DEPIXOL 20MG/ML SOLUTION FOR INJECTION

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

FLUPENTIXOL DECANOATE

Beschikbaar vanaf:

Lundbeck Limited

ATC-code:

N05AF01

INN (Algemene Internationale Benaming):

FLUPENTIXOL DECANOATE

Dosering:

20 Micromol

farmaceutische vorm:

Solution for Injection

Prescription-type:

Product subject to prescription which may not be renewed (A)

Therapeutisch gebied:

flupentixol

Autorisatie-status:

Marketed

Autorisatie datum:

1976-06-21

Bijsluiter

• Warfarin, ticlopidine, dipyramidole and similar medicines called
anticoagulants (used to thin the blood)
• Medicines known as non steroidal anti-inflammatory drugs (NSAIDs
e.g. ibuprofen, diclofenac, mefenamic acid) and aspirin which are
used to relieve pain and to thin the blood)
• Medicines such as diuretics (water tablets) that cause a disturbed
water or salt balance (too little potassium or magnesium in your
blood)
• Medicines known as phenothiazines used to treat mental illness
(e.g. chlorpromazine, fluphenazine).
• Medicines known as neuromuscular blocking agents
(e.g. suxamethonium) as concomitant treatment with this medicine
may prolong the effect of neuromuscular blocking agents
• Adrenergic medicines (e.g. atenolol) as concomitant treatment with
this medicine may reduce the effect of adrenergic medicines
The following medicines should not be taken with this medicine:
• Medicines for heart rhythm problems such as medicines used to
treat
irregular heartbeats (e.g. quinidine, amiodarone, sotalol,
dofetilide),
certain antibiotics (e.g. erythromycin, gatifloxacin, moxifloxacin),
certain antihistamines (e.g. astemizole, terfenadine) and other
medicines such as cisapride and lithium
• Other antipsychotic medicines (e.g. thioridazine)
Depixol Injection with alcohol
Depixol Injection may increase the sedative effects of alcohol making
you
drowsier. It is recommended not to drink alcohol during treatment with
this medicine.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you might be pregnant or
planning to have a baby, ask your doctor, pharmacist or nurse for
advice
before taking this medicine.
Pregnancy
If you are pregnant or think you might be pregnant, tell your doctor.
Depixol Injection should not be used during pregnancy unless clearly
necessary.
The following symptoms may occur in newborn babies of mothers that
have used this medicine in the last trimester (last three months of
their
pregnancy): shaking, muscle stiffness and/or weakness, sleepiness,
ag

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Depixol 20mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml ampoule contains 20 mg (2% w/v) cis(Z)-flupentixol decanoate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (injection)
Clear, colourless to slightly yellowish oil, practically free from
particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The management of schizophrenia and allied paranoid psychoses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The usual dosage is between 20 to 40 mg every two to four weeks.
Larger doses may be used if necessary, distributed
between two injection sites.
In patients who have not previously received depot neuroleptics,
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.
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.
The appropriate presentation of Depixol should be selected to achieve
an injection volume, which does not exceed 2
ml. Volumes greater than 2 ml should be distributed between two
injection sites.
When transferring patients from oral to depot neuroleptic treatment,
the oral medication should not be discontinued
immediately but gradually withdrawn over a period of several days
after administering the first injection.
_Older people_
Older people should receive dosages in the lower end of the dosage
range.
_Reduced renal function_
Flupentixol decanoate can be given in usual doses to patients with
reduced renal function.
_Reduced hepatic function_
Dose reduction (relative to the degree of hepatic impairment) should
be considered. If possible, where assay facilities
exist dosage should be adjusted according to serum levels.
_Child