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FLUOXETINE 60MG HARD CAPSULES

Active substance(s): FLUOXETINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluoxetine 60mg hard capsules
fluoxetine (as hydrochloride)

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.












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. See section 2, ‘Use in children and
adolescents aged 8 to 18 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 haven’t 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’ for further information.
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 Re-uptake
Inhibitors (SSRIs).
This medicine is used to treat:
Adults:
 Major depressive episodes.


The eating disorder bulimia nervosa. Fluoxetine is used alongside psychotherapy for the
reduction of binge-eating and purging.



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

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 if 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 or have taken within the last two weeks, any monoamine oxidase
inhibitors (MAO inhibitors). Examples include medicines used to treat depression

(e.g. Moclobemide) and also Linezolid (an antibiotic) and Methylthioninium
chloride also called Methylene blue (used to treat high levels of methaemoglobin
in the blood).
It is important not to start treatment with a MAO-inhibitor for at least five weeks
after stopping Fluoxetine treatment.
Warnings and precautions
Tell your doctor or pharmacist if any of the following applies to you:
 if you are diabetic. Your doctor may need to adjust your dose of insulin and/or other
antidiabetic treatment
 if you have a fit (seizure) or experience an increase in seizure frequency. Contact
your doctor immediately as fluoxetine might need to be discontinued;
 if you have a history of bleeding disorders or appearance of bruises or unusual bleeding
 if you suffer from kidney problems
 if you suffer from liver problems; your doctor may need to adjust your dosage
 if you suffer from 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 episodes (overactive behaviour or thoughts). Contact your
doctor immediately as fluoxetine might need to be discontinued
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). Although this syndrome occurs rarely, it may result in
potentially life-threatening conditions; contact your doctor immediately, since
fluoxetine may need to be discontinued

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
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 any of the following:















Certain monoamine oxidase inhibitors (MAOIs, some 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 “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 closely.
lithium, tryptophan; there is an increased risk of serotonin syndrome when these drugs
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.
tramadol (a painkiller) or triptans (for migraine); there is an increased risk of 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. This will also apply
if fluoxetine has been taken in the previous 5 weeks.
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)
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.
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.

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, think you might 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 showing an increased risk of birth defects, in particular those 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.
Breastfeeding
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
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. 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. Patients
with depression should be treated for at least 6 months.
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.
LIVER IMPAIRMENT
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.
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.
Symptoms 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 have thoughts of harming or killing yourself at any time, go to your doctor or nearest
hospital emergency department straight away (see section 2 ‘Thoughts of suicide…’)
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:











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 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. Those affected may have fever, sore throat, headache and/or diarrhoea
gastrointestinal bleeding resulting in dark, tarry stools or vomiting blood

These side effects are serious. You may need medical attention.
The following side effects have also been reported in patients taking fluoxetine:
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, 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, 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, hair loss, increased tendency to bruising, cold sweat, difficulty or 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 (detected in a blood test), untypical wild behaviour,
hallucinations (see, hear or feel things that are not there), feel agitated, panic attacks,

inflammation of a blood vessel (appearing as a rash or bruising), widening of blood vessels
(causing flushing of the skin), 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, inability to urinate, unusual bleeding or bruising, high prolactin levels in the
blood (detected in a blood test).
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, abnormal liver function test results, muscle pain,
problems urinating, confusion, stuttering, nose bleeds, ringing in the ears, excessive release of
antidiuretic hormone (detected in a blood test), a prolonged persistent erection.
Bone fractures - an increased risk of bone fractures has been observed in patients taking this
type of medicine.
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: 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 your capsules above 25oC.
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 starch flowable, dimeticone, gelatin, yellow iron oxide (E172),
titanium dioxide (E171), and black edible printing ink consisting of shellac, propylene glycol,
ammonium hydroxide, black iron oxide (E172) (formulation 1) or shellac, soya lecithin,
antifoam DC 1510, black iron oxide (E172) (formulation 2).
What Fluoxetine looks like and contents of the pack
Your medicine is a hard, cream coloured capsule marked “3109”.
Your medicine is available in blisters packs of 30 capsules.
Marketing Authorisation Holder
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL, United Kingdom

Manufacturer
Eli Lilly and Company Ltd, Kingsclere Road, Basingstoke, Hampshire RG21 6XA
This leaflet was last revised in 02/2014

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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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