Simamis

Package Leaflet: Information for the User

Symamis, 50 mg, tablets

Symamis, 100 mg, tablets

Symamis, 200 mg, tablets

Symamis, 400 mg, tablets

Amisulpride

Read the package 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Symamis and what is it used for
• 2. Important information before taking Symamis
• 3. How to take Symamis
• 4. Possible side effects
• 5. How to store Symamis
• 6. Contents of the pack and other information

1. What is Symamis and what is it used for

Symamis is a medicine used to treat mental disorders (antipsychotic).
It reduces the activity of certain areas of the brain that are relevant to the symptoms of mental illness.
Symamis is used to treat a disease called schizophrenia. Schizophrenia is a long-term mental state that affects the way a patient thinks, perceives, and behaves compared to normal.
The doctor may also prescribe Symamis to treat other symptoms. You should always follow the doctor's instructions.

2. Important information before taking Symamis

The doctor may also prescribe Symamis to treat symptoms other than those listed in this leaflet. You should always follow the doctor's instructions and the dosage instructions described in this leaflet.

When not to take Symamis:

• if the patient is allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6);
• if the patient has breast cancer;
• if the patient has a pituitary tumor;
• if the patient has an adrenal gland tumor (pheochromocytoma);
• during breastfeeding;
• if the patient has a rare hereditary heart disease characterized by a slow heart rate and irregular heartbeat (long QT syndrome);

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• if the patient is taking medicines that affect heart function (prolongation of the QT interval), such as:
• medicines used to treat Parkinson's disease (levodopa);
• medicines used to treat heart rhythm disorders (e.g., amiodarone, sotalol).

Symamis should not be used in children before puberty.

Warnings and precautions

Before starting treatment with Symamis, discuss with your doctor or pharmacist if:

• the patient has heart disease or has had heart disease in their family;
• there is a history of rare hereditary heart disease with a slow heart rate and irregular heartbeat (long QT syndrome) in the patient's family;
• the patient has kidney problems;
• the patient has epilepsy or has had seizures in the past;
• the patient has Parkinson's disease;
• the patient has diabetes or is at risk of developing diabetes;
• the patient or their family members have had blood clots (thrombosis), as taking medicines like Symamis may be associated with the formation of blood clots;
• the patient or their family members have had breast cancer.

You should immediately inform your doctor if:

• the patient experiences general malaise, has a tendency to inflammatory conditions, especially sore throat and fever (infections) due to a low white blood cell count (agranulocytosis);
• the patient experiences fever, muscle stiffness, altered consciousness, and excessive sweating. This condition can lead to death and requires immediate medical attention.

Warning: in certain patient groups (elderly patients and patients with dementia),
there is an increased risk of side effects, including stroke. You should consult your doctor.
The patient should inform their doctor if they are undergoing blood or urine tests while taking Symamis, as this medicine may affect the results of these tests.

Symamis and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take. Amisulpride may affect the action of other medicines. Additionally, other medicines may affect the action of amisulpride.

Do not take Symamis with medicines that may affect heart function (prolongation of the QT interval):

• medicines used to treat heart rhythm disorders (e.g., quinidine, disopyramide, amiodarone, and sotalol);
• certain antibiotics (e.g., erythromycin given intravenously);
• medicines used to treat Parkinson's disease (e.g., levodopa, bromocriptine, ropinirole).

You should inform your doctor if you are taking any of the following medicines:

• medicines used to treat high blood pressure (diltiazem, verapamil, beta-blockers, e.g., metoprolol);
• medicines used to treat heart rhythm disorders (digoxin);
• medicines used to treat migraine and facial flushing (clonidine);
• certain groups of diuretics;
• medicines used to treat constipation (sodium picosulfate, bisacodyl);
• medicines used to treat arthritis or connective tissue disorders (corticosteroids, e.g., prednisone);
• medicines used to treat anxiety and restlessness (benzodiazepines);

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• antidepressants (imipramine);
• other medicines used to treat mental illnesses (e.g., pimozide, haloperidol, lithium, clozapine);
• medicines used to treat epilepsy (phenobarbital);
• painkillers (e.g., morphine, oxycodone, tramadol);
• antihistamines that cause drowsiness (sedating antihistamines);
• sedatives;
• anesthetics used during surgery;
• anti-cough medications.

You should inform your doctorabout taking Symamis if you are going to have your adrenaline levels tested.

Symamis and alcohol

Do not drink alcohol while taking Symamis, as it may enhance the sedative effect of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.

The following symptoms may occur in newborns whose mothers took amisulpride in the last trimester of pregnancy (last three months of pregnancy):

• tremors, muscle stiffness, and (or) weakness;
• drowsiness, agitation, breathing difficulties;
• feeding difficulties. If you notice any of these symptoms in your child, contact your doctor.

Do not take Symamis while breastfeeding.

Driving and using machines

While taking this medicine, you may experience reduced alertness and blurred vision. If you experience these symptoms, do not drive or operate tools or machines.

Symamis contains lactose

Symamis contains lactose, a type of sugar. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

Symamis contains sodium

This medicinal product contains less than 1 mmol of sodium (23 mg) per tablet, which is considered to be essentially 'sodium-free'.

3. How to take Symamis

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:

Adults

Your doctor will adjust the dose according to your response to treatment. The usual dose of Symamis is 50-300 mg per day or 400-800 mg per day, depending on the symptoms of the disease.
In individual cases, the dose may be increased to 1200 mg per day.
If you are taking a single dose greater than 400 mg per day, the dose should be divided into two doses.
Use in children and adolescents
Symamis should not be given to children before puberty.

Use in patients with kidney problems

If you have reduced kidney function, your doctor may prescribe a lower dose. Follow your doctor's instructions.

Instructions for taking the medicine

Swallow the Symamis tablet before a meal, with a large amount of water.
Symamis, 200 mg, and Symamis, 400 mg: the dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses.

Taking a higher dose of Symamis than recommended

If you have taken more Symamis than recommended, contact your doctor or go to the nearest hospital immediately. Take the medicine packaging with you.
Overdose symptoms may include: drowsiness, sedation, involuntary movements, dizziness, fainting (due to low blood pressure), and coma.

Missing a dose of Symamis

Do not take a double dose to make up for a missed dose. Continue treatment with the usual dose.

Stopping treatment with Symamis

Treatment can only be stopped or ended after consulting your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Symamis can cause side effects, although not everybody gets them.

Severe side effects

Common:may affect up to 1 in 10 people

• altered consciousness related to excessive drowsiness. Contact your doctor;
• eye muscle spasms with forced upward gaze. Contact your doctor;
• rapid or very irregular heartbeat, which can lead to a heart attack. Contact your doctor immediately or go to the nearest emergency department.

Uncommon:may affect up to 1 in 100 people

• seizures. Contact your doctor immediately or go to the nearest emergency department;
• slow heart rate. Contact your doctor or go to the nearest emergency department;
• general malaise, tendency to inflammatory conditions (infections), especially sore throat and fever due to changes in blood (decreased white blood cell count, agranulocytosis). Contact your doctor or go to the nearest emergency department.

Rare:may affect up to 1 in 1000 people

• high fever, muscle stiffness, excessive sweating, confusion, drowsiness, or agitation (malignant neuroleptic syndrome). If you notice these symptoms, seek medical attention immediately;
• blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness of the leg). Clots can move through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately;
• pituitary tumor (manifested by milk secretion from the breast and menstrual disorders) caused by increased levels of hormone (prolactin) in the blood. In men: breast enlargement and erectile dysfunction.

Unknown: frequency cannot be estimated from the available data

• withdrawal syndrome in newborns (see section "Pregnancy and breastfeeding").

Other side effects

Very common:may affect more than 1 in 10 people

• slow, involuntary, twisting movements;
• side effects similar to Parkinson's disease symptoms: slow, involuntary tremors of hands and head, stiffness of movements, stiffness of facial expressions, muscle tension, and increased salivation;
• twisting movements, especially of the lower limbs.

Common:may affect up to 1 in 10 people

• neck twisting due to muscle spasms;
• reduced ability to open the jaw due to increased muscle tension;
• constipation, nausea, vomiting, dry mouth, which can increase the risk of tooth decay;
• dizziness, possible fainting due to low blood pressure;
• breast enlargement in men, chest tension, milk secretion, menstrual disorders;
• erectile dysfunction, inability to achieve orgasm;
• insomnia, anxiety, agitation;
• weight gain;
• blurred vision.

Uncommon:may affect up to 1 in 100 people

• slow, involuntary movements. May resolve after stopping the medicine;
• frequent urination, feeling of thirst, fatigue due to high blood sugar (glucose) levels; may develop into severe side effects. Contact your doctor;
• allergic reactions;
• increased risk of atherosclerosis due to high cholesterol and/or fat (triglyceride) levels in the blood;
• confusion;
• high blood pressure;
• nasal congestion (stuffy nose);
• pneumonia;
• increased risk of fractures due to osteopenia and osteoporosis. May develop into severe side effects. Contact your doctor if you experience sudden back pain.

Rare:may affect up to 1 in 1000 people

• rash and swelling. May be severe. Contact your doctor. Facial, lip, and tongue swelling may be life-threatening. If you notice these symptoms, seek medical attention immediately;
• nausea, discomfort, muscle weakness, and confusion due to low sodium levels in the blood (hyponatremia). May be (or develop into) a severe side effect. Contact your doctor;
• syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Amisulpride may cause side effects that the patient does not notice. These are usually changes visible in laboratory test results due to changes in blood, liver, or heart rhythm. Laboratory test results will return to normal after stopping treatment.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Symamis

Keep the medicine out of sight and reach of children.
Do not use the medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
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 Symamis contains

The active substance of Symamis is amisulpride. Each tablet contains 50 mg, 100 mg, 200 mg, or 400 mg of amisulpride.
Other ingredients are: lactose monohydrate, sodium carboxymethylcellulose (type A), hypromellose 2910, microcrystalline cellulose PH-101, magnesium stearate.

What Symamis looks like and contents of the pack

Symamis, 50 mg: white, round, flat tablets with a diameter of 7 mm.
Symamis, 100 mg: white, round, flat tablets with a diameter of 9.5 mm, with the inscription MC on one side.
Symamis, 200 mg: white, round, flat tablets with a diameter of 11.5 mm, with a dividing line on one side. The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses.
Symamis, 400 mg: white, biconvex tablets in the shape of a capsule, with a dividing line on both sides, measuring 19 mm x 10 mm. The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses.
PVC/PE/PVDC-Aluminum or PVC/PVDC-Aluminum blisters, containing 30, 60, or 90 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Symphar Sp. z o.o.
Koszykowa 65 Street
00-667 Warsaw

Manufacturer

Medochemie Ltd
1-10 Constantinoupoleos Street, 3011, Limassol
Cyprus
Date of last revision of the leaflet:November 2020