SOLIAN 400 mg FILM-COATED TABLETS

2. What you need to know before taking Solian 400 mg

Do not take Solian 400 mg tablets

• if you are allergic to the active substance or any of the other ingredients of this medication (listed in section 6).
• if you have any prolactin-dependent tumor (hormone secreted by the pituitary gland that stimulates milk production in the mammary glands), such as pituitary prolactinoma or breast cancer.
• if you have pheochromocytoma (tumor of the adrenal gland).
• 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,

• as with other antipsychotic medications, a malignant neuroleptic syndrome (a potentially fatal complication) may occur, characterized by high fever, muscle stiffness, instability of the autonomic nervous system, altered consciousness, rhabdomyolysis, and increased levels of an enzyme called creatine phosphokinase. In case 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 QT interval prolongation, and the use of neuroleptic medications should be avoided.
• if you have risk factors for stroke.
• 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 Side Effects").
• if you have a history or family history of breast cancer.
• if a pituitary tumor is diagnosed, treatment with amisulpride should be discontinued.
• if you have established 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 treatment at high doses. Psychotic symptoms and involuntary movement disorders may also reappear suddenly, such as akathisia, dystonia, and dyskinesia. Therefore, gradual withdrawal is recommended.
• as with other antipsychotic medications, leukopenia, neutropenia, and agranulocytosis may occur. The onset of unexplained fever or infections may indicate these blood disorders, and immediate blood analysis may be necessary.
• serious liver problems have been reported with Solian. Consult your doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain, or yellowing of the eyes or skin.

Using Solian 400 mg with Other Medications

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

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

The use of Solian 400 mg with levodopa is contraindicated.

Amisulpride may counteract the effect of dopaminergic agonists (e.g., bromocriptine and ropinirol).

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:

• CNS depressants, including narcotics, analgesics, sedating 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 the treatment of malaria (mefloquine).
• Lithium salts.
• Sucralfate.
• Antacids.

Taking Solian 400 mg with Food and Drinks

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

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy:

Solian is not recommended during pregnancy or in women of childbearing age 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 muscle weakness, tremors, numbness, breathing problems, or difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

Breastfeeding:

You should not breastfeed during treatment with Solian. Consult 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 in children between puberty and 18 years of age: the available data on the use of amisulpride in adolescents with schizophrenia are limited. Therefore, the use of amisulpride is not recommended between puberty and 18 years of age. In children, until puberty, amisulpride is contraindicated.

Driving and Using Machines

Solian 400 mg may cause symptoms such as drowsiness, dizziness, visual disturbances, blurred vision, and decreased reaction ability. These effects, as well as the underlying disease, may impair your ability to drive vehicles or operate machines. Therefore, do not drive, operate machines, 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 an intolerance to certain sugars, 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".

3. How to Take Solian 400 mg

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

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

Solian 400 mg is administered orally.

Adults:

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

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

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

Elderly:

Solian should be used with special caution due to the possible risk of hypotension 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 Toxicology Information Service, phone 91 562 04 20.

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

If You Forget to Take Solian 400 mg Tablets

Do not take a double dose to make up for forgotten doses.

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

4. Possible Side Effects

Like all medications, 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 not listed in this leaflet.

Side effects observed according to their frequency of presentation: Very common (may affect more than 1 in 10 patients); Common (may affect up to 1 in 10 patients); Uncommon (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); frequency not known (cannot be estimated from available data), have been:

Blood and Lymphatic System Disorders:

Uncommon: leukopenia and neutropenia (see "Warnings and Precautions").

Rare: agranulocytosis (see "Warnings and Precautions").

Immune System Disorders:

Uncommon: allergic reactions.

Endocrine Disorders:

Common: milk secretion, absence of menstruation, breast growth (in males), breast pain, and erectile dysfunction.

Rare: benign pituitary tumor, such as prolactinoma (see "Do Not Take Solian" and "Warnings and Precautions").

Metabolic and Nutrition Disorders:

Uncommon: hyperglycemia (see "Warnings and Precautions"), increased triglycerides and cholesterol in blood.

Rare: hyponatremia and syndrome of inappropriate antidiuretic hormone secretion.

Psychiatric Disorders:

Common: insomnia, anxiety, agitation, orgasmic dysfunction.

Uncommon: confusion.

Nervous System Disorders:

Very common: tremor, rigidity, poverty of movement, increased salivation, and inability to remain seated quietly, incoordination of movements.

Common: acute dystonia and somnolence.

Uncommon: rhythmic, involuntary movements in the tongue and/or face, after long-term administration, and epileptic seizures.

Rare: malignant neuroleptic syndrome, which is a potentially fatal complication (see "Warnings and Precautions").

Frequency not known: restless legs syndrome (unpleasant sensation in the legs, which is temporarily relieved by movement, and symptoms worsen at the end of the day).

Eyeball Disorders:

Common: blurred vision (see "Driving and Using Machines").

Cardiac Disorders:

Uncommon: bradycardia.

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

Vascular Disorders:

Common: hypotension.

Uncommon: increased blood pressure.

Rare: venous thromboembolism (process characterized by blood clotting in the veins), including pulmonary embolism, sometimes fatal, and deep vein thrombosis (see "Warnings and Precautions").

Respiratory, Thoracic, and Mediastinal Disorders:

Uncommon: nasal congestion and aspiration pneumonia (mainly associated with other antipsychotics and CNS depressants).

Gastrointestinal Disorders:

Common: constipation, nausea, vomiting, dry mouth.

Hepatobiliary Disorders:

Uncommon: liver tissue damage.

Skin and Subcutaneous Tissue Disorders:

Rare: angioedema and urticaria.

Frequency not known: increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity).

Musculoskeletal and Connective Tissue Disorders:

Uncommon: bone disorders (osteopenia, osteoporosis).

Frequency not known: rhabdomyolysis (rupture of muscles associated with muscle pain).

Renal and Urinary Disorders:

Uncommon: urinary retention.

Pregnancy, Puerperium, and Perinatal Disorders:

Frequency not known: withdrawal syndrome in newborns (see "Pregnancy and Breastfeeding").

Investigations:

Common: weight gain.

Uncommon: elevated liver enzymes, mainly transaminases.

Frequency not known: elevated creatine phosphokinase levels (blood test indicating muscle damage).

Accidents, Poisonings, and Complications of Surgical and Medical Care:

Frequency not known: falls due to reduced body balance, which sometimes result in fractures.

Important: you should see a doctor immediately:

• if during treatment with Solian 400 mg tablets you experience any of the following symptoms: high fever, generalized muscle stiffness, rapid breathing, abnormal sweating, or decreased mental alertness, a potentially fatal complication called malignant neuroleptic syndrome (see "Warnings and Precautions").
• or if you notice your heartbeat is altered, you experience dizziness, vertigo, difficulty breathing, or chest pain, as isolated cases of ventricular arrhythmias, such as torsades de pointes, ventricular tachycardia, which may lead to atrial fibrillation or cardiac arrest, and fatal outcome have been reported (see "Warnings and Precautions").

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Solian 400 mg Tablets

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 stated on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Solian 400 mg

• The active substance is amisulpride.

• The other ingredients are:

Core: sodium carboxymethyl starch, lactose monohydrate, microcrystalline cellulose, hydroxypropyl methylcellulose, and magnesium stearate.

Coating: hydroxypropyl methylcellulose, microcrystalline cellulose, polyethylene glycol 2000 monoester, and titanium dioxide (E171).

Appearance of the Product and Package Contents

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

Marketing Authorization Holder and Manufacturer

Holder:

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer:

Delpharm Dijon

6, Boulevard de l’Europe 21800

Quétigny (France)

Date of the Last Revision of this Leaflet: June 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/