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FLUOXETINE 10MG HARD CAPSULES

Active substance(s): FLUOXETINE HYDROCHLORIDE

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Package leaflet: Information for the user
Fluoxetine 10mg Capsules, hard
Fluoxetine

Important things you need to know about Fluoxetine capsules

• Fluoxetine treats depression, obsessive-compulsive symptoms and eating disorders. Like all
medicines, it can cause side effects. It is important that you and your doctor discuss the benefits and
possible unwanted effects of fluoxetine before you start taking it.
• Fluoxetine won’t work straight away. Some people taking antidepressants feel worse before feeling
better. Tell your doctor if you haven’t started feeling better after the first few weeks.
• Fluoxetine is not normally used in children and adolescents under 18. See Section 2, Children &
adolescents aged 8 to 18 years of age.
• 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
Section 2, Thoughts of suicide and worsening of your depression or anxiety disorder.
• Don’t stop taking Fluoxetine without talking to your doctor. If you stop taking your medicine suddenly
or miss a dose, you may get withdrawal effects. See Section 3, If you stop taking Fluoxetine.
• If you feel restless and feel like you can’t sit or stand still, tell your doctor straight away. These
symptoms may be more common in the first few weeks of treatment. See Section 4, Stop taking
fluoxetine and see your doctor immediately.
• Taking some other medicines with Fluoxetine can cause problems. See Section 2, Other medicines and
Fluoxetine Capsules.
• If you are pregnant or planning to get pregnant, talk to your doctor.

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 capsules are and what they are used for
2.
What you need to know before you take Fluoxetine capsules
3.
How to take Fluoxetine capsules
4.
Possible side effects
5.
How to store Fluoxetine capsules
6.
Contents of the pack and other information

1.

What Fluoxetine capsules are and what they are used for

Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) antidepressant that influences the central
nervous system.
Fluoxetine is used for the treatment of:
Adults:
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• Depression

• Obsessive-compulsive
disorder

• Bulimia Nervosa
(compulsive eating/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 capsules should be offered to a child or young person with
moderate to severe major depressive disorder only in combination with psychological therapy.

Note that the doctor may have prescribed this medicine for a different purpose and/or at a different
dosage from that given in the package leaflet. You must always follow the doctor’s prescription and
the instructions given on the label of the pack.
2.

What you need to know before you take Fluoxetine capsules

Do not take Fluoxetine capsules
• If you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6).
• If you are taking a medicine used for the treatment of heart-failure, called metoprolol.
• If you are taking other medicines known as non-selective monoamine oxidase inhibitors or
reversible monoamine oxidase inhibitors type A (MAOIs), since serious or even fatal reactions can
occur. Examples of such MAOIs include medicines used to treat depression such as nialamide,
iproniazid, moclobemide, phenelzine, tranylcypromine, isocarboxazid, toloxatone and also
linezolid (an antibiotic) and methylthioninium chloride also called methylene blue (used to treat
medicinal or chemical induced methaemoglobinaemia).
Treatment with Fluoxetine capsules should only be started 2 weeks after discontinuation of an
irreversible MAOI (for instance tranylcypromine). However, treatment with fluoxetine can be
started the following day after discontinuation of certain reversible MAOIs (for instance
moclobemide, linezolid, methylthioninium chloride (methylene blue)).
Do not take any MAOIs for at least 5 weeks after you stop taking Fluoxetine capsules.
If fluoxetine has been prescribed for a long period and/or at a high dose, a longer interval needs to
be considered by your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Fluoxetine capsules
• If you have diabetes Fluoxetine capsules can raise or lower your blood sugar. The dose of your
insulin or the antidiabetes medicines that you take by mouth may need to be adjusted.
• If you have had seizures, have epilepsy, 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 have a tendency to bleed easily or you are taking medicines which thin the blood
(anticoagulants).
• If you are taking other medicines or herbal preparations containing St. John’s wort (Hypericum
perforatum) (See “Other medicines and Fluoxetine capsules”).
• If you are receiving electric shock treatment.
• If you have any heart problems or a family history of heart problems (for example, long QT
syndrome or irregular heart rhythms). Your doctor may need to monitor your heart before, during
and after treatment with Fluoxetine capsules.
• If you have been told that you are at risk of glaucoma or you have a raised eye-pressure.
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If you get an allergic reaction such as itching, nettle rash or swelling of the face, lips, tongue
and/or throat (sometimes with breathlessness or difficulties in swallowing) the treatment with
Fluoxetine capsules must be stopped.
Contact your doctor if you develop symptoms such as high fever, muscle twitching, confusion and
anxiety (‘serotonergic syndrome’). The treatment with Fluoxetine capsules might need to be stopped.
Weight loss may occur during the treatment with Fluoxetine capsules.

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 of age)
Fluoxetine capsules 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 capsules for patients under 18 because he/she
decides that this in their interests.
If your doctor has prescribed Fluoxetine capsules 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 capsules.
Also, only limited information concerning the long-term safety of fluoxetine on growth, puberty,
mental, emotional and behavioural development in this age group is available.
Other medicines and Fluoxetine capsules
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines (up to 5 weeks ago) including medicines obtained without prescription.
Fluoxetine capsules may affect the way some other medicines work (interaction), especially the
following:





Monoamine oxidase inhibitors (MAOIs), used to treat depression. Non-selective Monoamine
oxidase inhibitors MAOIs and MAOIs type A. - these should not be taken at the same time as
fluoxetine (see Section 2, "Do not take Fluoxetine capsules"). MAOIs type B (selegiline) can be
used with Fluoxetine capsules provided that your doctor monitors you closely.
Blood-thinning medicine (such as aspirin or warfarin).
Other medicine for depression (e.g. tricyclic antidepressants), or medicines containing tryptophan
or lithium.
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Medicine for epilepsy (e.g. phenytoin or carbamazepine).
Medicine of the tryptan type for migraine (e.g. sumatriptan or zolmitriptan).
Pain-relieving medicine containing tramadol.
Medicine used to treat certain mental disorders (clozapine).
Medicines for heart problems (flecainide or encainide).
A natural remedy containing St. John’s wort (Hypericum perforatum).
Medicine containing flecainide or encainide (for irregular heart rhythm).
A medicine called Tamoxifen (used to treat breast cancer and other cancers).
A medicine used for the treatment of heart-failure, called Metoprolol.
Medicines used to treat allergies which contain Mequitazine.

Fluoxetine capsules with food, drink and alcohol
Food:
The capsules may be taken with or between meals.
Alcohol:
The combination of Fluoxetine capsules and alcohol is not recommended.
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.
Both intake of fluoxetine during pregnancy and breast-feeding may affect the unborn child/breastfed
infant.
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 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
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.
Information collected to date does not indicate an increased risk when used during pregnancy.
However 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.
Please tell your doctor if you are pregnant or think that you are pregnant.

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.
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Please tell your doctor if you are breast-feeding.

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 capsules may 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

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Fluoxetine can be taken as a single dose or divided into several doses.
Adults:
The usual dose is:
• 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. 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.
• Bulimia nervosa: The recommended dose is 60 mg daily.
Your doctor will review the need for continuing treatment beyond 6 months (3 months for bulimia),
and treatment will be reassessed if no improvement is seen.
• OCD: The recommended dose is 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 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.
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.

Older people:

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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 daily.
Hepatic 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 take fluoxetine every other day.
If you take more Fluoxetine capsules than you should
If you have taken too much Fluoxetine capsules you should contact your doctor or a hospital.
Symptoms of overdose: nausea, vomiting, seizures, anxiety, restlessness, excessive cheerfulness,
impaired heart function (e.g. irregular heartbeats) and impaired breathing.
If you forget to take Fluoxetine capsules
Do not take a double dose to make up for a forgotten dose.
If you stop taking Fluoxetine capsules
Do not stop taking Fluoxetine capsules until your doctor tells you to. Usually your doctor will help
you to reduce your dose slowly over a number of weeks. When treatment with Fluoxetine capsules is
stopped, especially if it is done abruptly, there is a risk of so-called withdrawal effects. The risk is
higher, when Fluoxetine capsules has been used for a long time or in high doses or when the dose is
reduced too quickly.
Withdrawal effects include: Feeling dizzy (unsteady or off-balance), feelings like pins and needles,
burning sensations and (less commonly) electric shock sensations, including in the head, sleep
disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling sick
(nausea), sweating (including night sweats), feeling restless or agitated, tremor (shakiness), feeling
confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances,
fluttering or pounding heartbeat (palpitations).
Most people find that the symptoms are mild and go away on their own within two weeks. If you get
severe withdrawal effects when you stop taking Fluoxetine capsules, please contact your doctor. He or
she may ask you to start taking your capsules again and come off them more slowly.
Please see your doctor if you are worried about withdrawal effects when stopping Fluoxetine capsules.
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 (feeling of "inner
restlessness", a constant urge to be moving); increasing your dose of Fluoxetine capsules 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:

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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.

The other side effects include:
Very common (may affect more than 1 in 10 people):
• Difficulty or inability to sleep (insomnia),
• Headache,
• Diarrhoea, feeling sick (nausea),
• Fatigue.
Common side effects (may affect up to 1 in 10 people):
• Not feeling hungry, weight loss,
• Anxiety, nervousness,
• 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,
• Changes in taste,
• Uncontrollable shaking movements,
• Blurred vision,
• Rapid and irregular heartbeat sensations,
• Flushing,
• Indigestion, vomiting,
• Dry mouth,
• Rash, urticaria, itching,
• Excessive sweating,
• Joint pain,
• Passing urine more frequently,
• Unexplained vaginal bleeding,
• Feeling shaky or having chills.
Uncommon side effects (may affect more than 1 in 1000 people but less than 1 in 100 people)









Feeling detached from yourself or feeling abnormal,
Strange thinking,
Abnormally high mood (euphoria),
Orgasm problems or difficulty having sex,
Grinding teeth (bruxism),
Muscle twitching, involuntary movements or problems with balance or co-ordination,
Becoming forgetful (memory impairment),
Enlarged (dilated) pupils,
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Ringing in the ears (tinnitus),
Low blood pressure (hypotension),
Shortness of breath (dyspnoea),
Difficulty swallowing (dysphagia),
Internal bleeding in the gut (gastrointestinal haemorrhage),
Hair loss (alopecia),
Increased tendency to bruise,
Cold sweat,
Difficulty passing urine,
Generally feeling weak (malaise),
Feeling cold or hot.

Rare side effects (affects more than 1 in 10,000 people but less than 1 in 1000 people)
• Various blood disorders (e.g. thrombocytopenia, neutropenia or leucopoenia),
• A type of allergic reaction called ‘Serum sickness’,
• Changes in water retention (Inappropriate antidiuretic hormone secretion),
• Low levels of salt in the blood,
• Abnormal or wild behaviour (hypomania or mania),
• Hallucinations,
• Feeling agitated,
• Panic attacks,
• Feeling confused,
• Difficulty in talking e.g. stammering or stuttering (dysphaemia),
• Being aggressive,
• Uncontrollable shaking or movements of the body (convulsions or buccoglossal syndrome),
• Inflammation, widening or changes in blood vessels (vasculitis, vasodilatation, fibrosis),
• Sore throat or gullet (pharyngitis or oesophageal pain),
• Hepatitis, abnormal liver function test results,
• Swelling of the deeper layers of the skin (angioedema),
• Unexplained bleeding, bruising or discolouration of the skin (ecchymosis, purpura),
• Allergy to the sun (photosensitivity reaction),
• Muscle pain,
• Problems urinating,
• Producing breast-milk,
• Nose bleeds.

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, tell your doctor or a pharmacist.
Most of these side effects are likely to disappear with continued treatment.
Additional side effects in children and adolescents (8-18 years):
Fluoxetine capsules 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 or pharmacist. 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 capsules

Keep this medicine out of the sight and reach of children.
Do not store above 25ºC.
Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’. 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 capsules 10mg contain
The active substance is fluoxetine hydrochloride equivalent to 10 mg fluoxetine.
The other ingredient is pre-gelatinised maize starch.
The capsule shell contains gelatine, brilliant blue (E133), titanium dioxide (E171), yellow iron oxide
(E172) and sodium lauryl sulfate. Printing ink components are shellac (E904), propylene glycol
(E1520), black iron oxide (E172), and potassium hydroxide (E525).
What Fluoxetine capsules 10mg look like and contents of the pack
Fluoxetine capsules 10 mg capsules are green gelatine capsules with C28 marked on it and available in
blister packs of 10, 14, 20, 30, 50, 70 or 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester.
LE3 0PA
UK.
Manufacturer
Morningside Pharmaceuticals Ltd
5 Pavilion Way
Loughborough.
LE11 5GW
UK.
This leaflet was last revised in December 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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