are potassiumsorbate, purified water .

Description of the appearance of LAEVOLAC EPS and contents of the pack
Laevolac EPS is presented as a syrup.
It is available in 450 ml bottles.

Marketing Authorisation Holder and Manufacturer
Chiesi Italia S.p.A. – Via G. Chiesi, 1 – 43122 Parma

Manufacturer
Patheon France S.A.S. – Bourgoin-Jallieu-Cedex plant - 40 Boulevard de Champaret-
38307 France.