Solian

Package leaflet: information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Solian ( Amisulpride Zentiva 400 mg)
400 mg, coated tablets
Amisulpridum
Solian and Amisulpride Zentiva 400 mg are different brand names for the same medicine.
Please read this leaflet carefully before taking 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. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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, emotional and social withdrawal), including patients with predominant negative symptoms.

2. Important information before using Solian

When not to use Solian:

• if the patient is allergic (hypersensitive) 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 whose growth is dependent on prolactin levels, e.g. prolactinoma (a pituitary tumour), breast cancer;
• if the patient has a phaeochromocytoma (a tumour of the adrenal gland);
• 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.

Do not take this medicine if any of the above conditions apply to the patient.
If in doubt, consult a doctor or pharmacist before starting treatment with
Solian.
Warnings and precautions
Consult a doctor or pharmacist if:

• the patient has kidney disease;
• the patient has Parkinson's disease;
• the patient has seizures (epileptic fits);
• the patient has an irregular heartbeat (rhythm);
• the patient has heart disease or there is a family history of heart disease;
• the patient has been informed they have had a stroke;
• the patient or a family member has had blood clots, as medicines such as Solian may increase the risk of blood clots;
• the patient has diabetes or has been told they are at increased risk of developing diabetes;
• the patient has a slow heartbeat (less than 55 beats per minute);
• the patient has been told they have low blood potassium levels;
• the patient is elderly: in older people, low blood pressure and excessive sedation occur more frequently. 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 antipsychotic medicines. A lower dose may be required due to impaired kidney function;
• the patient or a family member 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 the diagnosis is confirmed, treatment with Solian will be discontinued.

Severe liver function disorders have been reported with the use of Solian. Contact a doctor
immediately if fatigue, loss of appetite, nausea, vomiting,
abdominal pain, yellowing of the eyes or skin occur.
If in doubt about any of the above conditions, consult a
doctor or pharmacist before starting treatment with Solian.
Solian and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including herbal preparations. Solian and other medicines taken concomitantly may interact and 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 the doctor if the patient is taking any of the following medicines:

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

If in doubt about any of the above situations, consult a doctor or pharmacist before starting treatment with Solian.
If the patient feels that the effect of Solian is too weak or too strong, do not change the dose independently, 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 medicine's action.
The medicine can be taken with or without food.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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 a newborn whose mother took Solian during the last trimester (last three months) of pregnancy, the following symptoms may occur: agitation, increased muscle stiffness, involuntary trembling of the body, drowsiness, breathing difficulties or feeding problems. If such symptoms are observed in the child, contact a doctor.
Breastfeeding
Breastfeeding should not be undertaken while taking Solian. Speak with your doctor about 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 drug.
Driving and using machines
Solian may reduce alertness, cause drowsiness and blurred vision, which may affect the ability to drive and operate machinery. If such symptoms occur, stop performing these activities.
Solian contains lactose monohydrate
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult a doctor before taking this medicine.
Solian contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning this medicine is considered "sodium-free".

3. How to use Solian

This medicine should always be taken as directed by the doctor. If in doubt, consult your doctor.
Taking the medicine

• Take the medicine orally.
• Swallow the tablet 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 the doctor's instructions precisely.
Adults

• The usual dose ranges 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 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 are 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. 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.
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 modify the dose in case of liver function disorders.
Taking more Solian than prescribed
If more Solian has been taken than prescribed, contact a doctor immediately or go to the nearest hospital, as specialist medical help may be required. Bring 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. If in doubt, consult your doctor.
Stopping Solian treatment
Continue taking Solian unless otherwise directed by your doctor. Do not stop taking Solian just because you feel better. Stopping treatment may cause the illness to worsen or return. Do not stop taking Solian abruptly unless instructed by your doctor. 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 the hormone prolactin and liver function tests. If a blood test is planned, inform the 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 any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Amisulpride is generally a well-tolerated medicine, and sometimes it may be difficult to distinguish
the adverse effects of the medicine from the symptoms of the underlying disease. The following
adverse effects may also occur with the use of other neuroleptics.
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 effects:
Not common (affects less than 1 in 100 patients)

• Seizure (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 heartbeat, 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.

You should 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 cramps, slowed movements, increased salivation, restlessness, involuntary movements, mainly of the 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;
• Confusion (disoriented, chaotic: 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)

• Disturbed 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 gaze), 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 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 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 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 (a feeling of discomfort in the legs temporarily relieved by movement, symptoms worsening towards the end of the day);
• Increased sensitivity of the skin to sunlight and ultraviolet radiation;
• Falls due to disturbances in body balance, sometimes leading to fractures.

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, you should inform your doctor or pharmacist. 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 181C, 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 conditions are required.
The medicine should be kept out of the 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. This will help protect the environment.

6. Contents of the pack and other information

What Solian contains

• The active substance is amisulpride. Each tablet contains 400 mg of amisulpride.
• Other components: sodium carboxymethyl starch (type A), monohydrate lactose, microcrystalline cellulose, hypromellose, magnesium stearate.

Film-coating ingredients:

• hypromellose, microcrystalline cellulose, stearoyl polyglycol 40, titanium dioxide (E 171).

The pack contains 30 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in France, the country of export: 34009 365 5807 6
34009 365 5813 7
34009 565 9809 0
Parallel import authorisation number: 441/21