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FLUOXETINE 60MG HARD CAPSULES

Active substance(s): FLUOXETINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Fluoxetine 60 mg Hard Capsules
Fluoxetine
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you:
Keep this leaflet as you may wish 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 60 mg Hard Capsules are
and what they are used for
2. What you need to know before you take
Fluoxetine 60 mg Hard Capsules
3. How to take Fluoxetine 60 mg Hard Capsules
4. Possible side effects
5. How to store your Fluoxetine 60 mg Hard
Capsules
6. Contents of the pack and other information

1. What Fluoxetine 60 mg Hard
Capsules are and what they are
used for
Fluoxetine is one of a group of medicines
called selective serotonin re-uptake inhibitors
(SSRI) antidepressants.
Fluoxetine 60 mg Hard Capsules are used to
treat adults with:
• Major depressive episodes
• Bulimia nervosa: Fluoxetine 60 mg Hard
Capsules are used alongside psychotherapy for
the reduction of binge-eating and purging.
• Obsessive compulsive disorder (also
called OCD).

2. What you need to know before you
take Fluoxetine 60 mg Hard
Capsules
Do not take Fluoxetine 60 mg Hard
Capsules and tell your doctor or
pharmacist if the following apply:





If you are allergic (hypersensitive) to fluoxetine
or any of the other ingredients of Fluoxetine 60
mg Hard Capsules (listed in Section 6). An
allergy may include rash, itching, swollen face or
lips or shortness of breath.
If you are taking metoprolol for treating cardiac
failure
If you are taking medicines known as irreversible
non-selective monoamine oxidase inhibitors
(also called MAOIs) (which are also used to treat
depression), since serious or even fatal
reactions can occur.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Fluoxetine 60 mg Hard Capsules if any of the
following applies to you:
• 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 have epilepsy or have had a fit in
the past; if you have a fit (seizure) or
experience an increase in seizure
frequency, contact your doctor
immediately, the use of fluoxetine might
need to be discontinued.
• If you are having Electroconvulsive therapy
(ECT)
• If you have suffered from abnormally
elevated mood (mania) in the past; if you
have an episode of abnormally elevated
mood, contact your doctor immediately,
the use of fluoxetine might need to be
discontinued.
• If you have any liver or kidney problems,
you should discuss this with your doctor,
as he may wish to reduce the dose.
• If you are taking tamoxifen (for treatment of
breast cancer (see ‘Other medicines and
Fluoxetine 60 mg Hard Capsules’)
• If you suffer from congenital heart defect
(congenital long QT syndrome) or someone in
your family shows variations in the electrical
activity of the heart or you tend to show irregular
heartbeat (e.g. because of low levels of
potassium, low levels of magnesium, slow
heartbeat, heart attack or uncompensated heart
failure).
• If you have diabetes. You may need to adjust
your dose of insulin or other antidiabetic
treatment.
• If you have a history of bleeding disorders
or you develop bruises or unusual
bleeding
• If you are using medicinal products that
effect the coagulation of blood (see ‘Other
medicines and Fluoxetine 60 mg Hard
Capsules’).
• If you have raised intraocular pressure or are at
risk of acute narrow-angle-glaucoma.
• If you start to experience 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, the use of
fluoxetine might need to be discontinued.
Irreversible non-selective MAOI: Treatment with
fluoxetine should only be started 2 weeks after
discontinuation of an irreversible non-selective
MAOI. Do not take any MAOIs for at least five weeks
after you stop taking Fluoxetine 60 mg Hard
Capsules. Examples of irreversible non-selective
MAOIs include nialamide, iproniazide, moclobemide,
phenelzine, tranylcypromine and isocarboxazid.
Reversible MAOI: It is not recommended to combine
fluoxetine with a reversible MAOI (e.g.
moclobemide). Treatment with fluoxetine can be
started the following day after ending of a reversible
MAOI.
Suicidal thoughts and worsening of your
depression/anxiety disorder
If you are depressed 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.
Akathisia/inner restlessness: The use of fluoxetine
has been associated with the development of
akathisia, characterised by a subjectively unpleasant
or distressing restlessness and need to move often
accompanied by an inability to sit or stand still. This
is most likely to occur within the first few weeks of
treatment. In patients who develop these symptoms,
increasing the dose may be detrimental.
Withdrawal symptoms seen on discontinuation of
SSRI treatment: Withdrawal symptoms are common
when treatment is discontinued, particularly if
discontinuation is abrupt (see How to take Fluoxetine
60 mg Hard Capsules).
The risk of withdrawal symptoms may be dependent
on several factors, including the length of treatment,
the prescribed dose and how quickly the dose is
reduced. Effects that may be noticed when stopping
treatment are listed in Section 3 under ‘If you stop
taking Fluoxetine 60 mg Hard Capsules’. Generally,
these symptoms are mild to moderate; however,
sometimes they may be more intense. They usually
occur within the first few days of stopping treatment
and usually disappear within 2 weeks, but in some
people they may last for 2-3 months or more.
Therefore fluoxetine should be gradually decreased
when stopping treatment over a period of at least
one to two weeks (see ‘How to take Fluoxetine
60 mg Hard Capsules’).
Other medicines and Fluoxetine 60 mg Hard
Capsules
Please tell your doctor or pharmacist if you are taking
or have recently taken or might take any other
medicines, (up to five weeks ago) including
medicines obtained without prescription. This
medicine may affect the way some other medicines
work (interaction).
You must not take fluoxetine together with
• Irreversible, non-selective MAO-inhibitors (e.g.
iproniazid; used to treat depression). These must
not be used with Fluoxetine 60 mg Hard
Capsules as serious or even fatal reactions
(serotonin syndrome) can occur (see section “Do
not take Fluoxetine 60 mg Hard Capsules”).
MAO inhibitors type B (selegeline) can be used
with Fluoxetine 60 mg Hard Capsules provided
that your doctor monitors you closely.



Metoprolol (used to treat cardiac failure): Since
fluoxetine may slow down metabolism of
metoprolol and increase the risk of side effects
of Metoprolol including pronounced slowing of
the heartbeat.

Not recommended is a combination of fluoxetine with
• Tamoxifen (used to treat breast cancer): Since
fluoxetine may influence blood levels of of
tamoxifen and lower its efficacy.
• MAO inhibitors type A (linezolid,
methylthioninium chloride (methylene blue) as
the risk of developing a serotonin syndrome
arises. When fluoxetine is used in combination
with one of these drugs your doctor will carry out
more frequent check-ups.
• Reversible MAOI: It is not recommended to
combine fluoxetine with a reversible MAOI (e.g.
moclobemide). Treatment with fluoxetine can be
started the following day after ending of a
reversible MAOI.
• Mequitazine: Since fluoxetine may influence
blood levels of of tamoxifen and increase the risk
of side effects (QT prolongation).
Combinations requiring caution:
• Phenytoin (for epilepsy); because Fluoxetine 60
mg Hard Capsules 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 60 mg
Hard Capsules.
• Lithium (used to treat depression), tramadol
(painkiller), triptans (used to treat migraine),
tryptophan; selegeline (MAO inhibitors type B),
St. John’s Wort (Hypericum perforatum): There
is an increased risk of serotonin syndrome when
these drugs are coadministered with Fluoxetine
60 mg Hard Capsules. When fluoxetine is used
in combination with one of these drugs your
doctor will carry out more frequent check-ups.
• Drugs that may have an effect on heart rhythm
such as Class IA and III antiarrhythmics,
antipsychotics (e.g. phenothiazine derivatives,
pimozide, haloperidol), tricyclic antidepressants,
certain antimicrobial agents (e.g. sparfloxacin,
moxifloxacin, erythromycin IV, pentamidine),
anti-malaria treatment particularly halofantrine,
certain antihistamines (astemizole, mizolastine)
• Warfarin, non-steroidal anti-inflammatory drugs
or other medicines used to thin the blood
(including clozapine, used to treat certain metal
disorders, and acetylsalicylic acid (ASS);
Fluoxetine 60 mg Hard Capsules may alter the
effect of these medicines on the blood. If
Fluoxetine 60 mg Hard Capsules treatment is
started or stopped when you are taking warfarin,
your doctor will need to perform certain tests.
• Cyproheptadine: Cyproheptadine may reduce
antidepressive effect of fluoxetine.
• Drugs that may lower sodium concentration in
the blood (e.g. diuretics, carbamazepine,
oxcarbazepine)
• Combination with agents that may lower the
seizure threshold (e.g. tricyclic antidepressants,
other selective serotonin reuptake inhibitors,
phenotiazine, mefloquine, chloroquine,
bupropion, tramadol)
• Electroconvulsive therapy (ECT): There are rare
cases of prolonged seizures in patient that have
received an ECT while taking fluoxetine.


Flecainide, propafenone and nebivolol (used to
treat heart diseases), carbamazepine (used to
treat epilepsy), tricyclic antidepressants
(imipramine, desipramine, amitriptyline),
Risperidon (neuroleptic), atomoxetine: As
Fluoxetine 60 mg Hard Capsules may possibly
change the blood levels of these drugs, your
doctor may need to lower their dose when
administered with Fluoxetine 60 mg Hard
Capsules. This also applies if you have been
treated with fluoxetine in the last five weeks.

Taking Fluoxetine 60 mg Hard Capsules with
food and drink
You should avoid alcohol while you are taking this
medicine. You can take your capsules with or
separately from food.
Children and adolescents
Fluoxetine 60 mg Hard Capsules should not be used
in children and adolescents under the age of 18.
Lower strength fluoxetine medicine in a liquid or
capsule form is available that is better suited to
patients of this age group.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before
taking any medicine.
Talk to your doctor as soon as possible if you’re
pregnant, if you might be pregnant, or if you’re
planning to become pregnant.
Make sure your midwife and/or doctor know you are
on Fluoxetine.
Pregnancy
Talk to your doctor as soon as possible if you’re
pregnant, if you might be pregnant, or if you’re
planning to become pregnant.
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.
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.
When taken during pregnancy, particularly in the last
3 months of pregnancy, medicines like Fluoxetine 60
mg Hard Capsules 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.
Breast-feeding
Fluoxetine is excreted in breast milk and can cause
side effects in babies. You should only breast-feed 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 machinery
Some medicines may affect your judgement or coordination. Do not drive or use machinery unless you
are sure that you are not affected.
Fluoxetine 60 mg Hard Capsules contain
Tartrazine (E102) and Sunset Yellow FCF (E110)
These ingredients may cause allergic reactions in
some people.

3. How to take Fluoxetine 60 mg Hard
Capsules
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
Fluoxetine 60 mg Hard Capsules are for use
by adults for depression, bulimia nervosa,
obsessive compulsive disorder (OCD).
Your doctor will tell you how many capsules to
take, and when to take them.
You can take your capsules with or separately
from food.
The capsules should not be chewed or
crushed; they should always be swallowed
whole, with a drink of water.
Dosage information
Your doctor may start you on lower strength
fluoxetine (e.g. 20 mg) capsules that are available,
but check with your doctor or pharmacist if you are
not sure of the correct dose.
• Depression: The recommended dose is 20 mg
daily. Your doctor will review and adjust your
dosage if necessary within 3 to 4 weeks of the
start of treatment. When appropriate the dosage
can be gradually increased up to a maximum of
60 mg. 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. Patients with
depression should be treated for a period of at
least 6 months.




Bulimia nervosa: The recommended dose is 60
mg daily.
OCD: The recommended dose is 20 mg daily.
Your doctor will review and adjust your dosage if
necessary after 2 weeks of treatment. When
appropriate the dosage can be gradually
increased up to a maximum of 60 mg. If no
improvement is noted within 10 weeks, treatment
with fluoxetine should be reconsidered.

Elderly:
If you are elderly, your doctor will increase the dose
with more caution and the daily dose should
generally not exceed 40 mg. The maximum dose is
60 mg per day.
Liver impairment:
If you have a liver problem or are using other
medication that might have an influence on
fluoxetine, your doctor may decide to prescribe a
lower dose or instruct you to use fluoxetine every
other day
Fluoxetine 60 mg Hard Capsules should not be
used in children and adolescents under the age
of 18.
If you take more Fluoxetine 60 mg Hard Capsules
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 60 mg Hard Capsules 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 60 mg Hard
Capsules
If you forget to take your 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
individual dose. Taking your medicine at the same
time each day may help you to remember to take it
regularly.
If you stop taking Fluoxetine 60 mg Hard
Capsules
Always follow your doctor’s instructions on how many
Fluoxetine 60 mg Hard Capsules to take and for how
long to take them. Keep taking your medicine until
your doctor asks you to stop. Do not stop taking your
medicine without asking your doctor first, even when
you start to feel better. Make sure you do not run out
of capsules.
When your doctor does instruct you to stop taking
Fluoxetine 60 mg Hard Capsules he/she will help you
to reduce your dose slowly over one to two weeks –
this should help reduce the chance of withdrawal
effects.
You may notice the following effects when you stop
taking Fluoxetine 60 mg Hard Capsules: 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/being sick); tremor (shakiness);
headaches.
Most people find that any symptoms on stopping
Fluoxetine 60 mg Hard Capsules (under guidance
from your doctor) are mild and go away on their own
within a few weeks. If you experience symptoms
when you stop treatment, contact your doctor.
If you have any further questions of 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.
Tell your doctor immediately if:
• You have distressing thoughts, thoughts of
harming yourself or committing suicide
• You get a rash or an allergic reaction such as
itching, swollen lips, tongue or face, wheezing or
shortness of breath. If this happens, stop taking
the capsules straight away and tell your doctor
immediately.
• You feel restless and feel like you cannot sit or
stand still. You may have something called
akathisia; increasing your dose of Fluoxetine 60
mg Hard Capsules may make you feel worse. If
you feel like this, contact your doctor.
• Your skin starts to turn red or you develop a
varied skin reaction or your skin starts to blister
or peel. This is very rare.
• 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
on 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 rate.
• Inexplicable vaginal bleeding
• Inexplicable bruises or bleeding or bleeding in
the gastrointestinal tract
• Fits
• Uncontrollable movements
• Signs of liver inflammation (abdominal swelling,
distention or bloating, diarrhoea, discolored urine
and stool, fatigue, headache, Itchy skin, joint
pain, loss of appetite, low-grade fever, malaise
and lethargy, nausea with or without vomiting,
yellowing of the skin and whites of the eye)
• Small bleedings of skin and mucosa, painless
(rarely itching) skin swelling, acute, inflammatory
skin disease, heavy skin reactions StevensJohnson syndrome, Erythema multiforme, Toxic
Epidermal Necrolysis (Lyell Syndrome)
The following side ef fects have been reported in
patient during treatment with fluoxetine:
Very common (may affect more than 1 in 10 people):
• Inability to sleep
• Headache
• Diarrhoea
• Sickness
• Tiredness
Common (may affect up to 1 in 10 people)
• Poor appetite
• Change in taste
• Nervousness, anxiety
• Feeling tense
• Decreased sex drive or sexual difficulties
(including low sexual performance and
ejaculation problems)
• Sleep problems or unusual dreams
• Tremor
• Not being able to concentrate or think properly
• Drowsiness












Blurred vision
Flushing
Yawning
Indigestion, vomiting
Dry mouth
Skin rash, urticaria, itching, abnormal sweating
Joint pains
Passing urine too frequently
Feeling shaky or chills
Weight loss

Uncommon (may affect up to 1 in 100 people)
• Feeling detached from yourself
• Abnormal thinking
• abnormally high mood
• orgasm problems
• Teeth grinding
• Disturbances of motion sequence
• Disturbances of coordination
• Muscle twitching
• Involuntary impaired balance
• Memory impairment
• Enlarged pupils
• Ringing in the ears
• Low blood pressure
• Shortness of breath
• Nose bleeds
• Difficulties in swallowing
• Hair loss
• Inexplicable bruises or bleedings, also in
gastrointestinal tract
• Cold sweat
• Difficulty passing urine
• Sexual disorders
• Sensation disorders, discomfort
• Feeling hot or cold
Rare (may affect up to 1 in 1,000 people)
• Low levels of sodium in the blood
• Low numbers of platelets
• Low number of red and white blood cells
• Manic reactions (untypical wild behaviour)
• Hallucinations
• Uproariousness, aggression
• Panic attacks
• Confusion
• Stuttering
• Fits
• Agitation
• Uncontrollable movements
• Buccoglossal Syndrome
• Arrhythmias and QT prolongation
• Inflammation of blood vessels and vascular
dilation
• Pharyringitis
• Oesophageal pain
• Liver inflammation
• Lung problems
• Sensitivity to sun light
• Muscle aches
• Difficulties in passing urine
• Producing breast milk
• Anaphylactic reaction (shortness of breath,
swelling in the throat, low blood pressure,
gastrointestinal complaints, racing heart, vertigo,
shock)
• Serum sickness (rash, joint aches, fever,
swelling of lymph nodes, shock, low blood
pressure)
• Impaired ADH secretion
• Increased prolactin levels in the blood
• Abnormal liver function tests
Most of these are usually nothing to worry about and
go away after the first few weeks while you are
taking your medicine.
If any of the side effects get serious or you notice
any other side effects not mentioned in this leaflet,
please inform your doctor or pharmacist.
Children and Adolescents (8-18 years) if treated with
lower doses for moderate or severe depressive
episodes may experience slow growth or delayed
sexual maturity and have an increased risk of sideeffects such as suicide attempt, suicidal thoughts
and hostility (predominantly aggression, oppositional
behaviour and anger).
Do not stop taking Fluoxetine 60 mg Hard Capsules
until your doctor tells you to.
Reporting of side effects
If you get any side effects, talk to your doctor or
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
Website: www.mhra.gov.uk/yellowcard. By reporting
side affects you can help provide more information
on the safety of this medicine.

5. How to store your Fluoxetine 60 mg Hard
Capsules
Keep this medicine out of the sight and reach of
children.
This medicinal product does not require any special
storage conditions. Do not use Fluoxetine 60 mg
Hard Capsules after the expiry date which is stated
on the carton and the blister. The expiry date refers
to the last day of that month. 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.

6. Contents of the pack and other
information
What Fluoxetine 60 mg Hard Capsules contain
• The active substance is fluoxetine hydrochloride
• The other ingredients are pregelatinised (maize)
starch, gelatin capsules (containing tartrazine
(E102) [0.37mg], sunset yellow FCF (E110)
[0.0009mg], titanium dioxide (E171), sodium
lauril sulphate, sorbitan monolaurate and gelatin)
and black printing ink consisting of black iron
oxide (E172), propylene glycol and shellac.
What Fluoxetine 60 mg Hard Capsules look like
and contents of the pack
Fluoxetine 60 mg Hard Capsules are yellow and
white capsules, marked “FLX 60”.
Your Fluoxetine 60 mg Hard Capsules are presented
in blister packs. They are supplied in boxes
containing 5, 7, 10, 14, 28, 30, 42, 56 or 60 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer:
Dr. Reddy’s Laboratories (UK) Ltd
6 Riverview Road, Beverley, HU17 0LD, UK
Fluoxetine 60 mg Hard Capsules/ PL 08553/0262
This leaflet was last revised in September 2015
Component code
© Dr Reddy’s Laboratories (UK) Ltd

+ Expand Transcript

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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