LIMICAN 50 mg Tablet

Зміст інструкції

1. LIMICAN 50 mg tablets
   1. What is LIMICAN and what is it used for
   2. What you need to know before taking LIMICAN
   3. How to take LIMICAN
   4. Possible side effects
   5. How to store LIMICAN
   6. Contents of the pack and other information
2. LIMICAN 50 mg/2 ml injectable solution
   1. What is LIMICAN and what is it used for
   2. What you need to know before using LIMICAN
   3. How to use LIMICAN
   4. Possible side effects
   5. How to store LIMICAN
   6. Contents of the pack and other information

LIMICAN 50 mg tablets

Alizapride hydrochloride

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

1. What is LIMICAN and what is it used for

LIMICAN contains the active ingredient alizapride hydrochloride which belongs to a group of medicines
called antiemetics that work by reducing nausea and vomiting.
This medicine is indicatedfor the treatment of vomiting and nausea caused by various factors and before or
after surgical procedures (pre- and post-operative).
LIMICAN is not indicatedto reduce vomiting that occurs during pregnancy (pregnancy
vomiting).

2. What you need to know before taking LIMICAN

Do not take LIMICAN

• if you are allergic to alizapride hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced movement problems (tardive dyskinesia) when taking medicines for the treatment of certain mental disorders (neuroleptics);
• if you have a tumor of the adrenal gland (pheochromocytoma with confirmed or suspected diagnosis), as a sudden increase in blood pressure (hypertensive crisis) may occur;
• if you are taking levodopa, for the treatment of Parkinson's disease (See section “Other medicines and LIMICAN”);
• if you are pregnant (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking LIMICAN.
Do not take this medicine for more than 7 days.
If you suffer from severe kidney problems (severe renal insufficiency), your doctor must reduce the dose of
medicine to be taken (See section “How to take LIMICAN”).
LIMICAN is not recommended if you suffer from epilepsy, as it may facilitate the onset of
convulsions.
Stop treatment and immediately inform your doctor if you experience fever (hyperthermia), as
this may be a symptom of Neuroleptic Malignant Syndrome, a serious illness also characterized by
movement disorders (extrapyramidal symptoms), heart, muscle, gland (instability of the autonomic nervous system) problems and alteration of some laboratory tests (elevated CPK).

Other medicines and LIMICAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take LIMICAN if you are taking levodopa, used for the treatment of Parkinson's disease, as
a reduction in the effects of both medicines (reciprocal antagonism) may occur.
Take LIMICAN with caution and inform your doctor if you are taking the following medicines:

• neuroleptics, morphine derivatives, hypnotics, anxiolytics, anti-H1 antihistamines, antidepressants, barbiturates, clonidine which slow down brain activity, as LIMICAN increases their effects;
• anticholinergics used for the treatment of irritable bowel syndrome, asthma and incontinence, as they may reduce the effectiveness of LIMICAN;
• digoxin used for the treatment of certain heart disorders. In this case, the doctor must closely monitor the levels of digoxin in the blood (digoxinemia);
• antihypertensives used for the treatment of high blood pressure.

LIMICAN with alcohol
Alcohol may potentiate the depressive effects of LIMICAN if taken at the same time. Therefore,
avoid drinking alcoholic beverages during treatment with this medicine.

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.
Do not take LIMICAN if you are pregnant (See section “Do not take LIMICAN”).
If you are breastfeeding, ask your doctor who will assess whether to discontinue breastfeeding or
treatment with LIMICAN.

Driving and using machines
This medicine can cause drowsiness. Therefore, avoid driving vehicles or using
machinery.

LIMICAN contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you
with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take LIMICAN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The recommended dose is 2-4 tablets (100-200 mg) per day, to be taken in several
administrations during the day.

Use in people with severe kidney problems
If you suffer from severe kidney problems (severe renal insufficiency), inform your doctor as
it is necessary to reduce the dose of medicine to be taken.

If you take more LIMICAN than you should
In case of taking an excessive dose of this medicine, movement disorders (extrapyramidal
symptoms) and drowsiness may occur.
In case of accidental ingestion/taking of an excessive dose of LIMICAN, immediately notify
your doctor or go to the nearest hospital.

If you forget to take LIMICAN
Do not take a double dose to compensate for the missed tablet.
If you have any doubts about the use of this medicine, ask 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 may occur:

Frequency not known(the frequency of which cannot be estimated on the basis of available data):

• extrapyramidal symptoms such as difficulty in movements (acute dystonia), jerky movements (dyskinesia), symptoms typical of Parkinson's disease (Parkinsonian syndrome), motor restlessness (akathisia), especially in children and young people. These symptoms disappear after stopping treatment;
• persistent tardive dyskinesia, a condition characterized by rhythmic and uncontrollable movements, mainly of the tongue, lips and face, especially if you take this medicine for a long time or if you are elderly;
• drowsiness, dizziness, headache, inability to sleep (insomnia);
• diarrhoea, flatulence (meteorism);
• absence of menstrual periods (amenorrhoea), sudden production of milk (galactorrhoea), development of breast tissue in men (gynaecomastia), increased levels of a hormone, called prolactin, in the blood (hyperprolactinaemia);
• feeling dizzy when getting up, due to a rapid drop in blood pressure (orthostatic hypotension), which occurs if you take high doses of the medicine.

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 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 LIMICAN

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, for the product in intact packaging
and correctly stored.
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 LIMICAN contains

• The active ingredient is alizapride hydrochloride. Each tablet contains 55.8 mg of alizapride hydrochloride (equivalent to 50 mg of alizapride).
• The other ingredients are: starch, lactose, silica, methylcellulose 1500 Cps, talc, magnesium stearate.

Description of the appearance of LIMICAN and contents of the pack
Pack of 20 tablets.

Marketing Authorisation Holder
ACARPIA FARMACEUTICI S.r.l.-
Viale L. Majno, 18
20129 Milano (Italy)

Manufacturer
GALENICA S.A. Pharmaceutical Industry – Km 3. On “Old National Highway” Chalkida – Athens, Glyfa

• Chalkida C.P. 32 34100 Chalkida - Greece

LIMICAN 50 mg/2 ml injectable solution

Alizapride hydrochloride

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

1. What is LIMICAN and what is it used for

LIMICAN contains the active ingredient alizapride hydrochloride, which belongs to a group of medicines
called antiemetics that work by reducing nausea and vomiting.
LIMICAN is indicatedfor the treatment of vomiting and nausea of various origins, especially during
therapy with medicines to cure tumors (cytostatic, antineoplastic, radiation therapy) and before or after
surgical interventions (pre- and post-operative).
This medicine is not indicatedto reduce vomiting that occurs during pregnancy (pregnancy
vomiting).

2. What you need to know before using LIMICAN

Do not use LIMICAN

• if you are allergic to alizapride hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced movement problems (tardive dyskinesia) when taking medicines for the treatment of some mental disorders (neuroleptics);
• if you have a tumor of the adrenal gland (pheochromocytoma with confirmed or suspected diagnosis), as a sudden increase in blood pressure (hypertensive crisis) may occur;
• if you are taking levodopa, for the treatment of Parkinson's disease (See section “Other medicines and LIMICAN”);
• if you are pregnant (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using LIMICAN.
Do not use this medicine for more than 7 days.
If you suffer from severe kidney problems (severe renal insufficiency), your doctor must reduce the dose of
medicine to be administered (See section “How to take LIMICAN”).
LIMICAN is not recommended if you suffer from epilepsy, as it may facilitate the onset of
convulsions.
Stop treatment and immediately inform your doctor if you experience fever (hyperthermia), as
this may be a symptom of Neuroleptic Malignant Syndrome, a serious illness also characterized
by movement disorders (extrapyramidal symptoms), heart, muscle, and
gland problems (instability of the autonomic nervous system) and changes in some laboratory tests (elevated CPK).

Other medicines and LIMICAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not use LIMICAN if you are taking levodopa, used for the treatment of Parkinson's disease, as
a reduction in the effects of both medicines (mutual antagonism) may occur.
Use LIMICAN with caution and inform your doctor if you are taking the following medicines:

• neuroleptics, morphine derivatives, hypnotics, anxiolytics, anti-H1 antihistamines, antidepressants, barbiturates, clonidine which slow down brain activity, as LIMICAN increases their effects;
• anticholinergics used for the treatment of irritable bowel syndrome, asthma and incontinence, as they may reduce the effectiveness of LIMICAN;
• digoxin used for the treatment of some heart disorders. In this case, the doctor must closely monitor digoxin levels in the blood (digoxinemia);
• antihypertensives used for the treatment of high blood pressure.

LIMICAN with alcohol
Alcohol may potentiate the depressive effects of LIMICAN if taken at the same time. Therefore,
avoid drinking alcoholic beverages during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use LIMICAN if you are pregnant (See section “Do not use LIMICAN”).
If you are breastfeeding, ask your doctor who will assess whether to discontinue breastfeeding or
treatment with LIMICAN.

Driving and using machines
This medicine can cause drowsiness. Therefore, avoid driving vehicles or using
machinery.

LIMICAN contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. practically “sodium-free”.

3. How to use LIMICAN

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

Treatment of vomiting and nausea before and after surgery
The recommended dose is 1-4 vials (50-200 mg) per day, to be administered via an injection into the
muscle (intramuscularly) throughout the day.
If necessary, the doctor may decide to switch to oral administration (orally).

Treatment of vomiting and nausea during anticancer therapy
The recommended dose is:

• 2 vials (100 mg), to be administered via an injection into a vein (intravenously), 20-30 minutes before anticancer therapy;
• 1-2 vials (50-100 mg), to be administered via an injection into the muscle (intramuscularly), 4-8 hours after completing anticancer therapy.

If vomiting and nausea are persistent, the doctor may increase the dose based on the intensity and
frequency of vomiting (up to 4 vials intravenously 30 minutes before treatment, up to 4 vials
intravenously during anticancer treatment, up to 2 vials, intravenously or
intramuscularly, every 4 hours after completing treatment).

Use in children
In children taking medicines for cancer treatment, the doctor will determine the dose to be
administered, via injection into a vein or muscle, based on the child's weight (2-5 mg/kg/day).

Use in people with severe kidney problems
If you suffer from severe kidney problems (severe renal insufficiency), inform your doctor as it is
necessary to reduce the dose of medicine to be administered.

If you use more LIMICAN than you should
In case of administration of an excessive dose of this medicine, movement disorders (extrapyramidal symptoms) and drowsiness may occur.
In case of accidental ingestion/administration of an excessive dose of LIMICAN, immediately notify
your doctor or go to the nearest hospital.

If you forget to use LIMICAN
Do not use a double dose to make up for a missed dose.
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.
The following side effects may occur:

Frequency not known(the frequency cannot be estimated from available data):

• extrapyramidal symptoms such as difficulty in movements (acute dystonia), jerky movements (dyskinesia), symptoms typical of Parkinson's disease (Parkinsonian syndrome), motor restlessness (akathisia), especially in children and young people. These symptoms disappear after stopping treatment;
• persistent tardive dyskinesia, a condition characterized by rhythmic and uncontrollable movements, mainly of the tongue, lips and face, especially if you take this medicine for a long time or if you are elderly;
• drowsiness, dizziness, headache, inability to fall asleep (insomnia);
• diarrhoea, flatulence (meteorism);
• absence of the menstrual cycle (amenorrhoea), sudden production of milk (galactorrhoea), development of breast tissue in men (gynaecomastia), increased levels of a hormone called prolactin in the blood (hyperprolactinaemia);
• serious allergic reactions (anaphylaxis);
• excessive sweating and a burning sensation of the skin;
• weakness (asthenia) and dry mouth;
• feeling dizzy when getting up, due to a rapid drop in blood pressure (orthostatic hypotension), which occurs if you take high doses of the medicine.

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 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 LIMICAN

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, for the product in intact packaging
and correctly stored.
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 LIMICAN contains

• The active ingredient is alizapride hydrochloride. Each vial contains 55.8 mg of alizapride hydrochloride (equivalent to 50 mg of alizapride).
• The other ingredients are: sodium chloride, water for injections.

Description of the appearance of LIMICAN and contents of the pack
Pack of 6 vials of 2 ml.

Marketing Authorisation Holder
ACARPIA Serviços Farmaceuticos LDA – Rua dos Murcas, 88 – 9000 Funchal – Portugal

Manufacturers
A) KLEVA S.A. – 189, Parnitos Av. – Athens – Greece
B) GALENICA S.A. Pharmaceutical Industry – Km 3. On “Old National Highway” Chalkida –
Athens, Glyfa - Chalkida C.P. 32 34100 Chalkida – Greece
The medicinal product is produced and controlled in A or B respectively, if on the packaging, before the batch
number, A or B appears.