Package leaflet: Information for the patient

Levomentis
25 mg, coated tablets
Levomepromazine
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Levomentis is and what it is used for

Levomentis coated tablets are intended for the treatment of serious mental disorders. The medicine prevents the action of certain substances in the brain, thereby alleviating disease symptoms.
It belongs to a group of medicines known as neuroleptics, phenothiazine derivatives.
Indications include:

treatment of schizophrenia;
treatment of other mental illnesses characterized by motor or psychomotor agitation, as adjunctive treatment in intellectual disability;
treatment of anxiety syndromes – in low doses, as a single evening dose in sleep disorders;
treatment of chronic pain, either as monotherapy or in combination with other analgesic medicines.

2. Important information before using Levomentis

When not to use Levomentis:

if the patient is allergic to the active substance – levomepromazine, to other phenothiazine derivatives, or to any of the other ingredients of this medicine (listed in section 6);
in case of neuroleptic malignant syndrome;
if the patient has:
narrow-angle glaucoma;
urinary retention;
Parkinson's disease;
multiple sclerosis (a disease of the central nervous system);
myasthenia gravis (pathological muscle weakness) or hemiplegia (complete paralysis of one side of the body);
significant heart problems (heart failure, cardiomyopathy);
severe kidney or liver dysfunction;
clinically significant hypotension;
blood disorders, bone marrow disorders;
porphyria (a disease associated with impaired formation of an important chemical compound responsible for oxygen transport in blood vessels);
adrenal medulla tumour (pheochromocytoma);
if the patient is taking antihypertensive drugs (medicines lowering blood pressure) or MAO inhibitors (medicines used in the treatment of depression);
if the patient is using central nervous system depressants (e.g. alcohol, general anaesthetics, hypnotics) or if the patient has suffered a brain injury or significant reduction in consciousness level;
in breastfeeding women;
in children under 12 years of age.

Warnings and precautions
Before starting treatment with Levomentis, discuss this with your doctor or pharmacist.
If hypersensitivity reactions occur (swelling of lips, inside of mouth or throat causing difficulty swallowing or breathing, severe skin itching), discontinue use of the medicine immediately.
If fever occurs during treatment, always rule out the possibility of a serious adverse reaction known as neuroleptic malignant syndrome. This is a potentially life-threatening condition characterised by the following symptoms: muscle rigidity, high fever, confusion, unstable blood pressure, rapid heartbeat, cardiac arrhythmias, sweating, catatonia (a disorder characterised by extremely low motor activity – stupor – or excessive involuntary motor activity). If neuroleptic malignant syndrome occurs, treatment with Levomentis must be discontinued immediately. Similarly, treatment should be discontinued if high fever of unknown origin occurs during therapy.
Particular caution is required in the following cases:

If the patient is concurrently using medicines that depress the central nervous system or anticholinergic drugs (e.g. medicines used in chronic obstructive pulmonary disease and asthma, some medicines used in Parkinson's disease such as pridinol, biperiden, amantadine).
The patient has renal and/or hepatic impairment due to the risk of accumulation and toxic effects.
The patient has had a stroke or is at increased risk of stroke.
The patient has diagnosed diabetes or an increased risk of developing diabetes. In such patients, blood glucose levels should be monitored more frequently than usual during levomepromazine therapy, as this medicine may increase blood glucose levels.
In elderly patients (especially those with dementia), who are more susceptible to sudden drop in blood pressure upon changing position from lying to standing (orthostatic hypotension) and who are more sensitive to the drug's effects. Therefore, in such cases it is particularly important to start treatment with low initial doses and gradually increase them as needed, according to the doctor's instructions. After administration of the first dose, the patient should remain lying down for about half an hour to avoid hypotension. If dizziness occurs frequently after taking the medicine, bed rest is recommended after each dose.
If the patient, especially in old age, has cardiovascular disease (e.g. hypertension, cardiac dysfunction, circulatory disorders). Before starting Levomentis, an ECG should be performed to rule out any heart disease that might contraindicate treatment.
If the patient has bradycardia, congenital or familial long QT syndrome, or is taking other medicines affecting heart function (e.g. those prolonging the QT interval, such as certain diuretics or antibiotics). During treatment with Levomentis, severe, life-threatening cardiac arrhythmias may occur (such as tachycardia, QT interval prolongation on ECG, or even torsade de pointes).
Abrupt discontinuation of treatment, particularly in patients on high doses or long-term therapy, may lead to the following symptoms: recurrence of illness symptoms, nausea, vomiting, headache, tremor, sweating, tachycardia (rapid heartbeat), insomnia, motor restlessness, agitation. Therefore, unless contraindicated (e.g. in case of neuroleptic malignant syndrome as described above), the medicine should always be discontinued gradually under medical supervision by tapering the dose.
Laboratory tests may show increased activity of an enzyme – creatine phosphokinase, presence of myoglobin in urine, muscle breakdown, and acute kidney failure.
Many antipsychotic medicines, including Levomentis, increase the risk of seizures (lower the seizure threshold) and alter EEG patterns, making them resemble those seen in epileptic patients. Therefore, in patients with epilepsy, careful monitoring including EEG examinations is required, especially during dose escalation of Levomentis.
During treatment with Levomentis, depending on individual patient sensitivity, liver damage may occur, manifesting as cholestatic jaundice. Symptoms of this type of jaundice resolve completely after discontinuation of treatment. Therefore, regular monitoring of liver function is necessary during long-term therapy.
In some patients, significant reduction in white blood cell count (agranulocytosis and/or leukopenia) may occur during treatment with Levomentis. Although such cases are rare, regular blood morphology checks are recommended during prolonged treatment.
If the patient (or their family) has a history of thrombosis, as use of medicines similar to Levomentis may promote blood clot formation.

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

blood pressure, especially in patients with circulatory disorders and those prone to excessive drop in blood pressure (at risk of hypotension);
liver function (particularly in patients with pre-existing liver dysfunction);
blood morphology with blood smear in case of fever, sore throat, or suspicion of significant reduction in white blood cell count (agranulocytosis and/or leukopenia), especially at the beginning of treatment and during prolonged therapy;
ECG recording (in patients with cardiovascular or heart disease and in elderly patients);
serum potassium measurement; electrolyte levels should be monitored periodically and corrected if necessary, especially during long-term treatment.

In elderly patients with dementia treated with antipsychotic medicines, there is a slightly increased risk of death compared to patients not receiving antipsychotics.
During long-term treatment with levomepromazine, dry mouth may occur, increasing the risk of dental damage (caries). Therefore, brushing teeth with fluoride toothpaste at least twice daily is recommended. Regular dental check-ups are advised.
Elderly patients
Doses recommended for elderly patients are generally lower than those used in other adult patients due to increased susceptibility of older individuals to adverse effects.
Children and adolescents
Do not use in children under 12 years of age. Use in adolescents is not recommended.
Levomentis and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor if the patient is taking medicines that must not be used simultaneously with Levomentis:

antihypertensive medicines (blood pressure-lowering drugs), due to the risk of excessively low blood pressure (hypotension);
medicines used in depression (MAO inhibitors), due to the possibility of prolonged action of Levomentis and increased severity of adverse effects.

Also inform your doctor if the patient is taking:

medicines affecting the central nervous system such as:
antipsychotics (e.g. thioridazine, sertindole),
sedatives and hypnotics,
anxiolytics,
antidepressants (e.g. venlafaxine, paroxetine, fluoxetine, clomipramine),
antiepileptic drugs;
medicines used in Parkinson's disease (e.g. bromocriptine, cabergoline, levodopa);
antihistamines used in allergies (H receptor-blocking agents);
atropine (a medicine used e.g. in biliary colic, intestinal or urinary tract spasms);
scopolamine (used before surgical procedures to prevent cardiac arrhythmias);
succinylcholine (used in anaesthesiology to induce muscle relaxation);
central nervous system depressants [opioid analgesics, opioids (e.g. methadone, codeine), general anaesthetics];
medicines with central nervous system stimulant effects (e.g. amphetamine derivatives);
oral antidiabetic drugs;
medicines used in cardiac disorders (antiarrhythmics – e.g. quinidine);
certain antibiotics (e.g. macrolide antibiotics such as erythromycin);
certain antifungal medicines (belonging to azole derivatives);
mefloquine (an antimalarial medicine);
cisapride (used in the treatment of gastroesophageal reflux);
diuretics (causing decreased serum potassium levels);
dilevalol (used in coronary artery disease, cardiac arrhythmias, hypertension);
photosensitising medicines (causing photosensitivity);
lithium-containing medicines;
deferoxamine (used to remove excess iron or aluminium from the body).

Concomitant administration of vitamin C is recommended, as it reduces deficiency of this vitamin induced by Levomentis.
Levomentis with food, drink and alcohol
Alcoholic beverages must not be consumed during treatment with Levomentis and for approximately 4–5 days after completion of treatment.
The medicine can be taken during meals or independently of food intake.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
Pregnancy
Levomepromazine crosses the placenta. Levomepromazine should not be administered during the first trimester of pregnancy. In the second and third trimesters, the lowest effective dose may be considered only after careful evaluation of the benefit-risk balance for mother and child.
Administration of levomepromazine to pregnant women is acceptable only on explicit medical advice, after detailed assessment of the patient's health status, and solely when benefits outweigh the risks.
Newborns whose mothers took levomepromazine during the last three months of pregnancy (i.e. third trimester) may experience adverse effects such as tremors, increased and/or decreased muscle tone, drowsiness, agitation, breathing difficulties, and feeding problems. If these symptoms occur in the infant, contact a doctor immediately.
Breastfeeding
Levomepromazine passes into human milk. There are insufficient data to assess the safety of levomepromazine during breastfeeding; therefore, use of levomepromazine is contraindicated in breastfeeding women.
Fertility
As with other medicines in this group, levomepromazine may be associated with disturbances in reproductive and sexual function (menstrual irregularities, libido disturbances, erectile dysfunction).
Driving and operating machinery
Patients should not drive, operate machinery, or perform tasks involving increased risk of accidents, especially at the beginning of treatment.
Later, the extent of these restrictions should be individually assessed.
Levomentis contains lactose monohydrate and sodium
One coated tablet contains 51.2 mg of lactose monohydrate. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Levomentis

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult your
doctor or pharmacist.
Usually, the doctor will recommend starting treatment with low doses, which may then be gradually
increased depending on the patient's tolerance to the medicine. Once an appropriate improvement
in the patient's health condition has been achieved, the dose may be reduced to the most suitable
individual maintenance dose.
In schizophrenia and other psychoses, the initial dose is usually 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 have been achieved, the dose may
be reduced to a maintenance dose.
For pain relief, the dose should also be gradually increased, starting from 25 to 75 mg per day. The
maximum recommended daily dose is 150 mg for outpatients and 300 mg for hospitalized patients.
Levomentis coated tablets should be taken with water, during meals or independently of food.
Use of a higher than recommended dose of Levomentis
If more than the recommended dose of Levomentis is taken, or if the medicine is accidentally
ingested by another person, contact your doctor, pharmacist, or nearest hospital immediately.
Bring any remaining tablets and the patient information leaflet with you to show the doctor, who will
decide on further management based on the dose taken and symptoms of overdose.
Missed dose of Levomentis
Do not take a double dose to make up for a missed dose.
If a dose is missed, take it as soon as possible. If the next scheduled dose is approaching, skip the
missed dose and resume the regular dosing schedule.
Before traveling on vacation or a trip, the patient should ensure they have an adequate supply of
medicine sufficient for the entire duration of the trip until returning home.
Stopping Levomentis treatment
Do not stop taking this medicine without first consulting your doctor.
If treatment needs to be discontinued, the appropriate procedure will be determined by the doctor
depending on the individual patient's response to levomepromazine therapy.
Levomepromazine administration should be stopped immediately only in the event of the
development of neuroleptic malignant syndrome or hypersensitivity reactions (see section 2 of the
leaflet – Warnings and precautions).
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Symptoms occurring at the beginning of treatment most commonly include dizziness, especially when changing position from lying to standing, caused by a drop in blood pressure. These symptoms usually diminish during continued treatment.
Symptoms requiring immediate contact with a doctor include:

rhythmic, involuntary movements of the tongue, face, mouth or jaw, sometimes accompanied by involuntary movements of the limbs (indicative of tardive dyskinesia);
fever, excessive sweating, muscle stiffness, altered mental status, cardiac arrhythmias, and large fluctuations in blood pressure (indicative of neuroleptic malignant syndrome. This condition is life-threatening and may even result in death; therefore, in such a case, the medicine must be discontinued immediately and medical attention must be sought from a doctor or hospital);
blood clots in veins, particularly in the legs (symptoms include swelling, pain, redness of the leg), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties (so-called venous thromboembolic disease, pulmonary embolism and deep vein thrombosis);
hypersensitivity reactions (anaphylactic and pseudoanaphylactic) – severe allergic reactions with symptoms such as: difficulty breathing or swallowing, swelling of lips or larynx (throat), swelling of ankles, feet and fingers, asthma attack, high fever.

The following adverse effects have also been reported in patients treated with levomepromazine:
Very common or common

decreased number of white blood cells in blood (leukopenia)
increased number of white blood cells in blood (leukocytosis)
dizziness due to balance disorders, dizziness of labyrinthine origin
increased heart rate
arterial hypotension
orthostatic hypotension (excessive drop in blood pressure upon changing position, especially from lying to standing)
sedation, fatigue
dry mouth
allergic skin reactions (mainly urticaria, dermatitis, itching)
photosensitivity
akathisia (excessive motor restlessness)
parkinsonism

Not common

difficulty with accommodation of the eye
constipation
urinary retention
increased serum prolactin concentration (hyperprolactinemia)
menstrual disorders, breast enlargement, gynaecomastia

Rare or very rare

marked decrease in white blood cells (agranulocytosis)
aplastic anaemia (lack of blood cells due to impaired bone marrow production)
changes in glucose tolerance
changes in appetite and body weight
memory disturbances
involuntary muscle contractions causing uncontrolled movements and abnormal postures of various body parts (acute dystonia)
lowered seizure threshold
acute angle-closure glaucoma (eye disease)
clouding of the lens and cornea of the eye (deposits in lens and cornea)
cardiac arrhythmias (arrhythmias of the type torsades de pointes, tachycardia, ventricular arrhythmias – Morganier-Adams-Stokes syndrome, ventricular fibrillation, ventricular tachycardia)
QT interval prolongation on ECG
unexplained sudden death
circulatory arrest
hepatitis with accompanying jaundice
excessive hair growth
changes in libido and potency, delayed orgasm, reduced potency, ejaculation disorders, painful and prolonged erection

Frequency unknown

decrease in all blood cells (so-called pancytopenia)
increased number of a group of white blood cells important for immunity against infections called eosinophils (so-called eosinophilia)
decreased number of platelets (so-called thrombocytopenia)
benign pituitary tumours
vitamin deficiencies
pigmentary retinopathy ( retinitis pigmentosa , an eye disease characterised by pigment deposition in the retina)
nausea, vomiting
drug withdrawal syndrome in newborns
abnormal uterine contractions

Cases of pituitary adenoma have been reported in some patients treated with phenothiazines, but there is no evidence of a direct causal link with such treatment.
In elderly patient groups receiving antipsychotic medicines who have dementia, a slightly increased mortality rate has been reported compared to patient groups not taking such medicines.
Levomepromazine may reduce the number of white blood cells, thereby reducing resistance to infections. If signs of infection occur, such as fever and significant worsening of general condition, or fever with local signs of infection such as sore throat/oral cavity pain, or urinary symptoms, immediate contact with a doctor is required. A blood test will be performed to check white blood cell count (to rule out agranulocytosis). It is important that the patient informs the doctor about the medicine being taken.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the responsible entity.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Levomentis

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging after "Tw".
The expiry date refers to the last day of the stated month.
Medicines must 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 packaging and other information

What Levomentis contains

The active substance is levomepromazine. One coated tablet contains 25 mg of levomepromazine (corresponding to 33.8 mg of levomepromazine maleate).
The other ingredients (excipients) are: monohydrate lactose, maize gelatinized starch, sodium carboxymethyl starch type A, povidone K 30, talc, colloidal anhydrous silica, magnesium stearate, and the coating (containing polyvinyl alcohol, talc, macrogol 3350, titanium dioxide E 171).

What Levomentis looks like and contents of the pack
Levomentis is a white, round, biconvex coated tablet with a smooth surface.
One pack contains 30, 50, 60 or 100 tablets in a cardboard box.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal product information
tel.: (22) 742 00 22
email: [email protected]