SOLIAN 200 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 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:
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. Forgot to take Solian:
   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 as soon as possible 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 symptoms 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 and film-coated tablet forms 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). An allergic reaction may cause a rash, difficulty in breathing or swallowing, or swelling of the face, lips, throat, or tongue;
• if you have cancer that may be affected by the level of the hormone prolactin, such as prolactin-dependent tumor or breast cancer;
• if you have a tumor of the adrenal gland (phaeochromocytoma);
• if you are taking levodopa, a medicine for Parkinson's disease;
• if you are under 18 years old;
• if you are taking medicines that may cause serious heart rhythm problems, leading to death, such as medicines for irregular heartbeat (like quinidine, disopyramide, amiodarone, sotalol) and other medicines like bepridil, cisapride, sultopride, thioridazine, methadone, intravenous erythromycin, intravenous vincamine, halofantrine, pentamidine, sparfloxacin.

Do not take this medicine if you have any of the above conditions. 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 (epilepsy);
• you have an irregular heartbeat (arrhythmia);
• you have heart disease or have had heart disease in your family;
• you have had a stroke;
• you or someone in your family has had blood clots, as medicines like 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 levels of potassium in your blood;
• you are elderly: elderly people are more likely to experience low blood pressure or excessive sedation when taking amisulpride. Your doctor may need to reduce the dose of Solian;
• you or someone in your family has had breast cancer;
• you have vision problems 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, with or without fever, and changes in mental status: these may be signs of a rare but serious condition called neuroleptic malignant syndrome;

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

Solian and other medicines:

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

• 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 about any of the above, consult your doctor or pharmacist before taking Solian.

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 or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

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

Breastfeeding

Do not breastfeed while taking Solian. If you are taking Solian and wish to breastfeed, you should contact your doctor for advice.

Fertility

Amisulpride has been shown to reduce fertility in animal studies.

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, contact your doctor before taking Solian.

Solian contains sodium:

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is 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 or pharmacist.

How to take Solian:

• Take the tablets by mouth.
• Swallow the tablets with a non-alcoholic drink.
• If you feel that the effect of Solian is too strong or too weak, talk to your doctor. Do not change the dose of your medicine unless your doctor tells you to.

Dose:

The dose will depend on the severity of your illness. 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 and gradually increase it.
• Your doctor may prescribe a dose up to 1200 mg per day if necessary.
• Doses up to 400 mg can be taken as a single dose. Take the dose at the same time each day.
• Higher doses should be divided into two doses, taken in the morning and evening.

(A 400 mg tablet of Solian is also available).

Elderly:

In elderly patients, amisulpride should be used with caution, as it may cause low blood pressure or excessive sedation. The dose may need to be reduced due to kidney problems.

Children and adolescents:

The efficacy and safety of amisulpride in children and adolescents have not been established. Limited data are available in adolescents with schizophrenia. Therefore, amisulpride is not recommended for use in children and adolescents.

Renal impairment:

Amisulpride is eliminated by the kidneys. If you have kidney problems, your doctor may prescribe a lower dose.

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 medicine pack with you.

Forgot to take Solian:

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose. If you are not sure, contact your doctor.

Stopping Solian:

Do not stop taking Solian unless your doctor tells you to. If you stop taking Solian, your symptoms may come back. Do not stop taking Solian suddenly, unless your doctor tells you to. If you stop taking Solian suddenly, you may experience withdrawal symptoms, such as:

• nausea or vomiting;
• sweating;
• difficulty sleeping or feeling anxious;
• muscle stiffness or unusual body movements;
• return of your original symptoms.

Blood tests:

Taking Solian may affect some of your blood test results. This includes tests for prolactin and liver function. If you are going to have a blood test, tell your doctor that you are taking Solian.

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)

• seizure;
• 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 signs 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 clots may move 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 (breakdown of muscle tissue and associated muscle pain);
• increased levels of creatine phosphokinase (a blood test that indicates muscle damage).

Contact your doctor as soon as possible 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, feeling anxious; uncontrolled movements, mainly of the arms and legs (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 syndrome in newborns;

Other side effects:

Common (affects less than 1 in 10 people)

• disrupted milk production in women and men and breast pain;
• 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 (reduced white blood cell count), neutropenia (reduced neutrophil 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 (reduced bone density), osteoporosis;
• urinary retention;
• increased liver enzyme levels, mainly transaminases.

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

• agranulocytosis (reduced granulocyte count);
• prolonged QT interval on the electrocardiogram;
• pituitary tumor (a tumor of the pituitary gland);
• hyponatremia (low sodium levels), syndrome of inappropriate antidiuretic hormone secretion (SIADH).

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

• restless legs syndrome (a feeling of discomfort in the legs, temporarily relieved by movement, 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the contact details below.

5. How to store Solian

Store in the original package. Keep out of the sight and reach of children. Do not use this medicine after the expiry date 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 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.

Pack contents:

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 further information, contact the marketing authorization holder or its representative in Poland: Sanofi Sp. z o.o., ul. Marcina Kasprzaka 6, 01-211 Warszawa, tel.: +48 22 280 00 00.

Date of last revision of the leaflet: