Package leaflet: Information for the user

Tisercin
25 mg, coated tablets
Levomepromazine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Keep this leaflet, as you may need to read it again.

If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Tisercin is and what it is used for
Important information before taking Tisercin
How to take Tisercin
Possible side effects
How to store Tisercin
Contents of the pack and other information

1. What Tisercin is and what it is used for

Tisercin is a medicine used in the treatment of psychiatric disorders (a neuroleptic).
Indications:
Psychiatric disorders associated with psychomotor and motor agitation.
Paranoid syndromes (schizophrenia).
As an adjunctive treatment for certain accompanying symptoms in epilepsy, intellectual disability, and depression with anxiety.
Enhancement of analgesic effect of other medications.
Preparation for and deepening of general anaesthesia.

2. Important information before using Tisercin

When not to use Tisercin:

if the patient is allergic to levomepromazine or to any of the other ingredients of this medicine (listed in section 6);
if the patient has hypersensitivity (allergy) to drugs with similar action (e.g. chlorpromazine, thioridazine, fluphenazine, pipothiazine, trifluperazine), or experienced photosensitivity during treatment with such drugs;
if the patient is taking medicines used to treat high blood pressure (antihypertensives);
if the patient is taking MAO inhibitors (monoamine oxidase inhibitors), used for example in the treatment of depression (such as selegiline, moclobemide);
if the patient is using significant amounts of central nervous system depressants (alcohol, sleeping medicines, narcotics);
if the patient has narrow-angle glaucoma;
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 gravis (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-forming system disorder;
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, discuss this with your doctor, pharmacist, or nurse.

If the patient has a circulatory system disorder (hypotension, arrhythmia, circulatory disturbances) or a history of such, especially in elderly patients (over 65 years of age); this helps avoid potentially serious complications.
If the patient has had a stroke or is at increased risk of stroke.
If the patient has diabetes or is at increased risk of developing diabetes, as Tisercin may increase blood glucose levels. For this reason, blood glucose levels should be monitored more frequently than usual during treatment.
If the patient has epilepsy.
If the patient has other central nervous system disorders, as Tisercin may affect their symptoms or the patient may be more sensitive to certain adverse effects.
If the patient has impaired liver and/or kidney function.
If the patient or their family has a history of blood clots, as similar medicines have been associated with blood clot formation.
In case of hypersensitivity (swelling of lips, inside of mouth or throat causing difficulty in swallowing or breathing, severe skin itching), use of the medicine should be stopped immediately.
If the patient develops unexplained fever, especially in combination with other symptoms such as muscle rigidity and/or uncontrolled muscle contractions, and autonomic nervous system symptoms (e.g. palpitations, irregular heartbeat, unstable blood pressure, profuse sweating, rapid changes in vital signs, confusion with marked agitation), which may lead to coma, treatment must be stopped immediately. In case of fever, contact a doctor immediately.
In elderly patients with dementia treated with antipsychotics, there is a slightly increased risk of death compared to patients not taking antipsychotics.

Regular monitoring of the following parameters is recommended before starting and during treatment:

arterial blood pressure, especially in patients with circulatory disorders and those prone to hypotension (excessive lowering of blood pressure);
liver function (particularly in patients with pre-existing liver dysfunction);
blood count with blood smear in case of fever, sore throat, or suspicion of leukopenia or agranulocytosis (significant decrease in white blood cell count), at the beginning of treatment and during chronic use;
ECG (in patients with heart or circulatory diseases and in elderly patients over 65 years of age);
measurement of serum potassium levels.

Children and adolescents
Tisercin is contraindicated in children under 12 years of age.
Tisercin and other medicines
Inform your doctor and/or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take.
Note that possible interactions with other medicines also apply to medicines taken some time ago, as well as those to be used in the near future.
Before starting any medicine (especially those acting on the central nervous system) during or within one month after discontinuation of Tisercin treatment, inform your doctor.
Tisercin must not be administered simultaneously with:

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

Use of Tisercin together with the following medicines requires consultation with a doctor:

medicines acting on the central nervous system (including sedatives, sleeping medicines, strong analgesics, general anesthetics, antidepressants, anticonvulsants, amphetamines);
levodopa, a medicine used in Parkinson's disease;
antidiabetic medicines;
certain medicines used to treat irregular heartbeat or heart diseases, certain antibiotics (macrolides), antifungal medicines, allergy medicines (antihistamines), cisapride, certain diuretics;
dilevalol;
medicines increasing skin sensitivity to sunlight;
deferoxamine – used to remove excess iron or aluminium from the body;
epinephrine (adrenaline), used in the treatment of allergies.

When Tisercin is used concomitantly with any of these medicines, close medical monitoring is required, and dosage adjustment may be necessary in justified cases.
Other:

vitamin C should be administered to reduce vitamin deficiency caused by Tisercin.

Tisercin and alcohol
Consumption of alcoholic beverages is strictly prohibited during treatment with Tisercin and for 4–5 days after discontinuation of Tisercin.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
In newborns whose mothers used Tisercin during the third trimester (last three months of pregnancy), symptoms such as tremor, increased or decreased muscle tone, drowsiness, agitation, breathing difficulties, and feeding problems may occur. If these symptoms appear in your child, contact a doctor immediately.
Use of this medicine during pregnancy should be limited to exceptional cases and only when the attending physician determines that potential benefits outweigh possible risks.
The active substance of the medicine passes into breast milk. Due to lack of adequate clinical data, use of this medicine is contraindicated during breastfeeding.
Tisercin may impair fertility in both women and men.
Driving and operating machinery
At the beginning of treatment – for an individually determined period – driving and operating machinery should be avoided. Later, these restrictions may be maintained or lifted, depending on the outcome of consultation with a doctor.
Tisercin contains lactose (milk sugar) and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Tisercin

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Treatment should begin with low doses, which may then be gradually increased depending on
the patient's tolerance to the medicine. Once 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, divided into two doses. If necessary, the dose may be increased
to a daily dose of 150–250 mg (administered in 2–3 divided doses), and after therapeutic
effects are obtained, the dose may be reduced to a maintenance dose.

To avoid excessive drops in blood pressure upon changing to an upright position, 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, lying down is recommended after each dose.
Elderly patients (over 65 years of age) are more sensitive to adverse effects of Tisercin; therefore, in this patient group, treatment should be initiated with low doses, gradually increasing them.

Taking a higher than recommended dose of Tisercin
Contact your doctor immediately. In case of overdose, the following may occur:
hypotension, fever, conduction disturbances, arrhythmia, which may lead to sudden death or
cardiac arrest, muscle rigidity, muscle spasms, drowsiness, coma, central nervous system
excitation (epileptic seizures), and neuroleptic malignant syndrome (a life-threatening reaction
characterized by fever, muscle rigidity, confusion, profuse sweating, and changes in heart
rhythm). Overdose of Tisercin, especially in combination with alcohol or other medicines acting
on the central nervous system, may result in death.
In case of suspected overdose, seek immediate medical help.
Inducing vomiting is not recommended, because due to muscle rigidity of the head and neck,
and the risk of epileptic seizures, there is a danger of aspiration of vomit into the lungs.

Missed dose of Tisercin
If a dose has been missed, take it as soon as possible. However, if it is almost time for the next
dose, do not take a double dose to make up for the missed one. Doing so increases the risk of
overdose without enhancing the therapeutic effect. Continue treatment as previously, with the
doses prescribed by the doctor.

Stopping Tisercin treatment
Do not discontinue taking Tisercin without medical advice, even if the patient feels better, unless
severe adverse reactions occur. The doctor may recommend discontinuing treatment by
gradually reducing the dose, as abrupt withdrawal may lead to recurrence of psychotic
symptoms, anxiety, increased anxiety levels, insomnia, nausea, vomiting, headache, tremors,
profuse sweating, and tachycardia.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them. Adverse reactions are usually mild, resolve during treatment and do not require discontinuation of treatment.
There is insufficient information available regarding the frequency of their occurrence.
The following adverse reactions may occur:

The most important and commonly observed adverse reaction is a drop in blood pressure upon changing body position to standing, leading to dizziness, weakness or fainting.
Pancytopenia (reduction in all blood cell counts), agranulocytosis (marked decrease in white blood cells causing increased susceptibility to infections), leukopenia (reduced white blood cell count), thrombocytopenia (reduced platelet count), eosinophilia (increased number of blood cells called eosinophils), increased erythrocyte sedimentation rate. Anaphylactoid reactions (severe allergic reaction causing breathing difficulties or dizziness), throat swelling, ankle, foot and finger swelling, asthma attack.
Weight loss, vitamin deficiency.
Glucose intolerance, high blood sugar levels.
Low blood sodium levels, inappropriate antidiuretic hormone secretion (with symptoms such as concentrated urine, feeling unwell or nausea, muscle cramps, confusion and seizures).
Recurrence of psychotic symptoms, catatonia (movement disorder), confusion, disorientation, visual hallucinations, slurred speech, drowsiness.
Seizures, increased intracranial pressure, extrapyramidal symptoms (muscle stiffness, muscle contractions and involuntary movements), withdrawal symptoms.
Lens and corneal deposits, pigmentary retinopathy (eye disease associated with pigment deposition in the retina).
Abnormal ECG findings, irregular heartbeat, rapid heartbeat, flutter, cardiac arrest, sudden death (unexplained or cardiac).
Blood clots in veins, particularly in the legs (symptoms include leg swelling, pain, redness); clots may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If any of these symptoms occur, medical advice should be sought immediately.
Necrotizing enterocolitis (colic, abdominal pain, bloody diarrhoea), vomiting, nausea, constipation, abdominal discomfort, dry mouth.
Liver damage (jaundice, cholestasis).
Severe skin inflammation, urticaria, erythema, photosensitivity, increased skin pigmentation.
Difficulty urinating, change in urine colour.
Withdrawal syndrome in newborns.
Galactorrhea, menstrual disorders, very rarely abnormal uterine contractions.
Painful and prolonged erection (priapism).
Neuroleptic malignant syndrome (a serious reaction to the medicine characterized by high fever, muscle rigidity, confusion, profuse sweating and changes in heart rhythm), elevated body temperature (unexplained fever).
With long-term use of medicines such as Tisercin, mild (non-cancerous) pituitary gland tumours may occur.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tisercin

Keep the medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date (EXP) stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of in the sewage system or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Package contents and other information

What Tisercin contains
The active substance is levomepromazine. Each coated tablet contains 25 mg of levomepromazine (as levomepromazine maleate).
The other ingredients are: magnesium stearate, sodium carboxymethyl starch (type A), povidone K-25, microcrystalline cellulose, potato starch, lactose monohydrate.
Tablet coating: hypromellose, magnesium stearate, titanium dioxide, dimethicone.

What Tisercin looks like and contents of the pack
White, odourless coated tablets.
The pack contains 50 coated tablets in a brown glass bottle with a snap-cap closure made of polyethylene (LDPE), with a tamper-evident seal and a shock absorber, placed in a cardboard box with an instruction leaflet.

Marketing Authorisation Holder
PROTERAPIA sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Poland

Manufacturer
EGIS Pharmaceuticals PLC
Mátyás király u. 65
9900 Körmend
Hungary

For further information, please contact the representative of the Marketing Authorisation 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 the latest revision of the leaflet: