Clopixol 200mg/1ml solution for injection ampoules

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Zuclopenthixol decanoate

Disponible desde:

Lundbeck Ltd

Código ATC:

N05AF05

Designación común internacional (DCI):

Zuclopenthixol decanoate

Dosis:

200mg/1ml

formulario farmacéutico:

Solution for injection

Vía de administración:

Intramuscular

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 04020200; GTIN: 5702157109203

Información para el usuario

Package leaflet: Information for the patient
CLOPIXOL
® 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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT CLOPIXOL INJECTION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE CLOPIXOL INJECTION IS GIVEN
3.
HOW CLOPIXOL INJECTION IS GIVEN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CLOPIXOL INJECTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT CLOPIXOL INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is Clopixol 200 mg/ml solution for injection
(called Clopixol
Injection in this leaflet). Clopixol Injection contains the active
substance zuclopenthixol. It
belongs to a group of medicines known as antipsychotics (also called
neuroleptics).
These medicines act on nerve pathways in specific areas of the brain
and help to correct
certain chemical imbalances in the brain that are causing the symptoms
of your illness.
Clopixol Injection is used for the treatment of schizophrenia and
other psychoses.
Your doctor, however, may prescribe Clopixol Injection for another
purpose. Ask your doctor
if you have any questions about why this medicine has been prescribed
for you.
2.
WHAT YOU NEED TO KNOW BEFORE CLOPIXOL INJECTION IS GIVEN
Clopixol Injection is not given
•
If you are allergic (hypersensitive) to zuclopenthixol, other
thioxanthene drugs or
antipsychotic drugs or any of the other ingredients of this medicine
(listed in section 6).
Tell your doctor if you think you might be
•
If you are feeling less a

Ficha técnica

OBJECT 1
CLOPIXOL 200 MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 26-Jan-2017 | Lundbeck
Limited
1. Name of the medicinal product
Clopixol 200 mg/ml solution for injection.
Clopixol Conc. 500 mg/ml solution for injection.
2. Qualitative and quantitative composition
_Clopixol Injection:_
Zuclopenthixol decanoate 200 mg/ml.
_Clopixol Conc. Injection: _
Zuclopenthixol decanoate 500 mg/ml.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection.
Clear, yellowish oil, practically free from particles.
4. Clinical particulars
4.1 Therapeutic indications
The maintenance treatment of schizophrenia and paranoid psychoses.
4.2 Posology and method of administration
Posology
_Adults_
Dosage and dosage interval should be adjusted according to the
patient's symptoms and response to
treatment.
The usual dosage range of zuclopenthixol decanoate is 200 - 500 mg
every one to four weeks, depending
on response, but some patients may require up to 600 mg per week. The
maximum single dose at any one
time is 600 mg. For example, 1200 mg every 2 weeks should not be
given. In patients who have not
previously received depot antipsychotics, treatment is usually started
with a small dose (e.g. 100 mg) to
assess tolerance. An interval, of at least one week should be allowed
before the second injection is given
at a dose consistent with the patient's condition.
Adequate control of severe psychotic symptoms may take up to 4 to 6
months at high enough dosage.
Once stabilised lower maintenance doses may be considered, but must be
sufficient to prevent relapse.
Injection volumes of greater than 2 ml should be distributed between
two injection sites.
_Older patients_
In accordance with standard medical practice initial dosage may need
to be reduced to a quarter or half
the normal starting dose in the frail or older patients.
_Paediatric population_
Clopixol is not recommended for use in children due to lack of
clinical experience.
_Patients with renal impairment_
Clopixol can be giv