Fluanxol 0.5mg film-coated Tablets

Country: মাল্টা

ভাষা: ইংরেজি

সূত্র: Medicines Authority

সক্রিয় উপাদান:

FLUPENTIXOL

থেকে পাওয়া:

H. Lundbeck A.S. 9 Ottiliavej, 2500 Valby, Copenhagen, Denmark

এটিসি কোড:

N05AF01

INN (International Name):

FLUPENTIXOL 0.5 mg

ফার্মাসিউটিকাল ফর্ম:

FILM-COATED TABLET

রচনা:

FLUPENTIXOL 0.5 mg

প্রেসক্রিপশন টাইপ:

POM

Therapeutic area:

PSYCHOLEPTICS

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2006-04-18

তথ্য লিফলেট

REG_00032958 v.9.0
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUANXOL® 0.5 MG FILM-COATED TABLETS
FLUPENTIXOL
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 severe
breathing problems (such as asthma
or bronchitis)
•
have liver, kidney or thyroid problems
•
suffer from epilepsy, or have been told that you are at risk of having
fits (for example because of a brain
injury or because of alcohol withdrawal)
•
suffer from Parkinson’s disease, or myasthenia gravis (a condition
causing severe muscular weakness)
•
have an enlarged prostate or suffer from a condition known as
phaeochromocytoma (a rare type of
cancer of a gland near the kidney)
•
suffer from glaucoma (raised pressure withi

পণ্য বৈশিষ্ট্য

REG_00040835 v.7.0
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluanxol® 0.5 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)
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.
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 this situation and serum level
monitoring is advised (see section 4.4).
Patients often respond within 2-3 days. If no effect has been observed
within one week at maximum dosage
the drug should be withdrawn.
Method of administration
The tablets are swallowed with water