Solian

Patient Information Leaflet

Warning! Keep this leaflet. The packaging information in a foreign language.
Solian
400 mg, coated tablets
Amisulpridum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents:

1. What Solian is and what it is 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 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). Allergic reactions may include rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue;
• if the patient has tumours dependent on prolactin levels, such as prolactinoma or 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 heart rhythm disorders, potentially leading to death, such as: antiarrhythmic drugs (e.g. quinidine, disopyramide, amiodarone, sotalol); other medicines such as: bepridil, cisapride, sultopride, thioridazine, methadone, intravenous erythromycin, intravenous vinca alkaloids, halofantrine, pentamidine, sparfloxacin.

Do not take this medicine if any of the above conditions apply. If in doubt, consult a doctor or pharmacist before starting treatment with Solian.

Warnings and precautions

Before starting treatment with Solian, consult your doctor or pharmacist if:

• the patient has kidney disease;
• the patient has Parkinson's disease;
• the patient has seizures (epilepsy);
• the patient has irregular heart rhythm (arrhythmia);
• the patient has heart disease or a family history of heart disease;
• the patient has been diagnosed with stroke;
• the patient or a family member has a history of blood clots, as medicines like Solian may increase the risk of thrombosis;
• the patient has diabetes or has been told they are at increased risk of developing diabetes;
• the patient has a slow heart rate (less than 55 beats per minute);
• the patient has been informed they have low blood potassium levels;
• the patient is elderly: older people are more likely to experience low blood pressure and excessive sedation. Caution is advised 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 antipsychotics. Dose reduction may be required due to impaired kidney function;
• the patient or a family member has a history of 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 levels in blood, and altered mental status accompanied by unexplained fever: treatment must be stopped immediately and urgent medical advice sought, as this may lead to death.

Severe liver dysfunction has 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 (jaundice) occur.

If you have any doubts about whether any of the above conditions apply, consult your doctor or pharmacist before starting treatment with Solian.

Solian with other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including herbal preparations. Solian and other medicines may interact and affect each other's actions.

In particular, do not take levodopa, a medicine used to treat Parkinson's disease, or antiarrhythmic medicines such as quinidine, disopyramide, amiodarone, or 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 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 yourself. Contact 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 become pregnant, 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.

Newborns whose mothers took Solian during the third trimester (last three months) of pregnancy may experience symptoms such as agitation, increased muscle tone, tremors, drowsiness, breathing difficulties, or feeding problems. If such symptoms are observed in your baby, contact your doctor.

Breastfeeding

Breastfeeding is not recommended while taking Solian. Discuss the best feeding method for your baby with your doctor if you are taking Solian.

Fertility

Reduced fertility has been observed in animal studies, related to the pharmacological action of the drug.

Driving and using machines

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

Solian contains lactose monohydrate

If the patient has been previously diagnosed with an 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, i.e. it is considered "sodium-free".

3. How to take Solian

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

• Take the medicine orally.
• Swallow the medicine 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 required.
• 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.

(Also available: 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 risk of the medicine causing hypotension or excessive sedation. Dose reduction may be required due to renal impairment.
Use in children and adolescents
The efficacy and safety of amisulpride in individuals from puberty to the age of 18 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 to the age of 18 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.
The tablet may be divided into two equal doses.
Use in renal impairment
Amisulpride is eliminated from the body via the kidneys. In cases of renal impairment, the doctor may recommend a lower dose.
Use in hepatic impairment
There is no need to modify the dose in case of liver function disorders.
Taking more Solian than prescribed
If you take more Solian than prescribed, contact your doctor immediately or go to the nearest hospital, as specialist medical help 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 you miss a dose, take it as soon as possible, unless it is almost time for your next dose. Do not take a double dose to make up for a missed dose. In case of doubt, consult your doctor.
Stopping Solian treatment
Continue taking Solian unless your doctor advises 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 abruptly unless your doctor advises otherwise. After sudden 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 prolactin hormone levels and liver function tests. If you are scheduled for blood tests, inform your doctor that you are taking Solian.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will get them.
Amisulpride is generally a well-tolerated medicine, and sometimes it is difficult to distinguish
the medicine's adverse effects from the symptoms of the underlying disease. The following
adverse effects may also occur with other antipsychotics.
Stop taking Solian and contact your doctor or go to the nearest hospital emergency
department if the patient experiences any of the following adverse effects:

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, fast 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 the 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).

Contact your doctor as soon as possible if any of the following adverse effects occur:

Very common (affects more than 1 in 10 patients)

• Tremor, muscle stiffness or spasms, slowed movements, increased salivation, restlessness, involuntary 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)

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

Frequency unknown (cannot be estimated from available data)

• Withdrawal syndrome in newborns.

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

• Impaired milk production in women and men and breast pain;
• Absence of menstruation;
• Breast enlargement in men;
• Erectile dysfunction;
• Insomnia, anxiety, agitation;
• Orgasm disorders;
• Involuntary contractions of certain muscle groups: eyes (forced 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 (elevated blood triglyceride levels above normal, associated with risk of atherosclerosis) and hypercholesterolemia (elevated blood cholesterol levels above normal);
• Allergic reactions;
• High levels of sugar, triglycerides, or cholesterol in blood;
• Slowed heart function;
• Increased blood pressure;
• Nasal mucosa congestion;
• Aspiration pneumonia;
• Osteopenia (reduced bone density), osteoporosis;
• Urinary retention;
• Increased activity of liver enzymes, 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 tumour (a gland located in the brain);
• Hyponatremia (reduced blood sodium concentration 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 legs temporarily relieved by movement, symptoms worsening in the evening);
• Increased skin sensitivity to sunlight and ultraviolet radiation;
• Falls due to impaired body balance, sometimes leading to fractures.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 effects helps to 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 required. Such measures help protect the environment.

6. Contents of the packaging 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 ingredients:
  hypromellose, microcrystalline cellulose, stearic acid polyglycol, titanium dioxide (E 171).

What Solian looks like and contents of the packaging
White, coated, divisible, elongated tablets, with "AMI 400" embossed on one side.
The tablet can be divided into two equal doses.
Packaging contains:
30 tablets.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:
Sanofi Romania SRL
Str. Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9
Sector 2, Bucharest, Romania

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
Poland

Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing authorization number in Romania, the country of export: 722/2008/01
Parallel import authorization number: 46/26