FLUOXETINE CAPSULES 20MG

Active substance: FLUOXETINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluoxetine Capsules 20 mg

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Read all of this leaflet carefully before you start taking this medicine.
• 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. Do 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1. What Fluoxetine Capsules 20 mg are and what they are
used for
2. Before you take Fluoxetine Capsules 20 mg
3. How to take Fluoxetine Capsules 20 mg
4. Possible side effects
5. How to store Fluoxetine Tablets 20 mg
6. Further Information

1

What Fluoxetine Capsules 20 mg are and
what they are used for

The active ingredient in these capsules, fluoxetine belongs to a
group of medicines known as selective serotonin reuptake
inhibitors (SSRIs). Fluoxetine Capsules 20 mg are an
antidepressant that influences the central nervous system.

Fluoxetine Capsules 20 mg are used for:
• Major depressive episodes
• Obsessive-compulsive disorder
• Bulimia nervosa (compulsive eating)

Your doctor may have prescribed this medicine for a different
purpose and/or different dosage from that given in the package
leaflet. You must always follow the doctors prescription and the
instructions given on the label of the pack.

2

Before you take Fluoxetine Capsules 20 mg

Do not take Fluoxetine Capsules 20 mg
• If you have had any allergic reaction to fluoxetine or to any of
the other ingredients in the product.
• If you are taking a medicine to treat depression, known as
non-selective monoamine oxidase inhibitors (MAOIs), since
serious or even fatal reactions can occur.
Treatment with Fluoxetine should only be started 2 weeks
after discontinuation of an irreversible MAOI (for example
isocarbaxazid, phenelzine and selegeline).

However, treatment with Fluoxetine can be started the
following day after discontinuation of certain reversible
MAOIs (for example moclobemide).

Do not take any MAOIs for at least 5 weeks after you stop
taking fluoxetine. If fluoxetine has been prescribed for a long
period and/or at high dose, a longer interval needs to be
considered by your doctor.

Take special care with Fluoxetine Capsules 20 mg
• If you have diabetes Fluoxetine Capsules 20 mg can raise or
lower your blood sugar. The dose of your insulin or the
antidiabetes medicine that you take by mouth may need to be
adjusted.
• If you have started having fits (seizures) or have epilepsy
which is under control.
• If you have reduced liver, kidney or heart function or have
recently had a heart attack you must tell your doctor, because
it may be necessary to prescribe a lower dose for you.
• If you have or have had mania.
• If you start to lose weight.
• If you get an allergic reaction such as itching, rash or swelling
of the face, treatment with Fluoxetine Capsules 20 mg must
be stopped.
• If you have a tendency to bleed.
• If you are taking a herbal preparation containing St. Johnʼs
Wort (taking a hypericum perforatum).
• If you are receiving electric shock treatment.

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 under 18 years of age:

Fluoxetine should normally not be used for children and
adolescents under 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.
Despite this, your doctor may prescribe fluoxetine for patients
under 18 because he/she decides that this is in their best
interests. If your doctor has prescribed fluoxetine for a patient
under 18 and you want to discuss this, please go back to your
doctor. You should inform your doctor if any of the symptoms
listed above develop or worsen when patients under 18 are
taking fluoxetine. Also, the long-term safety effects concerning
growth, maturation and cognitive and behavioural development
of fluoxetine in this age group have not yet been demonstrated.

Taking other medicines
Certain other medicines can affect or be affected by Fluoxetine
Capsules 20 mg. Some of these medicines are:
• Certain MAO-inhibitors (used to treat depression).
Non-selective MAO-inhibitors (e.g. phenelzine) and
MAO-inhibitors type A (e.g. moclobemide) must not be used
with Fluoxetine Capsules 20 mg as serious or even fatal
reactions (serotonin syndrome) can occur. Some
MAO-inhibitors type B (selegeline) can be used with
Fluoxetine Capsules 20 mg provided that your doctor
monitors you closely.

It is especially important that you ask your doctor for advice if
you are taking
• medicine to thin the blood (warfarin)
• other medicine for depression (e.g. tricyclic antidepressants),
or medicines containing tryptophan or lithium
• medicine for epilepsy (e.g. phenytoin or carbamazepine)
• pain-relieving medicines containing tramadol
• a natural remedy containing St. Johnʼs Wort (Hypericum
perforatum)
• medicines containing flecainide or encainide (for irregular
heart rhythm).

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.

Taking Fluoxetine Capsules 20 mg with food and drink
Food: The capsules may be taken with or between meals.

Alcohol: The combination of Fluoxetine Capsules 20 mg and
alcohol is not recommended.

Pregnancy and breast-feeding
Always ask you doctor or pharmacist for advice before taking
Fluoxetine Capsules 20 mg.

Pregnancy
Talk to your doctor as soon as possible if youʼre pregnant, if you
might be pregnant, or if youʼre planning to become pregnant.

Continued on the next page >>

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 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 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.

Additional caution should be exercised especially during late
pregnancy or just before giving birth since the following effects
have been reported in new born children: irritability, tremor,
muscle weakness, persistant crying and difficulty in suckling or
in sleeping.

Breast-feeding
Fluoxetine is excreted in breast milk and can cause side effects.
You should only breast-feed if it is clearly necessary. If
breast-feeding is continued, your doctor may prescribe a lower
dose of fluoxetine.

Ask your doctor or pharmacist for advice before taking any
medicine.

Driving and using machines
Fluoxetine can impair judgement, thinking capacity and motor
skills. This should be taken into account in situations where
increased alertness is necessary, e.g. when driving or operating
hazardous machinery.

3

How to take Fluoxetine Capsules 20 mg

Always take Fluoxetine Capsules 20 mg exactly as your doctor
has told you. You should check with your doctor or pharmacist if
you are not sure.

Take Fluoxetine Capsules 20 mg with water.

The usual dose is:
Depression:
1 capsule daily (20 mg)

Obsessive thoughts and obsessive actions (OCD):
Between 1 and 3 capsules daily (20 – 60 mg)

Bulimia:
3 capsules daily (60 mg)

If you take more Fluoxetine Capsules 20 mg than you
should
When you have taken too much Fluoxetine than you should
contact your doctor or a hospital. Symptoms of overdose:
Nausea, vomiting, seizures, anxiety, restlessness and excessive
cheerfulness.

If you forget to take Fluoxetine Capsules 20 mg
Do not take a double dose to make up for a forgotten dose.

If you stop taking Fluoxetine Capsules 20 mg
Do not discontinue the treatment without consulting your doctor.
When you stop taking Fluoxetine Capsules 20 mg, withdrawal
reactions, e.g. headache, nausea, anxiety and dizziness, can
occur. These disorders are mild and temporary.
When stopping treatment with Fluoxetine Capsules 20 mg, your
doctor will help you to reduce the dose slowly over one or two
weeks in order to reduce the risk of withdrawal reactions.

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4

Possible side effects

Like all medicines, Fluoxetine Capsules 20 mg can cause side
effects, although not everybody gets them.

If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell you doctor
or pharmacist.
Body as a whole
Rash or allergic reaction, chills, sensitivity to sunlight, weight
loss.

Digestive system
Diarrhoea, nausea, vomiting, indigestion, difficulty swallowing or
a change in taste, dry mouth. Abnormal liver function tests have
been reported rarely, with very rare cases of hepatitis.

Nervous system
Headache, sleep problems or unusual dreams, dizziness, loss
of appetite, tiredness, abnormally high mood, uncontrolled
movement, fits, extreme restlessness, hallucinations, untypical
wild behaviour, confusion, agitation, anxiety, nervousness, not
being able to concentrate or think properly, panic attacks,
thoughts of suicide or harming yourself.

Urogenital system
Difficulty passing urine or passing urine too frequently.

Reproductive disorder
Poor sexual performance, prolonged erections, producing
breastmilk.

Other
Hair loss, yawning, blurred vision, unexplained bruising or
bleeding, sweating, hot flushes, feeling dizzy when you stand
up, joint or muscle pain, low levels of sodium in the blood.

Respiratory system
Sore throat, shortness of breath. Lung problems (including
inflammatory processes of varying histopathology and/or
fibrosis) have been reported rarely.

Other
Hair loss, yawning, blurred vision, unexplained bruising or
bleeding, sweating, hot flushes, feeling dizzy when you stand
up, joint or muscle pain, low levels of sodium in the blood.

An increased risk of bone fractures has been observed in
patients taking this type of medicine.

5

How to store Fluoxetine Capsules 20 mg

6

Further information

• Children: keep out of the reach and sight of children
• Use by date: do not use fluoxetine after the expiry date
which is stated on the carton. The expiry date refers to the
last day of that month
• Disposal: Medicines should not be disposed of via
wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures
will help to protect the environment.

What Fluoxetine Capsules 20 mg contain
The active substance is fluoxetine hydrochloride equivalent to
20 mg fluoxetine.

The other ingredients are pregelatinised maize starch,
anhydrous colloidal silica, magnesium stearate, talc, quinoline
yellow (E104), indigo carmine (E132), titanium dioxide (E171)
and gelatin.

What Fluoxetine Capsules 20 mg look like and the contents
of the pack
Fluoxetine Capsules 20 mg are light green opaque capsules
marked with “F20” and contain an almost white powder.

Fluoxetine Capsules 20 mg come in Aluminium/PVC blister strip
packs of 28 and 30 capsules.

Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturers
Actavis HF, Reykjavikurvegi 78, IS-222, Hafnarf Jordur, Iceland

or

Delta Limited, Borgartun 6, Reykjavik, IS-105, Iceland

or

Karib Kemi-Pharm Limited, Karib House, 63-65 Imperial Way,
Croydon, Surrey, CR0 4RR, United Kingdom

or

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR, UK.
This leaflet was last approved in 08/2010 (to be amended
after approval).

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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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