FLUANXOL 1 Base Milligrams Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUPENTIXOL DIHYDROCHLORIDE

Available from:

Lundbeck Limited

INN (International Name):

FLUPENTIXOL DIHYDROCHLORIDE

Dosage:

1 Base Milligrams

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

Please tell your doctor or pharmacist if you are taking, or have 
recently taken, any other medicines, including medicines 
obtained without a prescription.
Tell your doctor if you are taking any of the following medicines:
•  Tricyclic antidepressant medicines
•  Guanethidine, hydralazine and similar medicines (used to 
lower the blood pressure)
•  Alcohol and other medicines that make you drowsy such
as 
barbiturates
•  Medicines used to treat epilepsy (e.g. phenytoin, sodium 
valproate, gabapentin, carbamazepine, lamotrigine)
•  Levodopa and similar medicines (used to
treat Parkinson’s 
disease)
•  Metoclopramide (used in the treatment of gastro-intestinal 
disorders)
•  Piperazine (used in the treatment of roundworm and 
threadworm infections)
•  Digoxin (used in the treatment of heart conditions)
•  Corticosteroids (used to treat a range of conditions,
including 
inflammatory diseases)
•  Warfarin, ticlopidine, dipyramidole and similar medicines 
called anticoagulants (used 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 non steroidal anti-inflammatory drugs 
(e.g. ibuprofen, diclofenac, mefenamic acid) and aspirin 
which are used to relieve pain and to thin the blood
•  Medicines known as phenothiazines used to treat mental 
illness (e.g. chlorpromazine, fluphenazine).
The following medicines should not be taken with Fluanxol:
•  Medicines that change the heartbeat such as quinidine, 
amiodarone, sotalol, dofetilide, erythromycin, terfenadine, 
astemizole, gatifloxacin, moxifloxacin, cisapride, lithium.
•  Other antipsychotic medicines (e.g. thioridazine).

TAKING FLUANXOL WITH FOOD AND DRINK
Fluanxol can be taken with or without food.
Fluanxol may increase the sedative effects of alcohol making 
you dro

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluanxol 1 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg flupentixol present as flupentixol dihydrochloride.
Excipients: Also includes lactose monohydrate 19.85 mg per tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Oval, slightly biconvex, yellow, film-coated tablet marked FF.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term management of mild to moderate depression with or without anxiety.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults_
Initially 1 mg daily as a single morning dose or 0.5 mg twice daily. After one week the dosage may be increased to 2
mg daily if there is an inadequate clinical response. Daily dosage of more than 2 mg should be divided doses up to a
maximum of 3 mg.
_Elderly patients_
Elderly patients should receive half the recommended dosages, i.e. 0.5 – 1.5 mg daily.
Patients often respond to flupentixol within two or three days. If no effect has been observed within one week of
maximum dosage the drug should be withdrawn.
_Children:_
Fluanxol is not recommended for use in children due to lack of clinical experience.
_Reduced renal function_
Flupentixol can be given in usual doses in 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.
_Method of administration_
The tablets are swallowed with water.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 18/10/2013_
_CRN 2136316_
_page number: 1_
4.3 CONTRAINDICAT