Solian

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Solian (Amisulpride Zentiva 400 mg)

400 mg, coated tablets

Amisulpridum
Solian and Amisulpride Zentiva 400 mg are different trade names for the same medicine.

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 you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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, social withdrawal), including patients with predominantly negative symptoms.

2. Important information before taking Solian

When not to take Solian:

• if the patient is allergic (hypersensitive) 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); other medicines, such as bepridil, cisapride, sultopride, thioridazine, methadone, intravenous erythromycin, intravenous vincamine, halofantrine, pentamidine, sparfloxacin.

Do not take this medicine if you have any of the above conditions. If in doubt, consult a doctor or pharmacist before taking Solian.

Warnings and precautions

You should consult a doctor or pharmacist if:

• the patient has kidney disease;
• the patient has Parkinson's disease;
• the patient has seizure attacks (epilepsy);
• the patient has irregular heart rhythm;
• the patient has heart disease or has had heart disease in their 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 their blood;
• the patient is elderly: in older people, it is more common to experience a drop in blood pressure and excessive sedation. 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. It may be necessary to reduce the dose of the medicine due to kidney failure;
• 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.

Severe liver disorders have been reported in association with the use of Solian. You should immediately consult a doctor if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain, yellowing of the eyes or skin. If in doubt about the occurrence of the above conditions, consult a doctor or pharmacist before taking Solian.

Solian and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including herbal preparations. Solian and other medicines taken at the same time may affect each other's action. In particular, do 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 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.

If in doubt about the occurrence of the above situations, consult a doctor or pharmacist before taking Solian. If you feel that the effect of Solian is too weak or too strong, do not change the dosage yourself, but consult a doctor.

Solian with food and drink

Solian should be taken with non-alcoholic beverages. Do 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, consult a 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, difficulty breathing, or difficulty feeding. If you notice such symptoms in your child, consult a doctor. BreastfeedingDo not breastfeed while taking Solian. 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 operating machinery

Solian may cause reduced alertness, drowsiness, and blurred vision, which may affect the ability to drive vehicles and operate machinery. If such symptoms occur, stop performing these activities.

Solian contains lactose monohydrate

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

Solian contains sodium

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

3. How to take Solian

This medicine should always be taken as directed by a doctor. If in doubt, consult a 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, consult a doctor. Do not change the dosage yourself.

Dosage

The dosage depends on the severity of the disease. Follow the doctor's instructions 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 prescribe 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 every day.
• Larger doses should be divided into two and taken half in the morning and half in the evening.

(Solian 100 mg tablets 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 the medicine causing a drop in blood pressure or excessive sedation. It may be necessary to reduce the dose due to kidney failure.

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 administration of amisulpride to 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 kidney failure, the doctor may prescribe a lower dose of the medicine.

Use in hepatic impairment

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

Taking a higher dose of Solian than recommended

If you have taken a higher dose of Solian than recommended, consult a doctor or go to the nearest hospital immediately, as you may need specialized medical help. Take the medicine packaging with you, so the doctor knows what medicine you have taken. Symptoms such as anxiety or trembling, muscle stiffness, drowsiness, which can lead to loss of consciousness, may occur.

Missing a dose of Solian

If you miss a dose of Solian, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose of the medicine to make up for the missed dose. If in doubt, consult a doctor.

Stopping Solian treatment

Continue taking Solian unless your doctor decides otherwise. Do not stop taking Solian just because you feel better. Stopping the medicine may cause the disease to worsen or return. Do 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 abnormal body movements
• return to the pre-treatment state.

Blood tests

Taking Solian may affect the results of some blood tests. This includes measurements of prolactin levels and liver tests. If you are going to have a blood test, inform your doctor that you are taking Solian. If you have any further doubts about taking this medicine, consult a 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 can be difficult to distinguish between the side effects of the medicine and the symptoms of the underlying disease. The following side effects may also occur when using other neuroleptics.

Stop taking Solian and consult a 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, feeling disoriented, drowsiness, and agitation. These may be symptoms of a serious but rare malignant neuroleptic syndrome;
• irregular heart rhythm, rapid heartbeat, or chest pain, which can 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 difficulty breathing. If you notice such symptoms, consult a doctor immediately;
• allergic reactions. Symptoms may include: itchy rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue, hives, angioedema.

Consult a doctor immediately if you experience the following side effects:

Very common (affects more than 1 in 10 people)

• tremors, muscle stiffness, or spasms, slowed movements, 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 spasms of certain muscle groups: eye balls (forced upward gaze), face, neck (jaw clenched, torticollis);
• drowsiness;
• blurred vision;
• low blood pressure;
• constipation, nausea, or vomiting, dry mouth;
• weight gain.

Uncommon (affects less than 1 in 100 people)

• leukopenia (reduced white blood cell count), neutropenia (reduced 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 (reduced bone density), osteoporosis;
• urinary retention;
• increased liver enzyme activity, mainly transaminases.

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

• agranulocytosis (reduced granulocyte count);
• prolonged QT interval in 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, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, 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 this medicine.

5. How to store Solian

There are no special precautions for storage. The medicine should be stored out of sight and reach of children. Do not use the medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. 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 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).

The packaging contains 30 tablets. For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in France, the country of export:

zentiva France
35 rue du Val de Marne
75013 Paris, France

Manufacturer:

Delpharm Dijon
6, Boulevard de l’Europe
21800 Quétigny, France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in France, the country of export:34009 365 5807 6
34009 365 5813 7
34009 565 9809 0
Parallel import authorization number:441/21
Date of leaflet approval: 04.03.2022
[Information about the trademark]