Solian

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Solian
400 mg, coated tablets
Amisulpridum
Read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

1. What Solian is and what it is used for

Solian is available as 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 blunting, social and emotional withdrawal), including patients with predominant negative symptoms.

2. Important information before using Solian

When not to use 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 rash, difficulty swallowing or breathing, swelling of the lips, face, throat, and tongue;
• if the patient has tumours whose growth is dependent on prolactin levels, e.g. prolactinoma pituitary adenoma, breast cancer;
• if the patient has a phaeochromocytoma (adrenal gland tumour);
• concomitantly with levodopa;
• in children before puberty;
• concomitantly with medicines that may cause serious disturbances in heart rhythm, potentially leading to death, such as: drugs used to treat irregular heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol); other drugs such as: bepridil, cisapride, sultopride, thioridazine, methadone, intravenous erythromycin, intravenous vinpocetine, halofantrine, pentamidine, sparfloxacin.

This medicine should not be taken if any of the above conditions apply. If in doubt, consult a doctor or pharmacist before starting treatment with Solian.

Warnings and precautions

Before taking Solian, discuss with your doctor or pharmacist if:

• the patient has kidney disease;
• the patient has Parkinson's disease;
• the patient has seizures (epileptic fits);
• the patient has irregular heart rhythm (arrhythmia);
• the patient has heart disease or a family history of heart disease;
• the patient has been informed of having had a stroke;
• the patient or someone in their family has had blood clots, as treatment with medicines such as Solian may be associated with an increased risk of blood clots;
• the patient has diabetes or has been informed of an increased risk of developing diabetes;
• the patient has a slow heart rate (less than 55 beats per minute);
• the patient has been informed of low potassium levels in the blood;
• the patient is elderly: in older people, low blood pressure and excessive sedation occur more frequently. Caution is required when using amisulpride in elderly patients with psychosis associated with dementia, as there is an increased risk of death compared to patients not treated with antipsychotic medicines. A lower dose may be required due to impaired kidney function;
• 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 tumour. The doctor will order tests and, if diagnosis is confirmed, treatment with Solian will be discontinued.

Contact your doctor immediately if:

• during treatment the patient develops muscle stiffness or muscle pain associated with muscle breakdown (rhabdomyolysis), increased creatine kinase activity in the blood, and disturbances of consciousness accompanied by fever of unknown origin: treatment should be stopped immediately and urgent medical advice sought, as this may lead to death.

Severe liver function disorders have been reported with the use of Solian. Contact your doctor immediately if symptoms such as fatigue, loss of appetite, nausea, vomiting, abdominal pain, or yellowing of the eyes or skin occur.

If in doubt about any of the above conditions, consult your doctor or pharmacist before starting treatment with Solian.

Solian and other medicines

Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken, including herbal preparations. Solian and other medicines taken concomitantly 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. Inform your doctor if the patient is taking any of the following medicines:

• other antipsychotics used to treat mental disorders;
• 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;
• painkillers;
• anaesthetics;
• antihistamines that cause drowsiness;
• bromocriptine, ropinirole;
• clozapine, used to treat schizophrenia;
• medicines that lower potassium levels in the blood.

If in doubt about any of the above situations, consult your doctor or pharmacist before starting treatment with Solian.

If you feel that the effect of Solian is too weak or too strong, do not change the dose on your own; consult your doctor.

Solian with food and drink

Solian should be taken with non-alcoholic drinks. Do not drink alcohol while taking Solian, as it may affect the medicine's action.

The medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a baby, she should consult her doctor before using this medicine.

Pregnancy

Use of Solian is not recommended during pregnancy or in women of childbearing potential who are not using effective contraception.

In newborns whose mothers took Solian during the third trimester (last three months) of pregnancy, the following symptoms may occur: agitation, increased muscle tone, involuntary tremors, drowsiness, breathing difficulties, or feeding difficulties. If such symptoms are observed in your baby, contact your doctor.

Breastfeeding

Breastfeeding should not be undertaken while taking Solian. Discuss with your doctor the best way to feed your baby if you are taking Solian.

Fertility

Reduced 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 or operate machinery. If such symptoms occur, discontinue these activities.

Solian contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Solian contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Solian

This medicine should always be taken exactly as prescribed by your doctor. In case of doubt,
consult your doctor.
Taking the medicine

• The medicine should be taken orally.
• The medicine should be taken with a non-alcoholic drink.
• If the patient feels that the effect of the medicine is too weak or too strong, they should consult their doctor. Do not change the dose independently.

Dosage
The dosage depends on the severity of the disease. Always follow your doctor's instructions precisely.
Adults

• The usual daily dose ranges from 50 mg to 800 mg.
• The doctor may start treatment with a lower dose if necessary.
• The doctor may prescribe a dose up to 1200 mg per day if needed.
• Doses up to 400 mg may be taken as a single dose. The medicine should be taken at the same time each day.
• Higher doses should be divided into two doses, with half taken in the morning and half in the evening.

(Available also: Solian 100 mg tablets and Solian 200 mg tablets).
Use in elderly patients
Amisulpride should be used with particular caution in this patient group due to the possibility of the medicine causing drops in 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 individuals from puberty up 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 individuals from puberty up to 18 years of age is not recommended. Administration of amisulpride to children before puberty is contraindicated, as the safety of the medicine has not been established in this age group.
Use in renal impairment
Amisulpride is eliminated from the body via the kidneys. In cases of renal impairment, the doctor may prescribe a lower dose.
Use in hepatic impairment
There is no need to adjust the dose in case of liver function disorders.
Taking an overdose of Solian
If an overdose of Solian is taken, seek immediate medical advice from a doctor or go to the nearest hospital, as specialist medical assistance may be required. Take the medicine packaging with you so the doctor knows which medicine has been taken. Symptoms may include: anxiety or tremor, muscle stiffness, drowsiness, which may lead to loss of consciousness.
Missing a dose of Solian
If a dose is missed, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose. In case of doubt, consult your doctor.
Stopping treatment with Solian
Continue taking Solian unless your doctor decides otherwise. Do not stop taking Solian just because you feel better. Stopping the medicine may cause the illness to worsen or return. Do not stop taking Solian suddenly unless your doctor advises otherwise. After abrupt discontinuation of Solian, withdrawal symptoms may occur, such as:

• nausea or vomiting
• sweating
• difficulty sleeping or feeling restless
• muscle stiffness or unusual body movements
• return to the pre-treatment condition.

Blood tests
Taking Solian may affect certain blood test results. This includes measurements of the hormone prolactin levels and liver function tests. If the patient plans to have blood tests, they should inform the doctor about taking Solian.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Amisulpride is generally a well-tolerated medicine, and sometimes it may be difficult to distinguish
the medicine's adverse effects from symptoms of the underlying disease. The following adverse
reactions may also occur with other antipsychotics.
You should stop taking Solian and contact your doctor or go to the nearest hospital emergency
department if the patient experiences any of the following adverse reactions:
Not common (affects less than 1 in 100 patients)

• Seizure (epileptic fit);
• 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 patients)

• High temperature, sweating, muscle stiffness, rapid heartbeat, rapid breathing, confusion, drowsiness, and agitation. These may be symptoms of a serious but rare condition called neuroleptic malignant syndrome;
• Irregular heart function, 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 in the limbs). These clots may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If such symptoms occur, contact your doctor immediately;
• Allergic reactions. Symptoms may include: itchy rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue, urticaria, angioedema.

Frequency unknown (cannot be estimated from available data)

• Rhabdomyolysis (muscle breakdown and associated muscle pain);
• Increased creatine phosphokinase activity (a blood test indicating muscle damage).

You should contact your doctor as soon as possible if any of the following adverse reactions occur:
Very common (affects more than 1 in 10 patients)

• Tremor, muscle stiffness or spasms, slowed movements, increased salivation, restlessness, uncontrollable movements, mainly of hands and feet (these symptoms may be reduced if your doctor reduces the dose of Solian or prescribes an additional medicine).

Not common (affects less than 1 in 100 patients)

• Uncontrollable movements, mainly of the face and tongue;
• Confusion (inappropriate to reality, disorganized: speech, thinking, and behavior).

Frequency unknown (cannot be estimated from available data)

• Withdrawal syndrome in newborns.

Other adverse reactions:
Common (affects less than 1 in 10 patients)

• Disturbed milk production in women and men and breast pain;
• Absence of menstruation;
• Breast enlargement in men;
• Erectile dysfunction;
• Insomnia, anxiety, agitation;
• Orgasm disorders;
• Uncontrollable contractions of certain muscle groups: eyes (involuntary upward deviation of the eyes), face, neck (trismus, torticollis);
• Drowsiness;
• Blurred vision;
• Low blood pressure;
• Constipation, nausea or vomiting, dry mouth;
• Weight gain.

Not common (affects less than 1 in 100 patients)

• Leukopenia (reduced number of white blood cells in blood), neutropenia (reduced number of a type of white blood cells – neutrophils in blood);
• Hypertriglyceridemia (increased blood triglyceride levels above normal, associated with risk of atherosclerosis) and hypercholesterolemia (increased blood cholesterol levels above normal);
• Allergic reactions;
• High levels of glucose, triglycerides, or cholesterol in blood;
• Slowed heart function;
• Increased blood pressure;
• Nasal mucosa congestion;
• Aspiration pneumonia;
• Osteopenia (reduced bone density), osteoporosis;
• Urinary retention;
• Increased liver enzyme activity, mainly transaminases.

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

• Agranulocytosis (reduced number of a type of white blood cells – granulocytes in blood);
• QT interval prolongation in electrocardiogram;
• Benign pituitary gland tumor (a gland located in the brain);
• Hyponatremia (reduced sodium levels in blood below normal), syndrome of inappropriate antidiuretic hormone secretion (SIADH – a condition caused by excessive release of antidiuretic hormone – vasopressin – from the pituitary gland).

Frequency not known

• Restless legs syndrome (uncomfortable sensation in the legs temporarily relieved by movement, symptoms worsening towards the end of the day);
• Increased skin sensitivity to sunlight and ultraviolet radiation;
• Falls due to impaired body balance, sometimes leading to fractures.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Solian

No special storage instructions are required.
The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Solian contains

• The active substance is amisulpride. Each coated tablet contains 400 mg of amisulpride.
• Other ingredients are: sodium carboxymethyl starch (type A), monohydrate lactose, microcrystalline cellulose, hypromellose, magnesium stearate. Coating composition:
• hypromellose, microcrystalline cellulose, stearic acid macrogol 40 ester, titanium dioxide (E 171).

What Solian looks like and contents of the pack
Solian 400 mg: white, coated, divisible, elongated tablets, embossed with "AMI 400" on one side.
Pack contents:
Solian tablets 400 mg – 30 tablets.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in France, 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation numbers in France, 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 Licence Number: 170/23