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Package leaflet: Information for the patient
Fluoxetine 20mg Capsules, hard
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 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

What Fluoxetine is and what it is used for

The name of your medicine is Fluoxetine 20mg Capsules, hard. It contains the active
substance fluoxetine.
Fluoxetine belongs to a group of medicines called selective serotonin reuptake
inhibitor (SSRI) antidepressants.
Fluoxetine can be given to treat the following conditions:

Major depressive episodes

The symptoms of a condition called obsessive-compulsive disorder (OCD).

The eating disorder bulimia nervosa. This medicine is used alongside
psychotherapy for the reduction of binge-eating and purging.
Children and adolescents aged 8 years and above:

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.
you are already taking any of the following medicines:
medicines known as non-selective monoamine oxidase inhibitors
or reversible monoamine inhibitors type A (MAOIs) since serious
or even fatal reactions can occur. Examples of such MAOIs include
medicines used to treat mental illness including phenelzine
ipronazide and toloxatone and also linezolid (an antibiotic) or
methylthioninium chloride (also called methylene blue, used to treat
high levels of methaemoglobin in the blood).

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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluoxetine

if you have epilepsy or fits. If you have a fit (seizures) or experience an increase
in seizure frequency, contact your doctor immediately; Fluoxetine might need to
be discontinued

if you are experiencing mania now or have experienced it in the past; if you
have a manic episode, contact your doctor immediately because Fluoxetine
might need to be discontinued

if you have liver problems (your doctor may need to adjust your dosage)

if you have heart problems

if you have low resting heart rate and/or you know that you may have salt
depletion as a result of severe diarrhoea and vomiting (being sick) or usage of
diuretics (water tablets)

if you are recovering from a heart attack

if you are having electro-convulsive treatment (ECT)

if you have diabetes, as your doctor may need to adjust the dose of your diabetic

if you have a history of mental illness

if you have a history of bleeding disorders or appearance of bruises or unusual

if you have glaucoma (increased pressure in the eye)

if you are already taking any of the following medicines:
- diuretics (water tablets), especially if you are elderly
- other antidepressants eg. Amitriptyline, Tryptophan (Optimax®)
- medicine for epilepsy eg. Phenytoin, Carbamazepine


medicine to treat mental illness eg. Lithium, Clozapine, Chlorpromazine
medicines used to thin the blood (anticoagulants) eg. Warfarin (see Other
medicines and Fluoxetine)
- Aspirin
- a Triptan, to treat migraine attacks
- Flecainide, Encainide, to treat an irregular heart beat.
- Tamoxifen (used to treat breast cancer) (see Other medicines and
if you are starting to feel restless and cannot sit or stand still (akathisia).
Increasing your dose of Fluoxetine may make this worse;
if you have appearance of fever, muscle stiffness or tremor, changes in your
mental state like confusion, irritability and extreme agitation; you may suffer
from the so-called “serotonin syndrome” or “neuroleptic malignant syndrome”.
Although this syndrome occurs rarely it may result in potentially life threatening
conditions; contact your doctor immediately, since Fluoxetine might need to be

The herbal remedy St John’s wort (Hypericum perforatum) should not be taken at the
same time as this medicine. If you are already taking St John’s wort when you start
Fluoxetine capsules, stop taking the St John’s wort and consult your doctor.
If you are unsure what medicines you are already taking, check with your doctor.
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 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.
Children and adolescents aged 8 to 18 years:
Patients under 18 have an increased risk of side-effects such as suicide attempt,
suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and
anger) when they take 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) and it should
not be used to treat other conditions..
Additionally, 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 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 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 (up to 5 weeks
ago) or might take any other medicines.
Fluoxetine may affect the way some other medicines work (interaction), especially the
 Certain monoamine oxidase inhibitors (MAOIs, used to treat depression). Nonselective MAOIs and MAOIs type A (moclobemide) must not be used with
Fluoxetine as serious or even fatal reactions (serotonin syndrome) can occur (see
section “Do not take Fluoxetine”).
Treatment with Fluoxetine should only be started at least 2 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
and methylthioninium chloride (methylene blue)).Some MAOIs type B
(selegeline) can be used with Fluoxetine provided that your doctor monitors you
 lithium, tryptophan; there is an increased risk of serotonin syndrome when these
drugs are taken with Fluoxetine. Your doctor will carry out more frequent checkups.
 phenytoin (for epilepsy); because Fluoxetine may influence the blood levels of
this drug, your doctor may need to introduce phenytoin more carefully and carry
out check-ups when given with Fluoxetine.
 tramadol (a painkiller) or triptans (for migraine); there is an increased risk of
hypertension (raised blood pressure).
 flecainide or encainide (for heart problems), carbamazepine (for epilepsy),
tricyclic antidepressants (for example imipramine, desipramine and
amitriptyline); because Fluoxetine may possibly change the blood levels of these
medicines, your doctor may need to lower their dose when administered with
 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,
 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
You should not start to take the herbal remedy St John’s wort while you are being
treated with Fluoxetine since this may result in an increase in side effects. If you
are already taking St John’s wort when you start on Fluoxetine, stop taking St
John’s wort and tell your doctor at your next visit.

Fluoxetine with food, drink and alcohol
Fluoxetine can be taken with or without food.
You should avoid alcohol while you are taking this medicine.
Pregnancy, breastfeeding 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.
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
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, difficulty
in sucking or in sleeping.
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.
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

Fluoxetine may affect your judgement or co-ordination.
machinery without advice from your doctor or pharmacist.

Do not drive or use

Fluoxetine contains lactose
If you have been told by your doctor that you have an intolerance to some sugars
contact your doctor before taking this medicinal product.
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.
Swallow the capsule with a glass of water. Do not chew the capsule.
The recommended dose is:
Major depressive episodes: The recommended dose is 1 capsule (20 mg) daily. Your
doctor will review and adjust your dosage if necessary within 3 to 4 weeks of the start
of treatment. If required, the dosage can be gradually increased up to a maximum dose
of 60 mg a day (3 capsules). The dose should be increased carefully to ensure that you
receive the lowest effective dose. You may not feel better immediately when you first
start taking your medicine for depression. This is usual because an improvement in
depressive symptoms may not occur until after the first few weeks. Treatment should
be given for at least 6 months.
Obsessive-compulsive disorder (OCD) - The recommended dose is 1 capsule (20
mg) of Fluoxetine a day. If, after two weeks your condition is no better, your doctor
may gradually increase this to the maximum recommended dose of 60 mg (3
capsules) a day. If no improvement is noted within 10 weeks, your doctor will
reconsider your treatment.
Bulimia nervosa - The recommended dose is 3 capsules (60 mg) a day.
Your doctor will increase the dose with more caution and the daily dose should
generally not exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg)
Liver impairment:
If you have a liver problem or are using other medication that might affect Fluoxetine,
your doctor may decide to prescribe a lower dose or tell you to use Fluoxetine every
other day.
Use in children and adolescents aged 8 to 18 years with moderate to severe
Treatment should be started and supervised by a specialist.
The starting dose is 10mg a day (given as 2.5ml of fluoxetine liquid). After one to two
weeks, your doctor may increase the dose to 20mg a day. The dose should be
increased carefully to ensure that you receive the lowest effective dose. Lower weight
children may need lower doses. If there is a satisfactory response to treatment, your

doctor should review the need for continuing treatment beyond 6 months. If you have
not improved within 9 weeks, your doctor will reassess your treatment.
If you take more Fluoxetine than you should

If you take too many capsules, go to your nearest hospital emergency
department (or casualty) or tell your doctor straight away.

Take the pack of Fluoxetine with you if you can.
Symptoms of overdose include: nausea, vomiting, seizures, heart problems (like
irregular heart beat and cardiac arrest), lung problems and change in mental condition
ranging from agitation to coma.
If you forget to take Fluoxetine

If you miss a dose, do not worry. Take your next dose the next day at the usual
time. Do not take a double dose to make up for a forgotten dose.

Taking your medicine at the same time each day may help you to remember to
take it regularly.
If you stop taking Fluoxetine

Do not stop taking Fluoxetine without asking your doctor first, even when you
start to feel better. It is important that you keep taking your medicine.

Make sure you do not run out of capsules.
You may notice the following effects (withdrawal effects) when you stop taking
Fluoxetine: dizziness; tingling feelings like pins and needles; sleep disturbances (vivid
dreams, nightmares, inability to sleep); feeling restless or agitated; unusual tiredness
or weakness; feeling anxious; nausea/vomiting (feeling sick or being sick); tremor
(shakiness); headaches.
Most people find that any symptoms on stopping Fluoxetine are mild and disappear
within a few weeks. If you experience symptoms when you stop treatment, contact
your doctor.
When stopping Fluoxetine, your doctor will help you to reduce your dose slowly over
one or two weeks - this should help reduce the chance of withdrawal effects.
If you have any further questions on the use of this medicine, ask your doctor or
4. Possible side effects
Like all medicines, Fluoxetine can cause side effects, although not everybody gets

If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to the hospital straight away (see section 2, ‘Thoughts of
Stop taking the capsules straight away and tell your doctor immediately if
you have an allergic reaction. Such reactions may appear in the form of
anaphylaxis (a severe form of allergic reaction) with symptoms such as:

swelling of the face, lips, mouth, tongue or throat (angioedema)
sudden wheezing, fainting or difficulties in swallowing
fever, rapid swelling of the tissues around the neck, face, mouth and/or
throat, skin rash, enlargement of the lymph nodes (serum sickness)
If you feel restless and cannot sit or stand still, you may have akathisia;
increasing your dose of Fluoxetine may make you feel worse. If you feel like
this, contact your doctor.
Tell your doctor immediately if you experience any of the following;
- Skin rash, which may blister, and looks like small targets (central dark
spots surrounded by a paler area, with dark ring around the edge) (erythema
- A widespread rash with blisters and peeling skin, particularly around the
mouth, nose, eyes and genitals (Stevens Johnson Syndrome).
- A widespread rash with blisters and skin peeling on much of the body
surface (toxic epidermal necrolysis).
Tell your doctor immediately if you experience fits (convulsions).

Some patients have had:

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);

Feelings of weakness, drowsiness or confusion mostly in elderly people and in
(elderly) people taking diuretics (water tablets);

Prolonged and painful erection;

Irritability and extreme agitation;

heart problems, such as fast or irregular heart rate, fainting, collapsing or
dizziness upon standing which may indicate abnormal functioning of the heart
If you have any of the above side effects, you should tell you doctor immediately.
The following side effects have also been reported in patients taking Fluoxetine:
Very common: may affect more than 1 in 10 people
- insomnia
- headache
- diarrhoea, feeling sick (nausea)
- tiredness (fatigue), feeling unusually weak
Common: may affect up to 1 in 10 people
- not feeling hungry, weight loss
- nervousness, anxiety
- restlessness, poor concentration
- feeling tense
- decreased sex drive or sexual problems (including difficulty maintaining an erection
for sexual activity)
- sleep problems, unusual dreams (including nightmares), tiredness or sleepiness
- dizziness
- change in taste

- uncontrollable shaking movements
- blurred vision
- rapid and irregular heartbeat sensations
- flushing
- yawning
- indigestion, vomiting
- dry mouth
- rash, hives (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
- feeling detached from yourself
- strange thinking
- abnormally high mood
- orgasm problems
- teeth grinding
- muscle twitching, involuntary movements or problems with balance or co-ordination
- enlarged (dilated) pupils
- low blood pressure
- shortness of breath
- difficulty swallowing
- 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
- agitation
- panic attacks
- inflammation of a blood vessel (vasculitis)
- widening of blood vessels
- pain in the tube that takes food or water to your stomach
- sensitivity to sunlight
- producing breast milk
- increase in prolactin (a hormone) level in the blood
- sore throat and discomfort when swallowing
- bruising
- unexplained bruising or bleeding
- difficulty passing urine
Very rare: may affect up to 1 in 10,000 people

- reduction in blood platelets, which increases risk of bleeding or bruising
Not known: frequency cannot be estimated from the available data
- memory impairment
- lung problems
- liver disease with the following symptoms; nausea, vomiting, loss of appetite,
feeling generally unwell, fever, itching, yellowing of the skin and eyes, light
coloured bowel motions, dark coloured urine
- abnormal liver function test results
- muscle pain
- problems urinating
- confusion
- stuttering
- nose bleeds
- ringing in the ears
- gastrointestinal bleeding
- Excessive release of antidiuretic hormone
Bone fractures - an increased risk of bone fractures has been observed in patients
taking this type of medicine.
If you have any of the symptoms listed and they bother you, or last for some time, tell
your doctor or a pharmacist.
Most of these side effects are likely to disappear with continued treatment.
Additional side effects in children and adolescents (8-18 years)
Fluoxetine may slow growth or possibly delay sexual maturity. 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:
By reporting side effects, you can help provide more information on the safety of this
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 each month.
Do not store the capsules above 25°C.
Do not throw away any medicines via waste water or household waste. Ask your
pharmacist how to throw away medicines you longer use. These measures will help
protect the environment.

6. Contents of the pack and other information
What Fluoxetine contains
The active substance is fluoxetine hydrochloride.
Each capsule contains fluoxetine hydrochloride equivalent to 20 milligram (mg) of
The other excipients are lactose, maize starch, silica colloidal anhydrous, talc,
magnesium stearate, gelatin, shellac, sodium lauryl sulphate, propylene glycol,
ammonium hydroxide, brilliant blue (E133), quinoline yellow (E104), erythrosine
(E127), indigo carmine (E132), titanium dioxide (E171) and iron oxide black (E172).
What Fluoxetine looks like and contents of the pack
Fluoxetine is a hard capsule with a light green opaque body and a purple opaque cap
printed in black ink “FL20” on the body and “” on the cap.
Fluoxetine is available in HDPE bottles with polypropylene screw caps (with pressure
sensitive wad) containing 7, 10, 14, 20, 28, 30, 50, 60, 90 and 100 capsules, hard.
Fluoxetine is also available in PVC/PVDC/Al blisters packs containing 7, 10, 12, 14,
20, 28, 30, 50, 60, 90 and 100 capsules, hard.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Generics [UK] Limited trading as Mylan
Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Generics [UK] Limited
Station Close
Potters Bar, Hertfordshire
United Kingdom
McDermott Laboratories Limited t/a Gerard
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
This leaflet was last revised in December 2013

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