Clopixol

Leaflet accompanying the packaging: information for the user

Clopixol, 10 mg, coated tablets

Clopixol, 25 mg, coated tablets

Zuclopenthixol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Clopixol and what is it used for

How Clopixol works

Clopixol contains the active substance zuclopenthixol. Clopixol belongs to a group of medicines called antipsychotics (also known as neuroleptics). These medicines work on the nerve pathways in certain areas of the brain and help to balance some of the natural chemicals in the brain that may be involved in causing the symptoms of the illness.

What Clopixol is used for

Clopixol is used to treat acute and chronic schizophrenia and other psychoses, especially those with symptoms such as hallucinations, delusions, thought disorders, agitation, anxiety, hostility, and aggression. Clopixol is also used to treat mania in bipolar affective disorder.

2. Important information before taking Clopixol

When not to take Clopixol:

• if the patient is allergic (hypersensitive) to zuclopenthixol or any of the other ingredients of this medicine (listed in section 6).
• if the patient has a circulatory collapse, impaired consciousness (e.g., due to alcohol, barbiturates, or opioids) or coma.

Warnings and precautions

Before starting treatment with Clopixol, the patient should discuss the following with their doctor or pharmacist:

• if the patient has liver function disorders;
• if the patient has had seizures in the past;
• if the patient has diabetes (a change in antidiabetic treatment may be necessary);
• if the patient has an organic brain syndrome (a disease that may develop as a result of alcohol or organic solvent poisoning);
• if the patient has risk factors for stroke (e.g., smoking, hypertension);
• if the patient has hypokalemia (low potassium levels in the blood) or hypomagnesemia (low magnesium levels in the blood) or a genetic predisposition to such disorders;
• if the patient has had cardiovascular disorders in the past;
• if the patient is taking other antipsychotic medicines;
• if the patient or someone in their family has had blood clots, as the use of medicines like this one is associated with the formation of blood clots.

Children and adolescents

Clopixol is not recommended for this group of patients.

Clopixol and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take. The patient should tell their doctor about the use of the following medicines:

• tricyclic antidepressants;
• guanethidine and similar medicines (which lower blood pressure);
• barbiturates and similar medicines (which cause drowsiness);
• medicines used to treat epilepsy;
• levodopa and similar medicines (used to treat Parkinson's disease);
• metoclopramide (a medicine used to treat gastrointestinal disorders);
• piperazine (an antiparasitic medicine, effective against pinworms and roundworms);
• medicines that disrupt water and electrolyte balance (low potassium or magnesium levels in the blood);
• medicines known to increase the blood levels of zuclopenthixol, the active substance of Clopixol.

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

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

Taking Clopixol with food, drink, and alcohol

Clopixol can be taken with or without food. Clopixol may enhance the sedative effect of alcohol, causing drowsiness. It is not recommended to drink alcoholic beverages while taking Clopixol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

If the patient is pregnant or thinks they may be pregnant, they should inform their doctor. Clopixol should not be used in pregnant women unless it is absolutely necessary. In newborns of mothers who have taken Clopixol in the third trimester of pregnancy (the last three months of pregnancy), the following symptoms may occur: tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing difficulties, feeding problems. If such symptoms occur in the newborn, the patient should contact their doctor.

Breastfeeding

If the patient is breastfeeding, they should consult their doctor. Clopixol should not be used by breastfeeding women, as small amounts of the medicine may be excreted into breast milk.

Fertility

Studies in animals have shown that Clopixol affects fertility. The patient should consult their doctor for advice.

Driving and using machines

There is a risk of drowsiness and dizziness after taking Clopixol, especially at the beginning of treatment. If this occurs, the patient should not drive vehicles, operate machinery, or use tools until these symptoms have resolved.

Clopixol contains lactose and hydrogenated castor oil

The medicine contains lactose. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine. The medicine contains hydrogenated castor oil, which may cause gastrointestinal upset and diarrhea.

3. How to take Clopixol

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The medicine is taken in different doses, the size of which depends on the severity of the illness. Usually, at the beginning of treatment, the doctor prescribes small doses, which are then increased to the optimal effective level, depending on the response to therapy. In maintenance treatment, Clopixol should be taken in a single dose in the evening, before bedtime. The recommended dose is: Adults Acute schizophrenia and other acute psychoses. Severe acute agitation. Mania. Usually, 10-50 mg is taken per day.

Method of administration

Clopixol can be taken with or without food. The tablets should be swallowed with water. Do not chew.

Duration of treatment

The duration of treatment is determined by the doctor. Treatment should be continued for as long as the doctor recommends, even if the patient's condition improves. The illness may persist for a long time, and if treatment is stopped too early, the symptoms may return. The patient should not change the dose of the medicine without consulting their doctor.

Taking a higher dose of Clopixol than recommended

In case of suspected overdose, the patient should immediately contact their doctor or the nearest hospital emergency department, even if there are no symptoms or signs of poisoning. The patient should take the Clopixol packaging with them. The following overdose symptoms may occur: drowsiness; loss of consciousness; involuntary movements or muscle stiffness; seizures; decreased blood pressure, weak pulse, rapid heart rate, pallor, anxiety; increased or decreased body temperature; changes in heart rhythm, including irregularity or slowing of the heart rate, when Clopixol is administered in excessive doses in combination with medicines known to affect the heart.

Missing a dose of Clopixol

The patient should take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Clopixol

The decision to stop treatment is made by the doctor. Usually, it is recommended to gradually reduce the dose. The doctor will decide when and how to stop treatment to avoid unpleasant withdrawal symptoms that may occur when the medicine is stopped abruptly. Symptoms usually start within 1 to 4 days of stopping the medicine and subside within 7-14 days. Withdrawal symptoms include nausea, vomiting, loss of appetite, diarrhea, rhinorrhea, sweating, muscle pain, paresthesia, insomnia, anxiety, and agitation. Patients may also experience dizziness, increased sensitivity to heat or cold, and tremors. In case of any further doubts about the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Clopixol can cause side effects, although not everybody gets them. If the patient experiences any of the following symptoms, they should contact their doctor or go to the hospital immediately: Uncommon side effects (occurring in 1 in 1000 to 1 in 100 patients): involuntary rhythmic movements of the lips and tongue; this may be a sign of a condition called tardive dyskinesia.

Very rare but serious side effects (occurring in less than 1 in 10,000 patients): high fever, excessive muscle stiffness, and impaired consciousness, with sweating and rapid heart rate; these may be symptoms of a rare condition called neuroleptic malignant syndrome, which can occur with the use of various antipsychotic medicines. Yellowing of the skin and whites of the eyes (jaundice), which may indicate liver damage.

The following side effects are most pronounced at the beginning of treatment and usually subside as treatment continues.

Very common side effects (occurring in more than 1 in 10 patients):

• drowsiness, inability to sit or stand for a long time without moving (akathisia), involuntary movements (hyperkinesia), slowed or impaired movements (hypokinesia);
• dry mouth.

Common side effects (occurring in more than 1 in 100 and less than 1 in 10 patients):

• rapid heartbeat (tachycardia), feeling of rapid, strong, or irregular heartbeat (palpitations);
• tremors, twisting or repetitive movements or abnormal postures due to continuous muscle contraction (dystonia), increased muscle stiffness (hypertonia), dizziness, headache, feeling of tingling of the skin (paresthesia), attention disorders, memory impairment, gait disturbances;
• visual disturbances, blurred vision, accommodation disorders;
• feeling of spinning or swaying when the body is at rest (vertigo);
• "stuffy nose", breathing difficulties or painful breathing (dyspnea);
• increased salivation, constipation, vomiting, gastrointestinal problems or discomfort in the upper abdomen (indigestion), diarrhea;
• urination disorders, urinary retention, increased urine production (polyuria);
• increased sweating, itching (pruritus);
• muscle pain;
• increased appetite, weight gain;
• fatigue, feeling of weakness (asthenia), general feeling of discomfort or anxiety, pain;
• insomnia, depression, anxiety, nervousness, unusual dreams, agitation, decreased libido;

Uncommon side effects (occurring in more than 1 in 1000 and less than 1 in 100 patients):

• excessive reflexes (hyperreflexia), non-smooth movements (dyskinesia), parkinsonism, falls (syncope), inability to coordinate muscle movements (ataxia), speech disorders, decreased muscle tone (hypotonia), seizures, migraine;
• forced gaze with rotation of the eyeballs, pupil dilation;
• hypersensitivity to certain sound frequencies or difficulty tolerating ordinary sounds, ringing in the ears;
• abdominal pain, nausea, bloating with gas;
• rash, skin reactions related to hypersensitivity to light (phototoxicity), pigmentation disorders, oily, shiny, and yellowish skin due to increased sebum production (seborrhea), eczema or skin inflammation, subcutaneous bleeding observed as red discoloration of the skin (purpura);
• muscle stiffness, inability to normally open the mouth, neck twisting, and unnatural head position (neck stiffness);
• decreased appetite, weight loss;
• low blood pressure (hypotension), hot flashes;
• thirst, abnormal low body temperature (hypothermia), fever;
• abnormal liver function test results;
• sexual disorders (delayed ejaculation, erectile dysfunction, in women, orgasmic dysfunction, vaginal dryness);
• marked apathy, nightmares, increased libido, confusion;

Rare side effects (occurring in more than 1 in 10,000 and less than 1 in 1000 patients):

• low platelet count (thrombocytopenia), low white blood cell count (neutropenia), decreased white blood cell count (leukopenia), toxic bone marrow damage (agranulocytosis);
• increased prolactin levels in the blood (hyperprolactinemia);
• increased blood sugar levels (hyperglycemia), impaired glucose tolerance, increased lipid levels in the blood (hyperlipidemia);
• hypersensitivity (allergy), acute systemic and severe allergic reaction (anaphylaxis);
• breast enlargement in men (gynecomastia), excessive milk production (galactorrhea), absence of menstruation, prolonged and painful erection not associated with sexual arousal (priapism).

As with other medicines similar to zuclopenthixol (the active substance of Clopixol), rare cases of the following side effects have been reported:

• slow heart rate and changes in the ECG recording (QT interval prolongation);
• irregular heart rhythm (ventricular arrhythmias, torsades de pointes); in rare cases, irregular heart rhythm (arrhythmia) can lead to sudden death.

Blood clots in the veins, especially in the veins of the legs (symptoms include swelling, pain, and redness of the skin of the legs), which can move through the bloodstream to the lungs, causing chest pain and breathing difficulties. If any of these symptoms occur, the patient should immediately inform their doctor. In elderly patients with dementia, taking antipsychotic medicines, a slightly higher number of deaths has been observed compared to patients not taking antipsychotic medicines.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Clopixol

The medicine should be stored in a place inaccessible to children. Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month. There are no special precautions for the storage of the medicinal product. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Clopixol contains

The active substance of Clopixol is zuclopenthixol (in the form of a dihydrochloride). Each coated tablet contains 10 mg or 25 mg of zuclopenthixol. The other ingredients of the medicine are potato starch, lactose monohydrate, microcrystalline cellulose, copovidone, glycerol 85%, talc, hydrogenated castor oil, magnesium stearate. Coating: hypromellose 5, macrogol 6000, colorants: titanium dioxide (E 171), iron oxide red (E 172), magnesium stearate.

What Clopixol looks like and what the pack contains

Clopixol is available in the form of coated tablets in strengths of 10 mg and 25 mg. The 10 mg coated tablets are round, biconvex, light reddish-brown. The 25 mg coated tablets are round, biconvex, reddish-brown. The coated tablets are packed in high-density polyethylene (HDPE) containers with a desiccant, in a cardboard box. The 10 mg and 25 mg coated tablets: 50 or 100 tablets in one high-density polyethylene (HDPE) container with a desiccant, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

• H. Lundbeck A/S Ottiliavej 9 DK-2500 Valby Denmark

For more detailed information, the patient should contact the representative of the marketing authorization holder:

Lundbeck Poland Sp. z o.o.

Marszałkowska 142, 00-061 Warsaw, Tel.: +48 22 626 93 00, Fax: +48 22 626 93 01

Date of the last update of the leaflet: