GEALEVIDE 50 mg Coated Tablet

Зміст інструкції

1. GEALEVIDE 50 mg tablets, 200 mg tablets, 400 mg tablets
   1. What is GEALEVIDE and what is it used for
   2. What you need to know before taking GEALEVIDE
   3. How to take GEALEVIDE
   4. Possible side effects
   5. How to store GEALEVIDE
   6. Contents of the pack and other information

GEALEVIDE 50 mg tablets, 200 mg tablets, 400 mg tablets

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

1. What is GEALEVIDE and what is it used for

GEALEVIDE is a medicine used for mental disorders (antipsychotic). It reduces the activity of a
particular region of the brain that is important for the symptoms of mental disorders.
GEALEVIDE is used to treat a disease called schizophrenia. Schizophrenia is a chronic mental
condition that affects how a person thinks, perceives and behaves in relation to
reality.
Your doctor may prescribe GEALEVIDE for other uses. Always follow your doctor's instructions.

2. What you need to know before taking GEALEVIDE

The doctor may prescribe uses and dosages different from those specified in this leaflet. Always follow the doctor's instructions and the dosage information provided in this leaflet.

Do not take GEALEVIDE

• if you are allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6)
• if you have a pituitary gland tumor or a breast tumor
• if you have a tumor of the adrenal gland (pheochromocytoma)
• if you are breastfeeding
• if you have a rare, hereditary heart condition that manifests with a slowed heart rate and irregular heartbeat (prolonged QT syndrome)
• if you are taking medicines that have an effect on the heart (prolongation of the QT interval)
• if you are taking medicines for Parkinson's disease (levodopa)
• if you are taking medicines that have an effect on heart rhythm (for example quinidine, disopyramide, amiodarone, sotalol, bepridil, cisapride, sultopride, thioridazine, methadone, erythromycin i.v., vincamine i.v., halofantrine, pentamidine, sparfloxacin).

Children before puberty should not take GEALEVIDE.
Warnings and precautions
Talk to your doctor or pharmacist before taking GEALEVIDE if:

• you have heart disease or a family history of heart problems;
• someone in your family has a rare, hereditary heart condition with a slowed heart rate and irregular heartbeat (prolonged QT syndrome);
• you have kidney failure or other kidney problems;
• you suffer from epilepsy or have a history of seizures;
• you suffer from Parkinson's disease;
• you are diabetic or have been told you are at risk of developing diabetes;
• you or someone in your family has a history of blood clots (thrombosis), as medicines like these have been associated with the formation of blood clots (thrombi);
• you or someone in your family has had breast cancer;
• you have high levels of prolactin, in case of a pituitary tumor;
• you feel generally unwell, are prone to inflammation, especially tonsillitis and fever (infections), due to a low number of white blood cells (agranulocytosis);
• you have high fever, muscle rigidity, altered state of consciousness and profuse sweating, these are the symptoms of a very rare syndrome called Neuroleptic Malignant Syndrome. These symptoms can be fatal and require immediate medical attention.

Please note that:certain groups of patients (e.g. elderly and patients with dementia) have a higher risk of side effects, including stroke. Elderly patients may be more likely to have low blood pressure or feel sleepy. A slight increase in the number of deaths in elderly people with dementia treated with antipsychotics compared to those not treated has been reported. Talk to your doctor about this.
Tell your doctor if you need to undergo blood or urine tests if you are being treated with GEALEVIDE, as it may affect the test results.

Other medicines and GEALEVIDE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This is because amisulpride can affect the way some other medicines work. Also, some medicines can affect the way amisulpride works.

Do not take GEALEVIDE with medicines that can have an effect on the heart (prolongation of the QT interval):

• medicines used to treat heart rhythm disorders (e.g. quinidine, disopyramide, amiodarone and sotalol);
• other medicines such as bepridil, cisapride, sultopride, thioridazine, methadone, erythromycin i.v., vincamine i.v., halofantrine, pentamidine, sparfloxacin;
• medicines used to treat Parkinson's disease (e.g. levodopa, bromocriptine, ropinirole).

Tell your doctor if you are taking any of the following medicines that can affect heart rhythm:

• medicines used to treat high blood pressure (diltiazem, verapamil, guanfacine, beta-blockers);
• medicines for heart rhythm disorders (digoxin);
• medicines used for migraine and hot flashes (clonidine);
• certain types of diuretics;
• medicines used for constipation (stimulant laxatives);
• medicines for arthritis or connective tissue diseases (corticosteroids, tetracosactides);
• other medicines used to treat mental disorders (e.g. pimozide, haloperidol, lithium, imipramine, antidepressants).

GEALEVIDE can also interact with the following medicines:

• medicines used to treat fear and anxiety (benzodiazepines, other anxiolytics);
• other medicines used to treat mental disorders (clozapine);
• medicines for epilepsy (barbiturates);
• pain relievers (narcotics or analgesics)
• antihistamines that cause drowsiness (sedating antihistamines);
• sedatives;
• clonidine and derivatives;
• medicines that induce sleep during surgical procedures (anesthetics);
• antihypertensive drugs and other medicines that lower blood pressure.

Tell your doctorif you are taking GEALEVIDE if you need to undergo a study of adrenergic function.

GEALEVIDE with alcohol
Consumption of alcohol should be avoided during treatment with GEALEVIDE as it increases the sedative effect.

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

The following symptoms may occur in newborns from mothers who have used amisulpride during the last trimester (last three months of pregnancy):

• tremor, muscle rigidity and/or muscle weakness;
• drowsiness, agitation, breathing problems;
• difficulty feeding. If your baby develops any of these symptoms, you may need to contact your doctor.

Do not use GEALEVIDE if you are breastfeeding.

Driving and using machines
During treatment with this medicine you may feel less alert and may have blurred vision. If this happens, do not drive vehicles or use tools or machines.

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

3. How to take GEALEVIDE

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

Adults
The doctor will adjust the dose according to your individual response.
The normal dose may be 50-300 mg per day or 400-800 mg per day, depending on your symptoms. In
individual cases, the daily dose may be increased to up to 1200 mg per day.
If you take more than 400 mg per day, the dose should be divided into two.

Use in children and adolescents
GEALEVIDE should not be given to children before puberty.

Use in the elderly
Your doctor will need to monitor you carefully as you are more likely to develop low
blood pressure or drowsiness due to this medicine.
A dose reduction may also be necessary in case of kidney failure.

Use in patients with kidney problems
If you have reduced kidney function, your doctor may prescribe you a lower dose. You must follow the
doctor's instructions.

Instructions for use
Swallow GEALEVIDE tablets with a full glass of water before a meal.
GEALEVIDE 200 mg tablets and GEALEVIDE 400 mg tablets: the score line is only for
facilitating breaking to aid swallowing and not for dividing the tablet into two equal doses.

If you take more GEALEVIDE than you should
If you take more tablets than you should, inform your doctor immediately or go to the nearest hospital
emergency room. Bring the medicine packaging with you.
Symptoms of overdose may include: stupor, drowsiness, involuntary convulsive movements,
dizziness, fainting (due to low blood pressure) and coma.

If you forget to take GEALEVIDE
Do not take a double dose to make up for a missed dose. Continue with the usual dose.

If you stop taking GEALEVIDE
You can only stop or interrupt treatment with the agreement of your doctor.
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 everyone will experience them.

Serious side effects, for which you should immediately contact a doctor or go to the emergency room:
Common:may affect up to 1 in 10 people

• Drowsiness.
• Acute dystonia: alteration of muscle tone localized to some muscles of the neck (spastic torticollis), involuntary and prolonged deviation of the eyes upwards (oculogyric crisis), spasm of the chewing muscles, with difficulty opening the mouth (trismus).
• Cardiac rhythm disturbance that can potentially cause a fast and irregular heartbeat, which can lead to a heart attack (QT interval prolongation).

Uncommon:may affect up to 1 in 100 people:

• Convulsions. Weak pulse.

Rare:may affect up to 1 in 1000 people

• Changes in blood cells, such as a decrease in the number of white blood cells, agranulocytosis (with symptoms such as malaise, a tendency to inflammation, especially sore throat and fever).
• You have an allergic reaction called angioedema. The signs may include: an itchy rash with swelling, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• High temperature, muscle stiffness, profuse sweating, confusion, drowsiness or agitation (malignant neuroleptic syndrome).
• Cases of venous thromboembolism, including cases of pulmonary embolism, sometimes fatal, and cases of deep vein thrombosis (blood clots inside the veins, especially in the legs with symptoms including swelling, pain and redness of the legs), which may flow through the blood vessels to the lungs, causing chest pain and difficulty breathing.
• Benign pituitary tumor, such as prolactinomas (with symptoms such as milk secretion and cessation of menstruation).
• Irregular heartbeat (ventricular arrhythmias such as "torsades de pointes", ventricular tachycardia, ventricular fibrillation), cardiac arrest, sudden death.

Frequency not known

• Withdrawal syndrome in newborns (with symptoms such as tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, difficulty feeding (see section “Pregnancy and breastfeeding”).

Other side effects
Very common:may affect more than 1 in 10 people

• Extrapyramidal symptoms: tremor (abnormal and repetitive shaking movement of the body), rigidity (stiffness or inflexibility), hypokinesia (decreased or slow movements), akathisia (inability to remain seated, with motor restlessness and a feeling of muscle tremor), dyskinesia (alteration in the ability to control movements, characterized by spasmodic or repetitive movements or lack of coordination), hypersalivation (increased salivation).

Common:may affect up to 1 in 10 people

• Constipation, nausea, vomiting, dry mouth.
• Low blood pressure.
• Increased levels of prolactin in the blood, breast milk secretion, absence of menstruation, breast enlargement in men, breast pain, impotence, inability to achieve orgasm.
• Insomnia, anxiety, restlessness.
• Weight gain.
• Blurred vision.

Uncommon:may affect up to 1 in 100 people

• Decreased number of leukocytes (leukopenia, neutropenia).
• Tardive dyskinesia (characterized by rhythmic, involuntary movements mainly of the tongue and/or face that have been reported usually after long-term administration or discontinuation).
• High blood sugar (hyperglycemia). High levels of cholesterol and/or fats (triglycerides) in the blood.
• Allergic reactions.
• Confusion.
• High blood pressure.
• Nasal congestion (nasal congestion).
• Aspiration pneumonia.
• Osteopenia and osteoporosis.
• Urinary retention.
• Increased liver enzymes, mainly transaminases.

Rare:may affect up to 1 in 1000 people

• Skin rash (urticaria).
• Low levels of sodium in the blood (hyponatremia).
• Malaise, confusion or weakness, feeling unwell (nausea), loss of appetite, irritability. These may be signs of a condition called inappropriate secretion of antidiuretic hormone syndrome (SIADH).

Amisulpride can also cause side effects that are usually not noticed. These are
changes in some laboratory tests due to the effects on the blood, liver and heartbeat.
These tests will return to normal after stopping treatment.
In elderly people with dementia treated with antipsychotics, a slight increase in the
number of deaths has been reported compared to those not treated.

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 via 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 GEALEVIDE

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 “Scad.”. 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 GEALEVIDE contains
The active ingredient is amisulpride. Each tablet contains 50 mg, 200 mg or 400 mg of amisulpride.
The other ingredients are: lactose monohydrate, sodium starch glycolate type A, hypromellose 2910 E5,
microcrystalline cellulose PH-101, magnesium stearate.

Description of the appearance of GEALEVIDE and contents of the pack
GEALEVIDE 50 mg: white, round, flat tablets with a diameter of 7 mm.
GEALEVIDE 200 mg: white, round, flat tablets, notched on one side, with a diameter of 11.5 mm.
The notch is only intended to facilitate breaking for easier swallowing and not for dividing the
tablet into two equal doses.
GEALEVIDE 400 mg: white, biconvex, capsule-shaped tablets, with a notch on
both sides, with dimensions of 19 x 10 mm. The notch is only intended to facilitate breaking for
easier swallowing and not for dividing the tablet into two equal doses.
GEALEVIDE 50 mg tablets: packs in PVC/PE/PVDC-Aluminum blisters or in blisters of
PVC/PVDC-Aluminum containing 12, 30, 90 and 100 tablets.
GEALEVIDE 200 mg and 400 mg tablets: packs in PVC/PE/PVDC-Aluminum blisters or in blisters
of PVC/PVDC-Aluminum containing 30, 90 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Ecupharma S.r.l.
Via Mazzini 20
20123 Milan
Italy

Manufacturer:
Medochemie Ltd
Central Factory
1-10 Constantinoupoleos Street
3011, Limassol, Cyprus

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations: