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 package 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 illnesses.
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 for the treatment of other symptoms. You should always follow the doctor's instructions.

2. Important information before taking Symamis

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

When not to take Symamis:

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

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• if you are taking medicines that affect heart function (prolonged 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, you should discuss with your doctor or pharmacist if:

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

You should immediately inform your doctor if:

• you experience general malaise, you are prone to inflammatory conditions, especially sore throat and fever (infections) due to a low white blood cell count (agranulocytosis);
• you experience 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.
You should inform your doctor if you are undergoing blood or urine tests while taking Symamis, as this medicine may affect the results of these tests.

Symamis and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, 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.

You should not take Symamis at the same time as medicines that may affect heart function (prolonged QT interval):

• medicines used to treat heart rhythm disorders (e.g., quinidine, disopyramide, amiodarone, and sotalol);
• certain antibiotics (e.g., intravenous erythromycin);
• 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

You should 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, you should 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, you should contact your doctor.

You should not take Symamis during breastfeeding.

Driving and using machines

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

Symamis contains lactose

Symamis contains lactose, a type of sugar. If you have previously been diagnosed with an intolerance to some sugars, you should 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

This medicine should always be taken exactly as instructed by your doctor. If you are unsure, you should 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. You should follow your doctor's instructions.

Instructions for taking the medicine

You should 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, not to divide it into equal doses.

Taking a higher dose of Symamis than recommended

If you have taken more Symamis than recommended, you should immediately contact your doctor or go to the nearest hospital. You should take the medicine packaging with you.
Symptoms of overdose may include: drowsiness, sedation, involuntary movements, dizziness, fainting (caused by low blood pressure), and coma.

Missing a dose of Symamis

You should not take a double dose to make up for a missed dose. You should continue treatment with the usual dose.

Stopping treatment with Symamis

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

4. Possible side effects

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

Serious side effects

Common:may affect up to 1 in 10 people

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

Uncommon:may affect up to 1 in 100 people

• seizures. You should immediately contact your doctor or go to the nearest emergency department;
• slow heart rate. You should contact your doctor or go to the nearest emergency department;
• general malaise, prone to inflammatory conditions (infections), especially sore throat and fever, due to changes in blood (low white blood cell count, agranulocytosis). You should 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, you should immediately seek medical attention;
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg). Blood clots can move through the bloodstream to the lungs, causing chest pain and breathing difficulties. If you experience any of these symptoms, you should immediately seek medical attention;
• pituitary tumor (characterized by milk secretion from the breast and menstrual irregularities) caused by increased levels of a hormone (prolactin) in the blood. In men: breast enlargement and erectile dysfunction.

Unknown: frequency cannot be estimated from the available data

• withdrawal syndrome in the newborn (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 the hands and head, stiffness of movements, facial rigidity, muscle tension, and increased saliva production;
• 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 may increase the risk of tooth decay;
• dizziness, possible fainting due to low blood pressure;
• breast enlargement in men, chest tightness, milk secretion, menstrual irregularities;
• 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. These may disappear after stopping the medicine;
• frequent urination, thirst, fatigue due to high blood sugar (glucose) levels; may develop into serious side effects. You should 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 serious side effects. You should contact your doctor if you experience sudden back pain.

Rare:may affect up to 1 in 1000 people

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

Amisulpride may cause side effects that you do 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 package leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Symamis

The medicine should be stored out of sight and reach of children.
You should 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. You should 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 the medicine is amisulpride. Each tablet contains 50 mg, 100 mg, 200 mg, or 400 mg of amisulpride.
The 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, 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, 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
00-667 Warsaw

Manufacturer

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