SOLIAN 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Solian, 100 mg, tablets
3. Solian, 200 mg, tablets
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information:
4. What Solian is and what it is used for
5. Before you take Solian
   1. Do not take Solian:
   2. Warnings and precautions:
   3. Before taking Solian, tell your doctor or pharmacist if:
   4. If you experience any of the following, contact your doctor immediately:
   5. Solian with 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:
6. How to take Solian
   1. How to take Solian:
   2. Dose:
   3. Adults:
   4. Elderly:
   5. Children and adolescents:
   6. Renal impairment:
   7. Hepatic impairment:
   8. Overdose:
   9. Missed dose:
   10. Stopping Solian:
   11. Blood tests:
7. Possible side effects
   1. Stop taking Solian and contact your doctor or go to the nearest hospital immediately if you experience any of the following side effects:
   2. Contact your doctor immediately if you experience any of the following side effects:
   3. Other side effects:
   4. Reporting side effects:
8. How to store Solian
9. 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:

Package Leaflet: Information for the User

Solian, 100 mg, tablets

Solian, 200 mg, tablets

Amisulpride

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

• 1. What Solian is and what it is used for
• 2. Before you take 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 in tablet form and contains the active substance amisulpride. Amisulpride is an antipsychotic medicine. Solian is used to treat schizophrenia, a mental illness that can cause hallucinations, disturbed thoughts, and lack of motivation.

2. Before you take Solian

Do not take Solian:

• if you are allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6);
• if you have a tumor that may grow in response to prolactin, such as prolactinoma or breast cancer;
• if you have a pheochromocytoma, a rare tumor of the adrenal gland;
• if you are taking levodopa, a medicine used to treat Parkinson's disease;
• if you are under 18 years old;
• if you are taking medicines that may cause serious heart rhythm problems, such as quinidine, disopyramide, amiodarone, sotalol, bepridil, cisapride, sultopride, thioridazine, methadone, erythromycin given intravenously, vincamine given intravenously, halofantrine, pentamidine, sparfloxacin.

Do not take Solian if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking Solian.

Warnings and precautions:

Before taking Solian, tell your doctor or pharmacist if:

• you have kidney disease;
• you have Parkinson's disease;
• you have a history of seizures (fits);
• you have an irregular heartbeat;
• you have heart disease or have had heart disease in the past;
• you have had a stroke;
• you or a family member have had blood clots, as Solian may increase the risk of blood clots;
• you have diabetes or are at risk of developing diabetes;
• you have a slow heart rate (less than 55 beats per minute);
• you have low potassium levels in your blood;
• you are elderly: Solian may cause low blood pressure or excessive sedation in elderly patients. Your doctor may need to reduce the dose of Solian;
• you or a family member have had breast cancer;
• you have visual disturbances or headaches: these may be symptoms of a pituitary tumor.

If you experience any of the following, contact your doctor immediately:

• muscle stiffness or pain, or muscle breakdown (rhabdomyolysis) with fever, changes in mental status, and elevated creatine phosphokinase;

Severe liver disorders have been reported with Solian. If you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain, or yellowing of the skin or eyes, contact your doctor immediately.

Solian with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal products. Solian may interact with other medicines.

• other antipsychotic medicines used to treat mental illnesses;
• medicines used to treat pain, such as morphine;
• medicines used to treat malaria, such as mefloquine;
• medicines used to treat high blood pressure or heart disease;
• clonidine, used to treat migraine, 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 you are not sure, consult your doctor or pharmacist before taking Solian. Do not change the dose of Solian without consulting 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 way the medicine works. You can take Solian with or without food.

Pregnancy, breastfeeding, and fertility:

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor before taking Solian.

Pregnancy

Solian should not be used during pregnancy or in women of childbearing age who are not using effective contraception. If you become pregnant while taking Solian, consult your doctor immediately.

Breastfeeding

Do not breastfeed while taking Solian. Consult your doctor about the best way to feed your baby if you are taking Solian.

Fertility

Amisulpride may reduce fertility in animals. The effect on human fertility is not known.

Driving and using machines:

Solian may cause drowsiness, sedation, and blurred vision, which may affect your ability to drive or operate machinery. If you experience these symptoms, do not drive or operate machinery.

Solian contains lactose:

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

Solian contains sodium:

Solian contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Solian

Always take Solian exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

How to take Solian:

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

Dose:

The dose of Solian depends on the severity of your illness. Follow your doctor's instructions exactly.

Adults:

• The usual dose of Solian is between 50 mg and 800 mg per day.
• Your doctor may start you on a lower dose and gradually increase it.
• 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 Solian at the same time every day.
• Larger doses should be divided into two and taken in the morning and evening.

(A 400 mg Solian tablet is also available.)

Elderly:

Solian should be used with caution in elderly patients, as it may cause low blood pressure or excessive sedation. Your doctor may need to reduce the dose of Solian.

Children and adolescents:

The safety and efficacy of amisulpride in children and adolescents have not been established. Solian is not recommended for use in children and adolescents.

Renal impairment:

Amisulpride is excreted by the kidneys. If you have kidney disease, your doctor may need to reduce the dose of Solian.

Hepatic impairment:

No dose adjustment is necessary in patients with liver disease.

Overdose:

If you take more Solian than you should, contact your doctor or go to the nearest hospital immediately. Take the Solian packaging with you to show the doctor what you have taken. You may experience symptoms such as agitation, tremor, muscle stiffness, drowsiness, which may lead to loss of consciousness.

Missed dose:

If you miss a dose of Solian, take it as soon as possible. Do not take a double dose to make up for a missed dose. If you are not sure, consult your doctor or pharmacist.

Stopping Solian:

Do not stop taking Solian unless your doctor tells you to. Do not stop taking Solian just because you feel better. Stopping Solian suddenly may cause withdrawal symptoms, such as nausea, vomiting, sweating, difficulty sleeping, or restlessness.

Blood tests:

Taking Solian may affect some blood test results, such as 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, 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 illness.

Stop taking Solian and contact your doctor or go to the nearest hospital immediately if you experience any of the following side effects:

Uncommon (affects less than 1 in 100 people)

• seizures;
• liver damage (symptoms include fatigue, loss of appetite, nausea, vomiting, abdominal pain, or yellowing of the skin or eyes).

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

• high fever, sweating, stiff muscles, fast heartbeat, fast breathing, confusion, drowsiness, and agitation. These may be symptoms of a rare but serious condition called neuroleptic malignant syndrome;
• irregular heartbeat, fast 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 swelling, pain, and redness of the legs). These blood clots may travel to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately;
• 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 pain);
• increased creatine phosphokinase (a blood test that indicates muscle damage).

Contact your doctor immediately if you experience any of the following side effects:

Very common (affects more than 1 in 10 people)

• tremor, stiffness, or muscle spasms, slow movements, increased saliva production, restlessness, uncontrolled 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).

Uncommon (affects less than 1 in 100 people)

• uncontrolled movements, mainly of the face and tongue;
• confusion (disorganized, chaotic speech, thinking, and behavior).

Frequency not known (cannot be estimated from the available data)

• withdrawal symptoms in newborn babies;

Other side effects:

Common (affects less than 1 in 10 people)

• disrupted milk production in women and men and breast pain;
• amenorrhea (absence of menstruation);
• breast enlargement in men;
• erectile dysfunction;
• insomnia, anxiety, agitation;
• orgasm disorders;
• uncontrolled spasms of certain muscle groups: eye muscles (forced upward gaze), face, neck (lockjaw, torticollis);
• drowsiness;
• blurred vision;
• low blood pressure;
• constipation, nausea, or vomiting, dry mouth;
• weight gain.

Uncommon (affects less than 1 in 100 people)

• leukopenia (low white blood cell count), neutropenia (low neutrophil count);
• hypertriglyceridemia (high triglyceride levels) and hypercholesterolemia (high cholesterol levels);
• allergic reactions;
• high blood sugar, triglyceride, or cholesterol levels;
• slow heart rate;
• high blood pressure;
• nasal congestion;
• aspiration pneumonia;
• osteopenia (low bone density), osteoporosis;
• urinary retention;
• increased liver enzyme levels, mainly transaminases.

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

• agranulocytosis (low granulocyte count);
• QT prolongation (a heart rhythm disorder);
• pituitary tumor (a tumor of the pituitary gland);
• 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 (cannot be estimated from the available data)

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

Reporting side effects:

If you experience any side effects, talk to your doctor or pharmacist. You can also report side effects directly to the national reporting system: Department of Drug Safety, 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.

5. How to store Solian

Store in the original package. Do not store Solian in a place that can be accessed by children. Do not use Solian after the expiry date stated on the packaging. The expiry date refers to the last day of the 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 pack and other information

What Solian contains:

• The active substance is amisulpride. Each tablet contains 100 mg or 200 mg of amisulpride.
• The other ingredients are: carboxymethylcellulose sodium (type A), lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate.

What Solian looks like and contents of the pack:

Solian 100 mg: white or almost white, round, flat, scored tablets with "AMI 100" engraved on one side and a score line on the other side. Solian 200 mg: white or almost white, round, flat, scored tablets with "AMI 200" engraved on one side and a score line on the other side.

Packaging:

Solian 200 mg tablets: 30 or 90 tablets. Solian 100 mg tablets: 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 more information, contact the marketing authorization holder's representative 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: