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FLUOXETINE 60MG CAPSULES

Active substance(s): FLUOXETINE HYDROCHLORIDE

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(fluoxetine)
Eight important things you need to know
about Fluoxetine.
Please read all of this leaflet. It includes a lot
of additional important information about
this medicine.

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• Fluoxetine treats depression and anxiety
disorders. Like all medicines it can have
unwanted effects. It is therefore important that
you and your doctor weigh up the benefits
of treatment against the possible unwanted
effects, before starting treatment. See section 4
‘Possible side effects’, inside this leaflet.
• Fluoxetine is not for use in children under
8 years.
• Fluoxetine won’t work straight away. Some
people taking antidepressants feel worse
before feeling better. Your doctor should ask
to see you again a couple of weeks after you
first start treatment. Tell your doctor if you have
started feeling better. See section 3, ‘How to
take Fluoxetine’.
• 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 section 2 ‘What you need to
know before you take Fluoxetine’.
• Don’t stop taking Fluoxetine without talking
to your doctor. If you stop taking Fluoxetine
suddenly or miss a dose, you may get
withdrawal effects. See section 3, ‘If you stop
taking Fluoxetine’.
• If you feel restless and feel like you can’t sit or
stand still, tell your doctor. Increasing the dose
of Fluoxetine may make these feelings worse.
See section 4, ‘Possible side effects’.
• Taking some other medicines with Fluoxetine
can cause problems: You may need to talk to
your doctor. See section 2, ‘Other medicines
and Fluoxetine’.
• If you are pregnant or planning to become
pregnant, talk to your doctor. See section 2,
‘Pregnancy, breast-feeding and fertility’.
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 Fluoxetine is and what it is used for
2. What you need to know before you
take Fluoxetine
3. How to take Fluoxetine
4. Possible side effects
5. How to store Fluoxetine
6. Contents of the pack and other information

1. What Fluoxetine is and what it is
used for
Fluoxetine is one of a type of antidepressants
known as Selective Serotonin Reuptake Inhibitors
(SSRIs). Fluoxetine is used to treat:
Adults:
• The symptoms of depression and feelings
of anxiety
• The symptoms of a condition called obsessivecompulsive disorder (OCD)
• The eating disorder bulimia nervosa
Children and adolescents aged 8 years and above
(Under specialist supervision only):
• Moderate to severe major depressive disorder, if
the depression does not respond to psychological
therapy after 4-6 sessions. Fluoxetine should be
offered to a child or young person with moderate
to severe major depressive disorder only in
combination with psychological therapy.

2. What you need to know before you
take Fluoxetine
Do not take Fluoxetine:
• if you are allergic to fluoxetine or any of the other
ingredients of this medicine (listed in section 6).
If you develop a rash or other allergic reactions
(like itching, swollen lips or face or shortness of
breath), stop taking the capsules straight away
and contact your doctor immediately.
• if you are taking any medicines known specifically
as irreversible, non-selective monoamine oxidase
inhibitors (MAO inhibitors). An example of
such a medicine is iproniazid, which is used to
treat depression.
• if you are taking the medicine metoprolol, used to
treat heart failure.

Warnings and precautions

Talk to your doctor or pharmacist before taking
Fluoxetine if any of the following applies to you:
• if you are diabetic
• if you suffer from epilepsy or have ever had a fit.
Treatment should be discontinued in any patient
who develops a fit or who has more fits.
• if you have a history of bleeding disorders
• if you suffer from kidney, liver or heart problems
• If you have disturbances in heart rhythm called
QT prolongation (delayed conduction of electrical
signals which can be seen on an ECG, an electrical
recording of the heart), or a family history of
such conditions.
• if you suffer from any conditions that may make
you more prone to experiencing changes in
your heart beat (e.g. low blood potassium or
magnesium levels, a slow heart beat)
• if you suffer from manic phases (overactive
behaviour or thoughts). Fluoxetine should be
discontinued if you enter a manic phase
• if you are having electro-convulsive
treatment (ECT)
• if you have increased pressure in the eye
(glaucoma)
• if you start to feel restless and cannot sit or stand
still (akathisia). Increasing your dose of Fluoxetine
may make this worse
• if you get unexplained fever with faster breathing
or heart rate, sweating, muscle stiffness or tremor,
confusion, extreme agitation or sleepiness (these
are symptoms of ‘serotonin syndrome’) – see
section 4.

Thoughts of suicide and worsening of your
depression or anxiety disorder:

If you are depressed and/or have anxiety disorders
you can sometimes have thoughts of harming or
killing yourself. These may be increased when first
starting antidepressants, since these medicines all
take time to work, usually about two weeks but
sometimes longer. You may be more likely to think
like this:
• If you have previously had thoughts about killing
or harming yourself.
• If you are a young adult.
Information from clinical trials has shown an
increased risk of suicidal behaviour in adults aged
less than 25 years with psychiatric conditions who
were treated with an antidepressant.
If you have thoughts of harming or killing
yourself at any time, contact your doctor or go to
a hospital straight away.
You may find it helpful to tell a relative or close
friend that you are depressed or have an anxiety

Description Fluoxetine Hydrochloride 60 mg 30

Children and adolescents aged 8 to 18 years

Patients under 18 years of age have an increased
risk of side-effects such as suicide attempt, suicidal
thoughts and hostility (predominantly aggression,
oppositional behaviour and anger) when taking
this class of medicines. Fluoxetine should only
be used in children and adolescents aged 8 to
18 years for the treatment of moderate to severe
major depressive episodes (in combination with
psychological therapy); it should not be used to
treat other conditions.
Only limited information concerning the long-term
safety of fluoxetine on growth, puberty, mental,
emotional and behavioural development in this
age group is available. Despite this, your doctor
may prescribe fluoxetine for patients under 18 for
moderate to severe major depressive episode in
combination with psychological therapy because
he/she decides that this is in their best interests. If
your doctor has prescribed fluoxetine for a patient
under 18 years of age and you want to discuss this,
please go back to your doctor. You should inform
your doctor if any of the symptoms listed above
develop or worsen when patients under 18 years of
age are taking fluoxetine.
Fluoxetine should not be used in the treatment of
children under the age of 8 years.

Other medicines and Fluoxetine

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, especially the following:
• certain medicines known as monoamine
oxidase inhibitors (MAOIs, some used to treat
depression e.g. phenelzine, moclobemide,
nialamide). Irreversible, non-selective MAOIs (e.g.
iproniazid) must not be used with Fluoxetine
as serious or even fatal reactions (serotonin
syndrome) can occur (see section 2 above “Do not
take Fluoxetine”).
Treatment with fluoxetine should only be started
at least 2 weeks after stopping treatment with
an irreversible MAOI such as iproniazid. For other
types of MAOI, treatment can continue alongside
fluoxetine provided that your doctor monitors
you closely.
• lithium, tryptophan, tramadol, selegiline, the
herbal remedy St. John’s wort or medicines
known as ‘triptans’ (e.g. sumatriptan,
zolmitriptan); there is an increased risk of
serotonin syndrome when these medicines are
taken with fluoxetine.
• phenytoin (for epilepsy); because fluoxetine
may influence the blood levels of this drug,
your doctor may need to introduce phenytoin
more carefully.
• Flecainide, propafenone or nebivolol (for heart
problems), atomoxetine (for attention-deficit
hyperactivity disorder, ADHD), carbamazepine
(for epilepsy), risperidone (for mental illness),
tricyclic antidepressants (for example imipramine,
desipramine and amitriptyline); because
fluoxetine may possibly change the blood levels
of these medicines.
• tamoxifen (used to treat breast cancer), because
fluoxetine may change the blood levels of this
drug and a reduction of the effect of tamoxifen
cannot be excluded, your doctor may need to
consider different antidepressant treatments.
• medicines that affect the heart’s rhythm e.g.
Class IA and III antiarrhythmics, antipsychotics
(e.g. phenothiazines, pimozide, haloperidol),
tricyclic antidepressants, certain antimicrobials
(e.g. sparfloxacin, moxifloxacin, erythromycin
given through a vein, pentamidine), antimalarial
treatment particularly halofantrine, certain
antihistamines used to treat allergies
(astemizole, mizolastine)
• mequitazine or cyproheptadine, medicines used
to treat allergies.
• warfarin, NSAID or other medicines which can
thin the blood (including clozapine, used to
treat certain mental disorders, and aspirin);
fluoxetine may alter the effect of these medicines
on the blood. If Fluoxetine treatment is started
or stopped when you are taking warfarin, your
doctor will need to perform certain tests.
• medicines known as irreversible non-selective
monoamine oxidase inhibitors (MAOIs) normally
used to treat depression e.g. iproniazid.
Treatment with fluoxetine should only be started
two weeks after discontinuation of an irreversible
MAOI (for instance tranylcypromine).
However, treatment with fluoxetine can be
started the following day after discontinuation
of certain reversible MAOIs [for instance
moclobemide, linezolid, methylthioninium
chloride (methylene blue)].
Do not take any MAOIs for at least 5 weeks
after stopping fluoxetine. If fluoxetine has been
prescribed for a long period and/or at a high
dose, a longer interval needs to be considered by
your doctor.
• desmopressin, used to treat certain
hormone problems.
• medicines that can increase the chance of
seizures, such as other SSRI antidepressants (e.g.
sertraline, citalopram, paroxetine), medicines
for nausea and vertigo (e.g. perphenazine,
prochlorperazine, chlorpromazine),
certain medicines for mental illness
called butyrophenones (e.g. benperidol,
haloperidol), mefloquine or chloroquine (for
malaria), or bupropion (for depression or
nicotine dependence).
It is important that you consult your doctor or
pharmacist if you are taking these or any other
medicine, as he/she may need to monitor you more
closely or adjust your dose.

Fluoxetine with food, drink and alcohol

• This medicine may be taken with or without food.
• Do not drink alcohol while taking this medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breastfeeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine.
Pregnancy
In babies whose mothers took fluoxetine during
the first few months of pregnancy, there have
been some reports suggesting an increased
risk of birth defects affecting the heart. In the
general population, about 1 in 100 babies are
born with a heart defect. This increased to about
2 in 100 babies in mothers who took fluoxetine.
You and your doctor may decide that it is better
for you to gradually stop taking fluoxetine while
you are pregnant. However, depending on your
circumstances, your doctor may suggest that it is
better for you to keep taking fluoxetine.
Make sure your midwife and/or doctor know you
are on Fluoxetine. When taken during pregnancy,
particularly in the last 3 months of pregnancy,
medicines like Fluoxetine may increase the risk
of a serious condition in babies, called persistent
pulmonary hypertension of the newborn (PPHN),
making the baby breathe faster and appear bluish.
These symptoms usually begin during the first
24 hours after the baby is born. If this happens to
your baby you should contact your midwife and/or
doctor immediately.
Caution should be exercised when used during
pregnancy, especially during late pregnancy or just
before giving birth since the following effects have
been reported in new born children: irritability,
tremor, muscle weakness, persistent crying, and
difficulty in sucking or in sleeping.

Date: 30 Sep 2015

Component Type Leaflet

Pharma Code TBC

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Affiliate Item Code 713975

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Colours

Superceded Affiliate Item Code 538954
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MA No. 04569/0477
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Vendor Job No. 264479
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Client Market UK

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Fluoxetine 60 mg
Capsules, Hard

disorder, and ask them to read this leaflet. You
might ask them to tell you if they think your
depression or anxiety is getting worse, or if they are
worried about changes in your behaviour.

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Package leaflet: Information for the patient

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Non-Print
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Breast-feeding
Fluoxetine is excreted in breast milk and can
cause side effects in babies. You should only
breastfeed if it is clearly necessary. If breastfeeding
is continued, your doctor may prescribe a lower
dose of Fluoxetine.
Fertility
Fluoxetine has been shown to reduce the quality
of sperm in animal studies. Theoretically, this could
affect fertility, but impact on human fertility has
not been observed as yet.

Driving and using machines

Do not drive or use machines if you feel that
your abilities are affected. Medicines for the
treatment of mental illnesses may decrease your
ability to perform tasks requiring precision or
close attention.

Fluoxetine capsules contain lactose

If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.

3. How to take Fluoxetine
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
You should swallow your capsules whole with a
glass of water. This medicine may be taken with or
without food.
Your doctor may need to start you on the lower
strength Fluoxetine 20 mg capsules which
are available.

Adults
Depression (with or without anxiety
symptoms)

The recommended starting dose is 20 mg once a
day. Your doctor may decide to gradually increase
the dose up to a maximum of 60 mg per day.

Obsessive-compulsive disorder (OCD)

The recommended starting dose is 20 mg once a
day. Your doctor may decide to gradually increase
the dose up to a maximum of 60 mg per day. If
no improvement is noted within 10 weeks, your
doctor will reconsider your treatment.

Bulimia nervosa

The recommended dose is 60 mg daily.

Elderly

The daily dose should generally not exceed 40 mg.
The maximum recommended dose is 60 mg per day.

Patients with liver problems

If you have liver problems or are using another
medicine that might affect fluoxetine, your doctor
may prescribe a lower dose or tell you to use
fluoxetine every other day.

Use in children and adolescents aged 8 years
and above
Treatment should be started and supervised by a
specialist. Your specialist will prescribe the most
appropriate dose.
It is very important that you follow your doctor’s
instructions about how many capsules to take and
for how long you should continue to take them.
Even when you start to feel better it is important
that you keep taking them for as long as your
doctor tells you to.

If you take more Fluoxetine than you should

• Contact your doctor or go to the nearest hospital
casualty department immediately.
• Take the pack of capsules with you to show them.
Signs of overdose include feeling sick, being
sick, fits, heart flutter or heart attack, lung
problems, mental changes such as excitation or
possibly coma.

If you forget to take Fluoxetine

If you forget to take a dose, take it as soon as you
remember. However, if it is nearly time for the next
dose, miss the forgotten dose altogether and take
the next dose at the usual time. Do not take a
double dose to make up for a forgotten dose.

If you stop taking Fluoxetine

Do not stop taking Fluoxetine until your doctor
tells you to. Occasionally, side effects may occur
even when treatment with fluoxetine is stopped.
For this reason, when your doctor decides you
should stop taking the capsules, he/she may
choose to reduce the dose gradually over a number
of weeks. If you experience side effects when the
dose is reduced, your doctor may decide to reduce
the dose more slowly.

Withdrawal symptoms

When you stop taking this medicine you may get
withdrawal symptoms. This is most likely if you
stop taking your medicine suddenly. Withdrawal
symptoms include dizziness, tingling, numbness,
difficulty in sleeping, vivid dreams, agitation,
headache, tremor (shaking), feeling or being sick
and anxiety. Most people find that any symptoms
are mild and disappear within a few weeks but
if you experience any symptoms, contact your
doctor. You should not stop taking the capsules
abruptly and you should discuss stopping taking
this medicine with your doctor.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you experience any of the following side
effects, stop taking your capsules and either tell
your doctor immediately or go to your nearest
hospital emergency department:
Uncommon (may affect up to 1 in 100 people):
• thoughts of harming or killing yourself at
any time (see section 2 ‘Thoughts of suicide
and worsening of your depression or
anxiety disorder’)
Rare (may affect up to 1 in 1,000 people)
• serious allergic reactions such as severe skin
rashes, red itchy swollen skin, skin sensitive to
light, inflamed blood vessels (vasculitis), swelling
of the face or throat, tightness of the chest,
have difficulty breathing or dizzy, or have a
combination of symptoms including painful joints
or muscles, fever, and a rash
• fits
• disturbances in heart rhythm called QT
prolongation (delayed conduction of electrical
signals which can be seen on an ECG, an electrical
recording of the heart). In some people this can
develop into a potentially serious heart condition
known as torsades de pointes. This can result
in a very fast heartbeat causing a sudden loss
of consciousness
• restlessness and an inability to sit or stand still,
you may have ‘akathisia’
• a combination of symptoms (known as “serotonin
syndrome”) including unexplained fever with
faster breathing or heart rate, sweating, muscle
stiffness or tremor, confusion, extreme agitation
or sleepiness (only rarely)
• liver problems causing feeling or being sick,
loss of appetite, feeling generally unwell, fever,
itching, yellowing of the skin or whites of the eyes
(jaundice), dark urine, pale stools
• skin reddening or if you develop a varied skin
reaction or your skin starts to blister or peel
particularly around the mouth, nose, eyes
and genitals.
• a lower than normal level of sodium in the blood,
which may make you feel weak and confused
with aching of muscles. This may be due to
inappropriate ADH secretion, a hormone that
causes the body to retain water and dilute the
blood, reducing the amount of sodium
• frequent infections with fever, chills, sore throat
or mouth ulcers (reduced number of white
blood cells)

Description Fluoxetine Hydrochloride 60 mg 30

• lung problems, scarring and thickening in the
lungs with shortness of breath
• prolonged and painful erection

Other possible side effects

Very common (may affect more than 1 in
10 people)
• difficulties in sleeping
• headache
• feeling sick
• diarrhoea
• feeling tired or drowsy
Common (may affect up to 1 in 10 people)
• loss of appetite
• weight loss
• tiredness
• sleepiness
• feeling anxious or nervous
• restlessness
• difficulty concentrating
• feeling tense
• decreased sex drive or sexual problems (including
difficulty maintaining an erection for sexual
activity) abnormal or vivid dreams
• feeling dizzy
• changes in taste
• shaking
• blurred vision
• rapid and irregular heartbeat sensations
• feeling flushed
• yawning
• indigestion
• vomiting
• dry mouth
• rash, urticaria, itching
• excessive sweating,
• joint pain
• passing urine more frequently
• unexplained vaginal bleeding
• feeling shaky or chills
Uncommon (may affect up to 1 in 100 people)
• mood changes
• feeling detached
• strange thinking
• memory problems
• feel high (euphoria)
• inability to orgasm
• teeth grinding
• muscle twitching, involuntary movements or
problems with balance or coordination
• enlarged (dilated) pupils
• low blood pressure
• shortness of breath
• swallowing problems
• abdominal bleeding
• ringing in the ears
• nose bleeds
• hair loss
• increased tendency to bruising
• cold sweat
• pain when passing urine
• feeling hot or cold
• generally feeling unwell/abnormal
Rare (may affect up to 1 in 1,000 people)
• low levels of salt in the blood
• untypical wild behaviour
• hallucinations (see, hear or feel things that are
not there)
• feel agitated
• panic attacks
• confusion
• aggression
• stuttering or stammering
• widening of blood vessels
• pain in the tube that takes food or water to
your stomach
• sensitivity to sunlight
• leaking of milk from the breast
• sore throat and discomfort when swallowing
• aching muscles, muscle tenderness or weakness,
not caused by exercise
• difficulty passing urine
• unusual bleeding or bruising, frequent infections
with fever, chills, sore throat or mouth ulcers
(reduced number of white blood cells)
• high prolactin levels in the blood
• increase in liver enzymes seen in a blood test
• bleeding from the mucosal lining of areas such as
the mouth and nose
Bone fractures - an increased risk of bone fractures
has been observed in patients taking this type
of medicine.
Additional side effects in children and
adolescents (8-18 years): Fluoxetine may slow
growth or possibly delay sexual maturity. Other
behavioural changes may be seen such as; anger,
mood change or disorder, aggression and anxiety.
Nose bleeds were also commonly reported
in children.

Reporting side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side
effects, you can help provide more information on
the safety of this medicine.

5. How to store Fluoxetine
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the carton after EXP. The expiry
date refers to the last day of that month.
Do not store above 25°C.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help to protect the environment.

6. Contents of the pack and other
information
What Fluoxetine contains

• The active substance is fluoxetine (as
fluoxetine hydrochloride)
• The other ingredients are lactose monohydrate,
maize starch, colloidal anhydrous silica, talc,
magnesium stearate, gelatin, titanium dioxide
(E171), yellow iron oxide (E172), shellac,
potassium hydroxide, ammonium hydroxide and
iron oxide black (E172).

What Fluoxetine looks like and contents
of the pack

Your medicine is a hard capsule with a light-yellow,
opaque body and cap printed “FL60” on the body
and “G” on the cap.
Your medicine is available in blisters packs of
30 capsules.

Marketing Authorisation Holder

Mylan, Station Close, Potters Bar,
Hertfordshire EN6 1TL, United Kingdom

Manufacturer

Gerard Laboratories, 35/36 Baldoyle
Industrial Estate, Grange Road, Dublin 13, Ireland.
Generics [UK] Limited, Station Close, Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom
This leaflet was last revised in 09/2015

713975

Date: 30 Sep 2015

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 713975

SAP No. N/A

Colours

Superceded Affiliate Item Code 538954
TrackWise PR No. 713975
MA No. 04569/0477
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 264479
Trackwise Proof No. 1
Glams Proof No. 1
Client Market UK

1

Time: 12:05
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with

Keyline/Drawing No. N/A

Main Font

Barcode Info N/A

Dimensions

Myriad Pro
170 x 580 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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