CHLORPROTHIXEN 50 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Chlorprothixen Zentiva, 15 mg, coated tablets
3. Chlorprothixen Zentiva, 50 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains
   2. Table of contents of the leaflet:
4. What is Chlorprothixen Zentiva and what is it used for
5. Important information before taking Chlorprothixen Zentiva
   1. When not to take Chlorprothixen Zentiva:
   2. Warnings and precautions
   3. Children and adolescents
   4. Elderly patients
   5. Chlorprothixen Zentiva and other medicines
   6. Using Chlorprothixen Zentiva with food, drinks, and alcohol
   7. Pregnancy and breastfeeding
   8. Driving and operating machines
6. How to take Chlorprothixen Zentiva
   1. Taking a higher dose of Chlorprothixen Zentiva than recommended
   2. Missing a dose of Chlorprothixen Zentiva
   3. Stopping treatment with Chlorprothixen Zentiva
7. Possible side effects
   1. Reporting side effects
8. How to store Chlorprothixen Zentiva
9. Contents of the packaging and other information
   1. What does Chlorprothixen Zentiva contain
   2. What does Chlorprothixen Zentiva look like and what does the packaging contain
   3. Marketing authorization holder and manufacturer:
   4. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Chlorprothixen Zentiva, 15 mg, coated tablets

Chlorprothixen Zentiva, 50 mg, coated tablets

Chlorprothixene hydrochloride

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Chlorprothixen Zentiva and what is it used for

Chlorprothixen Zentiva is a medicine with a strong sedative effect, weak anti-emetic and anti-autistic effect, and a slight anti-depressive effect. It also has antihistamine and anti-emetic effects. In small doses, it has an anxiolytic effect. It does not cause a feeling of fatigue and drowsiness. It enhances the effect of alcohol, sleeping pills, and anesthetics. It lowers body temperature.

It is indicated for the treatment of endogenous and organic psychoses with motor agitation and aggression, anxiety and insomnia in neuroses and psychosomatic disorders, alcoholic psychoses, and in surgery for premedication to calm the patient and reduce neurovegetative reactions, as well as to prevent postoperative vomiting.

2. Important information before taking Chlorprothixen Zentiva

When not to take Chlorprothixen Zentiva:

torsade de pointes;

Warnings and precautions

Before starting treatment with Chlorprothixen Zentiva, discuss it with your doctor or pharmacist. In some disease states, special caution should be exercised when taking the medicine. For this reason, you should inform your doctor about all diseases you are suffering from.

Special caution should be exercised when taking the medicine in patients with:

• chromaffin tumor,
• prolactin-dependent tumor,
• severe hypotension,
• Parkinson's disease,
• cardiovascular disease,
• hyperthyroidism,
• urination disorders, urinary retention,
• pyloric stenosis, intestinal obstruction,
• alcoholism or abuse of opioids or sedative drugs acting on the central nervous system;
• severe respiratory disorders (e.g., pneumonia, asthma, pulmonary emphysema),
• risk factors for stroke (applies to elderly patients)
• exposed to extreme temperatures and during electroconvulsive therapy;
• cardiovascular disease or prolonged QT interval in history.

As with other neuroleptic drugs, caution should be exercised when taking chlorprothixene in patients with:

• organic brain damage,
• mental retardation,
• epilepsy,
• severe liver, kidney, and (or) heart function disorders,
• myasthenia (a disease characterized by muscle weakness),
• benign prostatic hyperplasia,
• diabetes (chlorprothixene may affect insulin and glucose levels in the blood, which requires correction of antidiabetic treatment).

Malignant neuroleptic syndrome

When taking any neuroleptic drug, there is a possibility of developing malignant neuroleptic syndrome, the symptoms of which are: high fever, muscle stiffness, consciousness disorders, instability of the autonomic nervous system.

Glaucoma

In patients with a rare disease - a shallow anterior chamber of the eye and a narrow angle of filtration, acute glaucoma attacks may occur, caused by pupil dilation.

Venous thromboembolic disease

Special caution should be exercised if the patient or someone in their family has had venous thrombosis, as the use of antipsychotic drugs (drugs used to treat behavioral disorders) is associated with the formation of blood clots.

Priapism

There have been reports of priapism (prolonged, usually painful erection of the penis, which may require surgical treatment) during the use of antipsychotic drugs. Chlorprothixen Zentiva belongs to the group of antipsychotic drugs, and therefore, the risk of priapism after its use cannot be ruled out. You should immediately inform your doctor if you experience prolonged or painful erection. Medical intervention may be necessary.

Chlorprothixene may cause false-positive results in the immunological pregnancy test with urine, urine test for bilirubin.

Children and adolescents

The use of Chlorprothixen Zentiva is not recommended in children and adolescents.

Elderly patients

Caution should be exercised when taking chlorprothixene in this group of patients.

Elderly patients are particularly prone to hypotension related to changes in body position to vertical.

Chlorprothixene is not intended for the treatment of behavioral disorders associated with dementia.

In elderly patients with dementia, an increased risk of cerebrovascular adverse events has been observed.

Chlorprothixen Zentiva and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as about medicines you plan to take.

Tell your attending doctor about the use of the following medicines:

• blood pressure lowering medicines (e.g., guanethidine and similar medicines);
• antidepressants (e.g., tricyclics);
• sedatives (barbiturates and similar medicines);
• medicines used to treat epilepsy (neuroleptic drugs and lithium compounds);
• medicines used to treat Parkinson's disease (levodopa and similar medicines);
• medicines used to treat hyperprolactinemia (e.g., bromocriptine) - the doctor may change the dosage if necessary.

The following medicines should not be taken at the same time as Chlorprothixen Zentiva:

• medicines that change heart action (quinidine, amiodarone, sotalol, dofetilide, erythromycin, terfenadine, astemizole, gatifloxacin, moxifloxacin, cisapride, lithium);
• other antipsychotic medicines (e.g., thioridazine).

It is recommended to avoid taking:

• medicines that disrupt water and electrolyte balance (e.g., thiazide diuretics);
• medicines known to increase chlorprothixene levels in the blood (e.g., paroxetine, fluoxetine, chloramphenicol, disulfiram, isoniazid, MAO inhibitors, oral contraceptives, buspirone, sertraline, citalopram).

The risk of extrapyramidal symptoms (e.g., slowed movement, facial mimicry disorders, muscle stiffness resulting from increased muscle tone, tremors) increases when taking:

• metoclopramide (anti-emetic medicine),
• phenothiazine derivatives, haloperidol, or reserpine (antipsychotic medicines),
• piperazine (anti-parasitic medicine, acting on pinworms and human roundworms).

Consuming alcohol, taking sedatives, antidepressants, anticonvulsants, painkillers, muscle relaxants, neuroleptics, antihistamines (medicines used to treat allergies) at the same time as chlorprothixene may enhance the inhibitory effect on the central nervous system.

The risk of enhanced anticholinergic effect (pupil dilation, dry mouth, bronchodilation, slowed intestinal peristalsis, hallucinations) increases when taking:

• medicines used to treat urinary system diseases, e.g., overactive bladder (antimuscarinic, anticholinergic medicines),
• medicines used to treat allergies (antihistamines),
• medicines used to treat Parkinson's disease.

Taking adrenaline with chlorprothixene increases the risk of hypotension (decreased blood pressure, manifested by dizziness) and tachycardia (rapid heart rate).

Chlorprothixene may reduce or neutralize the alcohol/disulfiram reaction.

Thioxanthenes may mask the toxic effects of other medicines on the ear (tinnitus, dizziness, etc.).

Using Chlorprothixen Zentiva with food, drinks, and alcohol

Tablets should be taken with a meal and swallowed whole, washed down with a glass of water or milk, to avoid irritating the stomach.

Chlorprothixen Zentiva may enhance the sedative effect of alcohol. You should not consume alcohol while taking Chlorprothixen Zentiva.

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.

The safety of using the medicine in pregnant women has not been confirmed. The medicine should not be given during pregnancy unless the expected benefit to the mother outweighs the risk to the fetus.

In newborns whose mothers took antipsychotic drugs (including chlorprothixene) in the last trimester of pregnancy (last 3 months of pregnancy), the following symptoms may occur: tremors, increased or decreased muscle tone and (or) muscle weakness, drowsiness, agitation, feeding problems, and respiratory problems. If your child experiences any of these symptoms, consult your doctor.

Chlorprothixene passes into breast milk in small amounts. You should not expect the medicine to have an effect on the infant when taken in therapeutic doses. However, since compounds with a similar chemical structure have an effect on the child, breastfeeding can be continued if it is clinically necessary, but it is recommended to monitor the infant, especially in the first 4 weeks after birth.

Driving and operating machines

The medicine may have a negative effect on performing tasks that require increased attention, coordination, and quick decision-making (e.g., driving a car, operating machines, working at heights), especially at the beginning of treatment. Such activities can only be performed with the doctor's permission.

Chlorprothixen Zentiva, 15 mg and 50 mg:

The medicine contains lactose and sucrose. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Chlorprothixen Zentiva, 15 mg:

The medicine contains orange yellow (E 110), which may cause allergic reactions.

3. How to take Chlorprothixen Zentiva

This medicine should always be taken according to the doctor's instructions. If you have any doubts, consult your doctor.

The dosage should be adjusted individually depending on the indications and patient tolerance.

Neuroses: the recommended dose is usually 15 mg 1 to 3 times a day.

Psychotic disorders: the recommended dose is usually 50 mg to 100 mg 2 to 4 times a day.

The daily dose should be divided so that the larger dose is taken before bedtime.

Taking a higher dose of Chlorprothixen Zentiva than recommended

The most likely symptoms of overdose are drowsiness, coma, convulsions, shock, movement disorders, significantly elevated or decreased body temperature, respiratory depression, low blood pressure, which may appear after a few hours and last from 2 to 3 days. In severe cases, kidney damage. When these symptoms subside, seizures, excessive restlessness, and hematuria may occur.

There have also been reports of heart rhythm disorders when the medicine was taken in excessive doses in combination with other medicines with known effects on the heart.

The doctor will administer symptomatic and supportive treatment: gastric lavage (as soon as possible after taking the medicine), administration of activated charcoal, supportive treatment of respiratory and cardiovascular function.

In case of malignant neuroleptic syndrome, the symptoms of which are: high fever, muscle stiffness, consciousness disorders, instability of the autonomic nervous system, the medicine should be discontinued. The doctor will administer symptomatic and supportive treatment.

In case of overdose or accidental ingestion of the medicine by a child, you should immediately consult a doctor.

Missing a dose of Chlorprothixen Zentiva

Take the missed dose as soon as possible. If it is almost time for the next dose, do not take the missed dose.

Do not take a double dose to make up for the missed dose.

Stopping treatment with Chlorprothixen Zentiva

Sudden discontinuation of chlorprothixene may be accompanied by withdrawal symptoms. Most often, these are nausea, vomiting, anorexia, diarrhea, rhinorrhea, sweating, muscle pain, paresthesia, insomnia, anxiety, and agitation. Patients may also experience dizziness, increased sensation of heat or cold, and tremors. Symptoms usually start within 1 to 4 days after stopping the medicine and subside within 7-14 days.

4. Possible side effects

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

The risk of developing side effects increases during long-term use of high doses of chlorprothixene. This risk is higher in children and elderly patients.

The following side effects are possible, with their frequency of occurrence:

Very common (may occur in up to 1 in 10 people):drowsiness, dizziness, dry mouth, increased salivation.

Common (may occur in up to 1 in 10 people):increased appetite, insomnia, nervousness, agitation, decreased libido, headaches, dystonia (involuntary movements causing twisting or bending of different body parts), accommodation disorders of the eye, blurred vision, rapid heart rate (especially after sudden discontinuation of treatment), palpitations, orthostatic hypotension (including dizziness, which usually occurs after sudden standing), constipation, indigestion, nausea, increased sweating, muscle pain, chronic weakness, fatigue, weight gain.

Uncommon (may occur in up to 1 in 100 people):decreased appetite, akathisia (inability to maintain a stable position), late dyskinesia (involuntary, uncoordinated movements of muscles, especially of the face), parkinsonism, seizures, attacks of forced gaze with eye rotation, hypotension, heat strokes, vomiting, diarrhea, rash, itching, hypersensitivity to light, skin inflammation, muscle stiffness, urination disorders, urinary retention, ejaculation disorders, erectile dysfunction, weight loss, abnormal liver function test results.

Rare (may occur in up to 1 in 1000 people):thrombocytopenia (decreased platelet count), leukopenia, neutropenia (decreased white blood cell count), agranulocytosis (decreased granulocyte count or absence of granulocytes in the blood), hypersensitivity, anaphylactic reaction, increased prolactin levels in the blood, increased glucose levels in the blood, impaired glucose tolerance, epileptiform seizures, prolonged QT interval in ECG, ventricular arrhythmias - atrial fibrillation, ventricular tachycardia, torsade de pointes, sudden unexplained death, rhinitis, dyspnea, skin flushing, rash, excessive growth of breast tissue in men, galactorrhea, menstrual disorders, body temperature regulation disorders;

Very rare (may occur in up to 1 in 10,000 people):decreased red blood cell count (hemolytic anemia), thrombocytopenic purpura, pancytopenia (deficiency of all normal morphological elements of the blood), eosinophilia, malignant neuroleptic syndrome, cardiac arrest, slow heart rate, venous thromboembolic disease, asthma, laryngeal edema, jaundice, lupus-like syndrome (a syndrome of autoimmune inflammation that can affect the skin, joints, and internal organs), increased uric acid levels in the urine.

After many years of treatment with high doses, pigmented degeneration of the retina, lens, and corneal deposits may occur.

Frequency not known (frequency cannot be estimated from available data):

withdrawal syndrome in the newborn; venous thrombosis (especially in the legs: swelling, pain, and redness), which can move through the bloodstream to the lungs, causing chest pain and breathing difficulties. If you experience any of these symptoms, you should immediately consult a doctor.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl

By reporting side effects, you can help gather more information on the safety of the medicine.

Side effects can also be reported to the marketing authorization holder or its representative in Poland.

5. How to store Chlorprothixen Zentiva

The medicine should be stored in a place invisible and inaccessible to children.

Store in a temperature below 25°C. Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.

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 packaging and other information

What does Chlorprothixen Zentiva contain

• The active substance of the medicine is chlorprothixene hydrochloride. Each coated tablet contains 15 mg or 50 mg of chlorprothixene hydrochloride.
• The other ingredients are: cornstarch, lactose monohydrate, sucrose, calcium stearate, talc. Coating compositionChlorprothixen Zentiva, 15 mg: hypromellose 2910/5, macrogol 6000, macrogol 300, talc, orange yellow (E 110), lake (E 110).

Chlorprothixen Zentiva, 50 mg:

hypromellose 2910/5, macrogol 6000, macrogol 300, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What does Chlorprothixen Zentiva look like and what does the packaging contain

Chlorprothixen Zentiva, 15 mg: orange, lens-shaped coated tablets.

Chlorprothixen Zentiva, 50 mg: light brown, lens-shaped coated tablets.

Package size: 30 or 50 coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer:

Zentiva k.s.

U kabelovny 130, Dolní Měcholupy

102 37 Prague 10

Czech Republic

To obtain more detailed information about this medicine, you should contact the representative of the marketing authorization holder:

Zentiva Polska Sp. z o. o.

ul. Bonifraterska 17

00-203 Warsaw

Tel. (22) 375 92 00

Date of last revision of the leaflet: