SOLIAN 400 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Solian, 400 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Solian and what is it used for
4. Important information before taking Solian
   1. When not to take Solian:
   2. Warnings and precautions
   3. Before taking Solian, discuss with your doctor or pharmacist if:
   4. Seek immediate medical attention if:
   5. Solian and other medicines
   6. Solian with food and drink
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Solian contains lactose
   10. Solian contains sodium
5. How to take Solian
   1. Taking the medicine
   2. Dosage
   3. Adults
   4. Use in elderly patients
   5. Use in children and adolescents
   6. Use in renal impairment
   7. Use in hepatic impairment
   8. Overdose of Solian
   9. Missed dose of Solian
   10. Stopping Solian treatment
   11. Blood tests
6. Possible side effects
   1. Stop taking Solian and seek immediate medical attention or go to the nearest hospital if you experience any of the following side effects:
   2. Seek medical attention immediately if you experience any of the following side effects:
   3. Other side effects:
   4. Reporting side effects
7. How to store Solian
8. Contents of the pack and other information
   1. What Solian contains
   2. What Solian looks like and contents of the pack
   3. Marketing authorization holder and manufacturer:
   4. Date of last revision of the leaflet:

Leaflet accompanying the packaging: information for the user

Solian, 400 mg, coated tablets

Amisulpride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your 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 pack 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:

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

Warnings and precautions

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

• you have kidney disease;
• you have Parkinson's disease;
• you have a history of seizures (epilepsy);
• you have irregular heart rhythm;
• you have heart disease or have had heart disease in your family;
• you have been told you have had a stroke;
• you or someone in your family has had blood clots, as Solian may increase the risk of blood clots;
• you have diabetes or have been told you are at risk of developing diabetes;
• you have a slow heart rate (less than 55 beats per minute);
• you have been told you have low potassium levels in your blood;
• you are elderly: elderly people are more likely to experience low blood pressure and excessive sedation. Caution should be exercised when using amisulpride in elderly patients with dementia-related psychosis, as they are at increased risk of death. A dose reduction may be required due to renal impairment;
• you or someone in your family has had breast cancer;
• you have visual disturbances and headaches: these may be symptoms of a benign pituitary tumor. Your doctor will carry out tests and if the diagnosis is confirmed, Solian treatment will be stopped.

Seek immediate medical attention if:

• you experience muscle stiffness or muscle pain associated with muscle breakdown (rhabdomyolysis) and increased creatine phosphokinase levels in the blood, and changes in mental status, including confusion, accompanied by fever of unknown origin: stop taking Solian and seek immediate medical attention, as this can lead to death.

Severe liver disorders have been reported with Solian. Seek immediate medical attention if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain, or yellowing of the eyes or skin. If in doubt about any of the above conditions, consult your doctor or pharmacist before taking Solian.

Solian and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about 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 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;
• 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 any of the above situations, consult your doctor or pharmacist before taking Solian. If you feel that the effect of Solian is too weak or too strong, do not change the dose yourself, but consult your 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, ask your doctor for advice before taking this medicine. PregnancySolian should not be used during pregnancy or in women of childbearing potential 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 muscle contractions, drowsiness, breathing difficulties, or feeding difficulties. If you notice any of these symptoms in your baby, seek medical attention. BreastfeedingDo not breastfeed while taking Solian. Discuss with your doctor the best way to feed your baby if you are taking Solian. FertilityDecreased 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 or operate machinery. If you experience these symptoms, stop driving or operating machinery.

Solian contains lactose

If you have been told you have an intolerance to some sugars, consult your doctor before taking this medicine.

Solian contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered to be essentially sodium-free.

3. How to take Solian

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor.

Taking the medicine

• Take the medicine by mouth.
• Swallow the medicine with a non-alcoholic beverage.
• If you feel that the effect of the medicine is too weak or too strong, consult your doctor. Do not change the dose yourself.

Dosage

The dosage depends on the severity of the disease. Follow your doctor's instructions exactly.

Adults

• The usual dose is between 50 mg and 800 mg per day.
• Your doctor may start you on a lower dose if necessary.
• Your 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. Take the medicine at the same time each 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 patient group, amisulpride should be used with caution, due to the risk of hypotension 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 patients from puberty to 18 years have not been established. Data on the use of amisulpride in adolescents with schizophrenia are limited. Therefore, the use of amisulpride in patients from puberty to 18 years 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 by the kidneys. In case of renal impairment, your doctor may prescribe a lower dose.

Use in hepatic impairment

No dose adjustment is required in patients with hepatic impairment.

Overdose of Solian

If you have taken more than the prescribed dose of Solian, seek immediate medical attention or go to the nearest hospital. You should take the packaging of the medicine with you so that the doctor knows what has been taken. Symptoms may include agitation, tremors, muscle stiffness, drowsiness, which may lead to loss of consciousness.

Missed 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. If in doubt, consult your doctor.

Stopping Solian treatment

Continue to take Solian unless your doctor tells you to stop. Do not stop taking Solian just because you feel better. Stopping the treatment may cause the disease to worsen or return. Do not stop taking Solian abruptly, unless your doctor tells you to. After stopping Solian, the following withdrawal symptoms may occur:

• nausea or vomiting
• sweating
• difficulty sleeping or restlessness
• muscle stiffness or unusual body movements
• return to the pre-treatment state.

Blood tests

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

Stop taking Solian and seek immediate medical attention or go to the nearest hospital if you experience any of 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, or 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 rare but serious 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 of the legs). These clots may travel to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, seek immediate medical attention;
• allergic reactions. Symptoms may include itchy rash, difficulty swallowing or breathing, swelling of the face, lips, 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 levels in the blood (a blood test indicating muscle damage).

Seek medical attention immediately if you experience any of the following side effects:

Very common (affects more than 1 in 10 people)

• tremors, muscle stiffness, or spasms, slowed movements, increased saliva production, restlessness, uncontrolled movements, mainly of the hands and feet (these symptoms may be reduced if your doctor lowers 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;
• involuntary muscle contractions: eye muscles (forced upward gaze), face, neck (jaw stiffness, 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);
• prolonged QT interval in the electrocardiogram;
• benign pituitary tumor (a tumor of the pituitary gland in the brain);
• hyponatremia (low sodium levels), syndrome of inappropriate antidiuretic hormone secretion (SIADH - a condition caused by excessive secretion of antidiuretic hormone by the pituitary gland).

Frequency not known

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring 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 You can also report side effects to the marketing authorization holder or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Solian

Storage - no special requirements. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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.
• The other ingredients are: carboxymethylcellulose sodium (type A), lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate.

Coating (Solian 400 mg, coated tablets):

• hypromellose, microcrystalline cellulose, macrogol 40 stearate, titanium dioxide (E171).

What Solian looks like and contents of the pack

Solian, 400 mg: white, coated tablets, scored, oblong, with "AMI 400" embossed on one side. Pack contains:30 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder: Sanofi Winthrop Industrie, 82, Avenue Raspail, 94250 Gentilly, France. Manufacturer: Delpharm Dijon, 6 boulevard de l’Europe, 21800 Quetigny, France. For further information, contact the representative of the marketing authorization holder in Poland: Sanofi Sp. z o.o., ul. Marcina Kasprzaka 6, 01-211 Warsaw, tel.: +48 22 280 00 00

Date of last revision of the leaflet: