CLOPIXOL-DEPOT 200 mg Solution

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Clopixol Depot, 200 mg/ml, Solution for Injection
   1. Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
   2. Contents of the pack and other information
3. What Clopixol Depot is and what it is used for
   1. How Clopixol Depot works
   2. What Clopixol Depot is used for
4. Before you use Clopixol Depot
   1. When not to use Clopixol Depot
   2. Warnings and precautions
   3. Children and adolescents
   4. Clopixol Depot with other medicines
   5. Using Clopixol Depot with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Pregnancy
   8. Breastfeeding
   9. Fertility
   10. Driving and using machines
5. How to use Clopixol Depot
   1. Duration of treatment
   2. Using more Clopixol Depot than you should
6. Possible side effects
   1. Reporting side effects
7. How to store Clopixol Depot
8. Contents of the pack and other information
   1. What Clopixol Depot contains
   2. What Clopixol Depot 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 Depot, 200 mg/ml, Solution for Injection

Zuclopenthixol Decanoate

Read all of this leaflet carefully before you start using 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, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Clopixol Depot is and what it is used for
• 2. Before you use Clopixol Depot
• 3. How to use Clopixol Depot
• 4. Possible side effects
• 5. How to store Clopixol Depot
• 6. Contents of the pack and other information

1. What Clopixol Depot is and what it is used for

How Clopixol Depot works

Clopixol Depot contains the active substance zuclopenthixol. Clopixol Depot 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 correct some of the chemical imbalances that cause the symptoms of the disease.

What Clopixol Depot is used for

Clopixol Depot is used for the maintenance treatment of schizophrenia and other psychoses, especially where there are symptoms such as hallucinations, delusions, thought disturbances with agitation, hostility, and aggression.

2. Before you use Clopixol Depot

When not to use Clopixol Depot

• if you are allergic (hypersensitive) to zuclopenthixol decanoate or any of the other ingredients of this medicine (listed in section 6).
• if you have a condition with severe circulatory problems, reduced consciousness (e.g. due to alcohol, barbiturates, or opioids), or coma.

Warnings and precautions

Before starting treatment with Clopixol Depot, tell your doctor or pharmacist:

• if you have liver problems;
• if you have had seizures (fits) in the past;
• if you have diabetes (your antidiabetic treatment may need to be adjusted);
• if you have an organic brain syndrome (a condition that can develop as a result of alcohol or organic solvent poisoning);
• if you have risk factors for stroke (e.g. smoking, high blood pressure);
• if you have low potassium or 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 such medicines is associated with the formation of blood clots.

Children and adolescents

Clopixol Depot is not recommended for use in children and adolescents.

Clopixol Depot with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including:

• 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 (leading to low potassium or magnesium levels in the blood);
• medicines known to increase blood levels of zuclopenthixol, the active substance of Clopixol Depot.

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

• medicines that affect heart action (quinidine, amiodarone, sotalol, dofetilide, erythromycin, terfenadine, astemizole, gatifloxacin, moxifloxacin, cisapride, lithium);
• other antipsychotic medicines (e.g. thioridazine);
• medicines that impair bone marrow function, such as those used to treat cancer.

Using Clopixol Depot with food, drink, and alcohol

Clopixol Depot may increase the sedative effect of alcohol, causing drowsiness. It is not recommended to drink alcoholic beverages while using Clopixol Depot.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you are pregnant or think you may be pregnant, tell your doctor. Clopixol Depot should not be used during pregnancy unless clearly necessary. In newborns of mothers who have used Clopixol during 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 problems, and feeding difficulties. If your baby develops any of these symptoms, you should contact your doctor.

Breastfeeding

If you are breastfeeding, consult your doctor. Clopixol Depot should not be used during breastfeeding as small amounts of the medicine may be excreted in 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 using Clopixol Depot, especially at the beginning. If this happens, do not drive or operate machinery until these symptoms have resolved.

3. How to use Clopixol Depot

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. The appropriate volume of Clopixol Depot is drawn into a syringe and then injected into the buttock muscle. Your doctor decides on the dose and frequency of injections. The medicine is slowly released from the injected solution into the bloodstream, providing a constant supply of the medicine between injections. The recommended dose is: Adults: For maintenance treatment, the dose is usually 200 mg to 400 mg (1 to 2 ml) every two or four weeks. For some patients, higher doses or shorter intervals between injections may be necessary. If the injected volume is greater than 2 ml, the dose should be divided and injected into two different sites. Patients who have previously been treated with other long-acting (depot) medicines should receive doses calculated according to the following scheme: 200 mg of zuclopenthixol decanoate corresponds to 25 mg of fluphenazine decanoate or 40 mg of cis(Z)-flupentixol decanoate or 50 mg of haloperidol decanoate. Sometimes your doctor may decide to change the dose or the interval between injections. Elderly patients (over 65 years): Elderly patients are usually given doses at the lower end of the dose range. Use in children: Clopixol Depot is not recommended for use in children. Patients with kidney problems: Patients with kidney problems can be given Clopixol Depot at the usual doses. Patients with liver problems: Caution is recommended when selecting the dose, and if possible, the blood level of the medicine should be monitored. If you feel that the effect of Clopixol Depot is too strong or too weak, talk to your doctor.

Duration of treatment

Treatment should be continued at regular intervals, even if you feel better. The disease can persist for a long time, and if treatment is stopped too early, symptoms may return. The duration of treatment is determined by your doctor.

Using more Clopixol Depot than you should

This medicine will be administered by a doctor or nurse. In the unlikely event of an overdose, the patient may experience symptoms of overdose. Symptoms of overdose may include: drowsiness, coma, abnormal movements, seizures, shock, increased or decreased body temperature, changes in heart rate, including irregularity or slowing of the heart, especially when Clopixol Depot is given in high doses in combination with medicines known to affect the heart. 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 Depot 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, accompanied by 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. blood clots in the veins, especially in the legs (the 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 difficulty breathing. The following side effects are most pronounced at the beginning of treatment and usually resolve as treatment continues. Very common side effects (occurring in more than 1 in 10 patients): drowsiness, inability to sit or stand for long periods without moving (akathisia), involuntary movements (hyperkinesia), slow or impaired movements (hypokinesia); dry mouth. Common side effects (occurring in more than 1 in 100 but less than 1 in 10 patients): rapid heartbeat (tachycardia), feeling of fast, 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 loss, abnormal gait; blurred vision, eye movement 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; urinary disorders, urinary retention, increased urine production (polyuria); excessive 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, abnormal dreams, agitation, decreased sex drive (libido). Uncommon side effects (occurring in more than 1 in 1000 but less than 1 in 100 patients): excessive reflexes (hyperreflexia), non-smooth movements (dyskinesia), parkinsonism, fainting (syncope), inability to coordinate muscle movements (ataxia), speech disorders, decreased muscle tone (hypotonia), seizures, migraine; involuntary eye movement, pupil dilation; hypersensitivity to certain sound frequencies or difficulty tolerating everyday sounds, ringing in the ears; abdominal pain, nausea, bloating with gas; rash, skin reactions related to hypersensitivity to light (phototoxicity), skin discoloration, oily, shiny, and yellowish skin due to increased sebum production (seborrhoea), 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; redness or pain at the injection site; abnormal liver function test results; sexual disorders (delayed ejaculation, erectile dysfunction, in women, orgasm disorder, vaginal dryness); marked apathy, nightmares, increased sex drive (libido), confusion. Rare side effects (occurring in more than 1 in 10,000 but 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 (ginecomastia), excessive milk production (galactorrhoea), absence of menstruation, persistent and painful erection unrelated to sexual desire (priapism); as with other medicines similar to zuclopenthixol decanoate (the active substance of Clopixol Depot), slow heart rate and changes in the ECG (prolonged QT interval); irregular heartbeat (ventricular arrhythmias, torsades de pointes); in rare cases, irregular heartbeat (arrhythmia) can lead to sudden death. In elderly patients with dementia treated with antipsychotic medicines, a slightly higher number of deaths has been observed than in those not taking antipsychotic medicines.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. Side effects can be reported directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clopixol Depot

Keep this medicine out of the sight and reach 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 storage precautions for the medicinal product. Store the ampoules in the outer packaging to protect from light. 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 Depot contains

The active substance is zuclopenthixol decanoate. Each milliliter (ml) of Clopixol Depot contains 200 mg of zuclopenthixol decanoate. The other ingredient is vegetable oil (medium-chain triglycerides).

What Clopixol Depot looks like and contents of the pack

Clopixol Depot is available as a solution for injection with a concentration of 200 mg/ml. Clopixol Depot is a clear, yellowish liquid. Clopixol Depot is available in colorless glass ampoules containing 1 ml (200 mg) of the medicine. The ampoules are packaged in cardboard boxes containing 1 ampoule of 1 ml or 10 ampoules of 1 ml. 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 marketing authorization holder.

Lundbeck Poland Sp. z o.o.

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

Date of last revision of the leaflet: