Leaflet CLOPIXOL 25mg film-coated tablets

Indicated for: schizophrenia; bipolar disorder

Route of administration: oral

Substance: zuclopenthixol (antipsychotic)

ATC: N05AF05 (Nervous system | Antipsychotics | Thioxanthene derivatives)

Precautions:
Driving impairment
Driving impairment

This medicine may affect your ability to drive or use machines.

Dizziness / vertigo
Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Hyperglycemia
Hyperglycemia

This medicine may increase blood sugar.

Cardiac risk / QT prolongation / arrhythmias
Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

Seizure risk
Seizure risk

This medicine may increase the risk of seizures.

Drowsiness / sedation
Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

Zuclopenthixol is an antipsychotic medication from the thioxanthene class, used to treat schizophrenia and other psychotic disorders characterized by symptoms such as hallucinations, delusions, agitation, and aggressive behavior. It works by blocking dopamine (D2) receptors in the brain, reducing psychotic symptoms and stabilizing mental state.

Zuclopenthixol is available in three main forms:

- Zuclopenthixol decanoate (long-acting injection) – used for maintenance treatment in patients with chronic schizophrenia or persistent psychotic disorders.
- Zuclopenthixol acetate (rapid-acting injection) – used for managing acute episodes of agitation or aggression.
- Zuclopenthixol dihydrochloride (tablets) – used for short-term treatment or as a transitional therapy.

Common side effects include drowsiness, dry mouth, dizziness, weight gain, and extrapyramidal symptoms (such as muscle stiffness or tremors). In rare cases, it may cause more severe reactions, such as neuroleptic malignant syndrome or tardive dyskinesia.

Treatment with zuclopenthixol should be administered under the supervision of a doctor, and patients should be regularly monitored to assess effectiveness and manage potential side effects. It is important for patients to follow the prescribed dosage and not discontinue treatment without consulting their doctor.

General data about CLOPIXOL 25mg

  • Substance: zuclopenthixol
  • Date of latest medicines list: 01-01-2019
  • Product code: W12439003
  • Concentration: 25mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 50
  • Product type: Original
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: H. LUNDBECK A/S - DANEMARCA
  • Holder: H. LUNDBECK A/S - DANEMARCA
  • Number: 1843/2009/02
  • Shelf life: 2 years

Pharmaceutical forms available for zuclopenthixol

Concentrations available for zuclopenthixol

  • 10mg
  • 200mg/ml
  • 20mg/ml
  • 25mg
  • 50mg/ml