Levomentis

Package Leaflet: Information for the Patient

Levomentis

25 mg, coated tablets

Levomepromazine

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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Levomentis and what is it used for

Levomentis coated tablets are used to treat severe mental disorders. The medicine prevents the action of certain substances in the brain, leading to a reduction in disease symptoms. It belongs to a group of so-called neuroleptics, phenothiazine derivatives. Indications for use include:

• treatment of schizophrenia;
• treatment of other mental illnesses with motor or psychomotor agitation, as adjunctive treatment in mental retardation;
• treatment of anxiety disorders - in small doses, in a single evening dose in sleep disorders;
• treatment of chronic pain in monotherapy or in combination with other painkillers.

2. Important information before taking Levomentis

When not to take 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 malignant neuroleptic syndrome;
• if the patient has:
• glaucoma with a narrow angle of vision;
• urination problems;
• Parkinson's disease;
• multiple sclerosis (a disease of the central nervous system);
• myasthenia (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 system disease, bone marrow disorders;
• porphyria (a disease related to the disorder of the production of an important chemical compound responsible for oxygen transport in blood vessels);
• adrenal gland tumor (so-called pheochromocytoma);
• if the patient is taking antihypertensive drugs (drugs that lower blood pressure) or so-called MAO inhibitors (drugs used in the treatment of depression);
• if the patient is using central nervous system depressants (e.g. alcohol, general anesthetics, sleeping pills) or has had a brain injury or significant reduction in the level of consciousness;
• in breastfeeding women;
• in children under 12 years of age.

Warnings and precautions

Before starting treatment with Levomentis, discuss it with your doctor or pharmacist. In case of hypersensitivity reactions (swelling of the lips, mouth or throat causing difficulty in swallowing or breathing, annoying skin itching), discontinue the medicine immediately. If fever occurs during treatment, always rule out the possibility of a severe side effect, such as malignant neuroleptic syndrome. This is a potentially life-threatening disease characterized by the following symptoms: muscle stiffness, high fever, confusion, unstable blood pressure, rapid heartbeat, arrhythmias, sweating, catatonia (a disorder characterized by a very low level of motor activity - stupor or excessive motor activity not subject to the patient's will). In case of malignant neuroleptic syndrome, discontinue Levomentis immediately. Similarly, discontinue the medicine if high fever of unknown origin occurs during treatment. Particular caution should be exercised in the following cases:

• If the patient is taking drugs that depress the central nervous system or anticholinergic drugs (e.g. drugs used in chronic obstructive pulmonary disease and asthma, some drugs used in Parkinson's disease, such as prydinol, biperiden, amantadine).
• If the patient has kidney or liver function disorders, due to the risk of accumulation and toxic effects.
• If the patient has had a stroke or has an increased risk of stroke.
• If the patient has been diagnosed with diabetes or has an increased risk of developing diabetes. In these patients, during levomepromazine therapy, blood sugar levels should be monitored more frequently than usual, as this medicine may increase blood sugar levels.
• In elderly patients (especially with dementia), as they are more prone to orthostatic hypotension and are more sensitive to the effects of the medicine. Therefore, in such cases, it is particularly important to start treatment with low initial doses and, in accordance with the doctor's recommendations, increase them if necessary. After the first dose of the medicine, the patient should lie down for about half an hour to avoid a drop in blood pressure. If dizziness occurs frequently after taking the medicine, it is recommended to lie in bed after each dose.
• If the patient, especially the elderly, has cardiovascular disease (such as hypertension, heart rhythm disorders, circulation disorders). Before starting treatment with Levomentis, an ECG examination should be performed to rule out any heart disease that may be a contraindication to treatment.
• If the patient has bradycardia, congenital or familial long QT syndrome, or is taking other medicines that affect heart function (e.g. prolonging the QT interval, such as some diuretics or antibiotics). During treatment with Levomentis, severe, life-threatening heart rhythm disorders (such as tachycardia, QT interval prolongation in the ECG, or even torsades de pointes arrhythmia) may occur.

Before starting treatment with Levomentis and during treatment, it is recommended to regularly monitor the following parameters:

• blood pressure, especially in patients with circulation disorders and in people with a tendency to excessive lowering of blood pressure (at risk of hypotension);
• liver function (especially in patients with existing liver function disorders);
• blood morphology with a smear in case of fever, sore throat, or suspected significant reduction in white blood cell count (agranulocytosis and/or leukopenia), especially at the beginning of treatment and during long-term use of the medicine;
• ECG recording (in people with cardiovascular diseases and heart diseases, as well as in the elderly);
• measurement of potassium levels in serum; electrolyte levels should be periodically monitored and corrected if necessary, especially in the case of long-term administration of the medicine.

In elderly patients with dementia, treated with antipsychotic drugs, the risk of death is slightly increased compared to patients not taking antipsychotic drugs. During long-term treatment with levomepromazine, dry mouth may occur, which can lead to tooth decay, so it is recommended to brush teeth with fluoride toothpaste at least twice a day. Regular dental check-ups are recommended. Elderly patients The doses prescribed to elderly patients are usually lower than those used in other adult patients. This is due to the greater susceptibility of older people to side effects. Children and adolescents Do not use in children under 12 years of age. It is not recommended to use this medicine in adolescents.

Levomentis and other medicines

Tell your doctor about all medicines you are taking, have recently taken, or plan to take. In particular, inform your doctor if you are taking medicines that should not be taken with Levomentis:

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

Also, inform your doctor if you are taking:

• medicines that affect the central nervous system, such as:
• antipsychotic drugs (e.g. thioridazine, sertindol),
• sedatives and sleeping pills,
• anxiolytics,
• drugs used in depression (e.g. venlafaxine, paroxetine, fluoxetine, clomipramine),
• antiepileptic drugs;
• drugs used in Parkinson's disease (e.g. bromocriptine, cabergoline, levodopa);
• drugs used in allergies (antihistamines blocking H1 receptors);
• atropine (a drug used in, for example, biliary colic, intestinal spasms, or urinary tract spasms);
• scopolamine (a drug used before surgical procedures to prevent heart rhythm disorders);
• succinylcholine (a drug used in anesthesiology to relax muscles);
• medicines that depress the central nervous system [opioid drugs, opioids (e.g. methadone, codeine), general anesthetics];
• medicines that stimulate the central nervous system (e.g. amphetamine derivatives);
• oral antidiabetic drugs;
• drugs used in heart rhythm disorders (e.g. quinidine);
• certain antibiotics (e.g. macrolides, such as erythromycin);
• certain antifungal drugs (azoles);
• mefloquine (an antimalarial drug);
• cisapride (a drug used in the treatment of gastroesophageal reflux disease);
• diuretics (causing a decrease in potassium levels in the blood);
• diltiazem (a drug used in coronary artery disease, arrhythmias, hypertension);
• medicines with a photosensitizing effect;
• lithium-containing drugs;
• deferoxamine (used to remove excess iron or aluminum from the body).

It is recommended to take vitamin C at the same time, as it reduces the deficiency of this vitamin caused by Levomentis.

Levomentis with food, drink, and alcohol

Do not consume alcoholic beverages during treatment with Levomentis and for 4-5 days after stopping treatment. The medicine can be taken during meals or independently of meals.

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. Pregnancy Levomepromazine passes through the placenta. Levomepromazine should not be administered during the first trimester of pregnancy, and in the second and third trimesters, it can be used at the lowest effective dose only after careful consideration of the benefit-risk ratio for the mother and fetus. Administration of levomepromazine to pregnant women is only allowed on the explicit recommendation of a doctor, after a thorough assessment of the patient's health and only when the benefits of such treatment outweigh the risks. In newborns whose mothers took levomepromazine in the last three months of pregnancy (i.e. in the third trimester), adverse reactions such as tremors, increased muscle tone, and/or decreased muscle tone, drowsiness, agitation, respiratory disorders, and feeding difficulties may occur. If these symptoms occur in the child, contact a doctor. Breastfeeding Levomepromazine passes into breast milk. There is no data on the safety of levomepromazine during breastfeeding, so it is contraindicated in breastfeeding women. Fertility As with other drugs in this group, levomepromazine may be associated with impaired reproductive and sexual function (disorders of menstruation and libido, erectile dysfunction).

Driving and using machines

Patients should not drive a car, operate machinery, or perform activities that involve an increased risk of accidents, especially at the beginning of treatment. Later, the scope of these restrictions is determined individually.

Levomentis contains lactose monohydrate and sodium

1 coated tablet contains 51.2 mg of lactose monohydrate. If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Levomentis

This medicine should always be taken according to the doctor's instructions. In case of doubts, consult a doctor or pharmacist. Usually, the doctor will recommend starting treatment with low doses, which can then be gradually increased depending on the patient's tolerance to the medicine. After achieving the desired improvement in the patient's condition, the dose may be reduced to the individually adjusted maintenance dose. In schizophrenia and other psychoses, the initial dose is usually 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 (administered in 2-3 divided doses), and then, after achieving the therapeutic effect, the dose can be reduced to a maintenance dose. In the case of pain relief, the dose should also be increased gradually, 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 meals.

Take a higher dose of Levomentis than recommended

In case of taking a higher dose of Levomentis than recommended or accidental ingestion of the medicine by an unauthorized person, contact a doctor, pharmacist, or the nearest hospital immediately. Take the remaining tablets and the package leaflet with you to show the doctor, who will decide on further action depending on the dose taken and the symptoms of overdose.

Miss a 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 it is almost time for the next dose, do not take the missed dose. Before going on vacation or a trip, the patient should ensure they have a sufficient supply of the medicine for the entire duration of the trip, until they return home.

Stop taking Levomentis

Do not stop taking this medicine without consulting your doctor first. If treatment needs to be discontinued, the doctor will determine the appropriate course of action, depending on the individual patient's reaction to levomepromazine treatment. Levomepromazine should be discontinued immediately only in case of malignant neuroleptic syndrome or hypersensitivity reactions (see section 2 of the leaflet - Warnings and precautions). In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Levomentis can cause side effects, although not everybody gets them. Symptoms that occur at the beginning of treatmentare usually dizziness, especially when changing position from lying down to standing, caused by a drop in blood pressure. These symptoms usually decrease during continued treatment.

Symptoms that require immediate contact with a doctor:

• rhythmic, involuntary movements of the tongue, face, mouth, or jaws, sometimes accompanied by involuntary movements of the limbs (indicating the occurrence of so-called late dyskinesia);
• fever, excessive sweating, muscle stiffness, changes in mental state, arrhythmias, and large fluctuations in blood pressure (indicating the occurrence of malignant neuroleptic syndrome. This disease is life-threatening and can be fatal, so in such a case, the medicine should be discontinued immediately and a doctor or hospital should be consulted);
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, redness of the leg), which can move through the blood vessels to the lungs, causing chest pain and breathing difficulties (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 the lips or throat (larynx), swelling of the ankles, feet, and toes, asthma attack, high fever.

Other side effects that have been reported in patients taking levomepromazine:

Very common or common

• decrease in white blood cell count (leukopenia)
• increase in white blood cell count (leukocytosis)
• dizziness due to balance disorders, dizziness of labyrinthine origin
• rapid heartbeat
• low blood pressure
• orthostatic hypotension (excessive drop in blood pressure when changing position, especially from lying down to standing)
• calmness, fatigue
• dry mouth
• allergic skin symptoms (mainly hives, skin inflammation, itching)
• increased sensitivity to light
• akathisia (excessive motor activity)
• Parkinson's disease-like symptoms

Uncommon

• difficulty with eye accommodation
• constipation
• urinary retention
• increase in prolactin levels in the blood (hyperprolactinemia)
• menstrual disorders, breast enlargement, gynecomastia

Rare or very rare

• significant decrease in white blood cell count (agranulocytosis)
• aplastic anemia (lack of blood cells due to bone marrow disorders)
• changes in glucose tolerance
• changes in appetite and body weight
• memory disorders
• involuntary muscle contractions causing uncontrolled movements and positioning of different parts of the body (acute dystonia)
• lowering of the seizure threshold
• acute angle-closure glaucoma (eye disease)
• clouding of the lens and cornea of the eye (deposits in the lens and cornea)
• heart rhythm disorders (torsades de pointes, tachycardia, ventricular arrhythmias - Morgagni-Adams-Stokes syndrome, atrial fibrillation, ventricular tachycardia)
• prolongation of the QT interval in the ECG
• unexplained sudden death
• cardiac arrest
• hepatitis with jaundice
• excessive hair growth
• changes in libido and potency, delayed orgasm, decreased potency, ejaculation disorders, painful and prolonged erection

Frequency not known

• decrease in the number of all blood cells (pancytopenia)
• increase in the number of a group of white blood cells important for immunity against infections, called eosinophils (eosinophilia)
• decrease in platelet count (thrombocytopenia)
• benign pituitary tumors
• vitamin deficiencies
• retinal pigment degeneration (retinitis pigmentosa, an eye disease involving the deposition of pigment in the retina)
• nausea, vomiting
• withdrawal syndrome in the newborn
• abnormal uterine contractions

There have been reports of pituitary tumors in some patients taking phenothiazines, but there is no evidence of a direct link with such treatment. In a group of elderly patients with dementia who were treated with antipsychotic drugs, a small increase in mortality was reported compared to patients who did not take such drugs. Levomepromazine may cause a decrease in white blood cell count, which reduces immunity to infections. If an infection occurs with symptoms such as fever and severe deterioration of the general condition, or fever with local symptoms of infection, such as sore throat or mouth, or disorders of urination, contact a doctor immediately. A blood test will be performed to check the white blood cell count (to rule out agranulocytosis). It is essential for the patient to inform the doctor about the medicine being taken.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your 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, phone: +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 gather more information on the safety of the medicine.

5. How to store Levomentis

Keep the medicine out of the sight and reach of children. Store in a temperature 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 specified month. 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 Levomentis contains

• The active substance of the medicine is levomepromazine. One coated tablet contains 25 mg of levomepromazine (which corresponds to 33.8 mg of levomepromazine maleate).
• The other ingredients (excipients) are: lactose monohydrate, maize 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 what the pack contains

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 authorization holder and manufacturer

Hasco-Lek Pharmaceutical Company S.A., 51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

phone: (22) 742 00 22 email: [email protected]

Date of the last revision of the leaflet: