Oxactin Capsules 20mg
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
19-04-2024
Summary of Product characteristics
(SPC)
19-04-2024
Active ingredient:
FLUOXETINE
Available from:
Genus Pharmaceuticals Limited Linthwaite, Huddersfied HD7 5QH, United Kingdom
ATC code:
N06AB03
INN (International Name):
FLUOXETINE 20 mg
Pharmaceutical form:
HARD CAPSULE
Composition:
FLUOXETINE 20 mg
Prescription type:
POM
Therapeutic area:
PSYCHOANALEPTICS
Authorization status:
Withdrawn
Authorization date:
2007-01-18
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
OXACTIN
®
CAPSULES 20MG
Fluoxetine (as Hydrochloride)
EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT OXACTIN
®
Please read the entire leaflet. It includes a lot of additional
important information about this medicine.
OXACTIN
®
TREATS DEPRESSION AND SOME ANXIETY DISORDERS. Like all medicines it
can have unwanted effects. It is important that you and your doctor
weigh up the
benefits of treatment against possible unwanted effects, before
starting treatment.
OXACTIN
®
CAN BE USED BY ADULTS AND IN SOME CASES BY CHILDREN AND ADOLESCENTS
AGED 8 YEARS AND ABOVE. See ‘Children and adolescents aged 8 to 18
years’
in section 2 of this leaflet.
OXACTIN
®
WON’T WORK STRAIGHT AWAY. Some people taking antidepressants feel
worse before feeling better. It may take two weeks or more before you
see
any benefit.
SOME PEOPLE WHO ARE DEPRESSED OR ANXIOUS THINK OF HARMING OR KILLING
THEMSELVES. If you start to feel worse, or think of harming or
killing yourself, SEE YOUR
DOCTOR OR GO TO A HOSPITAL STRAIGHT AWAY. See ‘Thoughts of suicide
and worsening of your depression or anxiety disorder’ in section 2
of this leaflet.
DON’T STOP TAKING OXACTIN
®
WITHOUT TALKING TO YOUR DOCTOR. If you stop taking Oxactin
®
suddenly or miss a dose, you may get withdrawal effects. See ‘If you
forget to take Oxactin
®
’ and ‘If you stop taking Oxactin
®
’ in section 3 of this leaflet.
IF YOU FEEL RESTLESS AND FEEL LIKE YOU CAN’T SIT OR STAND STILL,
FEEL VERY OVER-EXCITED, OR HAVE MUSCLE STIFFNESS OR TREMOR, TELL YOUR
DOCTOR. Increasing the dose
of Oxactin
®
may make some of these feelings worse. See section 4 ‘Possible
side-effects’, in this leaflet.
TAKING SOME OTHER MEDICINES WITH OXACTIN
®
CAN CAUSE PROBLEMS. You may need to talk to your doctor. See
‘Taking other medicines’ in section 2 of this leaflet.
IF YOU ARE PREGNANT OR PLANNING TO BECOME PREGNANT, talk to your
doctor. See ‘Pregnancy, breast-feeding and Oxactin
®
’ in section 2 of thi
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Summary of Product characteristics
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
PRODUCT SUMMARY
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Oxactin Capsules 20mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluoxetine 20mg present as 22.4mg Fluoxetine hydrochloride Ph.Eur.
3.
PHARMACEUTICAL FORM
Hard gelatin capsule.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
1) For the treatment of symptoms of depressive illness with or without associated symptoms
of anxiety, especially where sedation is not required.
2) For bulimia nervosa; for the reduction of binge-eating and purging activity.
3) For the treatment of obsessive-compulsive disorder.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
_ _
_ _
Depressive illness with or without associated symptoms of anxiety has a recommended dose
of 20mg per day in adults and the elderly.
Obsessive-compulsive disorder has a recommended initial dose of 20mg per day in adults
and the elderly.
_ _
_ _
Bulimia nervosa has a recommended dose of 60mg per day in adults and the elderly.
_ _
The maximum recommended dose for all conditions is 60mg per day.
The use of fluoxetine in children is not recommended because safety and efficacy have not
been established.
_ _
_ _
Fluoxetine is not recommended for patients with severe renal failure (GFR <10 ml/min). A
lower dose (e.g. alternate day dosing) is recommended for patients with significant hepatic
dysfunction or mild to moderate renal failure (GFR 10-50 ml/min).
Page 2 of 7
_METHOD OF ADMINISTRATION _
For oral administration. The capsules are to be swallowed whole with a drink of water and
taken at the same time each d
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