Chlorprothixene zentiva

Patient Information Leaflet

Chlorprothixen Zentiva, 15 mg, coated tablets
Chlorprothixen Zentiva, 50 mg, coated tablets
Chlorprothixeni hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Chlorprothixen Zentiva is and what it is 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 pack and other information

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

Chlorprothixen Zentiva is a medicine with strong sedative properties, weak antipsychotic and antiautistic effects, and slight antidepressant activity. It also has antihistaminic and antiemetic actions. At low doses, it has anxiolytic effects. It does not cause feelings of fatigue or drowsiness. It enhances the effects of alcohol, hypnotics, and anesthetic agents. It lowers body temperature.

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

2. Information before using Chlorprothixen Zentiva

When not to use Chlorprothixen Zentiva:

• if the patient is allergic (hypersensitive) to the active substance, other thioxanthene derivatives, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has circulatory collapse, disturbances of consciousness regardless of cause (e.g. alcohol, barbiturate or opioid intoxication), coma;
• if the patient has previously experienced cardiovascular disorders (e.g. slow heart rate - bradycardia, recent acute myocardial infarction, cardiac arrhythmias, myocardial hypertrophy), tachycardia with torsade de pointes );
• if the patient has prolonged QT interval (visible on ECG);
• if the patient is taking medicines that prolong the QT interval;
• if the patient has hypokalaemia (low potassium levels in the blood) or hypomagnesaemia (low magnesium levels in the blood).

Warnings and precautions
Before starting treatment with Chlorprothixen Zentiva, discuss this with your doctor or
pharmacist. Special caution is required during treatment in certain medical conditions.
Therefore, inform your doctor about all existing diseases. Special caution is required when using this medicine in patients with:

• phaeochromocytoma,
• prolactin-dependent tumour,
• severe hypotension,
• Parkinson's disease,
• cardiovascular diseases,
• hyperthyroidism,
• urinary disorders, urinary retention,
• pyloric stenosis, intestinal obstruction,
• alcoholism or opioid or sedative (calming) central nervous system drug abuse;
• severe respiratory disorders (e.g. pneumonia, asthma, pulmonary emphysema),
• risk factors for stroke (in elderly patients)
• exposure to extreme temperatures and during electroconvulsive therapy;
• history of cardiovascular disease or history of prolonged QT interval.

As with other neuroleptic medicines, caution should be exercised when administering chlorprothixene to patients with:

• organic brain damage,
• intellectual impairment,
• epilepsy,
• severe liver, kidney and (or) heart dysfunction,
• myasthenia gravis (a disease characterised by muscle weakness),
• benign prostatic hyperplasia,
• diabetes mellitus (chlorprothixene may affect insulin and glucose levels in the blood, requiring adjustment of antidiabetic treatment).

Neuroleptic Malignant Syndrome
When using any neuroleptic medicine, there is a risk of developing neuroleptic malignant syndrome, characterised by: high fever, muscle rigidity, altered mental status, autonomic nervous system instability.
Glaucoma
In patients with a rare condition – narrow anterior chamber of the eye and narrow filtration angle – acute glaucoma attacks may occur due to pupil dilation.
Venous thromboembolic disease
Special caution is required if the patient or a family member has a history of venous thrombosis, as antipsychotic medicines (medicines used to treat behavioural disorders) are associated with an increased risk of thrombosis.
Priapism
Cases of priapism (prolonged, usually painful erection, which may require surgical treatment) have been reported during treatment with antipsychotic medicines. Chlorprothixen Zentiva belongs to the group of antipsychotic medicines, and therefore, the risk of priapism cannot be excluded. Immediately inform your doctor if the patient experiences prolonged or painful erection. Immediate medical intervention may be necessary.
Chlorprothixene may cause false positive results in immunological pregnancy tests in urine and urine tests for bilirubin.

Children and adolescents
Chlorprothixen Zentiva is not recommended for use in children and adolescents.
Elderly patients
Caution should be exercised when using chlorprothixene in this patient group.
Elderly patients are particularly susceptible to postural hypotension (low blood pressure upon standing).
Chlorprothixene is not intended for the treatment of behavioural disorders associated with dementia.
In elderly patients with dementia, an increased incidence of cerebrovascular adverse events has been observed.
Chlorprothixen Zentiva and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to use.
Inform your treating doctor about the use of the following medicines:

• medicines that lower blood pressure (e.g. guanethidine and similar medicines);
• antidepressants (e.g. tricyclics);
• medicines causing drowsiness (barbiturates and similar medicines);
• medicines used to treat epilepsy (neuroleptics and lithium compounds);
• medicines used to treat Parkinson's disease (levodopa and similar medicines);
• medicines used to treat galactorrhoea (e.g. bromocriptine) – the doctor may adjust the dosage if necessary.

The following medicines should not be taken simultaneously with Chlorprothixen Zentiva:

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

Avoid concomitant use of:

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

The risk of extrapyramidal symptoms (e.g. slowed movement, facial expression disturbances, muscle stiffness due to increased muscle tone, tremor) increases when chlorprothixene is used concomitantly with:

• metoclopramide (an antiemetic medicine),
• phenothiazine derivatives, haloperidol or reserpine (antipsychotic medicines),
• piperazine (an antiparasitic medicine effective against pinworms and roundworms).

Consuming alcohol or using sedatives, antidepressants, anticonvulsants, analgesics, muscle relaxants, neuroleptics, antihistamines (medicines used to treat allergies) together with chlorprothixene may intensify the central nervous system depressant effects.
The risk of increased anticholinergic effects (dilated pupils, dry mouth, bronchodilation, slowed intestinal peristalsis, hallucinations) increases when chlorprothixene is used concomitantly with:

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

Concomitant use of adrenaline (epinephrine) with chlorprothixene increases the risk of hypotension (low blood pressure, manifesting as dizziness) and tachycardia (rapid heartbeat).
Chlorprothixene may reduce or abolish the alcohol-disulfiram reaction.
Thioxanthenes may mask toxic effects of other medicines on the auditory organ (e.g. tinnitus, dizziness).
Taking Chlorprothixen Zentiva with food, drink and alcohol
Tablets should be taken with food and swallowed whole, with a glass of water or milk, to avoid stomach irritation.
Chlorprothixen Zentiva may enhance the sedative effect of alcohol. Alcohol should not be consumed during treatment with Chlorprothixen Zentiva.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.
The safety of using this medicine during pregnancy has not been confirmed. The medicine should not be administered during pregnancy unless the expected benefit to the mother outweighs the potential risk to the foetus.
Newborns whose mothers used antipsychotic medicines (including chlorprothixene) during the third trimester of pregnancy (last 3 months) may experience the following symptoms: tremor, increased or decreased muscle tone and (or) muscle weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If any of these symptoms occur in the newborn, contact a doctor immediately.
Chlorprothixene passes into breast milk in small amounts. It is not expected that the medicine administered at therapeutic doses would affect the infant. However, since structurally similar compounds may affect the child, breastfeeding may be continued if clinically important, but the infant should be monitored, especially during the first 4 weeks after birth.
Driving and operating machinery
This medicine may adversely affect the ability to perform tasks requiring increased attention, motor coordination and rapid decision-making (e.g. driving a car, operating machinery, working at heights), particularly at the beginning of treatment. Therefore, such activities should only be performed after obtaining approval from a doctor.
Chlorprothixen Zentiva, 15 mg and 50 mg:
This medicine contains lactose and sucrose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Chlorprothixen Zentiva, 15 mg:
This medicine contains sunset yellow FCF (E 110), which may cause allergic reactions.

3. How to use Chlorprothixen Zentiva

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor.
The dosage should be individually adjusted according to the indication and patient tolerance.
Neuroses: the usual recommended dose is 15 mg 1 to 3 times daily.
Psychotic disorders: the usual recommended dose is 50 mg to 100 mg 2 to 4 times daily.
The daily dose should be divided so that the larger portion is administered before bedtime.

Use of a higher than recommended dose of Chlorprothixen Zentiva
The most likely symptoms of overdose include drowsiness, coma, convulsions, shock, movement disorders, markedly increased or decreased body temperature, respiratory depression, low blood pressure, which may appear several hours after ingestion and last from 2 to 3 days. In severe cases, kidney damage may occur. As these symptoms begin to subside, seizures, excessive motor activity, and hematuria may occur.
Cardiac arrhythmias have also been reported when the medicine was taken in excessive doses in combination with other medicines known to affect the heart.
The doctor will administer symptomatic treatment and supportive measures to maintain vital functions: gastric lavage (as soon as possible after ingestion), administration of activated charcoal, and supportive treatment for the respiratory and cardiovascular systems.
If neuroleptic malignant syndrome occurs, characterized by symptoms such as high fever, muscle rigidity, altered consciousness, and autonomic nervous system instability, the medicine should be discontinued. The doctor will provide symptomatic and life-supporting treatment.
In case of overdose or accidental ingestion by a child, seek immediate medical advice.

Missed dose of Chlorprothixen Zentiva
Take the missed dose as soon as possible. If the next scheduled dose is approaching, do not take the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping Chlorprothixen Zentiva
Abrupt discontinuation of chlorprothixene may be accompanied by withdrawal symptoms. These most commonly include nausea, vomiting, loss of appetite, diarrhea, watery nasal discharge, sweating, muscle pain, paresthesia, insomnia, restlessness, anxiety, and agitation. Patients may also experience dizziness, intensified sensation of heat or cold, and tremor. Symptoms usually begin 1 to 4 days after stopping the medicine and gradually subside over 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 with long-term use of high doses of
chlorprothixene. This risk is greater in children and elderly patients.
The possible side effects are listed below, with information on their frequency of occurrence:
Very common (may occur in no more than 1 in 10 people): drowsiness, dizziness, dry mouth,
increased salivation.
Common (may occur in no more than 1 in 10 people): increased appetite, insomnia, nervousness,
restlessness, decreased libido, headache, dystonia (involuntary movements causing twisting or
repetitive movements and abnormal postures of various body parts), eye accommodation disorders,
visual disturbances, rapid heartbeat (especially after sudden discontinuation of treatment), palpitations,
orthostatic hypotension (including dizziness, usually occurring after sudden standing up), constipation,
indigestion, nausea, excessive sweating, muscle pain, chronic weakness, fatigue, weight gain.
Uncommon (may occur in no more than 1 in 100 people): decreased appetite, akathisia (inability to
remain still), tardive dyskinesia (involuntary, uncoordinated muscle movements, especially of the
face), parkinsonism, seizures, oculogyric crisis (involuntary upward deviation of the eyes),
hypotension, hot flushes, vomiting, diarrhoea, rash, itching, photosensitivity, skin inflammation, muscle
stiffness, urinary disorders, urinary retention, ejaculation disorders, erectile dysfunction, weight loss,
abnormal liver function test results.
Rare (may occur in no more than 1 in 1000 people): thrombocytopenia (reduced number of platelets),
leukopenia, neutropenia (reduced number of white blood cells), agranulocytosis (reduced number or
absence of granulocytes in the blood), hypersensitivity, anaphylactic reaction, increased prolactin
levels in blood, increased blood glucose levels, impaired glucose tolerance, epileptic-like seizures, QT
interval prolongation on ECG, ventricular arrhythmias – ventricular fibrillation, ventricular tachycardia,
torsade de pointes, sudden unexplained death, rhinitis, dyspnoea, skin redness, skin eruption,
gynecomastia (excessive growth of glandular breast tissue in males), galactorrhea, menstrual disorders,
disturbances in body temperature regulation;
Very rare (may occur in no more than 1 in 10,000 people): decreased number of red blood cells
(haemolytic anaemia), thrombocytopenic purpura, pancytopenia (deficiency of all normal blood cells),
eosinophilia, neuroleptic malignant syndrome, cardiac arrest, bradycardia, venous thromboembolic
disease, asthma, laryngeal oedema, jaundice, lupus-like syndrome (an autoimmune inflammatory
condition which may affect the skin, joints and internal organs), increased urinary uric acid levels.
After many years of treatment with high doses, pigmentary retinopathy, lens pigmentation, lens
opacities, and corneal deposits may occur.
Frequency not known (frequency cannot be estimated from the available data): withdrawal syndrome
in newborns; venous thrombosis (especially in the legs: swelling, pain and redness), which may travel
through the bloodstream to the lungs, causing chest pain and breathing difficulties. If any of these
symptoms occur, contact a doctor immediately.
Reporting of side effects
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your
doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of
Adverse Drug Reactions at the 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
Reporting side effects helps provide more information on the safety of the medicine.
Side effects can also be reported to the marketing authorisation holder or the representative of the
marketing authorisation holder in Poland.

5. How to store Chlorprothixen Zentiva

Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the container. 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. Such practices help protect the environment.

6. Contents of the pack and other information

What Chlorprothixen Zentiva contains

• The active substance is chlorprothixene hydrochloride. Each coated tablet contains either 15 mg or 50 mg of chlorprothixene hydrochloride.
• The other ingredients are: maize starch, monohydrate lactose, sucrose, calcium stearate, talc.
  Coating composition
  Chlorprothixen Zentiva 15 mg: hypromellose 2910/5, macrogol 6000, macrogol 300, talc, sunset yellow, lac (E 110).

Chlorprothixen Zentiva 50 mg:
hypromellose 2910/5, macrogol 6000, macrogol 300, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What Chlorprothixen Zentiva looks like and contents of the pack
Chlorprothixen Zentiva 15 mg: orange, biconvex coated tablets.
Chlorprothixen Zentiva 50 mg: light brown, biconvex coated tablets.
Pack sizes: 30 or 50 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Zentiva k.s.
U kabelovny 130, Dolní Měcholupy
102 37 Prague 10
Czech Republic

For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. (22) 375 92 00