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FLUOXETINE CAPSULES 20MG

Active substance(s): FLUOXETINE HYDROCHLORIDE

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TEXT FOR NON-MARKETED PACKS
PIL FOR
FLUOXETINE CAPSULES 20mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUOXETINE CAPSULES 20MG
Fluoxetine (as Hydrochloride)
EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT FLUOXETINE
Please read the entire leaflet. It includes a lot of additional important information about this medicine.
Fluoxetine treats depression and some anxiety disorders. Like all medicines it can have unwanted
effects. It is important that you and your doctor weigh up the benefits of treatment against possible unwanted
effects, before starting treatment.
Fluoxetine can be used by adults and in some cases by children and adolescents aged 8 years and
above. See ‘Children and adolescents aged 8 to 18 years’ in section 2 of this leaflet.
Fluoxetine won’t work straight away. Some people taking antidepressants feel worse before feeling better.
It may take two weeks or more before you see any benefit.
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
‘Thoughts of suicide and worsening of your depression or anxiety disorder’ in section 2 of this leaflet.
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 ‘If you forget to take Fluoxetine’ and ‘If you stop taking
Fluoxetine’ in section 3 of this leaflet.
If you feel restless and feel like you can’t sit or stand still, feel very over-excited, or have muscle
stiffness or tremor, tell your doctor. Increasing the dose of Fluoxetine may make some of these feelings
worse. See section 4 ‘Possible side-effects’, in this leaflet.
Taking some other medicines with Fluoxetine can cause problems. You may need to talk to your doctor.
See ‘Taking other medicines’ in section 2 of this leaflet.
If you are pregnant or planning to become pregnant, talk to your doctor. See ‘Pregnancy, breast-feeding
and Fluoxetine’ in section 2 of this leaflet.
Now read the rest of this leaflet. It includes other important information on the safe and effective use of this
medicine that might be especially important for you.
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 (chemist). You may also find it helpful to
contact a self-help group, or patient organisation, to find out more about your condition. Your doctor will be
able to give you details.
-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 get 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 is and what it is used for
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2.
3.
4.
5.
6.

Before you take Fluoxetine
How to take Fluoxetine
Possible side-effects 6. Further information
How to store Fluoxetine
Further Information

1. WHAT FLUOXETINE IS AND WHAT THEY ARE USED FOR
Fluoxetine is an SSRI antidepressant (selective serotonin re-uptake inhibitor) and is used to treat the
following conditions:
In Adults:
Fluoxetine is used to treat severe depression (major depressive episodes), OCD (obsessivecompulsive disorder) and deliberate vomiting following binge eating (bulimia nervosa) where
Fluoxetine is used together with psychotherapy.
In Children: In children and adolescents aged 8 years and above Fluoxetine is used to treat moderate to
severe depression (major depressive disorder). It must only be used if a previous course of
psychological therapy (4 to 6 sessions) has not improved their condition. Children must only
use Fluoxetine in combination with psychological therapy.
2. BEFORE YOU TAKE FLUOXETINE
Do not take Fluoxetine if you are:
• allergic (hypersensitive) to Fluoxetine hydrochloride or any of the ingredients of Fluoxetine (see section
6 for list of ingredients). 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.
• suffering from severe renal failure with GFR <10 ml/min (severe kidney failure with less than 10ml of
blood filtered by the kidneys per minute), because the drug may build up in the body.
• taking any of the following medicines: -non-selective MAOIs (monoamine oxidase inhibitors) in the
last 2 weeks, since serious or even fatal reactions can occur -reversible MAOIs type A (e.g.
Moclobemide). Fluoxetine can be taken the day after you stop using reversible MAOIs type A.
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 a higher dose, a longer interval needs to be considered by your doctor.
Take special care with Fluoxetine
Tell your doctor if any of the following applies to you:
• epilepsy or have had a fit in the past
• suffered an extremely high mood (mania) in the past
• diabetes, as your doctor may need to adjust your diabetes treatment
• liver or kidney problems. Your doctor may need to change the amount of medicine you receive
• heart problems
• increased pressure in the eye (glaucoma)
• are having treatment with water tablets (diuretics), especially if you are elderly
• had ECT (electro-convulsive therapy) treatment
• a history of bleeding disorders or you develop bruises or unusual bleeding
• treatment with medicines that thin the blood
• treatment with tamoxifen (used to treat breast cancer)
• hyponatraemia, a deficiency of sodium in your blood.
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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, Fluoxetine might 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 are 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 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
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 the age group is available. Despite this, your doctor may
prescribe Fluoxetine for patients under 18 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.
Taking other medicines
Tell your doctor if you take or have recently taken (up to 5 weeks ago) any other medicines including
medicines obtained without a prescription.
Fluoxetine may affect the way some other medicines work, especially the following: certain MAO-inhibitors
(used to treat depression). Non-selective MAO-inhibitors and MAO-inhibitors type A (moclobemide) must
not be used with Fluoxetine as serious or even fatal reaction (serotonin syndrome) can occur (see section
‘Do not take Fluoxetine Capsules’. Some MAO-inhibitors type B (selegiline) can be used with Fluoxetine
provided that your doctor monitors you closely.


Lithium or Tryptophan, as there is an increased risk of serotonin syndrome your doctor will carry out
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more frequent check-ups.
Phenytoin or Carbamazepine (for epilepsy), as Fluoxetine may increase the levels of this drug in your
body
Clozapine (used to treat certain mental disorders), Tramadol (a painkiller) or triptans (for migraine) as
there is an increased risk of high blood pressure (hypertension)
Flecainide or Encainide (for heart problems), tricyclic antidepressants (for example Imipramine,
Desipramine and Amitriptyline), as Fluoxetine may increase the levels of these drugs in your body.
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 or other medicines used to thin the blood, as Fluoxetine may alter the effect of these medicines
on the blood
blood clotting medicines
water tablets (diuretics) especially if you are elderly.
St. John’s Wort. Taking this at the same time as Fluoxetine may result in more side-effects. Stop taking
St. John’s Wort and tell your doctor at your next visit.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines (up to 5 weeks
ago) including medicines obtained without a prescription.
Do not take any MAOIs for at least 5 weeks after you stop taking Fluoxetine. Examples of MAOIs
include: Nialamide, Iproniazide, Selegeline, Moclobemide, Phenelzine, Tranylcypromine, Isocarboxazid and
Toloxatone.
Children and adolescents aged 8 to 18 years:
• Fluoxetine must not be used in the treatment of children under the age of 8 years
• children (aged 8 to 18) must only use Fluoxetine in combination with psychological therapy
• children (aged 8 to 18) must only take Fluoxetine for treatment of moderate to severe depression and
nothing else.
Only limited information concerning the long-term safety of Fluoxetine on growth, puberty, mental,
emotional and behavioural development in this age group is available. If you have any concerns, talk to your
doctor.
Taking Fluoxetine with food or drink
• You can take Fluoxetine with or without food.
• Do not drink alcohol while you are taking this medicine.
Pregnancy, breast-feeding, fertility and 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.
In babies whose mothers took fluoxetine (the active ingredient of Fluoxetine hard capsules) 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 capsules while you are pregnant. However, depending on
your circumstances, your doctor may suggest that it is better for you to keep taking Fluoxetine capsules.
Make sure your midwife and/or doctor know you are on Fluoxetine capsules. When taken during pregnancy,
particularly in the last 3 months of pregnancy, medicines like Fluoxetine capsules may increase the risk of a
serious condition in babies, called persistent pulmonary hypertension of the new born (PPHN), making the
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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
Do not drive or use machinery without advice from your doctor or pharmacist. This medicine may affect
your judgment and/or co-ordination.
Important information about the ingredients of Fluoxetine
Do not use this medicine if you are allergic (hypersensitive) to any of the ingredients of Fluoxetine (see
section 6 for list of ingredients). These capsules contain lactose. If you have been told by your doctor that
you are intolerant to some sugars, contact your doctor or pharmacist before taking these capsules.
3. HOW TO TAKE FLUOXETINE
Always take Fluoxetine exactly as your doctor has told you. Check with your doctor or pharmacist if you are
unsure.
Swallow the capsules whole with a drink of water. Do not chew the capsules.
Your doctor may adjust your dose slowly between week 1 and week 4 of treatment in order to find the
lowest dose which is effective.
Dosage and recommendations for use
Condition
Dosage and recommendations for use
1 capsule (20mg) every day. The dosage can be carefully and slowly
Depression
increased up to a maximum of 3 capsules (60mg) every day. Patients
- Adults
with depression should be treated for a period of at least 6 months.
Treatment should be started and be supervised by a specialist. The
starting dose is 10mg/day. Children who have a low weight may need
- Children aged 8
lower doses. After 1 to 2 weeks, your doctor may increase the dose to
to 18 years
20mg/day. Your doctor should review your need for continuing
treatment beyond 6 months. If no improvements have been seen in this
time, treatment should be re-assessed.
Binge eating &
3 capsules (60mg) every day
vomiting (Bulimia
nervosa)
1 capsule (20mg) every day. The dosage can be carefully and slowly
OCD (Obsessive
increased up to a maximum of 3 capsules (60mg) every day. If no
Compulsive
improvement is noted within 10 weeks, treatment with Fluoxetine
Disorder)
should be reconsidered.
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If you are 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 3 capsules (60 mg) daily.
If you have a liver or kidney problem or are using other medication, your doctor may decide to prescribe a
lower dose or instruct you to use Fluoxetine every other day.
If you take more Fluoxetine than you should
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 heartbeat and cardiac arrest), lung problems and changes in mental condition
ranging from agitation to coma.
If you forget to take Fluoxetine
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 your medicine at the same time each day may help you to remember to take it.
If you stop taking Fluoxetine
Do not stop taking Fluoxetine until your doctor tells you to. It is important that you keep taking your
medicine even when you start to feel better.
Make sure you do not run out of capsules.
You may notice the following effects when you stop taking Fluoxetine: dizziness, pins and needles, unusual
dreams, difficulty sleeping, feeling restless or agitated, unusual tiredness or weakness, feeling anxious,
feeling sick or being sick, shakiness and headaches.
Most people find that any symptoms are mild and go away on their own 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 1 or 2 weeks - this
should help reduce the chance of withdrawal effects.
If you have any further questions on the use of Fluoxetine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Fluoxetine 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.


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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
• orgasm problems
• teeth grinding
• muscle twitching, involuntary movement or problems with balance or co-ordination
• enlarged (dilated) pupils
• low blood pressure
• shortness of breath
• difficulty swallowing
• hair loss
• increased tendency to bruising
• cold sweat
• difficulty passing urine
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feeling hot or cold

Rare (seen in 1 to 10 in every 10,000 patients)
• low levels of salt in the blood
• untypical wild behaviour
• hallucinations
• agitation
• panic attacks
• fits
• 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
Very rare (seen in less than 1 to 10,000 patients)
• reduction in blood platelets, which increases risk of bleeding or bruising
Other (frequency cannot be estimated)
• thoughts of suicide or harming yourself
• memory impairment
• lung problems
• hepatitis, abnormal liver function test results
• muscle pain
• problems urinating
• confusion
• stuttering
• nose bleeds
• ringing in the ears
• unexplained bruising or bleeding
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.
In children and adolescents (8-18 years) – In addition to the possible side effects listed above. Fluoxetine
may slow growth or possible 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.

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5. HOW TO STORE FLUOXETINE
Keep all medicines out of the sight and reach of children.
Do not store your capsules above 25°C.
Do not take Fluoxetine after the expiry date which is shown on the pack. The expiry date refers to the last
day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Fluoxetine capsules contain:
Active substance: fluoxetine hydrochloride 22.4mg equivalent to 20mg fluoxetine.
Other ingredients: lactose, cellulose, magnesium stearate, colloidal silica, gelatin, titanium dioxide (E171),
yellow iron oxide (E172), quinoline yellow (E104) and indigo carmine (E132).
What Fluoxetine looks like and contents of the pack
Fluoxetine Capsules 20mg are green. Fluoxetine Capsules 20mg are available in blister packs containing 28,
30, 56, 60, 90 and 98 capsules. Not all pack sizes may be marketed.
POM
PL 06831/0067 Fluoxetine Capsules 20mg
Marketing Authorisation Holder and Manufacturer: Genus Pharmaceuticals, Linthwaite, Huddersfield,
HD7 5QH, UK.
Manufacturer: Stada Arzneimittel AG, Stadastraße 2-18, 61118 Bad Vilbel, Germany.
This leaflet was last revised in February 2015

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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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