Clopixol 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clopixol 10 mg film-coated tablets

Zuclopentixol

Read the entire leaflet carefully before you start taking this medicine, because 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

Clopixol contains the active substance zuclopentixol. Clopixol 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.

Clopixol is used for the treatment of chronic and subchronic schizophrenia, including acute episodes, particularly in agitated and/or aggressive patients.

However, your doctor may prescribe Clopixol for another purpose. Speak with your doctor if you have any questions about why Clopixol has been prescribed for you.

2. What you need to know before taking Clopixol

Do not take Clopixol

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

Warnings and precautions

• Consult your doctor or pharmacist before starting Clopixol if you:
  • Have a liver problem (liver disease).
  • Have a severe respiratory illness.
  • Have Parkinson's disease, thyroid disorders, myasthenia gravis, pheochromocytoma, or prostate enlargement.
  • Have a history of seizures or fits.
  • Have diabetes (adjustment of your antidiabetic therapy may be necessary).
  • Have organic brain syndrome (this may be a condition occurring after 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 prevent 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.
  • You or a family member have a history of blood clots, as medicines in this group have been associated with blood clot formation.

If you have persistent symptoms of infection, consult your doctor, as this may indicate a reduction in white blood cells (leukopenia).

A very rare but serious condition called neuroleptic malignant syndrome has been reported with the use of various antipsychotics. It is characterized by symptoms such as high fever, unusual muscle stiffness, and altered consciousness, especially if accompanied by sweating and rapid heartbeat. If you experience these symptoms, they may indicate this condition and you should see a doctor immediately (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 it may be necessary to reduce the dose. Inform your doctor if you continue to experience symptoms of constant restlessness, as these can be managed with appropriate medication. Inform your doctor if you experience uncontrolled movements of the face and jaw, as treatment may need to be discontinued.

Difficulty 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 is not recommended for use in this patient group.

Taking Clopixol with other medicines

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

Tell 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 (use 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 in your blood.

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

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

Taking Clopixol with food and alcohol

Clopixol may be taken with or without food.

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

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 during pregnancy unless clearly necessary.

You should not use Clopixol while 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 use of machines

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

Clopixol contains lactose and hydrogenated castor oil

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Hydrogenated castor oil may cause stomach discomfort and diarrhea.

3. How to take Clopixol

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose varies considerably and depends on the severity of the illness.

The recommended dose is:

Adults

The usual starting dose is generally between 20 mg and 30 mg per day, which may be gradually increased up to a maximum of 150 mg per day, divided into several doses.

In some cases, a considerable increase in dose may be required. The maximum dose is 150 mg per day.

The maintenance dose is generally 20–40 mg per day.

Elderly patients

The dose is normally between 2 mg and 6 mg per day, taken in the late afternoon. The dose may be increased to 10–20 mg per day.

Patients at special risk

Patients with hepatic impairment usually receive the lowest dose range.

Use in children

Clopixol is not recommended for use in children.

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

How and when to take Clopixol

Swallow the tablets with a glass of water. They must not be chewed.

At the beginning of treatment, Clopixol should normally be taken in 2 or 3 separate doses during the day.

For maintenance treatment, Clopixol may be taken as a single daily dose.

Duration of treatment

As with other medicines for psychosis, it may take a couple of weeks before you start to feel better.

Your doctor will decide the duration of treatment. Continue taking the tablets for the length of time recommended by your doctor. The underlying illness may last a long time, and if you stop treatment too early, your symptoms may return.

Never change the dose of your medicine without first talking to your doctor.

If you take more Clopixol than you should

In case of overdose, contact your doctor immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose may include:

• Drowsiness.
• Unconsciousness.
• Unusual muscle movements or rigidity.
• Seizures.
• Low blood pressure, weak pulse, rapid heart rate, pallor, restlessness.
• High or low body temperature.
• Changes in heartbeat have been observed, including irregular heartbeats or slow heart rate, when Clopixol has been administered in overdose together with drugs known to affect the heart.

If you forget to take Clopixol

If you forget to take a dose, take the next dose at your usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Clopixol

Your doctor will decide when and how to stop your treatment to avoid unpleasant symptoms that may occur if treatment is stopped abruptly (e.g. difficulty sleeping, muscle stiffness, feeling unwell).

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 or standing (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):

• Rapid heartbeat (tachycardia), sensation of rapid, forceful, or irregular heartbeats (palpitations).
• Tremor, repetitive 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 stationary (vertigo).
• Nasal passage blockage (nasal congestion), breathing difficulty 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.
• Insomnia, fatigue, weakness (asthenia), general discomfort or restlessness (malaise), pain.
• Sleeplessness (insomnia), depression, anxiety, nervousness, abnormal dreams, agitation, decreased sexual behavior (decreased libido).

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

• Hyperactive or hyperresponsive reflexes (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), pigmentation disorder, oily, shiny skin with yellowish discoloration due to increased sebum secretion (seborrhea), eczema or skin inflammation (dermatitis), bleeding under the skin observed as purple or red skin discolorations (purpura).
• Muscle rigidity, inability to open the mouth normally (trismus), neck twisting and unnatural head position (torticollis, neck twisting, neck stiffness).
• Decreased appetite, weight loss.
• Low blood pressure (hypotension), hot flushes.
• Thirst, abnormally low body temperature (hypothermia), fever (pyrexia).
• Abnormal liver function tests.
• Sexual disorders (delayed ejaculation, erection problems, women may have difficulty achieving orgasm, vaginal dryness (vulvovaginal dryness)).
• Marked indifference to 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 (leucopenia), bone marrow poisoning (agranulocytosis).
• Increased prolactin level in blood (hyperprolactinemia).
• High blood sugar (hyperglycemia), impaired 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 penile erection, persistent and not accompanied by sexual excitement or desire (priapism).

As with other medicines that act similarly to zuclopentixol (the active substance in Clopixol), 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 specific 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 slight 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 adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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

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 is the last day of the month indicated.

No special storage conditions are required.

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. Contents of the pack and other information

Composition of Clopixol

The active substance is zuclopentixol (as dihydrochloride).

Each film-coated tablet contains 10 mg of zuclopentixol as dihydrochloride.

The other components are: potato starch, lactose monohydrate, microcrystalline cellulose, copovidone, glycerol 85%, talc, hydrogenated castor oil, and magnesium stearate.

Coating: hypromellose 5 and macrogol 6000.

Colourants: titanium dioxide (E-171) and red iron oxide (E-172).

Appearance of the product and contents of the pack

Clopixol is available as film-coated tablets (tablets) containing 10 mg.

Description of the film-coated tablets:

The 10 mg film-coated tablets are round, biconvex, light reddish-brown in colour.

Clopixol film-coated tablets are available in packs containing 30 or 50 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Lundbeck España, S.A.
Av. Diagonal, 605, 7º2ª
E-08028 Barcelona
Tel.: 93 494 96 20

Manufacturer

• Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark

Date of the most recent revision of this leaflet: 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/