Solian

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Solian

400 mg, coated tablets

Amisulpride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Solian and what is it used for
• 2. Important information before taking Solian
• 3. How to take Solian
• 4. Possible side effects
• 5. How to store Solian
• 6. Contents of the packaging and other information

1. What is Solian and what is it used for

Solian is available in the form of tablets and coated tablets and contains amisulpride as the active substance. Amisulpride is an antipsychotic, neuroleptic medicine. Solian is indicated for the treatment of acute and chronic schizophrenia with positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as emotional flattening, emotional withdrawal, and social withdrawal), including patients with predominantly negative symptoms.

2. Important information before taking Solian

When not to take Solian:

• if the patient is allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a rash, difficulty swallowing or breathing, swelling of the lips, face, throat, and tongue;
• if the patient has tumors whose growth is dependent on prolactin levels, such as prolactinoma, breast cancer;
• if the patient has a pheochromocytoma;
• in combination with levodopa;
• in children before puberty;
• in combination with medicines that may cause serious heart rhythm disorders, leading to death, such as medicines used to treat irregular heart rhythm (such as quinidine, disopyramide, amiodarone, sotalol) and other medicines, such as bepridil, cisapride, sultopride, thioridazine, methadone, intravenous erythromycin, intravenous vincamine, halofantrine, pentamidine, sparfloxacin.

You should not take this medicine if you have any of the above conditions. In case of doubts, you should consult a doctor or pharmacist before starting to take Solian.

Warnings and precautions

Before starting to take Solian, you should discuss it with your doctor or pharmacist if:

• the patient has kidney disease;
• the patient has Parkinson's disease;
• the patient has a history of seizures (epileptic fits);
• the patient has irregular heart rhythm;
• the patient has heart disease or has had heart disease in the family;
• the patient has been informed that they have had a stroke;
• the patient or someone in their family has had blood clots, as the use of medicines like Solian is associated with the formation of blood clots;
• the patient has diabetes or has been informed that they are at risk of developing diabetes;
• the patient has a slow heart rate (less than 55 beats per minute);
• the patient has been informed that they have low potassium levels in the blood;
• the patient is elderly: in older people, low blood pressure and excessive sedation occur more frequently. Caution should be exercised when using amisulpride in elderly patients with psychosis associated with dementia, as the risk of death is increased compared to patients not treated with antipsychotic medicines. A dose reduction may be required due to renal impairment;
• the patient or someone in their family has had breast cancer;
• the patient has visual field defects and headaches: these may be symptoms of a benign pituitary tumor. The doctor will order tests and if the diagnosis is confirmed, the use of Solian will be discontinued.

You should contact your doctor immediately if:

• during treatment, the patient experiences muscle stiffness or muscle pain associated with muscle breakdown (rhabdomyolysis) and has increased creatine phosphokinase activity in the blood, and altered consciousness, accompanied by fever of unknown origin: you should then stop taking the medicine immediately and consult your doctor urgently, as this may lead to death.

Severe liver disorders have been reported with the use of Solian. You should contact your doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain, yellowing of the eyes or skin. In case of doubts about the occurrence of the above conditions, you should consult a doctor or pharmacist before starting to take Solian.

Solian and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including herbal preparations. Solian and other medicines taken at the same time may affect each other's action. In particular, you should not take levodopa, a medicine used to treat Parkinson's disease, or medicines used to treat irregular heart rhythm, such as quinidine, disopyramide, amiodarone, sotalol, and you should inform your doctor if you are taking any of the following medicines:

• other antipsychotic medicines used to treat mental illnesses;
• medicines used to treat acute pain, such as morphine;
• medicines used to treat malaria, such as mefloquine;
• medicines used to treat high blood pressure and heart disease;
• clonidine used to treat migraine, facial flushing, or high blood pressure;
• medicines used to treat sleep disorders, such as barbiturates or benzodiazepines;
• analgesics;
• anesthetics;
• antihistamines that cause drowsiness;
• bromocriptine, ropinirole;
• clozapine, used to treat schizophrenia;
• medicines that lower potassium levels in the blood.

In case of doubts about the occurrence of the above situations, you should consult a doctor or pharmacist before starting to take Solian. If you feel that the effect of Solian is too weak or too strong, you should not change the dose yourself, but consult your doctor.

Solian with food and drink

Solian should be taken with non-alcoholic beverages. You should not drink alcohol while taking Solian, as it may affect the action of the medicine. The medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine. PregnancyThe use of Solian is not recommended during pregnancy or in women of childbearing age not using effective contraception. In newborns whose mothers took Solian during the last trimester (last three months) of pregnancy, the following symptoms may occur: agitation, increased muscle tone, involuntary trembling of the body, drowsiness, breathing difficulties, or feeding difficulties. If you notice such symptoms in your child, you should consult your doctor. BreastfeedingYou should not breastfeed while taking Solian. You should discuss with your doctor the best way to feed your child if you are taking Solian. FertilityA decrease in fertility has been observed in animal studies, related to the pharmacological action of the medicine.

Driving and using machines

Solian may cause decreased alertness, drowsiness, and blurred vision, which may affect your ability to drive and use machines. If you experience such symptoms, you should stop performing these activities.

Solian contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Solian contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Solian

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult your doctor.

Taking the medicine

• The medicine should be taken orally.
• The medicine should be taken with a non-alcoholic liquid.
• If you feel that the effect of the medicine is too weak or too strong, you should consult your doctor. You should not change the dose yourself.

Dosage

The dosage depends on the severity of the disease. You should follow the doctor's recommendations exactly.

Adults

• The usual dose of the medicine is from 50 mg to 800 mg per day.
• The doctor may start treatment with a lower dose if necessary.
• The doctor may recommend a dose of up to 1200 mg per day if necessary.
• Doses up to 400 mg can be taken as a single dose. The medicine should be taken at the same time of day.
• Larger doses should be divided into two and taken half in the morning and half in the evening.

(Solian 100 mg and Solian 200 mg tablets are also available).

Use in elderly patients

In this group of patients, amisulpride should be used with caution, due to the possibility of causing low blood pressure or excessive sedation. A dose reduction may be required due to renal impairment.

Use in children and adolescents

The efficacy and safety of amisulpride in people from puberty to 18 years of age have not been established. Data on the use of amisulpride in adolescents with schizophrenia are limited. Therefore, the use of amisulpride in people from puberty to 18 years of age is not recommended. The use of amisulpride in children before puberty is contraindicated, as the safety of the medicine in this age group has not been established.

Use in renal impairment

Amisulpride is eliminated from the body by the kidneys. In case of renal impairment, the doctor may recommend a lower dose of the medicine.

Use in hepatic impairment

There is no need to modify the dose in case of liver function disorders.

Use of a higher dose of Solian than recommended

In case of taking a higher dose of Solian than recommended, you should immediately consult a doctor or go to the nearest hospital, as specialized medical help may be required. You should take the packaging of the medicine with you, so that the doctor knows which medicine was taken. Symptoms such as anxiety or trembling, muscle stiffness, drowsiness, which can lead to loss of consciousness, may occur.

Missing a dose of Solian

In case of missing a dose of the medicine, you should take it as soon as possible, unless it is almost time for the next dose. You should not take a double dose of the medicine to make up for the missed dose. In case of doubts, you should consult your doctor.

Stopping the use of Solian

You should continue taking Solian unless your doctor decides otherwise. You should not stop taking Solian just because you feel better. Stopping the medicine may cause the disease to worsen or return. You should not suddenly stop taking Solian unless your doctor decides otherwise. After sudden discontinuation of Solian, withdrawal symptoms such as nausea or vomiting, sweating, difficulty sleeping or feeling anxious, muscle stiffness or unusual body movements, and return to the pre-treatment state may occur.

Blood tests

Taking Solian may affect some blood test results. This includes measurements of prolactin levels and liver tests. If you are going to have a blood test, you should inform your doctor that you are taking Solian. In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Solian can cause side effects, although not everybody gets them. Amisulpride is generally well tolerated, and it is sometimes difficult to distinguish between the side effects of the medicine and the symptoms of the underlying disease. The following side effects may also occur with the use of other neuroleptics.

You should stop taking Solian and consult your doctor or go to the nearest emergency department if you experience the following side effects:

Uncommon (affects less than 1 in 100 people)

• seizure;
• liver damage (symptoms include fatigue, loss of appetite, nausea, vomiting, abdominal pain, yellowing of the eyes or skin).

Rare (affects less than 1 in 1,000 people)

• high fever, sweating, muscle stiffness, rapid heartbeat, rapid breathing, confusion, drowsiness, and agitation. These may be symptoms of a serious but rare malignant neuroleptic syndrome;
• irregular heart rhythm, rapid heartbeat, or chest pain, which may lead to a heart attack or life-threatening heart disease;
• blood clots in the veins, especially in the legs (symptoms include itching, pain, and redness of the legs). These clots can move through the bloodstream to the lungs, causing chest pain and breathing difficulties. If you notice such symptoms, you should immediately consult your doctor;
• allergic reactions. Symptoms may include: itchy rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue, hives, angioedema.

Frequency not known (cannot be estimated from the available data)

• rhabdomyolysis (muscle breakdown and associated muscle pain);
• increased creatine phosphokinase activity (blood test indicating muscle damage).

You should consult your doctor as soon as possible if you experience the following side effects:

Very common (affects more than 1 in 10 people)

• tremor, muscle stiffness, or muscle spasm, slowed movement, increased saliva production, feeling anxious, uncontrolled movements, mainly of the hands and feet (these symptoms may be reduced if the doctor reduces the dose of Solian or prescribes an additional medicine).

Uncommon (affects less than 1 in 100 people)

• uncontrolled movements, mainly of the face and tongue;
• confusion (inadequate to reality, chaotic: speech, thinking, and behavior).

Frequency not known (cannot be estimated from the available data)

• withdrawal syndrome in newborns.

Other side effects:

Common (affects less than 1 in 10 people)

• disrupted milk production in women and men and breast pain;
• amenorrhea;
• breast enlargement in men;
• erectile dysfunction;
• insomnia, anxiety, agitation;
• orgasm disorders;
• uncontrolled spasm of certain muscle groups: eye balls (forced upward gaze), face, neck (jaw clenching, torticollis);
• drowsiness;
• blurred vision;
• low blood pressure;
• constipation, nausea, or vomiting, dry mouth;
• weight gain.

Uncommon (affects less than 1 in 100 people)

• leukopenia (decreased white blood cell count), neutropenia (decreased granulocyte count);
• hypertriglyceridemia (elevated triglyceride levels) and hypercholesterolemia (elevated cholesterol levels);
• allergic reactions;
• high blood sugar, triglyceride, or cholesterol levels;
• slow heart rate;
• high blood pressure;
• nasal congestion;
• aspiration pneumonia;
• osteopenia (decreased bone density), osteoporosis;
• urinary retention;
• increased liver enzyme activity, mainly transaminases.

Rare (affects less than 1 in 1,000 people)

• agranulocytosis (decreased granulocyte count);
• QT interval prolongation on the electrocardiogram;
• benign pituitary tumor (a gland located in the brain);
• hyponatremia (low sodium levels), syndrome of inappropriate antidiuretic hormone secretion (SIADH - a disease caused by excessive secretion of antidiuretic hormone by the pituitary gland).

Frequency not known

• restless legs syndrome (feeling of discomfort in the legs, temporarily relieved by movement, symptoms worsening at the end of the day);
• increased skin sensitivity to sunlight and ultraviolet radiation;
• falls, caused by balance disorders, sometimes leading to fractures.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warszawa, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Solian

There are no special recommendations for storage. The medicine should be stored in a place that is out of sight and reach of children. You should not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Solian contains

• The active substance of the medicine is amisulpride. Each coated tablet contains 400 mg of amisulpride.
• The other ingredients are: sodium carboxymethylcellulose (type A), lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate. Coating:
• hypromellose, microcrystalline cellulose, macrogol 40 stearate, titanium dioxide (E 171).

What Solian looks like and contents of the packaging

Solian, 400 mg: white, coated tablets, divisible, oblong, with "AMI 400" embossed on one side. Packaging contains:Solian, coated tablets 400 mg - 30 tablets. For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in France, the country of export:

Sanofi-Aventis France, 82, Avenue Raspail, 94250 Gentilly, France

Manufacturer:

Delpharm Dijon, 6 boulevard de l’Europe, 21800 Quetigny, France

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing authorization number in France, the country of export:

34009 348 748 0 2, 34009 351 207 7 9, 34009 576 788 7 6, 34009 561 313 8 9

Parallel import authorization number: 170/23

Date of leaflet approval: 24.08.2023

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