Amisulpride EG

Package leaflet: Information for the user

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

Generic medicine
Please read all of this leaflet carefully before you take 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 other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including 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 taking 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 behavioural disorders, such as hallucinations or agitation.

2. WHAT YOU SHOULD KNOW BEFORE TAKING AMISULPRIDE EG

Do not take AMISULPRIDE EG:

• if you are allergic to the active substance (amisulpride) or to any of the other ingredients of this medicine (listed in section 6),
• if you have phaeochromocytoma (excessive growth of the adrenal glands located on the kidneys that release substances causing high blood pressure),
• if you are a child under 15 years of age,
• if you are breastfeeding,
• if you have a prolactin-dependent tumour (prolactin is the hormone that stimulates milk production), for example 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 precautions Talk to your doctor or pharmacist before taking AMISULPRIDE EG.

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

• in elderly patients, especially if they suffer from dementia, due to the risk of low blood pressure or drowsiness. If you have kidney disease, your doctor may reduce your dose,
• if you have risk factors for stroke (a stroke, also known as cerebrovascular accident, occurs when blood supply to part of the brain suddenly stops),
• if you or someone in your family has a history of blood clots, as antipsychotic medicines may cause blood clots to form,
• if you have kidney disease (renal failure); in this case, your doctor may reduce your dose,
• if you have epilepsy or Parkinson's disease,
• if you are diabetic or have risk factors for diabetes,
• if you have a history of hyperprolactinaemia (excessively high levels of prolactin in the blood) or a prolactin-dependent tumour (prolactin is the hormone that stimulates milk production), for example breast cancer or pituitary disorders. In this case, your doctor will monitor you closely during treatment.

If, during treatment, you experience muscle stiffness and altered consciousness,
accompanied by unexplained fever: stop taking this
medicine immediately 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 medicine may cause blood disorders (reduction in white blood cells), detectable in blood test results
(see section 4 “Possible side effects”).
Treatment with this medicine should not be stopped abruptly, as withdrawal symptoms may occur. These may include symptoms such as
difficulty sleeping, feeling unwell, vomiting, abnormal movements, or recurrence of your psychotic symptoms.
Children and adolescents

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

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 (a medicine used to treat nausea and vomiting), hydroxyzine
(a medicine used to treat anxiety or hives), piperazine (a medicine used to treat malaria).
Avoid taking this medicine at the same time as:

• certain medicines used to treat Parkinson's disease (amantadine, apomorphine, bromocriptine, entacapone, lisuride, pergolide, piribedil, pramipexole, rasagiline, ropinirole, rotigotine, selegiline, tolcapone),
• levodopa,
• sodium oxybate (a medicine used to treat narcolepsy),
• certain medicines that may cause a serious heart rhythm problem (torsades de pointes), such as:
  • medicines used to treat irregular heartbeat (class Ia antiarrhythmics such as quinidine, hydroquinidine, disopyramide, and class III antiarrhythmics such as amiodarone, dronedarone, sotalol, dofetilide, and ibutilide),
  • certain medicines used to treat psychiatric disorders (chlorpromazine, tiaramide, droperidol, flupentixol, fluphenazine, haloperidol, levomepromazine, pimozide, pipamperone, pipotiazine, sulpiride, sultopride, tiapride, zuclopentixol),
  • certain antiparasitic medicines (chloroquine, halofantrine, lumefantrine, pentamidine),
  • a medicine used to treat drug dependence (methadone),
  • and other medicines such as: arsenic trioxide, difemazole, 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 consuming
alcohol during treatment.
Pregnancy, breastfeeding and fertility
Pregnancy
Use of this medicine during pregnancy is not recommended.
If you become pregnant during treatment, consult your doctor immediately, who will
determine whether continuing treatment is necessary.
If you have taken AMISULPRIDE EG during the last three months of pregnancy, the baby
may show the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation,
breathing problems and feeding difficulties.
If the baby develops any of these symptoms, contact your doctor promptly.
Breastfeeding
Do not breastfeed your baby while taking this medicine.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This medicine may cause drowsiness and blurred vision. Be cautious when
driving or operating machinery.
AMISULPRIDE EG contains lactose
This medicine contains a sugar (lactose) that breaks down into galactose and glucose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome (rare hereditary conditions).
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking
this medicine.

3. HOW TO TAKE AMISULPRIDE EG

Take this medicine exactly as directed by 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 is for oral use.
Swallow the tablet with some water.

If you take more AMISULPRIDE EG than you should
Inform your doctor or pharmacist immediately.
You may experience drowsiness, sedation (a calming effect), low blood pressure, extrapyramidal symptoms (particularly tremor, muscle rigidity), or even fall into a coma.
If any of these symptoms occur, you or a family member must 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 the missed dose. Take the next dose at the usual time.
If you have missed several doses, consult your doctor.

If you stop taking AMISULPRIDE EG
Not applicable.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If, during treatment, you experience muscle stiffness and altered consciousness, accompanied by unexplained fever, you must stop treatment immediately and consult your doctor as soon as possible.

The following adverse reactions are very common (may affect more than 1 in 10 people):

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

The following adverse reactions are common (may affect from 1 to 10 in 100 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),
• hyperprolactinaemia (excessive levels of prolactin in the blood (prolactin is the hormone responsible for milk production), which may result in: in women: irregular menstrual cycles, unusual milk production, breast pain; in men: breast enlargement and impotence (erection problems)),
• weight gain,
• low blood pressure (hypotension).

The following adverse reactions are uncommon (may affect from 1 to 10 in 1,000 people):

• involuntary movements of the tongue and/or face,
• convulsive seizures (involuntary contractions of one or more muscles),
• hyperglycaemia (high blood sugar levels),
• slowing of the heartbeat,
• increased liver enzymes, particularly transaminases,
• allergic reactions.

The following adverse reactions may also occur, but their frequency is unknown:

• unexplained fever associated with systemic and neurological problems,
• hypertriglyceridaemia (high levels of fats (triglycerides) in the blood),
• hypercholesterolaemia (high cholesterol levels in the blood),
• confusion,
• blurred vision,
• reduced bone density and changes in bone structure (osteopenia, osteoporosis), bone weakening,
• nasal congestion,
• severe episodes of fainting (loss of consciousness), heart rhythm problems that may be fatal (see section 2),
• swelling, pain and redness in the legs. Blood clots in the veins (especially in the legs) may travel through blood vessels to the lungs, causing chest pain and breathing difficulties.
• sudden swelling of the face and/or neck which may make breathing difficult and may be life-threatening (angioedema), itchy red skin rashes (urticaria),
• leucopenia, neutropenia and agranulocytosis (reduction in white blood cells) (see section 2 “Warnings and precautions”),
• benign tumour of the pituitary gland which may cause symptoms such as blurred vision or headache,
• low sodium levels in the blood (hyponatraemia), syndrome of inappropriate antidiuretic hormone secretion (SIADH),
• neonatal withdrawal syndrome (see section 2 “Pregnancy”).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, 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 special storage conditions.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What AMISULPRIDE EG contains
50 mg

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

200 mg

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

400 mg

• The active substance is amisulpride. Each tablet contains 400 mg of amisulpride.
• The other components are:
  Core: monohydrate lactose, 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 pack sizes

50 mg
This medicine is supplied as divisible tablets in packs of 12, 30, 60 or 150 tablets.
200 mg and 400 mg
This medicine is supplied as divisible tablets in packs of 30, 60 or 150 tablets.

Marketing Authorization Holder
EG S.p.A. Via Pavia 6 – 20136 Milan, Italy

Manufacturers
Doppel Farmaceutici S.r.l. Via Volturno, 48 – 20089 Quinto de’ Stampi Rozzano – Milan (Italy)
Cosmo S.p.A. Via C. Colombo, 1 20020 Lainate – Milan (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 authorized in the European Economic Area countries under the following names:
France: AMISULPRIDE EG 50 mg, comprimé sécable
AMISULPRIDE EG 100 mg, comprimé sécable
AMISULPRIDE EG 200 mg, comprimé sécable
AMISULPRIDE EG 400 mg, comprimé pelliculé sécable

Belgium: AMISULPRIDE EG 50 mg tabletten
AMISULPRIDE EG 100 mg tabletten
AMISULPRIDE EG 200 mg tabletten
AMISULPRIDE EG 400 mg filmomhulde tabletten

Luxembourg: AMISULPRIDE EG 50 mg tabletten
AMISULPRIDE EG 100 mg tabletten
AMISULPRIDE EG 200 mg tabletten
AMISULPRIDE EG 400 mg filmomhulde tabletten

Italy: AMISULPRIDE EG 50 mg compresse
AMISULPRIDE EG 200 mg compresse
AMISULPRIDE EG 400 mg compresse rivestite con film