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FLUOXETINE 20MG HARD CAPSULES

Active substance(s): FLUOXETINE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

Fluoxetine 20mg Hard Capsules
(Fluoxetine as the hydrochloride)
Please read this entire leaflet carefully before you start taking this medicine.
 Keep this leaflet. You may need to read it again.
 If you have further questions, please ask your doctor or your pharmacist.
 This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
 If any of the side effects become serious or you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

In this leaflet:
1
2
3

What this medicine is and what it is used for
Before you take
How to take

1 What this medicine is and what it is
used for
Fluoxetine belongs to a group of medicines called selective
serotonin re−uptake inhibitor (SSRI) antidepressants.
This medicine is used to treat:
 Major depressive episodes
 Eating disorder (bulimia nervosa)
 Anxiety disorder (obsessive−compulsive disorder − OCD)
 Mood disorder that occurs at certain times in the menstrual
cycle (pre−menstrual dysphoric disorder − PMDD)

2 Before you take
Do not take if:
 you are allergic (hypersensitive) to Fluoxetine, or any of
the other ingredients (see list of ingredients, Section 6).
If you develop a rash or other allergic reactions (such as
itching, swollen lips or face or shortness of breath), stop
taking Fluoxetine and contact your doctor
 you are taking other medicines used to treat major
depressive episodes, known as non−selective
monoamine oxidase inhibitors or reversible monoamine
oxidase inhibitors type A (MAOIs) since serious or even
fatal reactions can occur. (See `Taking other medicines,
Section 2).




Treatment with Fluoxetine should only be started 2
weeks after discontinuing of an irreversible MAOI (such
as tranylcypromine). However, treatment with Fluoxetine
can be started the following day after discontinuation of
certain reversible MAOIs (such as Moclobemide)
you have unstable epilepsy
you have severe kidney problems

Take special care if:
 you have liver problems (a lower dose may be required)
 you have controlled epilepsy (needs to be carefully
monitored by your doctor)
 you develop fits (seizures) or epilepsy or experience an
increase in seizure frequency, contact your doctor
immediately as you might need to stop taking Fluoxetine
 you have diabetes as Fluoxetine can raise or lower your
blood sugar (see ’Taking other medicines’, section 2)
 you have heart problems
 you are pregnant, think you may be pregnant or breast−
feeding (see ’Pregnancy and breast−feeding’, section 2)
 you have a feeling being elated or over−excited, which
causes unusual behaviour (mania) or a history of mania.
If you have a manic episode, contact your doctor
immediately as you might need to stop taking Fluoxetine
 you have a history of bleeding disorders
 you are taking medicines which may increase the risk of
bleeding e.g. medicines for thinning the blood
(anticoagulants), some medicines used to treat mental
disorders, medicines for pain and inflammation
(NSAIDs non−steroidal anti−inflammatory drugs) (see
’Taking other medicines)
 you are having ECT (electro−convulsive therapy) treatment
 you start to experience fever, probably with
faster breathing, sweating, muscle stiffness or tremor,
confusion, extreme agitation and sleepiness. You may
have 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 discontinued.
 you are taking Tamoxifen, used to treat breast cancer
(see ’Taking other medicines)
 you start to feel restless and cannot sit or stand still
(akathisia). Increasing your dose of Fluoxetine may
make this worse.
 You have increased pressure in the eye (glaucoma)
If you have any of these symptoms contact your doctor
immediately as you might need to stop taking Fluoxetine
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.
Use in children and adolescents aged 8 to 18 years of age:
Clinical trials have shown that patients under 18, treated
with antidepressants, have an increased risk of side−effects
such as suicide attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional behaviour and anger).
In clinical trials some children and adolescents taking
Fluoxetine were also reported to be feeling elated or over−
excited, which causes unusual behaviour.
Fluoxetine should only be used in children and adolescents
aged 8 to 18 years for the treatment of moderate to severe
major depressive episodes and it should not be used in
other indications.
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.
Fluoxetine may slow growth or possibly delay sexual maturity.
However, your doctor may prescribe Fluoxetine for patients
under 18 for moderate to severe major depressive episodes,
if it is thought to be in their best interest. 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.
If any of the above under ’Do not take’ or ’Take Special
care’ applies to you, please consult your doctor or
pharmacist.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines including those
obtained without prescription.

4

Possible side effects
How to store
Further information

5
6

In particular, you should ask your doctor for advice if you
are taking the following:
Medicines not to be taken with Fluoxetine Capsules:
Monoamine oxidase inhibitors (MAOIs)
 You must not take Fluoxetine Capsules if you are taking
certain MAOI’s, used to treat depression or you have
stopped taking one within the last 2 weeks, as serious or
even fatal reactions (serotonin syndrome) can occur
 Fluoxetine must not be used with non−selective MAOIs,
such as phenelzine (e.g nardil), tranylcypromine (e.g
parnate or parstelin) and isocarboxazide (e.g marplan)
and reversible MAOIs, such as moclobemide.
MAOIs type B, such as selegiline can be used with
Fluoxetine provided that your doctor monitors you closely
 Treatment with Fluoxetine should only be started 2 weeks
after you have stopped taking an irreversible MAOI,
such as tranylcypromine. However, treatment with
Fluoxetine can be started the following day after stopping
reversible MAOIs, such as moclobemide
 Do not take any MAOIs for at least 5 weeks after you
stop taking Fluoxetine. Your doctor may recommend a
longer period if you have taken Fluoxetine for a long
time and/or at a high dose.
St John’s Wort
 The herbal remedy St John’s wort, used to treat
depression, should not be taken with Fluoxetine Capsules.
It may result in an increase in undesirable effects
 If you are already taking St John’s wort, stop taking it
and tell your doctor at your next visit
Other medicines, which may interact
 Selegiline (MAOI type B), used to treat Parkinson’s
Disease
 Lithium, used to treat mental illness or tryptophan, used
to treat depression
 Phenytoin, used to treat epilepsy
 Medicines for thinning the blood, such as warfarin
(anticoagulants)
 Other medicines which may increase the risk of
bleeding, such as;
− clozapine, used to treat certain mental disorders
− medicines used for anxiety, feeling sick (nausea) or
being sick (vomiting) or mental disorders, such as
trifluoperazine (phenothiazines)
− aspirin, used to relieve pain
− medicines to reduce inflammation, such as ibuprofen
& Indometacin (NSAIDs)
− medicines used to treat depression, such as
amitriptyline (tricyclic antidepressants). Your doctor
may need to lower the dose − see below
 Tramadol, used to relieve pain
 Medicines for migraine, such as sumatriptan (triptans)
 Diuretics (water tablets), especially if elderly
 Tamoxifen, used to treat breast cancer
 Medicines that may effect the heart‘s rhythm, such as:
− class IA antiarrhythmics such as quinidine,
procainamide, disopyramide
− class III antiarrhythmics such as amiodarone, sotalol
− phenothiazine derivatives, pimozide, haloperidol
(antipsychotics)
− tricyclic antidepressants (such as amitriptyline)
− sparfloxacine, moxifloxacin, erythromycin IV,
pentamidine (antimicrobial agents)
− halofantrine (anti−malaria treatment)
− astemizole, mizolastine (antihistamines)
Medicines, which may need the dosage adjusted
 Flecainide and encainide, for heart problems
 Carbamazepine, used to treat epilepsy
 Medicines for depression (tricyclic antidepressants − see
above)
 Medicines for diabetes, such as insulin
Taking with alcohol
It is recommended that you do not drink alcohol with this
medicine. Although Fluoxetine does not increase the effect
of alcohol, it might affect your judgement or co−ordination.
Pregnancy, breast−feeding and fertility
Ask your doctor or pharmacist for advice before taking any
medicine.
Pregnancy
Talk to your doctor as soon as possible if you are pregnant,
if you might be pregnant, or if you are planning to become
pregnant.
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 taking 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 new born
(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 especially when used during
late pregnancy or just before giving birth.The following
effects have been reported in newborn children: irritability,
shaking, muscle weakness, persistent crying and difficulty
in sucking or in sleeping.
Breast−feeding
Fluoxetine should not be taken whilst breast−feeding.
Fluoxetine passes into breast milk and there is a risk that it
could affect the baby. If treatment with Fluoxetine is
continued, you should only breast−feed, if considered
necessary. If breast−feeding is continued, your doctor may
prescribe a lower dose of Fluoxetine. Adverse events have
been reported in breast−feeding infants.
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
Antidepressants, such as Fluoxetine, may affect your
judgment or co−ordination. Do not drive or operate
machinery unless you are sure you are not affected.

3 How to take
You should always take this medicine as prescribed by
your doctor. Read and follow the instructions on the
pharmacist’s label. If you are not sure about anything
please ask your doctor or pharmacist.

Certain medicines can affect or be affected by Fluoxetine.

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Phone

continued....

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for help
Ver.8.4s

 Fluoxetine Capsules are for oral use only
 Swallow the capsules whole with water
 The capsules can be taken as a single or divided dose,
during or between meals
How long Fluoxetine Capsules take to work
If you are taking Fluoxetine Capsules for major depressive
episodes, you may not feel any better for the first two weeks
or more. You should keep taking your medicines until your
doctor tells you to stop.
The effect of Fluoxetine Capsules on the symptoms of pre−
menstrual dysphoric disorder (PMDD) is usually rapid, with
improvement generally occurring during the first cycle of
treatment.
Usual doses
Major depressive episodes:
Adults and the elderly: One 20mg capsule daily. Your doctor
will review and adjust your dosage if necessary within 3 to 4
weeks of the start of treatment. If required, the dose may be
increased gradually up to a maximum of 60mg. The dose
should be increased gradually to ensure that you receive
the lowest effective dose.
Patients with major depressive episodes should be treated
for at least 6 months.
Bulimia nervosa (eating disorder):
Adults and the elderly: Three 20mg capsules daily
Obsessive−compulsive disorder − (OCD) (anxiety disorder):
Adults and the elderly: One 20mg capsule daily. Your
doctor will review and adjust your dosage if necessary after
2 weeks of treatment. If required, the dose may be increased
gradually up to a maximum of 60mg.
If there is no improvement within 10 weeks, treatment with
Fluoxetine should be reconsidered.
However, if response is good, treatment may be continued
beyond 10 weeks. Your doctor may adjust your dose to
ensure that you receive the lowest effective dose and may
also recommend treatment is combined with psychological
therapy.
Pre−menstrual dysphoric disorder − (PMDD) (mood
disorder that occurs at certain times in the menstrual cycle):
One 20mg capsule daily. The dose may be increased or
decreased.
Initial treatment should be limited to 6 months after which,
your doctor will decide whether treatment should be
continued.
Adults − All indications:
The recommended dose may be increased or decreased.
Patients with liver problems or taking other medication
that might affect Fluoxetine:
Your doctor may prescribe a lower or less frequent dose
(e.g. 20mg every other day).
Elderly patients:
Your doctor will increase your dose with more caution and
the daily dose should not normally exceed 40mg. The
maximum recommended dose is 60mg daily.
Children and adolescents aged 8 to 18 years (moderate
to severe major depressive episodes):
Treatment should be started and be supervised by a
specialist. The starting dose is 10mg daily (given as 2.5ml
of Fluoxetine oral liquid). After one to two weeks, your doctor
may increase the dose to 20mg daily. The dose should be
increased carefully to ensure that you receive the lowest
effective dose.Your doctor should review the need for
continuing treatment beyond 6 months. If you have not improved
within 9 weeks, your treatment should be reassessed.
Lower weight children may need lower doses.
Children under 8 years of age
Fluoxetine is not recommended for children under 8 years.
If you forget to take Fluoxetine
If you forget to take a dose, take one as soon as you
remember. Then go on as before. Do not take a double
dose to make up for a forgotten individual dose.
If you take more Fluoxetine than you should
If you take too many capsules or if a child has taken any
consult your doctor or the nearest hospital casualty
department immediately. Take this leaflet and the
container with you so they know what you have taken.
Symptoms of an overdose include: feeling sick, being sick,
fits, heart problems (e.g. irregular heart beat and cardiac
arrest), lung problems and change in mental condition
ranging from agitation to coma.
If you stop taking Fluoxetine
Do not stop taking Fluoxetine until your doctor tells
you to. It is important to keep taking your medicine, even
when you feel better.
Withdrawal effects
Treatment with Fluoxetine should not be stopped suddenly.
When stopping Fluoxetine, your doctor will help you to
reduce your dose slowly over one to two weeks − this
should reduce the risk of having withdrawal effects.
The most common effects when stopping Fluoxetine
include: dizziness, tingling feeling like pins and needles,
sleep disturbances (e.g. inability to sleep, vivid dreams),
feeling weak, feeling agitated or anxious, feeling or being
sick, shaking and headache.
The symptoms above are usually mild and go away within
2 weeks. However, some people may find they are more
severe and last 2 to 3 months. If the symptoms are very
severe, your doctor may recommend you start taking your
previous prescribed dose again and reduce it more slowly.

 Decreased sex drive or sexual problems (including
maintaining an erection for sexual activity and problems
with ejaculation)
 Sleep problems, unusual dreams (including nightmares),
tiredness or sleepiness
 Dizziness
 Change in taste
 Uncontrollable shaking movements (tremor)
 Blurred vision
 Feeling your heartbeat (palpitations)
 Flushing including hot flushes
 Yawning
 Indigestion (dyspepsia)
 Vomiting (being sick)
 Dry mouth
 Skin rash, hives (urticaria), itching (pruritus)
 Excessive sweating
 Joint pain (arthralgia)
 Passing urine more frequently
 Unexplained vaginal bleeding
 Feeling shaky or chills
Uncommon (may affect up to 1 in 100 people)
 Feeling detached from yourself (depersonalization),
abnormal thinking
 Elevated mood or abnormally high mood (euphoric)
 Orgasm problems, sexual problems
 Teeth grinding (bruxism)
 Muscle twitching, involuntary movements or problems
with balance or co−ordination (Ataxia) or delayed
abnormal movement (dyskinesia)
 Enlarged (dilated) pupils (mydriasis)
 Low blood pressure (hypotension)
 Shortness of breath (dyspnoea)
 Difficulty swallowing (dysphagia)
 Hair loss (alopecia)
 Increased tendency to bruise
 Cold sweat
 Pain when passing urine (dysuria)
 Generally feeling unwell (malaise), feeling abnormal
 Feeling hot or cold
Rare (may affect up to 1 in 1,000 people)
 Rash, fever, joint pain, enlarged lymph nodes (serum
sickness like reaction)
 Low levels of salt in the blood (hyponatraemia)
 Seeing or hearing things that are not real (hallucinations)
 Agitation, panic attacks or fits
 Rapid swelling of the tissues around the neck, face,
mouth and/or throat (buccoglossal syndrome) or sore
throat (pharyngitis)
 Inflammation of a blood vessel (vasculitis)
 Widening of the blood vessels (vasodilatation)
 Lung problems
 Pain in the tube that takes food or water to your stomach
 Sensitivity to sunlight (photosensitivity)
 Red or purple discolouration of the skin (purpura)
 Difficulty passing urine
 Producing breast milk (galactorrhoea)
 Increased level of prolactin in the blood (hyper−
prolactinaemia)
 Abnormal liver function tests
Very rare (may affect up to 1 in 10,000 people)
 Reduction in blood platelets, which increases risk of
bleeding or bruising (thrombocytopenia)
 Bleeding from the stomach, gums or bottom
(gastrointestinal haemorrhage)
Other side effects (frequency cannot be estimated)
 Confusion, hallucinations, drowsiness, fits, coma, difficulty
breathing (syndrome of inappropriate antidiuretic hormone)
 Stroke
 Thoughts of suicide or harming yourself
 Confusion
 Stuttering (dysphemia)
 Memory impairment
 Ringing in the ears (tinnitus)
 Fall in blood pressure when standing up or stretching
(postural hypotension)
 Nose bleeds (epistaxis)
 Yellowing of the skin or whites of the eyes caused by
liver problems (hepatitis)
 Muscle pain (myalgia)
 Problems urinating (micturation disorder)
 Unusual bleeding from the nose, mouth, stomach or
vagina (mucosal haemorrhage)
 Prolonged and painful erection
 Bone fractures
In children and adolescents (8 − 18 years)
In addition to the possible side effects listed above,
Fluoxetine may slow growth or possibly delay sexual
maturity. Nose bleeds were also commonly reported in
children. See also "Use in children and adolescents aged 8
to 18 years of age" − Section 2.
If any of the side effects become serious or you notice
any side effects not listed, contact your doctor or
pharmacist.

5 How to store
 Keep out of the sight and reach of children
 Store below 25°C in a dry place protected from light and
in the original container
 Do not use after the expiry date (EXP) on the label


When your doctor has told you to stop taking this
medicine return any unused tablets to the pharmacist for
safe disposal. 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 protect the environment.

4 Possible side effects
Like all medicines Fluoxetine capsules can cause side
effects, although not everyone gets them.
Contact the doctor immediately if you have any of the
following side effects:
 Distressing thoughts of harming yourself or committing
suicide
 Fits (seizures) or epilepsy or experience an increase in
seizure frequency
 Feel restless and cannot keep still. You may have akathisia.
Increasing your dose may make you feel worse
 Fever, probably with faster breathing, sweating, muscle
stiffness or tremor, confusion, extreme agitation and
sleepiness. Although rare, you may have serotonin
syndrome or neuroleptic malignant syndrome
 Skin rash or other allergic reaction such as itching or
shortness of breath fever or swollen face or throat
 Red skin rash of many shapes which could progress into
a serious illness with blistering of the skin, mouth, eyes
and genitals (Stevens−Johnson Syndrome)
 Feel elated or over−excited, which causes unusual
behaviour (mania)
 Feel tired, confused, have muscles that twitch, have fits
or a coma. This may be due to a low level of sodium in
your blood and it is more likely to happen if you are
elderly or taking water tablets (diuretics)
 Prolonged and painful erection
 Fast or irregular heart beat and fainting which could be
symptoms of a life− threatening condition known as
Torsade de Pointes
Very common (may affect more than 1 in 10 people)
 Difficulty in sleeping (insomnia)
 Headache
 Diarrhoea
 Feeling sick (nausea)
 Fatigue

What Fluoxetine Capsules contains:
Active ingredient: Fluoxetine Hydrochloride. Each capsule
contains 22.4mg of Fluoxetine Hydrochloride equivalent to
20mg of Fluoxetine.
Other ingredients: Pregelatinized maize starch,
Dimethicone 350. The capsule shell contains: Gelatin and
colouring agents Patent Blue V (E131) Titanium Dioxide (E
171) and Yellow Ferric Oxide (E172)
What Fluoxetine Capsules look like and the contents of
the pack:
Hard shell gelatin capsules, opaque light green coloured
cap and body, filled with homogenous white powder.
Capsules are available in packs of 28, 30, 56 or 84.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Tillomed Laboratories Ltd,
3 Howard Road, Eaton Socon, St. Neots, Cambridgeshire
PE19 8ET,
UK
Manufacturer
Tillomed Laboratories Ltd.
or
Bristol Laboratories Ltd.
Unit 3, Canalside, Northbridge Road, Berkhamsted,
Hertfordshire, HP4 1EG,
UK
Product Licence Number
PL 11311/0047
Date of revision: May 2013.

Common (may affect up to 1 in 10 people)
 Not feeling hungry, weight loss
 Nervousness, anxiety
 Restlessness, disturbance in attention
 Feeling tense

Hard to Read?

6 Further information

Phone

0800 970 6115

for help
Ver.8.4s

Product Name
Strength / Form
Type
Dimensions
Typefaces
Rev #
Last updated
No. of Colours

Fluoxetine
20 mg Capsules
PIL
175 x 550 mm
Font SansSerif − Min. Text 8pt
Ver.8.4s
25/06/2013
Pantone Black CVC

Tillomed Laboratories Ltd
3 Howard Road Eaton Socon, St Neots, Cambs PE19 8ET, UK

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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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