Prozac 20mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUOXETINE HYDROCHLORIDE

Available from:

LTT Pharma Limited

ATC code:

N06AB; N06AB03

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Dosage:

20 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

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

Therapeutic area:

Selective serotonin reuptake inhibitors; fluoxetine

Authorization status:

Authorised

Authorization date:

2012-10-19

Patient Information leaflet

•
muscle twitching, involuntary movements or
problems with balance or co-ordination
•
memory impairment
•
enlarged (dilated) pupils
•
ringing in the ears
•
low blood pressure
•
shortness of breath
•
nose bleeds
•
difficulty swallowing
•
hair loss
•
increased tendency to bruising
•
unexplained bruising or bleeding
•
cold sweat
•
difficulty passing urine
•
feeling hot or cold
•
abnormal liver test results
RARE (may affect up to 1 in 1,000 people)
•
low levels of salt in the blood
•
reduction in blood platelets, which increases
risk of bleeding or bruising
•
reduction in white blood cell count
•
untypical wild behaviour
•
hallucinations
•
agitation
•
panic attacks
•
confusion
•
stuttering
•
aggression
•
fits
•
vasculitis (inflammation of a blood vessel)
•
rapid swelling of the tissues around the neck,
face, mouth and/or throat
•
pain in the tube that takes food or water to your
stomach
•
hepatitis
•
lung problems
•
sensitivity to sunlight
•
muscle pain
•
problems urinating
•
producing breast milk
BONE FRACTURES - an increased risk of bone
fractures has been observed in patients taking this
type of medicines.
Most of these side effects are likely to disappear
with continued treatment.
_In children and adolescents (8-18 years_) – In
addition to the possible side effects listed above,
Prozac may slow growth or possibly delay sexual
maturity. Suicide-related behaviours (suicide
attempt and suicidal thoughts), hostility, mania and
nose bleeds were also commonly reported in
children.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via HPRA Pharmacovigilance,
Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1
6764971; Fax: [phone]. Website:
www.hpra.ie; e-mail: [e-mail]. By
reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE PROZAC H

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prozac 20mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fluoxetine hydrochloride equivalent to 20mg of
fluoxetine.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Hard capsules.
_Product imported from the UK:_
The capsules are green and yellow, printed 'Lilly 3105'.
4 CLINICAL PARTICULARS
As per PA0047/077/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0047/077/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Maize starch flowable
Dimeticone
Capsule components:
Gelatin
Patent blue V (E131)
Yellow iron oxide (E172)
Titanium dioxide (E171)
Pharmaceutical grade edible printing ink, containing shellac, hydrated
ferric oxide (black) E172, propylene glycol and
may contain ammonium hydroxide and potassium hydroxide.
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
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6.5 NATURE AND CONTENTS OF CONTAINER
PVC/aluminium blister packs of 30 capsules.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AN