Depixol 20mg/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Flupentixol decanoate

Available from:

Lundbeck Ltd

ATC code:

N05AF01

INN (International Name):

Flupentixol decanoate

Dosage:

20mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020200; GTIN: 5702157120055

Patient Information leaflet

Package leaflet: Information for the patient
DEPIXOL
® 20 MG/ML SOLUTION FOR INJECTION
FLUPENTIXOL 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
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT DEPIXOL INJECTION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE DEPIXOL INJECTION IS GIVEN
3.
HOW DEPIXOL INJECTION IS GIVEN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DEPIXOL INJECTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT DEPIXOL INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is Depixol 20 mg/ml solution for injection
(called Depixol
Injection in this leaflet).
Depixol Injection contains the active substance flupentixol decanoate.
Depixol Injection
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.
Depixol Injection is used for the treatment of schizophrenia and other
psychoses.
Your doctor, however, may prescribe Depixol Injection for another
purpose. Ask your doctor
if you have any questions about why Depixol Injection has been
prescribed for you.
2.
WHAT YOU NEED TO KNOW BEFORE DEPIXOL INJECTION IS GIVEN
DEPIXOL INJECTION IS NOT GIVEN IF YOU
•
are allergic (hypersensitive) to flupentixol, other thioxanthene drugs
or antipsychotic
drugs or any of the other ingredients of this medicine (listed in
section 6)
•
are feeling less alert than usual or are drowsy or sleepy,

Summary of Product characteristics

OBJECT 1
DEPIXOL 20 MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 06-Apr-2017 | Lundbeck
Limited
1. Name of the medicinal product
Depixol
®
20 mg/ml solution for injection
Depixol
®
Conc. 100 mg/ml solution for injection
2. Qualitative and quantitative composition
Depixol Injection:
20 mg/ml flupentixol decanoate in thin vegetable oil.
Depixol Conc. Injection:
100 mg/ml flupentixol decanoate in thin vegetable oil.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection.
Depixol Injection:
Clear, colourless to slightly yellowish oil, practically free from
particles.
Depixol Conc. Injection:
Clear, yellowish to yellow oil, practically free from particles.
Oily solution for deep intramuscular injection.
4. Clinical particulars
4.1 Therapeutic indications
The treatment of schizophrenia and other psychoses.
Use of Depixol should be restricted to those stabilised on oral
therapy.
4.2 Posology and method of administration
Posology
_Adults_
The usual dosage of flupentixol decanoate lies between 50 mg every 4
weeks and 300 mg every 2 weeks,
but some patients may require up to 400 mg weekly. The maximum single
dose at any one time is 400
mg. For example, 800 mg ever 2 weeks should not be given. Other
patients may be adequately maintained
on dosages of 20-40 mg flupentixol decanoate every 2-4 weeks. In
patients who have not previously
received depot antipsychotic, treatment is usually started with a
small dose (e.g. 20 mg) to assess
tolerability. An interval of at least one week should be allowed
before the second injection is given at a
dose consistent with the patients' condition.
Depixol Injection 20 mg/ml is not intended for use in patients
requiring doses of greater than 60 mg (3
ml) of flupentixol. Injection volumes of 2 – 3 ml should be
distributed between two injection sites.
More concentrated solutions of flupentixol decanoate (Depixol Conc
Injection or Depixol Low Volume
Injection) should be used if doses greater than 3 ml (60 mg) are
required.
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