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FLUOXETINE 60 MG CAPSULES HARD

Active substance(s): FLUOXETINE HYDROCHLORIDE

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Fluoxetine 60 mg capsules, hard
fluoxetine hydrochloride
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 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 is used for
Fluoxetine contains fluoxetine which is one of a group of medicines
called selective serotonin reuptake inhibitor (SSRI)
antidepressants.
This medicine is used to treat the following conditions:
Adults:

Major depressive episodes

Obsessive-compulsive disorder

Bulimia nervosa: Fluoxetine 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.

taking other medicines known as irreversible, non-selective
monoamine oxidase inhibitors (e.g. iproniazid)

taking metoprolol (a medicine used to treat heart problems)
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluoxetine
Tell your doctor if any of the following applies to you:





















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;
mania now or in the past; if you have a manic episode,
contact your doctor immediately because Fluoxetine might
need to be discontinued;
diabetes (your doctor may need to adjust your dose of
insulin or other antidiabetic treatment);
liver problems (your doctor may need to adjust your
dosage);
heart problems;
low resting heart-rate and/or if you know that you may have
salt depletion as a result of prolonged severe diarrhea and
vomiting (being sick) or usage of diuretics (water tablets);
glaucoma (increased pressure in the eye);
ongoing treatment with diuretics (water tablets), especially
if you are elderly;
ongoing ECT (electro-convulsive therapy);
history of bleeding disorders or appearance of bruises or
unusual bleeding;
ongoing treatment with medicines that thin the blood (see
‘Other medicines and Fluoxetine);
ongoing treatment with tamoxifen (used to treat breast
cancer) (see ‘Other medicines and Fluoxetine);
starting to feel restless and cannot sit or stand still
(akathisia). Increasing your dose of Fluoxetine may make
this worse;
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 discontinued.
taking or have taken with in the last 14 days, another
medicine known as irreversible, non-selective monoamine
oxidase inhibitors (MAOI) ( see “Other medicines and
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.
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, and if you are a patient under 18, your doctor may
prescribe fluoxetine for moderate to severe major depressive
episodes, in combination with psychological therapy, because
he/she decides that this is in your 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.

Black

P150

P150

Fluoxetine

Package leaflet: Information for the user

Fluoxetine

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

Fluoxetine should not be used in the treatment of children under
the age of 8 years.
Other medicines and Fluoxetine
Please tell your doctor or pharmacist if you are taking or have
recently taken or might take any other medicines (up to 5 weeks
ago).
Fluoxetine may affect the way some other medicines work
(interaction), especially the following:

Monoamine oxidase inhibitors (MAOIs): You should not take
Fluoxetine if you are taking, or have recently taken (within the
last 14 days) an antidepressant medicine called irreversible,
non-selective monoamine oxidase inhibitors (e.g. iproniazid).
Taking a MAOI together with many prescription medicines,
including Fluoxetine, can cause serious or even life-threatening
side effects. You must wait at least 14 days after you have
stopped taking an MAOI before you can take Fluoxetine. Also,
you need to wait at least 5 weeks after you stop taking
Fluoxetine before you take a MAOI. However treatment with
fluoxetine can be started the following day after discontinuation
of certain reversible MAOIs (for instance moclobemide,
linezolid, methythioninium chloride (methylene blue)). Some
MAOIs type B (selegeline) can be used with Fluoxetine
provided that your doctor monitors you closely.

Metoprolol, a beta-blocker used to treat high blood pressure
and heart problems.

lithium, tryptophan; there is an increased risk of serotonin
syndrome when these drugs are taken with Fluoxetine. Your
doctor will carry out more frequent check-ups.

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).

medicines that may affect the heart’s rhythm (QT interval
prolongation)
- Class IA and III antiarrhythmics, antipsychotics
(e.g. fentiazine derviatives, pimozide, haloperidol), tricyclic
antidepressants, certain antimicrobial agents (e.g.
sparfloxacin, moxifloxacin, erythromycin IV,pentamidine),
anti-malaria treatment particularly halofantrine, certain
antihistamines (astemizole, mizolastine).
- Mequitazine (used to treat allergy)

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 Fluoxetine.

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.

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.
Some medicines can affect the way Fluoxetine works, or make it
more likely that you’ll have side effects

Cyproheptadine (used to treat allergy)

Drugs associated with hyponatremia(e.g. diuretics,
desmopressin, carbamazepine and oxcarbazepine)

Drugs which may lower the seizure threshold (for example,
tricyclic antidepressants, other SSRIs, phenothiazines,
butyrophenones, mefloquine, chloroquine, bupropion,
tramadol)

Drugs metabolised by CYP2D6 (such as flecainide,
propafenone,nebivolol,atomoxetine, carbamazepine, tricyclic
antidepressants and risperidone)
Fluoxetine with food, drink and alcohol

You can take Fluoxetine with or without food, whatever you
prefer.

You should avoid alcohol while you are taking this medicine.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for
advice before taking this 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.
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.
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
breast-feeding 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
Fluoxetine may affect your judgment or co-ordination. Do not drive
or use machinery without advice from your doctor or pharmacist.
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.
Do not take more capsules than your doctor tells you.
Swallow the capsules with a drink of water. Do not chew the
capsules.
Adults:
The usual dose is:

Depression: 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 of 3 capsules (60 mg) daily. 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 at least 6 months.
Bulimia nervosa: The recommended dose is 3 capsules (60
mg) daily.
Obsessive-compulsive disorder: The recommended dose is
1 capsule (20 mg) daily. Your doctor will review and adjust your
dosage if necessary after 2 weeks of treatment. If required, the
dosage can be gradually increased up to a maximum of 3
capsules (60 mg) daily. If no improvement is noted within 10
weeks, your doctor will reconsider your treatment.

Use in children and adolescents (aged 8 to 18 years with
depression):
Treatment should be started and be supervised by a specialist. The
starting dose is 10mg/day (given as 2.5 ml of fluoxetine oral liquid).
After 1 to 2 weeks, your doctor may increase the dose to 20mg/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
will review the need for continuing treatment beyond 6 months. If
you have not improved within 9 weeks, your doctor will reassess
your treatment.
Elderly:
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 60 mg daily.
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.
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 you 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 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,
contact your doctor or go to a hospital straight away (see
Section 2).

If you get a rash or allergic reaction such as itching, swollen
lips/tongue or wheezing/shortness of breath, stop taking the
capsules straight away and tell your doctor immediately.

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 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.
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 rate.
If you have any of the above side effects, you should tell your
doctor immediately.
The following side effects have also been reported in patients
taking fluoxetine:
Very common (seen in more than 1 in every 10 patients)

insomnia

headache

diarrhoea, feeling sick (nausea)

fatigue
Common (seen in 1 to 10 in every 100 patients)

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, tiredness or sleepiness

dizziness

change in taste

uncontrollable shaking movements

blurred vision

rapid and irregular heartbeat sensations

flushing

yawning

indigestion, vomiting

dry mouth

rash, urticaria, itching

excessive sweating

joint pain

passing urine more frequently

unexplained vaginal bleeding

feeling shaky or chills
Uncommon (seen in 1 to 10 in every 1,000 patients)

feeling detached from yourself

strange thinking

abnormally high mood

thoughts of suicide or harming yourself


















memory impairment
orgasm problems
teeth grinding
muscle twitching, involuntary movements or problems with
balance or co-ordination
enlarged (dilated) pupils
ringing in the ears
nose bleeds
unexpected bleeding of the gastrointestinal tract
low blood pressure
shortness of breath
difficulty swallowing
hair loss
increased tendency to bruising
cold sweat
difficulty passing urine
feeling hot or cold

Rare (seen in 1 to 10 in every 10,000 patients)

low levels of salt in the blood

reduction in blood platelets, which increases risk of bleeding or
bruising

decrease in neutrophils (that make you more susceptible to
different infections)

inappropriate antidiuretic hormone secretion (a condition
associated with abnormally low levels of sodium in the blood)

untypical wild behavior

feeling confused

aggressive behaviour

stuttering

hallucinations

agitation

panic attacks

fits

lung problems

hepatitis

skin rash, which may blister, and looks like small targets
(central dark spots surrounded by a paler area, with a dark ring
around the edge) called erythema multiforme

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)

muscle pain

problems urinating

vasculitis (inflammation of a blood vessel)

rapid swelling of the tissues around the neck, face, mouth
and/or throat

pain in the tube that takes food or water to your stomach

sensitivity to sunlight

producing breast milk

painful erection of the penis that won’t go away

unexplained bruising or bleeding

abnormal liver function
Bone fractures - an increased risk of bone fractures has been
observed in patients taking this type of medicines.
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 effectsin 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.
Reporting of 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 take this medicine after the expiry date which is stated on
the label, carton after EXP. The expiry date refers to the last day of
that month.
This medicinal product does not require any special storage
conditions
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 contains
The active substance is fluoxetine hydrochloride.
Each hard capsule contains 67.072 mg fluoxetine hydrochloride
equivalent to 60 mg of Fluoxetine
The other ingredients are:
Capsule contents: Starch pregelatinised (maize starch), cellulose
microcrystalline, silica colloidal anhydrous
Capsule shell: Iron oxide yellow (E172), patent blue V (E131),
titanium dioxide (E171), gelatin, sodium lauryl sulfate.
Printing ink: Shellac, propylene glycol, black iron oxide (E172),
potassium hydroxide.
What Fluoxetine looks like and contents of the pack
Capsule, hard.
Opaque green cap/yellow body, size “1” hard gelatin capsule filled
with white to off-white powder and imprinted with ‘J’ on opaque
green cap and ‘95’ on yellow body with black ink.
Fluoxetine 60 mg capsules are available in clear PVC/PVdC Aluminium foil blister pack and HDPE bottle pack with
polypropylene closure.
Blister pack: 5, 7, 10, 14, 20, 28, 30, 56 and 60 capsules, hard
Bottle pack: 28 and 500 capsules, hard
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This medicinal product is authorised in the Member States of
the EEA under the following names:
Cyprus:
Fluoxetine Aurobindo 20 mg καψάκιο,
σκληρό
Czech Republic:
Fluoxetine Aurobindo 20 mg Tvrdé
tobolky
Malta:
Fluoxetine 20 mg capsules, hard
Poland:
Fluoxetine Vitama
Portugal:
Fluoxetina Aurobindo
Spain:
FLUOXETINA AUROBINDO 20 mg
cápsulas duras EFG
The United Kingdom:
Fluoxetine 60 mg capsules, hard
The leaflet was last revised in 07/2014.

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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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