FLUOXETINE CAPSULES 20MG

Active substance: FLUOXETINE HYDROCHLORIDE

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Sandoz Ltd

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Fluoxetine Capsules 20 mg

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluoxetine Capsules 20 mg
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

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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. John’s 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

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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 20mg 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. John’s 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, breast-feeding and fertility
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Always ask you doctor or pharmacist for advice before taking Fluoxetine Capsules 20 mg.
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.
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.
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.
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.

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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.

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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.

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


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.

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Fluoxetine Capsules 20 mg

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6. Further Information
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
gelatine.
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.
Aluminium/PVC blister strips packed in an outer carton: 28 and 30 capsules.
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
United Kingdom
Manufacturers
Actavis HF, Reykjavikurvegi 78, IS-222, Hafnarf Jordur, Iceland OR
Delta Limited, Borgartun 6, Reykjavik, IS-105, Iceland OR
Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United
Kingdom
This leaflet was last approved in 10/2013

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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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