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FLUOXETINE 10 MG FILM-COATED TABLETS

Active substance(s): FLUOXETINE HYDROCHLORIDE / FLUOXETINE HYDROCHLORIDE

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Bone fractures - an increased risk of bone fractures has been observed in patients
taking this type of medicines.

restlessness, poor concentration
feeling tense
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








• yawning
• indigestion, vomiting
• dry mouth
• rash, urticaria, itching
• excessive sweating
• joint pain
• passing urine more frequently
• unexplained vaginal bleeding
• feeling shaky or chills
Uncommon (may affect up to 1 in 100 people)
• feeling detached from yourself
• strange thinking
• abnormally high mood
• orgasm problems
• thoughts of suicide or harming yourself
• teeth grinding
• muscle twitching, involuntary movements or problems with balance or
co-ordination
• memory impairment
• enlarged (dilated) pupils
• ringing in the ears
• low blood pressure
• shortness of breath
• nose bleeds

• hair loss
• increased tendency to bruising
• unexplained bruising or bleeding
• cold sweat

• feeling hot or cold
• abnormal liver function test results
Rare (may affect up to 1 in 1,000 people)
• low levels of salt in the blood
• reduction in blood platelets, which increases risk of bleeding or bruising
• reduction in white blood cell count
• untypical wild behaviour
• hallucinations
• agitation
• panic attacks
• confusion
• stuttering
• aggression


• 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
• hepatitis
• lung problems
• sensitivity to sunlight
• muscle pain
• problems urinating
• producing breast milk
7

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 possibly delay sexual maturity. Suiciderelated behaviours (suicide attempt and suicidal thoughts), hostility, mania, and
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
via the Yellow Card Scheme.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of
this medicine.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton (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 medicine via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help to protect the environment.
6. Contents of the pack and other information



The other ingredients are: Cellulose microcrystalline, crospovidone, silica
colloidal anhydrous, maize starch (core) and polyvinyl alcohol-part. hydrolysed
(E1203), titanium dioxide (E171), macrogol/peg (E1521) and talc (coating).

scored and debossed with “E” and “P” on one side and “360” on the other side.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluoxetine 10 mg Film-coated Tablets
EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT FLUOXETINE
Fluoxetine treats depression and anxiety disorders.
Like all medicines it can have unwanted effects. It is therefore important that you
effects, before starting treatment.
Fluoxetine is not for use in children and adolescents under 18. See section 2,
Use in children and adolescents aged 8 to 18 years.
Fluoxetine won’t work straight away. Some people taking antidepressants feel
worse before feeling better. Your doctor should ask to see you again a couple of
t started feeling
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.
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
section 3 for further information.
If you feel restless and feel like you can’t sit or stand still, tell your doctor.
Increasing the dose of Fluoxetine may make these feelings worse. See section 4,
Possible side-effects.
Taking some other medicines with Fluoxetine can cause problems. You may
need to talk to your doctor. See section 2, Taking other medicines.
If you are pregnant or planning to get pregnant, talk to your doctor.
See section 2, Pregnancy and breastfeeding.
because it contains important information for you
- 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

20, 28, 30, 50, 56, 70, 98, 100 and 500. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
The Marketing Authorisation Holder:
Endo Ventures Ltd.
First Floor, Minerva House,
Simmonscourt Road,
Ballsbridge,
Dublin 4,
Ireland.
The manufacturer is:
Par Laboratories Europe, Ltd.
69-71 Meridien House, Clarendon Road WD17 1DS
Watford, United Kingdom
July 2017

4. Possible side effects
6. Contents of the pack and other information
Fluoxetine belongs to 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.
How Fluoxetine works
Everyone has a substance called serotonin in their brain. People who are depressed
or have obsessive-compulsive disorder or bulimia nervosa have lower levels of

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serotonin than others. It is not fully understood how Fluoxetine and other SSRIs
work but they may help by increasing the level of serotonin in the brain.
Treating these conditions is important to help you get better. If it’s not treated, your
treat.
You may need to be treated for a few weeks or months to ensure that you are free
from symptoms.
Do not take Fluoxetine if you are:

section 6). If you develop a rash or other allergic reactions (like itching,
swollen lips or face or shortness of breath), stop taking the tablets
straight away and contact your doctor immediately.
• 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, iproniazide, moclobemide, phenelzine,
tranylcypromine, isocarboxazid, toloxatone and also linezolid (an antibiotic) and
methylthioninium chloride also called methylene blue (used to treat medicinal
or chemical induced methaemogobinaemia).
Treatment with Fluoxetine should only be started at least 2 weeks after
discontinuation of an irreversible MAOI (for instance tranylcypromine).
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. 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 if any of the following
applies to you:
• heart problems;
• 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.
• mania now or in the past; if you have a manic episode, contact your doctor
immediately because Fluoxetine might need to be discontinued;
• history of bleeding disorders or appearance of bruises or unusual bleeding;
• ongoing treatment with medicines that thin the blood (see ‘Other medicines
and Fluoxetine’);

frequency, contact your doctor immediately; Fluoxetine might need to be
discontinued;
• ongoing ECT (electro-convulsive therapy);
• 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;
• 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);
• low resting heart-rate and/or if you know that you may have salt depletion as
a result of prolonged severe diarrhoea and vomiting (being sick) or usage of
diuretics (water tablets);
• ongoing treatment with diuretics (water tablets), especially if you are elderly;
• glaucoma (increased pressure in the eye).
2

Thoughts of suicide and worsening of your depression or anxiety disorder.
If you are depressed and/or have anxiety disorders you can sometimes have
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.
that you are depressed
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.
Fluoxetine should not be used in the treatment of children under the age of 8
years.
Other medicines and Fluoxetine
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines
Do not take Fluoxetine with:
• Certain irreversible, non-selective monoamine oxidase inhibitors
(MAOIs), some used to treat depression. Irreversible, non-selective MAOIs
must not be used with Fluoxetine as serious or even fatal reactions (serotonin
syndrome) can occur (see section “Do not take Fluoxetine”). Treatment with
Fluoxetine should only be started at least 2 weeks after discontinuation of an
irreversible, non-selective MAOI (for instance tranylcypromine). Do not take
any irreversible, non-selective MAOIs for at least 5 weeks after you stop taking
Fluoxetine. If Fluoxetine has been prescribed for a long period and/or at a
high dose, a longer interval than 5 weeks may need to be considered by your
doctor.
• metoprolol when used for heart failure; there is an increased risk of your heart
beat becoming too slow.
Fluoxetine may affect the way the following medicines work (interaction):
• tamoxifen (used to treat breast cancer); because Fluoxetine may change
the blood levels of this drug, resulting in the possibility of a reduction in the
effect of tamoxifen, your doctor may need to consider prescribing a different
antidepressant treatment.
• monoamine oxidase inhibitors A (MAOI-A) including moclobemide,
linezolid (an antibiotic) and methylthioninium chloride (also called methylene
blue, used for the treatment of medicinal or chemical product induced
methemoglobinemia): due to the risk of serious or even fatal reactions (called
stopping treatment with reversible MAOIs but the doctor may wish to monitor
3

you carefully and use a lower dose of the MAOI-A drug.
• mequitazine (for allergies); because taking this drug with Fluoxetine may
increase the risk of changes in the electrical activity of the heart.
• phenytoin
of this drug, your doctor may need to introduce phenytoin more carefully and
carry out check-ups when given with Fluoxetine.
• lithium, selegiline, St. John’s Wort, tramadol (a painkiller), triptans
(for migraine) and tryptophan; there is an increased risk of mild serotonin
syndrome when these drugs are taken with Fluoxetine. Your doctor will carry
out more frequent check-ups.
• medicines that may affect the heart’s rhythm, e.g. Class IA and III
antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide,
haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g.
anti-malaria
treatment particularly halofantrine or certain antihistamines (astemizole,
mizolastine), because taking one or more of these drugs with Fluoxetine may
increase the risk of changes in the electrical activity of the heart.
• Anti-coagulants (such as warfarin), NSAID (such as ibruprofen, diclofenac),
aspirin and other medicines which can thin the blood (including clozapine,
used to treat certain mental disorders). 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, adjust your
dose and check on you more frequently.
• cyproheptadine (for allergies); because it may reduce the effect of Fluoxetine.
• drugs that lower sodium levels in the blood (including, drug that causes
increase in urination, desmopressin, carbamazepine and oxcarbazepine);
because these drugs may increase the risk of sodium levels in the blood
becoming too low when taken with Fluoxetine.
• anti-depressants such as tricyclic anti-depressants, other selective serotonin
reuptake inhibitors (SSRIs) or bupropion,
or chloroquine (used to
treat malaria), tramadol (used to treat severe pain) or anti-psychotics such as
phenothiazines or butyrophenones; because Fluoxetine may increase the risk of
seizures when taken with these medicines.

, propafenone, nebivolol or encainide (for heart problems),
carbamazepine (for epilepsy), atomoxetine or tricyclic antidepressants
(for example imipramine, desipramine and amitriptyline) or risperidone
(for schizophrenia); because Fluoxetine may possibly change the blood levels of
these medicines, your doctor may need to lower their dose when administered
with Fluoxetine.
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’re pregnant, if you might be
pregnant, or if you’re planning to become pregnant.
there have been some studies describing an increased risk of birth defects affecting
the heart. In the general population, about 1 in 100 babies are born with a heart
When taken during pregnancy, particularly in the last 3 months of pregnancy,
called persistent pulmonary hypertension of the newborn (PPHN), making the baby
hours after the baby is born. If this happens to your baby you should contact your
midwife and/or doctor immediately.
It is preferable not to use this treatment during pregnancy unless the potential

However, depending on your circumstances, your doctor may suggest that it is
better for you to keep taking Fluoxetine.
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
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
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
Psychotropic drugs such as Fluoxetine may affect your judgment or co-ordination.
Do not drive or use machinery until you know how Fluoxetine affects you.
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 tablets than
your doctor tells you.
Swallow the tablets with a drink of water.
Adults:
The recommended 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 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
weeks. Patients with depression should be treated for at least 6 months.
• Bulimia nervosa: The recommended dose is 60 mg daily.
• Obsessive-compulsive disorder: 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
10 mg/day. After 1 to 2 weeks, your doctor may increase the dose to 20 mg/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 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 tablets, 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.

gradually stop taking Fluoxetine while you are pregnant or before being pregnant.
4

5

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 your medicine at the same time each day may help you to remember to
take it regularly.
If you stop taking Fluoxetine


Do not
start to feel better. It is important that you keep taking your medicine

• Make sure you do not run out of tablets.
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.
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. The following side effects may happen with this medicine.
• 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 tablets 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.
The most frequent sides effects (very common side effects that may affect more
than 1 user in 10) are insomnia, headache, diarrhoea, feeling sick (nausea) and
fatigue.
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:
Common (may affect up to 1 in 10 people)
• not feeling hungry, weight loss
• nervousness, anxiety
6

Expand Transcript

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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