Fluanxol 500microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Flupentixol dihydrochloride

Available from:

Lundbeck Ltd

ATC code:

N05AF01

INN (International Name):

Flupentixol dihydrochloride

Dosage:

500microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030400; GTIN: 5702157123254

Patient Information leaflet

Package leaflet: Information for the user
FLUANXOL
® 0.5 MG AND 1 MG FILM-COATED TABLETS
FLUPENTIXOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or Pharmacist
•
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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT FLUANXOL IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUANXOL
3.
HOW TO TAKE FLUANXOL
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE FLUANXOL
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT FLUANXOL IS AND WHAT IT IS USED FOR
Fluanxol contains the active substance flupentixol. Fluanxol belongs
to a group of medicines
known as antidepressants. These medicines act on nerve pathways in
specific areas of the
brain and help to correct certain chemical imbalances that are causing
the symptoms of your
illness.
Fluanxol is used to treat depression in patients who may, or may not,
also be showing signs
of anxiety.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUANXOL
DO NOT TAKE FLUANXOL
•
If you are allergic (hypersensitive) to flupentixol, other
thioxanthene drugs or
antipsychotic drugs or to any of the other ingredients of this
medicine (listed in section 6).
•
If you are feeling less alert than usual, or are drowsy or sleepy, or
have serious problems
with your blood circulation
•
If you suffer with severe depression, which needs you to stay in
hospital or if you need
electroconvulsive therapy (ECT)
•
If you suffer from periods of excitement, overactivity or mania.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Fluanxol if you:
•
have a heart condition (including an irregular heart beat) or se

Summary of Product characteristics

OBJECT 1
FLUANXOL TABLETS
Summary of Product Characteristics Updated 26-Jan-2017 | Lundbeck
Limited
1. Name of the medicinal product
Fluanxol
®
0.5 mg film-coated tablets
Fluanxol
®
1 mg film-coated tablets
2. Qualitative and quantitative composition
Each 0.5 mg film-coated tablet contains 0.5 mg flupentixol (as 0.5840
mg flupentixol dihydrochloride)
Each 1 mg film-coated tablet contains 1 mg flupentixol (as 1.168 mg
flupentixol dihydrochloride).
Excipients with known effect:
Lactose monohydrate
For the full list of excipients, see section 6.1
3. Pharmaceutical form
0.5 mg Film-coated tablet
Round, slightly biconvex, yellow, film-coated tablet marked FD.
1 mg Film-coated tablet
Oval, slightly biconvex, yellow, film-coated tablet marked FF.
4. Clinical particulars
4.1 Therapeutic indications
Symptomatic treatment of depression (with or without anxiety).
4.2 Posology and method of administration
Posology
_Adults_
The standard initial dosage is 1 mg as a single morning dose. After
one week the dose may be increased
to 2 mg if there is inadequate clinical response. Daily dosage of more
than 2 mg should be in divided
doses up to a maximum of 3 mg daily.
_Older patients_
Older patients should receive half the recommended dosages. The
standard initial dosage is 0.5 mg as a
single morning dose. After one week, if response is inadequate, dosage
may be increased to 1 mg once a
day.
Caution should be exercised in further increasing the dosage but
occasional patients may require up to a
maximum of 1.5 mg a day which should be given in divided doses.
_Children_
Flupentixol is not recommended for use in children due to lack of
clinical experience.
_Patients with reduced renal function_
Flupentixol has not been studied in renal impairment. Increased
cerebral sensitivity to antipsychotics has
been noted in severe renal impairment (see section 4.4).
_Patients with reduced hepatic function_
Flupentixol has not been studied in hepatic impairment. It is
extensively metabolised by the liver and
particular caution should be used in