Limican

Package leaflet: Information for the patient

LIMICAN 50 mg tablets

Alizapride hydrochloride
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 LIMICAN is and what it is used for

LIMICAN contains the active substance alizapride hydrochloride, which belongs to a group of medicines called antiemetics that work by reducing nausea and vomiting.
This medicine is indicated for the treatment of vomiting and nausea caused by various factors, and before or after surgical procedures (pre- and post-operatively).
LIMICAN is not indicated for reducing vomiting occurring during pregnancy (pregnancy-related vomiting).

2. What you need to know before taking LIMICAN

Do not take LIMICAN

• if you are allergic to alizapride hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced movement disorders (tardive dyskinesia) while taking medicines used to treat certain mental disorders (neuroleptics);
• if you have a tumour of the adrenal gland (pheochromocytoma, confirmed or suspected), as this may cause a sudden increase in blood pressure (hypertensive crisis);
• 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 longer than 7 days.
If you have severe kidney problems (severe renal failure), your doctor must reduce the dose of the medicine to be taken (see section "How to take LIMICAN").
LIMICAN is not recommended if you have epilepsy, as it may increase the risk of seizures.
Stop treatment and inform your doctor immediately if you develop fever (hyperthermia), as this may be a symptom of Neuroleptic Malignant Syndrome, a serious condition also characterised by movement disorders (extrapyramidal symptoms), heart and muscle problems, glandular disorders (autonomic instability), and changes in certain laboratory tests (elevated CPK).

Other medicines and LIMICAN
Inform 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 this may result in reduced effectiveness of both medicines (mutual antagonism).
Take LIMICAN with caution and inform your doctor if you are taking the following medicines:

• neuroleptics, morphine derivatives, hypnotics, anxiolytics, H1-antihistamines, antidepressants, barbiturates, clonidine – these slow down brain activity, and LIMICAN may enhance their effects;
• anticholinergics used to treat irritable bowel syndrome, asthma, or incontinence, as they may reduce the effectiveness of LIMICAN;
• digoxin, used to treat certain heart conditions. In this case, your doctor must closely monitor digoxin levels in the blood (digoxinemia);
• antihypertensive medicines used to treat high blood pressure.

LIMICAN and alcohol
Alcohol may enhance the depressant effects of LIMICAN when taken together. Therefore, avoid drinking alcoholic beverages during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take LIMICAN if you are pregnant (see section "Do not take LIMICAN").
If you are breastfeeding, consult your doctor, who will decide whether to discontinue breastfeeding or treatment with LIMICAN.

Driving and using machines
This medicine may cause drowsiness. Therefore, avoid driving vehicles or operating 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 him before taking this medicine.

3. How to take LIMICAN

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2–4 tablets (100–200 mg) per day, taken in divided
doses throughout the day.
Use in patients with severe kidney problems
If you suffer from severe kidney problems (severe renal insufficiency), inform your doctor, as the dose of the medicine needs to be reduced.
If you take more LIMICAN than you should
If you take an excessive dose of this medicine, movement disorders (extrapyramidal symptoms) and drowsiness may occur.
In case of accidental ingestion/overdose of LIMICAN, contact your doctor immediately or go to the nearest hospital.
If you forget to take LIMICAN
Do not take a double dose to make up for the missed tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

• extrapyramidal symptoms such as movement difficulties (acute dystonia), jerky movements (dyskinesia), Parkinson-like symptoms (parkinsonism), motor restlessness (akathisia), especially in children and young people. These symptoms disappear after discontinuation of treatment;
• persistent tardive dyskinesia, a condition characterized by rhythmic and involuntary movements, mainly of the tongue, lips and face, particularly if you take this medicine for a long time or if you are elderly;
• drowsiness, dizziness, headache (cephalalgia), inability to fall asleep (insomnia);
• diarrhoea, flatulence (meteorism);
• absence of menstrual cycle (amenorrhoea), sudden production of milk (galactorrhoea), breast development in males (gynaecomastia), increased levels of a hormone called prolactin in the blood (hyperprolactinaemia);
• sensation of dizziness when standing up, due to a rapid drop in blood pressure (orthostatic hypotension), which may occur if you take high doses of this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 properly stored.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What LIMICAN contains

• The active substance 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
Carton pack containing 20 tablets.
Marketing Authorization Holder
ACARPIA FARMACEUTICI S.r.l.
Viale L. Majno, 18
20129 Milan (Italy)
Manufacturer
GALENICA S.A. Pharmaceutical Industry – Km 3. On “Old National Highway” Chalkida – Athens, Glyfa

• Chalkida P.O. Box 32 34100 Chalkida - Greece

Package leaflet: information for the user

LIMICAN 50 mg/2 ml injectable solution

Alizapride hydrochloride
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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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. Package contents and other information

1. What LIMICAN is and what it is used for

LIMICAN contains the active substance alizapride hydrochloride, which belongs to a group of medicines called antiemetics that work by reducing nausea and vomiting.
LIMICAN is indicated for the treatment of vomiting and nausea of various origins, especially during therapy with medicines used to treat tumors (cytostatic, antineoplastic agents, radiation therapy) and before or after surgical procedures (pre- and post-operative).
This medicine is not indicated for reducing vomiting occurring during pregnancy (pregnancy-related vomiting).

2. What you need to know before using LIMICAN

Do not use LIMICAN

• if you are allergic to alizapride hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced movement disorders (tardive dyskinesia) while taking medicines used to treat certain mental disorders (neuroleptics);
• if you have a tumor of the adrenal gland (pheochromocytoma, confirmed or suspected), as a sudden increase in blood pressure (hypertensive crisis) may occur;
• if you are taking levodopa, used to treat 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 longer than 7 days.
If you have severe kidney problems (severe renal impairment), your doctor must reduce the dose to be administered (See section “How to take LIMICAN”).
LIMICAN is not recommended if you have epilepsy, as it may increase the risk of seizures.
Stop treatment and contact your doctor immediately if you develop fever (hyperthermia), as this may be a symptom of Neuroleptic Malignant Syndrome, a serious condition also characterized by movement disorders (extrapyramidal symptoms), heart and muscle problems, gland dysfunction (autonomic instability), and abnormal laboratory test results (elevated CPK).

Other medicines and LIMICAN
Inform 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 to treat Parkinson's disease, as this may result in reduced effectiveness of both medicines (mutual antagonism).
Use LIMICAN with caution and inform your doctor if you are taking any of the following medicines:

• neuroleptics, morphine derivatives, hypnotics, anxiolytics, antihistamines (H1-antagonists), antidepressants, barbiturates, clonidine—medicines that slow down brain activity—as LIMICAN may enhance their effects;
• anticholinergics used to treat irritable bowel syndrome, asthma, or incontinence, as they may reduce the effectiveness of LIMICAN;
• digoxin, used to treat certain heart conditions. In this case, your doctor must closely monitor digoxin levels in the blood (digoxinemia);
• antihypertensive medicines used to treat high blood pressure.

LIMICAN and alcohol
Alcohol may enhance the depressant effects of LIMICAN when taken together. Therefore, avoid drinking alcoholic beverages during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use LIMICAN if you are pregnant (See section “Do not use LIMICAN”).
If you are breastfeeding, consult your doctor, who will decide whether to discontinue breastfeeding or treatment with LIMICAN.

Driving and using machines
This medicine may cause drowsiness. Therefore, avoid driving or operating machinery.

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

3. How to use LIMICAN

Use this medicine exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.

Treatment of vomiting and nausea before and after surgical procedures
The recommended dose is 1–4 vials (50–200 mg) per day, administered via intramuscular injection throughout the day.
If necessary, your doctor may decide to switch to oral administration.

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

• 2 vials (100 mg), administered via intravenous injection 20–30 minutes before antitumor therapy;
• 1–2 vials (50–100 mg), administered via intramuscular injection 4–8 hours after completion of antitumor therapy.

If vomiting and nausea persist, your doctor may increase the dose according to the severity and frequency of vomiting (up to 4 vials intravenously 30 minutes before treatment, up to 4 vials intravenously during antitumor therapy, and up to 2 vials intravenously or intramuscularly every 4 hours after completion of treatment).

Use in children
In children receiving antitumor medications, the doctor will determine the dose to be administered via intravenous or intramuscular injection based on the child's body weight (2–5 mg/kg/day).

Use in patients with severe kidney problems
If you have severe kidney problems (severe renal insufficiency), inform your doctor, as the dose of medicine needs to be reduced.

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

If you forget to use LIMICAN
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult 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 (frequency cannot be estimated from the available data):

• extrapyramidal symptoms such as movement difficulties (acute dystonia), jerky movements (dyskinesia), Parkinson-like symptoms (parkinsonism), motor restlessness (akathisia), especially in children and young people. These symptoms disappear after discontinuation of treatment;
• persistent tardive dyskinesia, a condition characterised by rhythmic and uncontrollable movements, mainly of the tongue, lips and face, particularly if you take this medicine for a long time or if you are elderly;
• drowsiness, dizziness, headache (cephalalgia), inability to fall asleep (insomnia);
• diarrhoea, flatulence (meteorism);
• absence of menstrual periods (amenorrhoea), sudden production of breast milk (galactorrhoea), breast development in males (gynaecomastia), increased levels of a hormone called prolactin in the blood (hyperprolactinaemia);
• allergic reactions, even severe ones (anaphylaxis);
• excessive sweating and skin burning sensation;
• weakness (asthenia) and dry mouth;
• dizziness upon standing due to a rapid drop in blood pressure (orthostatic hypotension), which may occur if you take high doses of the medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report side effects directly via 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 properly stored.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 LIMICAN contains

• The active substance is alizapride hydrochloride. Each vial contains 55.8 mg of alizapride hydrochloride (equivalent to 50 mg of alizapride).
• The other components 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 Authorization 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, Old National Highway Chalkida –
Athens, Glyfa - Chalkida, P.O. Box 32, 34100 Chalkida – Greece
The product is manufactured and controlled in site A or B respectively, as indicated by the letter A or B appearing on the packaging before the batch number.