Clopixol-depot

Package leaflet: Information for the user

Clopixol Depot, 200 mg/ml, solution for injection
Zuclopenthixol decanoate
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Clopixol Depot is and what it is used for
2. Important information before using 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 act on nerve pathways in specific areas of the brain and help correct certain imbalances in brain chemistry that cause illness symptoms.

When Clopixol Depot is used
Clopixol Depot is used for the maintenance treatment of schizophrenia and other psychoses, particularly those with symptoms such as hallucinations, delusions, thought disorders with agitation, psychomotor restlessness, hostility, and aggression.

2. Important information before using Clopixol Depot

When not to use Clopixol Depot:

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

Warnings and precautions
Before starting treatment with Clopixol Depot, discuss the following with the doctor or pharmacist:

• if the patient has impaired liver function;
• if the patient has previously experienced seizures;
• if the patient has diabetes (treatment with antidiabetic medicines may need to be adjusted);
• if the patient has organic brain syndrome (a condition that may develop as a result of alcohol or organic solvent intoxication);
• if the patient has risk factors for stroke (e.g. smoking, hypertension);
• if the patient has hypokalaemia (low blood potassium levels) or hypomagnesaemia (low blood magnesium levels), or genetic predisposition to such abnormalities;
• if the patient has previously had cardiovascular disorders;
• if the patient is taking other antipsychotic medicines;
• if the patient or someone in their family has had venous thrombosis, as use of medicines like this may increase the risk of blood clots.

Children and adolescents
Clopixol Depot is not recommended for use in this patient group.

Clopixol Depot and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Inform the treating doctor if any of the following medicines are being used:

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

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

• medicines affecting heart rhythm (quinidine, amiodarone, sotalol, dofetilide, erythromycin, terfenadine, astemizole, gatifloxacin, moxifloxacin, cisapride, lithium);
• other antipsychotic medicines (e.g. thioridazine);
• medicines that suppress bone marrow function, e.g. medicines used in cancer treatment.

Use of Clopixol Depot with food, drink and alcohol
Clopixol Depot may enhance the sedative effect of alcohol and cause drowsiness. Drinking alcoholic beverages is not recommended during treatment with Clopixol Depot.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
If the patient is pregnant or suspects she may be pregnant, she should inform her doctor. Clopixol Depot should not be used during pregnancy unless clearly necessary.

Newborn babies of mothers who have taken Clopixol during the third trimester (last three months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, restlessness, breathing difficulties, feeding problems. If such symptoms occur in the newborn, contact a doctor immediately.

Breastfeeding
If the patient is breastfeeding, she should consult her doctor. Clopixol Depot should not be used by breastfeeding women, as small amounts of the medicine may be excreted in breast milk.

Fertility
Animal studies indicate that Clopixol may affect fertility. The patient should consult a doctor for advice.

Driving and operating machinery
There is a risk of drowsiness and dizziness after using Clopixol Depot, especially at the beginning of treatment. If this occurs, the patient should not drive, operate machinery, or use tools 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 have any doubts,
please consult your doctor or pharmacist.
The appropriate volume of Clopixol Depot is drawn into a syringe and then injected into the gluteal
muscle.
Your doctor will determine the dose and frequency of injections.
The medicine is slowly released from the injected solution into the bloodstream, providing a steady supply of the drug between injections.

Recommended dose:
Adults
For maintenance treatment, the usual dose is 200 mg to 400 mg (1 to 2 ml) every two or four weeks.
Some patients may require higher doses or shorter intervals between doses. If the volume of medicine to be injected exceeds 2 ml, the divided dose should be administered at two different injection sites.

When switching treatment from oral zuclopenthixol or intramuscular zuclopenthixol acetate to maintenance treatment with zuclopenthixol decanoate, follow the recommendations below:

1) Switching from oral zuclopenthixol to zuclopenthixol decanoate
x mg of zuclopenthixol dihydrochloride taken orally per day corresponds to 8 x mg of zuclopenthixol decanoate every two weeks (for example, 1 mg of zuclopenthixol dihydrochloride taken orally per day corresponds to 8 mg of zuclopenthixol decanoate every two weeks);
x mg of zuclopenthixol dihydrochloride taken orally per day corresponds to 16 x mg of zuclopenthixol decanoate every four weeks (for example, 1 mg of zuclopenthixol dihydrochloride taken orally per day corresponds to 16 mg of zuclopenthixol decanoate every four weeks).
For one week after the first injection, continue oral zuclopenthixol treatment but gradually reduce the dose.

2) Switching from zuclopenthixol acetate to zuclopenthixol decanoate
At the same time as the (last) injection of zuclopenthixol acetate (100 mg), administer 200–400 mg (1 to 2 ml) of zuclopenthixol decanoate intramuscularly in a solution of 200 mg/ml concentration.
Thereafter, repeat zuclopenthixol decanoate injections every two weeks. Higher doses or shorter intervals between injections may be required.
Zuclopenthixol acetate and zuclopenthixol decanoate may be mixed in the same syringe and administered in a single injection.

Patients previously treated with other depot (long-acting) formulations should receive doses calculated according to the following conversion:
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.

Your doctor may occasionally decide to adjust the dose or change the injection intervals.

Elderly patients (over 65 years of age)
Elderly patients are usually given doses at the lower end of the recommended dose range.

Use in children
Clopixol Depot is not recommended for use in children.

Patients with impaired kidney function
Clopixol Depot may be administered to patients with impaired kidney function at the usual recommended doses.

Patients with impaired liver function
Caution is advised when determining the dose, and if possible, monitoring of blood drug levels is recommended.

If you feel that the effect of Clopixol Depot is too strong or too weak, please consult your doctor.

Duration of treatment
Treatment should be continued at regular intervals, even if your condition improves. The illness may persist for a long time, and if treatment is stopped too early, symptoms may return.
The duration of treatment is determined by your doctor.

Overdose of Clopixol Depot
This medicine will be administered by a doctor or nurse. In the unlikely event of overdose, symptoms of overdose may occur.
Symptoms of overdose may include:

• drowsiness;
• coma;
• abnormal movements;
• seizures;
• shock;
• elevated or reduced body temperature;
• changes in heart function, including irregularity or slowing of heartbeat, particularly when Clopixol Depot has been administered in too high a dose in combination with medicines known to affect the heart.

If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Clopixol Depot may cause adverse reactions, although not everyone experiences them.
If any of the symptoms described below occur, contact your doctor or go to hospital immediately:

Uncommon adverse reactions (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 adverse reactions (occurring in fewer than 1 in 10,000 patients):

• high fever, excessive muscle stiffness, and disturbances in consciousness, accompanied by sweating and rapid heartbeat; these may be symptoms of a rare condition called neuroleptic malignant syndrome, which may occur after using various antipsychotic medicines.

• yellowing of the skin and whites of the eyes (jaundice), which may indicate liver damage.

• blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness of the skin in the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties.

The adverse reactions listed below are most pronounced at the beginning of treatment, and most of them diminish with continued therapy.

Very common adverse reactions (occurring in more than 1 in 10 patients):

• drowsiness, inability to sit or stand still for a prolonged period (akathisia), involuntary movements (hyperkinesia), slowed or reduced movements (hypokinesia);
• dry mouth.

Common adverse reactions (occurring in more than 1 and fewer than 10 in 100 patients):

• palpitations (tachycardia), sensation of rapid, strong, or irregular heartbeat;
• tremor, twisting or repetitive movements or unusual postures due to sustained muscle contractions (dystonia), increased muscle stiffness (hypertonia), dizziness, headache, sensation of tingling or numbness of the skin (paresthesia), attention disturbances, forgetfulness, abnormal gait;
• blurred vision of nearby objects (accommodation disorders), visual disturbances;
• sensation of spinning or swaying while the body is at rest (dizziness);
• "stuffy nose", difficulty breathing or painful breathing (dyspnea);
• increased salivation (sialorrhea), constipation, vomiting, digestive problems or discomfort in the upper abdomen (dyspepsia), diarrhea;
• urinary disorders, urinary retention, increased urine volume (polyuria);
• excessive sweating, itching (pruritus);
• muscle pain;
• increased appetite, weight gain;
• fatigue, feeling of weakness (asthenia), general discomfort or uneasiness, pain-related symptoms;
• insomnia, depression, anxiety, nervousness, abnormal dreams, restlessness, reduced sexual drive (decreased libido);

Uncommon adverse reactions (occurring in more than 1 in 1000 and fewer than 1 in 100 patients):

• exaggerated reflexes (hyperreflexia), uncoordinated movements (dyskinesia), parkinsonism, falls (fainting), inability to coordinate muscle activity (ataxia), speech disturbances, reduced muscle tone (hypotonia), seizures, migraine;
• sudden forced eye deviation with eye rotation, pupil dilation;
• hypersensitivity to certain sound frequencies or difficulty tolerating normal (everyday) sounds, ringing in the ears (tinnitus);
• abdominal pain, nausea, bloating with gas release;
• skin rash, skin reactions due to light sensitivity (photosensitivity), pigmentary disturbances, oily, shiny, and yellowish skin due to increased sebum production (seborrhoea), eczema or skin inflammation, bleeding under the skin observed as red skin discolorations (purpura);
• muscle stiffness, inability to open the mouth normally, neck twisting, and unnatural head position (neck stiffness);
• decreased appetite, weight loss;
• low blood pressure (hypotension), hot flushes;
• thirst, abnormally low body temperature (hypothermia), fever;
• redness or pain at the injection site of Clopixol Depot;
• abnormal liver function test results;
• sexual disorders (delayed ejaculation, erectile dysfunction, in women: orgasmic disorders, vaginal dryness);
• marked indifference to surroundings (apathy), nightmares, increased sexual drive (increased libido), confusion;

Rare adverse reactions (occurring in more than 1 in 10,000 and fewer than 1 in 1000 patients):

• low platelet count (thrombocytopenia), low white blood cell count (neutropenia), reduced white blood cell count (leukopenia), toxic bone marrow damage (agranulocytosis);
• increased prolactin levels in blood (hyperprolactinaemia);
• increased blood sugar levels (hyperglycaemia), impaired glucose tolerance, increased blood lipid levels (hyperlipidaemia);
• overreaction (hypersensitivity), acute systemic and severe allergic reaction (anaphylactic reaction);
• breast enlargement in men (gynaecomastia), excessive milk production (galactorrhoea), absence of menstruation, persistent painful erection not associated with sexual excitement (priapism);
• as with other medicines acting similarly to zuclopenthixol decanoate (the active substance in Clopixol Depot): slow heart rate and changes in ECG recording (QT interval prolongation);
• irregular heartbeat (ventricular arrhythmias, torsade de pointes);
• in rare cases, irregular heartbeat (arrhythmia) may lead to sudden death. In elderly patients with dementia treated with antipsychotic medicines, a slightly higher number of deaths has been observed compared to patients not receiving antipsychotic treatment.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Clopixol-Depot

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 stated month.
There are no special requirements regarding the storage temperature of the medicinal product.
Store the ampoules in the outer packaging to protect them from light.
Medicines must 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 package and other information

What Clopixol Depot contains
The active substance in Clopixol Depot is zuclopenthixol decanoate.
Each millilitre (ml) of Clopixol Depot contains 200 mg of zuclopenthixol decanoate.
Another component of the medicine is plant oil (medium-chain triglycerides).

What Clopixol Depot looks like and contents of the pack
Clopixol Depot is available as an injection solution at a concentration of 200 mg/ml.
Clopixol Depot is a clear, yellowish liquid.
Clopixol Depot is supplied in colourless glass ampoules containing 1 ml (200 mg) of the medicine.
The ampoules are packed in cardboard boxes containing either 1 ampoule of 1 ml or 10 ampoules of 1 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
H. Lundbeck A/S
Ottiliavej 9,
DK-2500 Valby
Denmark

For further information, please contact the Marketing Authorisation Holder.

Swixx Biopharma Sp. z o.o.
ul. Prosta 51
00-838 Warsaw, Poland
Tel. +48 22 4600 720