SOLIAN 100 mg TABLETS

2. What you need to know before you take Solian 100 mg

Do not take Solian 100 mg tablets

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you have a tumor that is dependent on prolactin (a hormone produced by the pituitary gland that stimulates milk production in the mammary glands), for example, pituitary prolactinomas or breast cancer.
• if you have pheochromocytoma (a tumor of the adrenal gland).
• if you are a child, up to puberty.
• if you are being treated with levodopa.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before starting Solian 100 mg,

• as with other antipsychotic medicines, a potentially life-threatening condition called neuroleptic malignant syndrome (characterized by high fever, muscle stiffness, altered nervous system function, altered consciousness, muscle breakdown, and increased levels of an enzyme called creatine phosphokinase) may occur. In case of high fever, especially when using high doses, all antipsychotic medicines, including amisulpride, should be discontinued.

Muscle breakdown has also been observed in patients without neuroleptic malignant 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 antipsychotic medicines 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 section "Possible side effects").
• if you have a history or family history of breast cancer.
• if 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 kidney problems.
• 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 (inability to remain seated), dystonia (permanent involuntary muscle contractions), and dyskinesia (uncoordinated movements). Therefore, gradual withdrawal is recommended.
• as with other antipsychotic medicines, leukopenia, neutropenia, and agranulocytosis may occur. The onset of unexplained fever or infections may indicate these blood disorders (see section "Warnings and precautions") and may require immediate blood tests.
• 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 100 mg with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Certain medicines used may alter the effect of Solian 100 mg, and your doctor may change the dose during combined treatment.

The use of Solian 100 mg with levodopa is contraindicated.

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

It is not recommended to use medicines containing alcohol with Solian 100 mg, as amisulpride may enhance the central effects of alcohol.

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

• Central nervous system depressants, including narcotics, analgesics, antihistamines, barbiturates, benzodiazepines, and other anxiolytics, clonidine, and derivatives.
• Blood pressure-lowering medicines.
• Clozapine.
• Medicines that prolong the QT interval, such as antiarrhythmic medicines (quinidine, disopyramide, amiodarone, and sotalol), some antihistamines, other antipsychotics, and some medicines for the treatment of malaria (mefloquine).
• Lithium salts.
• Sucralfate.
• Antacids.

Taking Solian 100 mg with food and drinks

This medicine may enhance 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 medicine.

Pregnancy:

Solian is not recommended during pregnancy or in women of childbearing potential 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 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, up to puberty, amisulpride is contraindicated.

Driving and using machines

Solian 100 mg may cause symptoms such as drowsiness, dizziness, vision changes, 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 medicine.

Solian 100 mg contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Solian 100 mg contains sodium

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

3. How to take Solian 100 mg

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Solian 100 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 caution due to the possible risk of hypotension (abnormally low blood pressure) and sedation. Your doctor will adjust the dose due to kidney problems.

Patients with kidney problems:

Your doctor will adjust the dose.

If you take more Solian 100 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, telephone 91 562 04 20.

In case of taking 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 100 mg tablets

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Solian 100 mg tablets can cause side effects, although not everybody gets them.

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

The side effects observed according to their frequency of occurrence: 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 the available data), have been:

Blood and lymphatic system disorders:

Uncommon: leukopenia (decrease in the number of white blood cells) and neutropenia (decrease in a type of white blood cells, neutrophils) (see section "Warnings and precautions").

Rare: agranulocytosis (decrease in a type of white blood cells, granulocytes) (see section "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 sections "Do not take Solian" and "Warnings and precautions").

Metabolism and nutrition disorders:

Common: hyperglycemia (increase in blood glucose levels) (see section "Warnings and precautions"), increased triglycerides and cholesterol in the 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 movements, increased salivation, and inability to remain seated.

Common: dystonia (acute torticollis, oculogyric crisis, contraction of the masticatory muscles) and somnolence.

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

Rare: neuroleptic malignant syndrome, which is a potentially life-threatening complication (see section "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 section "Driving and using machines").

Cardiac disorders:

Uncommon: bradycardia (slow heart rate).

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

Respiratory, thoracic, and mediastinal disorders:

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

Gastrointestinal disorders:

Common: constipation, nausea, vomiting, dry mouth.

Hepatobiliary disorders:

Uncommon: liver tissue damage.

Disorders of the skin and subcutaneous tissue:

Rare: angioedema (generalized urticaria accompanied by inflammation of the feet, hands, throat, lips, and airways) 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: muscle breakdown (rhabdomyolysis).

Renal and urinary disorders:

Uncommon: urinary retention.

Pregnancy, puerperium, and perinatal disorders:

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

Investigations:

Common: weight gain.

Uncommon: elevated liver enzymes, mainly transaminases.

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

Damage, poisoning, and complications of therapeutic procedures:

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 100 mg tablets you experience any of the following symptoms: high fever, generalized muscle stiffness, rapid breathing, abnormal sweating, or decreased mental alertness, a potentially life-threatening complication called neuroleptic malignant syndrome (see section "Warnings and precautions").
• or if you notice your heart rhythm is altered, you experience dizziness, vertigo, difficulty breathing, or chest pain, as isolated cases of severe ventricular arrhythmias, such as torsades de pointes, ventricular tachycardia, which can lead to atrial fibrillation or cardiac arrest, and fatal outcome have been reported (see section "Warnings and precautions").

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Solian 100 mg tablets

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Solian 100 mg

• The active substance is amisulpride.

• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, hypromellose, magnesium stearate, and purified water.

Appearance of the product and contents of the pack

Solian 100 mg is presented in the form of tablets. Each pack contains 60 tablets, flat, scored, white or almost white.

Marketing authorization holder and manufacturer

Marketing authorization 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 on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/