Clopixol Depot 200 mg/ml solution for injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

Clopixol Depot 200 mg/ml injection solution

zuclopentixol decanoate

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Clopixol Depot is and what it is used for.
2. What you need to know 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 Clopidox Depot is and what it is used for

Clopidox Depot contains the active substance zuclopentixol. Clopidox 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 chemical imbalances in the brain that cause the symptoms of your illness.

Clopidox Depot is indicated for the treatment of chronic and subchronic schizophrenia, particularly in patients in whom establishing compliance with oral administration is difficult.

However, your doctor may prescribe Clopidox Depot for other purposes. Speak with your doctor if you have any questions about why Clopidox Depot has been prescribed for you.

2. What you need to know before taking Clopixol Depot

Do not take Clopixol Depot

• If you are allergic (hypersensitive) to zuclopentixol or to any of the other ingredients of this medicine (listed in section 6).
• If you have reduced consciousness.
• If you have circulatory failure.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Clopixol Depot if you:

• Have a liver problem (liver disease).
• Have a severe respiratory disease.
• Have Parkinson's disease, thyroid disorders, myasthenia gravis, pheochromocytoma, or prostate enlargement.
• Have a history of seizures or fits.
• Have diabetes (your antidiabetic therapy may need adjustment).
• Have organic brain syndrome (this may be a condition resulting from alcohol or organic solvent poisoning).
• Have risk factors for stroke (cerebral infarction), e.g. smoking, hypertension.
• Clopixol belongs to a group of medicines that may cause changes in the electrocardiogram (ECG). To avoid this, it should be used with caution in patients with hypokalemia or hypomagnesemia (low potassium or magnesium levels in the blood) or genetic predisposition to cardiac arrhythmias.
• Have a history of cardiovascular disorders.
• Are taking other antipsychotic medicines.
• Are being treated for any type of cancer.

If you or someone in your family has a history of blood clots, because medicines in this group have been associated with blood clot formation.

If you have persistent signs of infection, consult your doctor, as this may indicate a decrease in white blood cells (leukocytes).

With the use of various antipsychotics, a very rare but serious condition called neuroleptic malignant syndrome has been reported. It is characterized by symptoms such as high fever, unusual muscle stiffness, and altered mental status, especially if accompanied by sweating and rapid heartbeat. If you experience these symptoms, they may indicate this condition and you should contact your doctor (see section on possible side effects).

Movement disorders such as tremors and muscle spasms may occur, especially during the first few days after starting treatment. Inform your doctor, as the dose may need to be reduced. Inform your doctor if symptoms of constant urge to move persist, as these can be controlled with appropriate medication. Inform your doctor if you experience uncontrolled movements of the face and jaw, as discontinuation of treatment may be necessary.

Difficulty in swallowing may occur as a side effect of extrapyramidal symptoms (such as tremors, muscle spasms, or movement disorders), sedation (drowsiness), increased salivation, and/or neuroleptic malignant syndrome (a rare but dangerous reaction with fever, rigid muscles, changes in blood pressure, and coma).

Children and adolescents

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

Taking Clopixol Depot with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor or pharmacist if you are taking any of the following medicines:

• Tricyclic antidepressants.
• Guanethidine and similar medicines (used to lower blood pressure).
• Barbiturates and similar medicines (using these with Clopixol may make you feel drowsy).
• Medicines used to treat epilepsy.
• Levodopa and similar medicines (used to treat Parkinson's disease).
• Metoclopramide (used to treat gastrointestinal disorders).
• Piperazine (used to treat worm infections such as pinworms).
• Medicines that cause disturbances in fluid and electrolyte balance (too little potassium or magnesium in your blood).
• Medicines known to increase the concentration of Clopixol Depot in your blood.

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

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

Clopixol Depot and alcohol

Clopixol Depot may enhance the sedative effects of alcohol, causing drowsiness. It is advisable not to drink alcohol during treatment with Clopixol Depot.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Do not take Clopixol Depot during pregnancy unless clearly necessary.

You should not use Clopixol Depot during breastfeeding, as small amounts of the medicine may pass into breast milk.

The following symptoms may occur in newborns whose mothers have taken Clopixol during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, sleepiness, agitation, breathing difficulties, and feeding problems.

If your baby shows any of these symptoms, you should contact your doctor.

Animal studies have shown that Clopixol affects fertility. Please consult your doctor.

Driving and using machines

Clopixol may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may reduce reaction ability. These effects, as well as the illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your doctor has assessed your response to this medicine.

3. How to take Clopixol Depot

Follow exactly the administration instructions for this medicine as given by your doctor. Your doctor will decide the correct volume of medicine and how often it should be administered.

A small volume of Clopixol Depot is drawn into a syringe and then injected intramuscularly into your buttock.

The medicine is slowly released from the injection you receive in your buttock, providing an almost constant amount of drug in the bloodstream between injections.

The recommended dose is:

Adults

The usual dose is 1–3 ml, and the interval between injections is normally 1 to 4 weeks.

If your dose exceeds 2 ml of medication, it will likely be divided between two injection sites.

If you have been treated with Clopixol tablets and have switched to Clopixol Depot, you will be asked to continue taking the tablets for a few days after the first injection.

Occasionally, your doctor may decide to adjust your dose or the interval between injections.

Elderly patients (over 65 years of age)

The lower dose range is generally recommended.

Patients at special risk

Patients with liver problems usually receive the lowest dose range.

Use in children

Clopixol Depot is not recommended for use in children.

If you feel that the effect of Clopixol Depot is too strong or too weak, talk to your doctor or pharmacist.

Duration of treatment

It is important that you continue receiving your treatment at regular intervals, even if you feel completely well, as the underlying illness may persist for a long time. If you stop treatment too early, your symptoms may return.

Your doctor will decide the duration of treatment.

If you receive more Clopixol Depot than you should

This medicine will be administered by your doctor or nurse. It is unlikely that you will receive more Clopixol Depot than prescribed.

In case of overdose or accidental ingestion, contact your doctor immediately or call the Toxicology Information Service at: 91 562 04 20, stating the name of the medicine and the amount administered.

Symptoms of overdose may include:

• Drowsiness
• Coma
• Unusual movements
• Seizures
• Shock
• High or low body temperature
• Changes in heartbeats have been observed, including irregular heartbeats or slow heart rate, when Clopixol Depot has been administered in overdose together with drugs known to affect the heart.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following symptoms, you should contact your doctor or go to hospital immediately.

Uncommon (may affect up to 1 in 100 people):

• Unusual movements of the mouth and tongue.

This may be an early sign of a condition called tardive dyskinesia.

Rare (may affect up to 1 in 1,000 people):

• Difficulty swallowing (see section 2).

Very rare (may affect up to 1 in 10,000 people):

• High fever, unusual muscle rigidity, and altered consciousness, especially if occurring with sweating and rapid heartbeat. These symptoms may be signs of a rare condition called neuroleptic malignant syndrome, which has been reported with the use of various antipsychotics.

• Yellowing of the skin and whitening of the eyes; this may indicate liver involvement and is a sign of a condition known as jaundice.

The following adverse effects are more pronounced at the beginning of treatment and most of them usually disappear during continued treatment.

Very common (may affect more than 1 in 10 people):

• Drowsiness (somnolence), difficulty sitting still or staying upright (akathisia), involuntary movements (hyperkinesia), slow or reduced movements (hypokinesia).
• Dry mouth.
• Movement disorders (extrapyramidal symptoms): due to effects on a part of the brain that regulates movement, which may cause tremors, muscle spasms, or movement disorders (see section 2).

Common (may affect up to 1 in 10 people):

• Fast heartbeat (tachycardia), sensation of rapid, forceful, or irregular heartbeats (palpitations).
• Tremor, repetitive circles or movements, or abnormal postures due to continuous muscle contractions (dystonia), increased muscle stiffness (hypertonia), dizziness, headache, tingling, burning, or numbness of the skin (paresthesia), attention disturbance, amnesia, abnormal gait.
• Difficulty focusing on objects close to the eye (accommodation disorder), visual abnormalities.
• Sensation of spinning or swaying when the body is still (vertigo).
• Nasal passage blockage (nasal congestion), difficulty breathing or painful breathing (dyspnea).
• Increased salivary secretion (hypersalivation), constipation, vomiting, digestive problems or discomfort centered in the upper abdomen (dyspepsia), diarrhea.
• Urinary disorder (urinary retention), increased urine volume (polyuria).
• Increased sweating (hyperhidrosis), itching (pruritus).
• Muscle pain (myalgia).
• Increased appetite, weight gain.
• Lack of sleep (insomnia), depression, anxiety, nervousness, abnormal dreams, agitation, decreased sexual behavior (decreased libido).
• General feeling of discomfort or restlessness (malaise), fatigue, weakness (asthenia), pain.

Uncommon (may affect up to 1 in 100 people):

• Hyperactive or hyperresponsive (hyperreflexia), jerky movements (dyskinesia), parkinsonism, fainting (syncope), inability to coordinate muscle activity (ataxia), speech disorder, decreased muscle tone (hypotonia), seizures, migraine.
• Circular eye movements (oculogyria), dilated pupils (mydriasis).
• Oversensitivity to certain sound frequencies or difficulty tolerating everyday sounds (hyperacusis), ringing in the ears (tinnitus).
• Abdominal pain, flatulence.
• Rash, skin reaction due to sensitivity to light (photosensitivity reaction), pigment disorder, oily, shiny skin with yellowish color due to increased sebum secretion (seborrhea), eczema or skin inflammation (dermatitis), bleeding under the skin observed as purple or red skin discolorations (purpura).
• Muscle stiffness, inability to open the mouth normally (trismus), neck twisting and unnatural head position (torticollis, wry neck, neck stiffness).
• Decreased appetite, weight loss.
• Low blood pressure (hypotension), hot flushes.
• Thirst, abnormally low body temperature (hypothermia), fever (pyrexia).
• Redness or pain at the injection site of Clopixol depot.
• Abnormal liver function tests.
• Sexual disorder (delayed ejaculation, erection problems, women may have difficulty reaching orgasm, vaginal dryness (vulvovaginal dryness)).
• Marked indifference to one's surroundings (apathy), nightmares, increased sexual behavior (increased libido), confusion.

Rare (may affect up to 1 in 1,000 people):

• Low platelet count in blood (thrombocytopenia), low white blood cell count in blood (neutropenia), reduced number of white blood cells in blood (leukopenia), bone marrow poisoning (agranulocytosis).
• Increased prolactin level in blood (hyperprolactinemia).
• High blood sugar (hyperglycemia), altered glucose tolerance, increased blood fat levels (hyperlipidemia).
• Excessive sensitivity (hypersensitivity), acute and severe systemic allergic reaction (anaphylactic reaction).
• Breast development in men (gynecomastia), excessive milk production (galactorrhea), absence of menstrual periods (amenorrhea), painful, persistent erection of the penis not associated with sexual excitement or desire (priapism).

As with other medicines that act similarly to zuclopentixol decanoate (the active substance in Clopixol Depot), the following adverse effects have been reported in rare cases:

• QT prolongation (slow heartbeat and changes in the ECG).
• Irregular heartbeats (ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia).
• Torsades de Pointes (a special type of irregular heartbeat).

In rare cases, irregular heartbeats (arrhythmias) may result in sudden death.

Blood clots in the veins, particularly in the legs (symptoms include swelling, pain, and redness in the legs), may travel through blood vessels to the lungs and cause chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.

In elderly patients with dementia, a small increase in the number of deaths has been reported among those taking antipsychotics compared to those who do not.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clopixol Depot

Normally your doctor or nurse will store this medicine for you.

If you store it at home:

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Keep the ampoules in the outer container to protect them from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Clopixol Depot

The active substance is zuclopentixol decanoate.

Each millilitre (ml) of Clopixol Depot contains 200 mg of zuclopentixol decanoate.

The other component is medium-chain triglycerides.

Appearance of the product and contents of the pack

Clopixol Depot 200 mg/ml injection is supplied in glass ampoules containing 1 ml (200 mg), packed in a cardboard carton.

Clopixol Depot is a clear, yellowish liquid.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Lundbeck España, S.A.

Av. Diagonal, 605, 7º-2ª

08028 Barcelona

Spain

Tel.: 93 494 96 20

Manufacturer

• Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Date of the most recent revision of this summary: 01/2026

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/