AMISULPRIDE 50 mg Tabletka Powlekana

Treść ulotki

1. AMISULPRIDE EG 50 mg tablets, 200 mg tablets, 400 mg film-coated tablets
   1. WHAT AMISULPRIDE EG IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMISULPRIDE EG
   3. HOW TO TAKE AMISULPRIDE EG
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE AMISULPRIDE EG
   6. PACKAGE CONTENTS AND OTHER INFORMATION

AMISULPRIDE EG 50 mg tablets, 200 mg tablets, 400 mg film-coated tablets

Generic medicine

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

1. WHAT AMISULPRIDE EG IS AND WHAT IT IS USED FOR

Pharmacotherapeutic group: ATC code: N05AL05
AMISULPRIDE EG belongs to a group of medicines called antipsychotics.
This medicine is used to treat people with schizophrenia. Schizophrenia is a mental
illness characterized by certain psychiatric and behavioral disorders, such as hallucinations or
agitation.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMISULPRIDE EG

Do not take AMISULPRIDE EG:

• if you are allergic to the active ingredient (amisulpride) or to any of the other ingredients of this medicine (listed in section 6),
• if you suffer from pheochromocytoma (excessive growth of the adrenal glands located on the kidneys that release substances causing a rise in blood pressure),
• if you are a child under 15 years of age,
• if you are breastfeeding,
• if you have a prolactin-dependent tumor (prolactin is the hormone that activates milk production), such as breast cancer or pituitary disorders,
• if you are taking another medicine, make sure that its combination with AMISULPRIDE EG is not contraindicated (see section "Other medicines and AMISULPRIDE EG"). Warnings and precautionsTalk to your doctor or pharmacist before taking AMISULPRIDE EG.

Before you begin this treatment, your doctor may perform an electrocardiogram (ECG).
This is because this medicine can cause heart rhythm problems (see section 4).
The medicine should be used with caution in the following cases:

• in the elderly, especially if they suffer from dementia, due to the risk of a drop in blood pressure or drowsiness. If you suffer from kidney disease, your doctor may reduce the dose,
• if you have risk factors for stroke (a stroke, also known as a cerebrovascular accident, occurs when the blood supply to a part of the brain is suddenly interrupted),
• if you or someone in your family has a history of blood clots, as antipsychotic drugs can cause blood clots to form,
• if you suffer from kidney disease (renal insufficiency); in this case, your doctor may reduce the dose,
• if you suffer from epilepsy or Parkinson's disease,
• if you are diabetic or have risk factors for diabetes,
• if you have a history of hyperprolactinemia (excessive prolactin in the blood) or a prolactin-dependent tumor (prolactin is the hormone that activates milk production), such as breast cancer or pituitary disorders. In this case, your doctor will monitor you closely during treatment.

If, during treatment, you experience muscle rigidity and altered consciousness,
accompanied by unexplained fever: immediately stop taking this
medicine and consult your doctor as soon as possible.
If you experience blurred vision or headache, consult your doctor as soon as possible.
If you develop an infection or unexplained fever, your doctor may need to perform
blood tests immediately. This is because the drug can cause blood disorders (decreased white blood cells), detectable in blood test results
(see section 4 “Possible side effects”).
Treatment with this medicine should not be stopped abruptly, as this may
cause withdrawal symptoms. These manifest with the development of signs such as
difficulty sleeping, feeling unwell, vomiting, abnormal movements, or recurrence of your
psychotic problems.

Children and adolescents

• This medicine should not be used in children under 15 years of age.
• This medicine is not recommended in adolescents between 15 and 18 years of age.

Other medicines and AMISULPRIDE EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Never take this medicine with cabergoline, quinagolide (medicines used in the
treatment of lactation disorders), citalopram, escitalopram (medicines used to treat
anxiety or depression), domperidone (medicine used to treat nausea and vomiting), hydroxyzine
(medicine used to treat anxiety or urticaria), piperazine (medicine used to treat
malaria)
Avoid taking this medicine at the same time as:

• some drugs used to treat Parkinson's disease (amantadine, apomorphine, bromocriptine, entacapone, lisuride, pergolide, piribedil, pramipexole, rasagiline, ropinirole, rotigotine, selegiline, tolcapone),
• levodopa,
• sodium oxybate (medicine used to treat narcolepsy),
• some medicines that can cause a serious heart rhythm problem (torsades de pointes) such as: o medicines to treat irregular heartbeat (class Ia antiarrhythmics, such as quinidine, hydroquinidine, disopyramide and class III antiarrhythmics, such as amiodarone, dronedarone, sotalol, dofetilide and ibutilide), o some medicines to treat psychiatric problems (chlorpromazine, ciamemazine, droperidol, flupentixol, fluphenazine, haloperidol, levomepromazine, pimozide, pipamperone, pipothiazine, sulpiride, sultopride, tiapride, zuclopentixol), o some anti-parasitic drugs (chloroquine, halofantrine, lumefantrine, pentamidine), o a medicine used to treat addiction to some drugs (methadone), o and other medicines such as: arsenic trioxide, difemanil, dolasetron i.v., erythromycin i.v., hydroxychloroquine, levofloxacin, mequitazine, mizolastine, prucalopride, vincamine i.v., moxifloxacin, spiramycin i.v., toremifene, vandetanib,
• medicines containing alcohol.

AMISULPRIDE EG with food, drinks and alcohol
As with all antipsychotic medicines belonging to this group, you should avoid drinking
alcohol while taking this medicine.

Pregnancy, breastfeeding and fertility
Pregnancy
The use of this medicine is not recommended during pregnancy.
If you become pregnant during treatment, consult your doctor immediately, who will be
able to determine whether it is necessary to continue treatment.
If you have taken AMISULPRIDE EG in the last three months of pregnancy, the baby
may experience the following symptoms: tremor, stiffness and/or muscle weakness, drowsiness, agitation,
breathing problems and difficulty feeding.
If the baby develops any of these symptoms, contact your doctor quickly.

Breastfeeding
Do not breastfeed your baby if you are taking this medicine.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
This medicine can cause drowsiness and blurred vision. You should be careful if you
drive or use machines.

AMISULPRIDE EG contains lactose
This medicine contains a sugar (lactose) that breaks down into galactose and glucose.
It is not recommended for use in patients with galactose intolerance, Lapp lactase deficiency, or
galactose or glucose malabsorption syndrome (rare hereditary diseases).
If your doctor has diagnosed you with intolerance to some sugars, contact them before taking
this medicine.

3. HOW TO TAKE AMISULPRIDE EG

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Do not stop taking the medicine on your own initiative.
This medicine must be taken orally.
Swallow the tablet with a little water.

If you take more AMISULPRIDE EG than you should
Inform your doctor or pharmacist immediately.
You may experience drowsiness, sedation (calming effect), low blood pressure, extrapyramidal symptoms
(in particular tremor, muscle rigidity) or you may fall into a coma.
If any of these symptoms appear, you or someone in your family should call a doctor or the Emergency
Room immediately.

If you forget to take AMISULPRIDE EG
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
If you have forgotten several doses, consult your doctor.

If you stop taking AMISULPRIDE EG
Not relevant.
If you have any further questions on 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.
If, during treatment, you experience muscle rigidity and altered consciousness,
accompanied by unexplained fever, you should immediately stop treatment and
consult your doctor as soon as possible.
The following side effects are very common (may affect more than 1 in 10 people):

• tremors, muscle rigidity, cramps, abnormal movements, excessive salivation.

The following side effects are common (may affect up to 1 in 10 people):

• torticollis, oculogyric crisis (abnormal movements of certain eye muscles), intense jaw contractions.
• drowsiness,
• insomnia, anxiety, agitation,
• constipation, nausea, vomiting, dry mouth,
• frigidity (lack of sexual pleasure in women),
• hyperprolactinemia (excessive amount of prolactin in the blood (prolactin is the hormone that activates milk production) which can determine: or in women: missed periods, unusual milk production, breast pain, or in men: breast enlargement and impotence (erection problems).
• weight gain,
• low blood pressure (hypotension).

The following side effects are uncommon (may affect up to 1 in 1,000 people):

• involuntary movements of the tongue and/or face,
• convulsions (involuntary contractions of one or more muscles),
• hyperglycemia (high blood sugar levels),
• slowing of the heartbeat,
• increased liver enzymes, in particular transaminases,
• allergic reactions.

The occurrence of the following side effects is possible, but their frequency is unknown:

• unexplained fever associated with systemic and neurological problems,
• hypertriglyceridemia (high concentrations of fats (triglycerides) in the blood),
• hypercholesterolemia (high cholesterol levels in the blood)
• confusional state,
• blurred vision,
• reduced bone density and altered bone structure (osteopenia, osteoporosis), weakening of the bones,
• nasal congestion,
• severe episodes of fainting (loss of consciousness), heart rhythm problems that can be fatal (see section 2),
• swelling, pain and redness in the legs. Blood clots in the veins (especially in the legs) can reach the lungs through the blood vessels, causing chest pain and difficulty breathing.
• sudden swelling of the face and/or neck that can make breathing difficult and can endanger the patient's life (angioedema), itchy red spots on the skin (urticaria),
• leukopenia, neutropenia and agranulocytosis (reduction of white blood cells) (see section 2 “Warnings and precautions”),
• benign pituitary tumor that can cause symptoms such as blurred vision or headache,
• low levels of sodium in the blood (hyponatremia), syndrome of inappropriate antidiuretic hormone secretion (SIADH),
• neonatal withdrawal syndrome (see section 2 “Pregnancy”).

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 AMISULPRIDE EG

Keep this medicine out of the sight and reach of children
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 AMISULPRIDE EG contains

50 mg

• The active ingredient is amisulpride. Each tablet contains 50 mg of amisulpride.
• The other ingredients are: corn starch, methylcellulose (E461), lactose monohydrate, magnesium stearate (E572), anhydrous colloidal silica

200 mg

• The active ingredient is amisulpride. Each tablet contains 200 mg of amisulpride.
• The other ingredients are: corn starch, methylcellulose (E461), lactose monohydrate, magnesium stearate (E572), anhydrous colloidal silica

400 mg

• The active ingredient is amisulpride. Each tablet contains 400 mg of amisulpride.
• The other ingredients are: Core: lactose monohydrate, sodium carboxymethylcellulose, microcrystalline cellulose, methylcellulose (E461), magnesium stearate (E572) Coating: EUDRAGIT E100, talc, titanium dioxide (E171), magnesium stearate, macrogol
• 6000. Description of the appearance of AMISULPRIDE EG and contents of the pack

50 mg
This medicine is supplied in divisible tablets in packs of 12, 30, 60 or 150 tablets.

200 mg and 400 mg
This medicine is supplied in divisible tablets in packs of 30, 60 or 150 tablets.

Marketing Authorisation Holder
EG S.p.A. Via Pavia 6 – 20136 Milano

Manufacturers
Doppel Farmaceutici S.r.l. Via Volturno, 48 – 20089 Quinto de’ Stampi Rozzano – Milano (Italy)
Cosmo S.p.A. Via C. Colombo, 1 20020 Lainate – Milano (Italy)
Pharma-Developpement, Chemin De Marcy- 58800, Corbigny (France) (only for 50/200 mg
tablets)
Sanico N.V. Veedijk 59, Industriezone 4 Turnhout (Belgium)
Dragenopharm GmbH & Co KG, Göllstrasse, 1- 84529 - Tittmoning (Germany)
Laboratoires BTT, ZI de Krafft 67150 Erstein (France)

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
France: AMISULPRIDE EG 50 mg, divisible tablet
AMISULPRIDE EG 100 mg, divisible tablet
AMISULPRIDE EG 200 mg, divisible tablet
AMISULPRIDE EG 400 mg, film-coated divisible tablet
Belgium: AMISULPRIDE EG 50 mg tablets
AMISULPRIDE EG 100 mg tablets
AMISULPRIDE EG 200 mg tablets
AMISULPRIDE EG 400 mg film-coated tablets
Luxembourg: AMISULPRIDE EG 50 mg tablets
AMISULPRIDE EG 100 mg tablets
AMISULPRIDE EG 200 mg tablets
AMISULPRIDE EG 400 mg film-coated tablets
Italy: AMISULPRIDE EG 50 mg tablets
AMISULPRIDE EG 200 mg tablets
AMISULPRIDE EG 400 mg film-coated tablets