CLOPIXOL 25 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Clopixol, 10 mg, coated tablets
3. Clopixol, 25 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the package leaflet:
4. What is Clopixol and what is it used for
   1. How Clopixol works
   2. What Clopixol is used for
5. Important information before taking Clopixol
   1. When not to take Clopixol:
   2. Warnings and precautions
   3. Children and adolescents
   4. Clopixol and other medicines
   5. Taking Clopixol with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Pregnancy
   8. Breastfeeding
   9. Fertility
   10. Driving and using machines
   11. Clopixol contains lactose and hydrogenated castor oil
6. How to take Clopixol
   1. Method of administration
   2. Duration of treatment
   3. Taking a higher dose of Clopixol than recommended
   4. Missing a dose of Clopixol
   5. Stopping treatment with Clopixol
7. Possible side effects
   1. Very common side effects (occurring in more than 1 in 10 patients):
   2. Common side effects (occurring in more than 1 in 100 and less than 1 in 10 patients):
   3. Uncommon side effects (occurring in more than 1 in 1000 and less than 1 in 100 patients):
   4. Rare side effects (occurring in more than 1 in 10,000 and less than 1 in 1000 patients):
   5. Reporting side effects
8. How to store Clopixol
9. Contents of the pack and other information
   1. What Clopixol contains
   2. What Clopixol looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Lundbeck Poland Sp. z o.o.
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the User

Clopixol, 10 mg, coated tablets

Clopixol, 25 mg, coated tablets

Zuclopenthixol

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

• Keep this package 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 inform your doctor or pharmacist. See section 4.

Contents of the package 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 pack 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 pathways of the nerves in certain parts of the brain and help to correct some of the chemical imbalances that cause the symptoms of the disease.

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

Warnings and precautions

Before taking Clopixol, discuss with your doctor or pharmacist:

• if you have liver function disorders;
• if you have had seizures in the past;
• if you have diabetes (your antidiabetic treatment may need to be adjusted);
• if you have an organic brain syndrome (a disease that can develop as a result of alcohol or organic solvent poisoning);
• if you have risk factors for stroke (e.g., smoking, hypertension);
• if you have hypokalemia (low potassium levels in the blood) or hypomagnesemia (low magnesium levels in the blood) or genetic predispositions to such disorders;
• if you have had cardiovascular disorders in the past;
• if you are taking other antipsychotic medicines;
• if you or a family member have 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

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about any medicines you plan to take. Tell your doctor about the use of the following medicines:

• tricyclic antidepressants;
• guanethidine and similar medicines (that lower blood pressure);
• barbiturates and similar medicines (that 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Pregnancy

If you are pregnant or think you may be pregnant, inform your 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 these symptoms occur in the newborn, contact your doctor.

Breastfeeding

If you are breastfeeding, consult your doctor. Clopixol should not be used by breastfeeding women, as small amounts of the medicine may be excreted into breast milk.

Fertility

Animal studies have shown that Clopixol affects fertility. You should consult your doctor for advice.

Driving and using machines

There is a risk of drowsiness and dizziness after taking Clopixol, especially at the beginning. If this happens, do 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 you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine. The medicine contains hydrogenated castor oil, which can cause gastrointestinal upset and diarrhea.

3. How to take Clopixol

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. The medicine is taken in different doses, the size of which depends on the severity of the disease. 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. For 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 per day is used. In cases of moderate and severe severity, the initial dose is 20 mg per day, increased if necessary by 10-20 mg every 2 to 3 days to 75 mg or more per day. The maximum single dose is 40 mg, and the total daily dose is 150 mg. Chronic schizophrenia and other chronic psychoses The maintenance dose is usually 20-40 mg per day. Use in children Clopixol is not recommended for children. Elderly patients Elderly patients should take doses at the lower end of the dosage range. Patients with renal impairment Patients with renal impairment should take Clopixol at the usual doses. Patients with hepatic impairment It is recommended to exercise caution when selecting a dose by the doctor, and if possible, to determine the blood level of the medicine. If you feel that the effect of Clopixol is too strong or too weak, you should consult your doctor.

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 your doctor. Treatment should be continued for as long as your doctor recommends, even if you feel better. The disease can persist for a long time, and if treatment is stopped too early, symptoms may return. You should not change the dose of the medicine without consulting your doctor.

Taking a higher dose of Clopixol than recommended

If you suspect that you have taken too many Clopixol tablets, you should immediately contact your doctor or the emergency department of the nearest hospital, even if you do not have any complaints or symptoms of poisoning. You should take the Clopixol packaging with you. The following symptoms of overdose may occur: drowsiness; loss of consciousness; involuntary movements or muscle stiffness; seizures; decreased blood pressure, weak pulse, rapid heartbeat, pallor, anxiety; increased or decreased body temperature; changes in heart rhythm, including irregularity or slowing of the heartbeat, when Clopixol was administered in too high a dose in combination with medicines known to affect the heart.

Missing a dose of Clopixol

Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Clopixol

The decision to stop treatment is made by your doctor. It is usually recommended to gradually reduce the dose. Your 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 after 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, fear, and agitation. Patients may also experience dizziness, increased sensitivity to heat or cold, and tremors. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Clopixol can cause side effects, although not everybody gets them. If you experience any of the following symptoms, contact your 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. 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 heartbeat; 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;
• feeling of spinning or swaying when the body is at rest (dizziness);
• "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 by the skin (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, abnormally low body temperature (hypothermia), fever;
• abnormal liver function test results;
• sexual disorders (delayed ejaculation, erection problems, in women, orgasm disorder, 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);
• elevated prolactin levels in the blood (hyperprolactinemia);
• elevated blood sugar levels (hyperglycemia), impaired glucose tolerance, elevated 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, persistent and painful erection unrelated to sexual arousal (priapism).

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

• slow heart rate and changes in the ECG (QT interval prolongation);
• irregular heartbeat (ventricular arrhythmias, torsades de pointes); in rare cases, irregular heartbeat (arrhythmia) can be fatal.

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 you experience any of these symptoms, you should immediately inform your doctor. In elderly patients with dementia, taking antipsychotic medicines has been associated with a slightly higher number of deaths than in those not taking antipsychotic medicines.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to: Department for Monitoring of Adverse Reactions to Medicinal Products, 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, you can help provide more information on the safety of this medicine.

5. How to store Clopixol

Keep the medicine out of the reach and sight of 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 storage of the medicinal product. Medicines should 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 pack and other information

What Clopixol contains

The active substance of Clopixol is zuclopenthixol (in the form of 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 contents of the pack

Clopixol is available in the form of coated tablets in a dose 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 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, please 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 last revision of the leaflet: