Package Insert: Information for the Patient

Solian 400 mg Film-Coated Tablets

Amisulpride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Amisulpride belongs to a group of medicines called antipsychotics.

Solian 400 mg is indicated for the treatment of schizophrenia.

Do not take Solian 400 mg tablets

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• if you have any tumor dependent on prolactin (hormone secreted by the pituitary gland and that stimulates milk production in the mammary glands), for example, prolactinomas or breast cancer.
• if you have phaeochromocytoma (adrenal gland tumor).
• if you are a child, until puberty.
• if you are being treated with levodopa.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Solian 400 mg.

• like with other antipsychotic medications, there may be a risk of malignant neuroleptic syndrome (a complication that can be fatal) characterized by high fever, muscle rigidity, alteration of the nervous system (autonomic instability), alteration of consciousness (obnubilation), rhabdomyolysis (muscle breakdown associated with muscle pain) and increased levels of an enzyme called creatine phosphokinase (CPK). In cases of high fever, especially when using high doses, all antipsychotic medications, including amisulpride, should be discontinued.

Rhabdomyolysis has also been observed in patients without malignant neuroleptic syndrome.

• if you have Parkinson's disease.
• if you have known cardiovascular disease or a family history of prolonged QT interval, and antipsychotic medications should be avoided.
• if you have risk factors for cerebral infarction.
• in elderly patients with dementia-related psychosis, who are being treated with antipsychotics (possibility of increased risk of death).
• in patients with risk factors for thromboembolism (see "Possible adverse effects").
• if you have a history or family history of breast cancer.
• if a diagnosis of pituitary tumor is confirmed, amisulpride treatment should be discontinued.
• if you have established diagnosis of diabetes mellitus or risk factors for diabetes.
• if you have a history of seizures.

• if you have renal insufficiency.
• withdrawal symptoms (nausea, vomiting, or insomnia) have been described after abrupt discontinuation of high doses. The psychotic symptoms and involuntary movement disorders, such as akathisia (inability to remain seated calmly), dystonia (permanent involuntary contractions of the muscles of one or more parts of the body), and dyskinesia (incoordination of movements) may also reappear suddenly. Therefore, a gradual withdrawal is recommended.
• like with other antipsychotic medications, there may be a risk of leukopenia, neutropenia, and agranulocytosis. The appearance of fever or unexplained infections may indicate these blood disorders (discrasias) (see "Possible adverse effects") and require immediate blood analysis.
• severe liver problems have been reported with Solian. Consult your doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain, or yellow discoloration of the eyes or skin.

Use of Solian 400 mg with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Certain medications used may modify the effect of Solian 400 mg and your doctor may change the dose during combined treatment.

It is contraindicated to use Solian 400 mg with levodopa.

Amisulpride may counteract the effect of dopamine agonists (e.g. bromocriptine and ropinirole).

It is not recommended to use medications containing alcohol with Solian 400 mg, as amisulpride may potentiate the central effects of alcohol.

It is essential to inform your doctor if you are currently taking any of the following medications:

• central nervous system depressants, including narcotics, analgesics, sedating H1 antihistamines, barbiturates, benzodiazepines, and other anxiolytics, clonidine, and derivatives.
• blood pressure-lowering medications.
• clozapine.
• medications that prolong the QT interval, such as antiarrhythmic medications (quinidine, disopyramide, amiodarone, and sotalol), some antihistamines, other antipsychotics, and some medications for malaria treatment (mefloquine).
• lithium salts.
• sucralfate.
• antacids.

Taking Solian 400 mg with food and drinks

This medication may potentiate the effects of alcohol, so it is not recommended to consume alcoholic beverages during treatment.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before taking this medication.

Pregnancy:

Solian is not recommended during pregnancy or in fertile women who do not use contraceptive methods.

If you take Solian during the last three months of pregnancy, your baby may experience agitation, muscle stiffness, and/or weakness, involuntary tremors, numbness, breathing problems, or difficulty with lactation. If your baby develops any of these symptoms, contact your doctor.

Lactation:

Do not breastfeed during treatment with Solian. Consult with your doctor about the best way to feed your baby if you are taking Solian.

Use in children

The safety and efficacy of amisulpride have not been established between puberty and 18 years: available data on the use of amisulpride in adolescents with schizophrenia are limited. Therefore, amisulpride is not recommended for use between puberty and 18 years. In children, until puberty, amisulpride is contraindicated.

Driving and operating machinery

Solian 400 mg may cause symptoms such as drowsiness, dizziness, visual disturbances, blurred vision, and decreased reaction time. These effects, as well as the underlying disease, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Solian 400 mg contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Solian 400 mg contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication. Your doctor will indicate the duration of treatment as well as the way to increase the dose. Do not stop treatment abruptly, as symptoms of your disease may reappear.

Solian 400 mg are oral tablets for administration.

Adults:

The dose should be adjusted according to your clinical response and tolerance to treatment.

A recommended dose is between 400 mg/day and 800 mg/day. In individual cases, the daily dose may be increased up to 1200 mg/day.

The daily dose should be administered in a single dose, or divided into two doses in case of doses exceeding 400 mg/day.

Seniors:

Solian should be used with special caution due to the possible risk of hypotension (abnormal decrease in blood pressure) and sedation. Your doctor will adjust the dose due to renal insufficiency.

Patients with renal insufficiency:

Your doctor will adjust the dose.

If you take more Solian 400 mg tablets than you should

Consult your doctor immediately or go to the nearest hospital.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20.

In case of taking more doses than prescribed, you may experience symptoms such as drowsiness, sedation, and even coma, decreased blood pressure, as well as abnormal movements. Cases of death have been reported, mainly in combination with other psychotropic agents.

If you forgot to take Solian 400 mg tablets

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Solian 400 mg tablets may cause side effects, although not everyone will experience them.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.

The side effects observed according to their frequency of presentation:Very frequent (may affect more than 1 in 10 patients); Frequent (may affect up to 1 in 10 patients); Infrequent (may affect up to 1 in 100 patients); Rare (may affect up to 1 in 1,000 patients); Very rare (may affect up to 1 in 10,000 patients); Unknown frequency (cannot be estimated from available data), have been:

Blood and lymphatic system disorders:

Infrequent: leucopenia (decrease in the number of white blood cells)and neutropenia (decrease in a type of white blood cell, neutrophils) (see section “Warnings and precautions”).

Rare: agranulocytosis (decrease in a type of white blood cell, granulocytes)(see section “Warnings and precautions”).

Immune system disorders:

Infrequent: allergic reactions.

Endocrine disorders:

Frequent: galactorrhea, amenorrhea, gynecomastia (in males), breast pain, and erectile dysfunction.

Rare: benign pituitary tumor such as prolactinoma (see sections “Do not take Solian” and “Warnings and precautions”).

Metabolism and nutrition disorders:

Infrequent: hyperglycemia (increase in blood glucose levels) (see section “Warnings and precautions”), increase in triglycerides and cholesterol in the blood.

Rare: hyponatremia and syndrome of inappropriate antidiuretic hormone secretion.

Psychiatric disorders:

Frequent: insomnia, anxiety, agitation, and orgasmic dysfunction.

Infrequent: confusion.

Nervous system disorders:

Very frequent: tremor, rigidity, bradykinesia, increased salivation, and inability to remain seated quietly, incoordination of movements.

Frequent: acute dystonia (torticollis, ocular crisis (involuntary deviation of the gaze to one side), contraction of the masticatory muscles) and somnolence.

Infrequent: rhythmic, involuntary movements in the tongue and/or face, after long-term administrations and epileptic crises.

Rare: malignant neuroleptic syndrome, a potentially fatal complication (see section “Warnings and precautions”).

Unknown frequency:restless legs syndrome (unpleasant sensation in the legs, which is temporarily relieved by movement and symptoms worsen at the end of the day).

Eye disorders:

Frequent: blurred vision (see section “Driving and the use of machines”).

Cardiac disorders:

Infrequent: bradycardia (slowing of heart rate).

Rare: QT interval prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, which may lead to ventricular fibrillation or cardiac arrest, sudden death(see section “Warnings and precautions”).

Vascular disorders:

Frequent: hypotension.

Infrequent: increase in blood pressure.

Rare:venous thromboembolism (process characterized by blood coagulation in the veins), including pulmonary embolism, sometimes fatal, and deep vein thrombosis (see section “Warnings and precautions”).

Respiratory, thoracic, and mediastinal disorders:

Infrequent:nasal congestion and aspiration pneumonia (mainly associated with other antipsychotics and central nervous system depressants).

Gastrointestinal disorders:

Frequent: constipation, nausea, vomiting, dry mouth.

Hepatobiliary disorders:

Infrequent:hepatotoxicity.

Skin and subcutaneous tissue disorders:

Rare: angioedema(generalized urticaria accompanied by inflammation of the feet, hands, throat, lips, and respiratory tract) andurticaria.

Unknown frequency:increased sensitivity of your skin to the sun and ultraviolet light (photosensitivity).

Musculoskeletal and connective tissue disorders:

Infrequent: bone alterations (osteopenia, osteoporosis).

Unknown frequency:myolysis (muscle rupture associated with muscle pain).

Renal and urinary disorders:

Infrequent: urinary retention.

Pregnancy, puerperium, and perinatal diseases:

Unknown frequency: neonatal withdrawal syndrome (see section “Pregnancy and lactation”).

Complementary examinations:

Frequent: weight gain.

Infrequent: elevation of liver enzymes, mainly transaminases.

Unknown frequency:elevated levels of creatine phosphokinase (blood test indicating muscle damage).

Accidents, poisonings, and complications of therapeutic procedures:

Unknown frequency:falls due to reduced body balance, which sometimes causes fractures.

Important: you must seek medical attention immediately:

- if during treatment withSolian 400 mg tabletsany of the following symptoms occur: high fever, generalized muscle rigidity, rapid breathing, abnormal sweating, or decreased mental alertness, a potentially fatal complication, known as malignant neuroleptic syndrome (see section “Warnings and precautions”).

- or note your altered heart rhythm, you experience dizziness, vertigo, difficulty breathing, or chest pain, as isolated cases of: severe ventricular arrhythmias such as torsades de pointes, ventricular tachycardia that may lead to atrial fibrillation or cardiac arrest, and fatal outcome (see section “Warnings and precautions”).

Reporting of Adverse Reactions

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

No special storage conditions are required.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not dispose of medications through the drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Solian 400 mg

• The active ingredient is amisulpride.

-The other components are:

Core: sodium carboxymethylcellulose, lactose monohydrate, microcrystalline cellulose, hydroxypropylmethylcellulose, and magnesium stearate.

Coating: hydroxypropylmethylcellulose, microcrystalline cellulose, polyethylene glycol 2000 monostearate, and titanium dioxide (E171).

Appearance of the product and content of the packaging

Solian 400 mg is presented in the form of tablets. Each package contains 30 tablets, oblong, breakable, and white in color.

Holder of the marketing authorization and manufacturer responsible

Holder:

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer responsible:

Delpharm Dijon

6, Boulevard de l’Europe 21800

Quétigny (France)

Last review date of this leaflet: June 2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/