Tisercin

Package Leaflet: Information for the User

Tisercin

25 mg, coated tablets

Levomepromazine

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.

• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section
• 4.

Table of Contents of the Leaflet:

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

1. What is Tisercin and what is it used for

Tisercin is a medicine used to treat mental disorders (neuroleptic).
Indications:
Mental illnesses with motor and psychomotor agitation.
Paranoid syndromes (schizophrenia).
As an adjunct in certain accompanying symptoms of epilepsy, mental retardation, and depression with anxiety.
Enhancement of the analgesic effect of other medicines.
Preparation and deepening of general anesthesia.

2. Important information before taking Tisercin

When not to take Tisercin:

• if the patient is allergic to levomepromazine or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypersensitivity (allergy) to medicines with similar action (e.g., chlorpromazine, thioridazine, fluphenazine, pipotiazine, trifluperazine) or has experienced hypersensitivity to light during treatment with such medicines;
• if the patient is taking medicines used to treat high blood pressure (hypotensive);
• if the patient is taking medicines from the group of MAO inhibitors (monoamine oxidase), used in the treatment of, e.g., depression (such as selegiline, moclobemide);
• if the patient is taking significant amounts of substances with a depressive effect on the central nervous system (alcohol, sleeping pills, narcotic drugs);
• if the patient has glaucoma with a narrow angle of filtration;
• if the patient has problems with urination;
• if the patient has Parkinson's disease;
• if the patient has multiple sclerosis (a disease of the central nervous system);
• if the patient has myasthenia (pathological muscle weakness) or hemiplegia (complete paralysis of the left or right side of the body);
• if the patient has severe kidney or liver dysfunction;
• if the patient has serious heart problems (cardiomyopathy, heart failure);
• if the patient has low blood pressure;
• if the patient has a blood system disease;
• if the patient has porphyria metabolism disorders;
• if the patient is breastfeeding;
• the medicine is contraindicated in children under 12 years of age.

Warnings and precautions

Before starting treatment with Tisercin, the patient should discuss it with their doctor, pharmacist, or nurse.

• If the patient has a cardiovascular disease (hypotension, arrhythmia, circulation disorders) or a history of such conditions, especially if the patient is elderly (over 65 years old), this allows for the avoidance of possible severe complications.
• If the patient has had a stroke or has an increased risk of stroke.
• If the patient has diabetes or has an increased risk of developing diabetes, as Tisercin may increase blood sugar levels. For this reason, blood sugar levels should be monitored more frequently than usual during therapy.
• If the patient has epilepsy.
• If the patient has other central nervous system diseases, as Tisercin may affect their symptoms or the patient may be more sensitive to some side effects.
• If the patient has impaired liver and/or kidney function.
• If there have been blood clots in the patient's or their family's medical history, as similar medicines have been associated with the formation of blood clots.
• In case of hypersensitivity (swelling of the lips, mouth, or throat causing difficulty swallowing or breathing, troublesome itching of the skin), the patient should stop taking the medicine immediately.
• If the patient experiences unexplained fever, especially in combination with other symptoms such as stiffness and/or uncontrolled muscle contractions and symptoms of the autonomic nervous system (e.g., palpitations, irregular heartbeat, unstable blood pressure, sweating, rapid changes in vital parameters, confusion), which can lead to coma, treatment should be discontinued immediately. In case of fever, the patient should contact their doctor immediately.
• In elderly patients with dementia treated with antipsychotic medicines, there is a slightly increased risk of death compared to patients not taking antipsychotic medicines.

Before starting treatment and during therapy, regular monitoring of the following parameters is recommended:

• arterial blood pressure, especially in patients with circulation disorders and those with a tendency to hypotension (excessive lowering of arterial blood pressure)
• liver function (especially in patients with existing liver dysfunction)
• blood morphology with a smear in case of fever, sore throat, or suspected leukopenia or agranulocytosis (significant decrease in white blood cell count), at the beginning of treatment and during prolonged use of the medicine
• ECG (in patients with heart diseases and circulation disorders, as well as in elderly patients over 65 years old)
• measurement of potassium levels in serum.

Children and adolescents

The medicine is contraindicated in children under 12 years of age.

Tisercin and other medicines

The patient should inform their doctor and/or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should remember that possible interactions with other medicines also apply to medicines taken some time ago, as well as those that will be taken in the near future.
Before starting to take any medicine (especially those acting on the central nervous system) during or within a month after stopping treatment with Tisercin, the patient should inform their doctor about this intention.
Tisercin should not be taken at the same time as:

• medicines used to treat high blood pressure;
• certain antidepressant medicines (MAO inhibitors).

Taking Tisercin with the following medicines requires consultation with a doctor:

• medicines acting on the central nervous system (including sedatives, sleeping pills, strong painkillers, general anesthetics, antidepressants, antiepileptics, amphetamines),
• levodopa, a medicine used in Parkinson's disease
• antidiabetic medicines,
• certain medicines used to treat irregular heartbeat or heart diseases, certain antibiotics (macrolides), medicines used to treat fungal infections, medicines used to treat allergies (antihistamines), cisapride, certain medicines that increase urine production and excretion,
• dilevalol
• medicines that increase skin sensitivity to sunlight
• deferoksamina - used to remove excess iron or aluminum from the body,
• epinephrine (adrenaline), used to treat allergies.

In cases where Tisercin is used in combination with any of these medicines, close medical supervision is indicated, and in justified cases, dosage modification may be necessary.
Other:

• the patient should take vitamin C to reduce the deficiency caused by Tisercin

Tisercin and alcohol

Consuming alcoholic beverages is strictly prohibited during treatment with Tisercin, as well as for 4-5 days after stopping the medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
In newborns whose mothers took Tisercin in the last trimester (last three months of pregnancy), the following may occur: tremors, increased muscle tone and/or decreased muscle tone, sleepiness, agitation, breathing disorders, and feeding disorders. If these symptoms occur in the patient's child, they should contact their doctor.
During pregnancy, the use of the medicine should be limited to exceptional cases and only when the doctor considers that the potential benefits outweigh the possible risk.
The active substance of the medicine passes into breast milk. Due to the lack of adequate clinical data, the use of this medicine is contraindicated during breastfeeding.
Tisercin may affect fertility in both men and women.

Driving and using machines

At the beginning of treatment - for an individually determined period - the patient should avoid driving vehicles and operating machines. Later, these restrictions may be maintained or lifted, depending on the outcome of the consultation with the doctor

Tisercin contains lactose (milk sugar) and sodium.

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Tisercin

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Treatment should be started with small doses, which can then be gradually increased depending on the patient's tolerance to the medicine. After improvement is achieved, the dose should be reduced to an individually determined maintenance dose. In psychoses, the initial dose is 25-50 mg (1-2 coated tablets) per day in two divided doses. If necessary, the dose can be increased to a daily dose of 150-250 mg per day (administered in 2-3 divided doses), and then, after achieving therapeutic effects, the dose can be reduced to a maintenance dose.

• To avoid excessive blood pressure drops when changing position to standing, it is recommended to lie down for at least half an hour after taking the first dose. If the patient experiences dizziness after taking the tablet, it is recommended to lie down after taking each dose of the medicine.
• Elderly patients (over 65 years old) are more sensitive to the side effects of Tisercin, so in this group of patients, it is recommended to start treatment with small doses and gradually increase them.

Taking a higher dose of Tisercin than recommended

The patient should contact their doctor immediately. In case of overdose, the following may occur:
hypotension, fever, conduction disorder, arrhythmia, which can lead to sudden death or cardiac arrest, muscle stiffness, muscle contractions, sleepiness, coma, central nervous system stimulation (seizures) and malignant neuroleptic syndrome (a serious reaction characterized by fever, muscle stiffness, confusion, sweating, and changes in heart rhythm). Overdose of Tisercin, especially in combination with alcohol or other medicines acting on the central nervous system, can lead to death.
In case of suspected overdose, the patient should immediately seek medical help.
It is not recommended to induce vomiting, as due to muscle stiffness of the head and neck, as well as the risk of seizures, there is a risk of choking on vomit and getting it into the lungs.

Missing a dose of Tisercin

A missed dose should be taken as soon as possible. However, if it is already time for the next dose, the patient should not take a double dose to make up for the missed dose. This will increase the risk of overdose and will not affect the therapeutic effect. Treatment should be continued as before, in the doses prescribed by the doctor.

Stopping treatment with Tisercin

The patient should not stop taking Tisercin without their doctor's recommendation, even if they feel better, unless severe side effects have occurred. The doctor may recommend stopping treatment by gradually reducing the dose of the medicine, as sudden discontinuation may lead to a recurrence of psychotic symptoms, anxiety, increased anxiety, insomnia, nausea, vomiting, headaches, tremors, sweating, and tachycardia.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Tisercin can cause side effects, although not everybody gets them. Side effects are usually mild, disappear during treatment, and do not require discontinuation of the medicine.
There is a lack of adequate information on the frequency of their occurrence.

The following side effects may occur:

• The most important and most common side effect is a drop in blood pressure when changing body position to standing, leading to dizziness, weakness, or fainting.
• Pancytopenia (decrease in the number of all morphological elements of blood), agranulocytosis (significant decrease in white blood cell count, increasing susceptibility to infections), leukopenia (decrease in white blood cell count), thrombocytopenia (decrease in platelet count), eosinophilia (increase in the number of blood cells called eosinophils), increased erythrocyte sedimentation rate. Pseudoanaphylactic reactions (severe allergic reaction causing difficulty breathing or dizziness), throat swelling, swelling of the ankles, feet, and toes, asthma attacks.
• Weight loss, vitamin deficiency.
• Glucose intolerance, high blood sugar levels.
• Low sodium levels in the blood, inappropriate secretion of antidiuretic hormone (with symptoms such as concentrated urine, feeling of thirst, nausea, muscle cramps, confusion, and seizures).
• Recurrence of psychotic symptoms, catatonia (movement disorder), confusion, disorientation, visual hallucinations, slurred speech, sleepiness.
• Seizures, increased intracranial pressure, extrapyramidal symptoms (muscle stiffness, muscle contractions, and involuntary movements), withdrawal symptoms.
• Deposits in the lens and cornea, pigmentary retinopathy (eye disease related to the deposition of pigment in the retina).
• Abnormal ECG, arrhythmia, rapid heartbeat, fibrillation, cardiac arrest, sudden death (unexplained or cardiac).
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, redness of the leg); clots can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If any of these symptoms are observed, the patient should immediately seek medical attention.
• Necrotizing enterocolitis (colic, abdominal pain, bloody diarrhea), vomiting, nausea, constipation, abdominal discomfort, dry mouth.
• Liver damage (jaundice, bile stasis).
• Severe skin inflammation, urticaria, rash, increased skin sensitivity to sunlight, increased skin pigmentation.
• Difficulty urinating, change in urine color.
• Withdrawal syndrome in newborns.
• Galactorrhea, menstrual disorders, very rarely abnormal uterine contractions.
• Painful and prolonged erection (priapism).
• Malignant neuroleptic syndrome (a serious reaction to the medicine characterized by high fever, muscle stiffness, confusion, sweating, and changes in heart rhythm), elevated body temperature (unexplained fever).
• In the case of long-term use of medicines such as Tisercin, mild (non-cancerous) tumors of the pituitary gland may occur.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Tisercin

The medicine should be stored in a place invisible and inaccessible to children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date (EXP) stated on the carton.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Tisercin contains

The active substance of the medicine is levomepromazine. Each coated tablet contains 25 mg of levomepromazine (in the form of levomepromazine maleinate).
Other ingredients are: magnesium stearate, sodium carboxymethylcellulose (type A), povidone K-25, microcrystalline cellulose, potato starch, lactose monohydrate.
Tablet coating: hypromellose, magnesium stearate, titanium dioxide, dimethicone.

What Tisercin looks like and what the pack contains

White, odorless coated tablets.
The pack contains 50 coated tablets in a brown glass bottle with a snap-on cap made of polyethylene (LDPE), with a tamper-evident seal and a shock absorber, in a cardboard box with an information leaflet.

Marketing authorization holder

PROTERAPIA sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw

Manufacturer

EGIS Pharmaceuticals PLC
Mátyás király u. 65
9900 Körmend
Hungary
To obtain more detailed information, the patient should contact the representative of the Marketing Authorization Holder in Poland.
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Phone number: +48 22 417 92 00

Date of last revision of the leaflet: