Package leaflet: Information for the patient
Fluoxetin Mylan 20 mg Dispersible Tablets
fluoxetine
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 Fluoxetin Mylan is and what it is used for
2.
What you need to know before you take Fluoxetin Mylan
3.
How to take Fluoxetin Mylan
4.
Possible side effects
5.
How to store Fluoxetin Mylan
6.
Contents of the pack and other information
1.
What Fluoxetin Mylan is and what it is used for
Fluoxetin Mylan is an antidepressant that influences the central nervous system. Fluoxetin Mylan is used
for:
Adults

Depression

Obsessive thoughts and obsessive actions

Bulimia (compulsive eating)
Children and adolescents aged 8 years and above (Under specialist supervision only):
 Moderate to severe major depressive disorder, if the depression does not respond to psychological
therapy after 4-6 sessions. Fluoxetin Mylan 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 Mylan
Do not use Fluoxetin Mylan:
if you are allergic to fluoxetine or to any of the other ingredients of this medicine (listed in section 6).

If you are taking any medicines known specifically as irreversible, non-selective monoamine oxidase
inhibitors (MAO inhibitors). An example of such a medicine is iproniazid, which is used to treat
depression.

if you are taking the medicine metoprolol, used to treat heart failure.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluoxetin Mylan:

if you have diabetes, as Fluoxetin Mylan 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 disturbances in heart rhythm called QT prolongation (delayed conduction of electrical
signals which can be seen on an ECG, an electrical recording of the heart), or a family history of such
conditions.

if you suffer from any conditions that may make you more prone to experiencing changes in your
heart beat (e.g. low blood potassium or magnesium levels, a slow heart beat)

if you are starting to feel restless and cannot sit or stand still (akathisia). Increasing your dose of
Fluoxetin Mylan may make this worse

if you have or have had mania.

if you have a tendency to bleed.

if you are taking tamoxifen (used to treat breast cancer) (see section 2 below “Other medicines and
Fluoxetin Mylan”);

if you are taking other medicines or herbal preparations containing St. John’s wort (Hypericum
perforatum) (see section 2 below “Other medicines and Fluoxetin Mylan).

if you are receiving electro-convulsive shock treatment (ECT).

if you have increased pressure in the eye (glaucoma)
Thoughts of suicide and worsening of your depression
If you are depressed 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 and ask them to read
this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are
worried about changes in your behaviour.
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 Fluoxetin Mylan must be
stopped.
Contact your doctor if you develop symptoms such as high fever, muscle twitching, confusion and
anxiety (‘serotonin syndrome’ or ‘neuroleptic malignant syndrome’). The treatment with Fluoxetin Mylan
might need to be stopped.
Weight loss may occur during the treatment with Fluoxetin Mylan.
Children and adolescents aged 8 to 18 years
Patients under 18 years of age have an increased risk of side-effects such as suicide attempt, suicidal
thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when taking 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); it
should not be used to treat other conditions.
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, your doctor may
prescribe fluoxetine for patients under 18 for moderate to severe major depressive episode in combination
with psychological therapy because he/she decides that this is in their best interests. If your doctor has
prescribed fluoxetine for a patient under 18 years of age 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 years of age are taking fluoxetine.
Fluoxetine should not be used in the treatment of children under the age of 8 years.
Other medicines and Fluoxetin Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Certain other medicines can affect or be affected by Fluoxetin Mylan. Please contact your doctor if you are
taking any of the medicines listed below.
















certain medicines known as monoamine oxidase inhibitors (MAOIs, some used to treat conditions
such as depression and Parkinson’s disease). Irreversible, non-selective MAOIs (e.g. iproniazid)
must not be used with Fluoxetine as serious or even fatal reactions (serotonin syndrome) can occur
(see also, “Do not take Fluoxetine”).Treatment with fluoxetine should only be started at least 2
weeks after stopping treatment with an irreversible non-selective MAOI. At least 5 weeks should
pass after stopping fluoxetine treatment before starting an irreversible, non-selective MAOI. For
other types of MAOI (e.g. linezolid, methylthioninium chloride (methylene blue)), treatment can
continue alongside fluoxetine provided that your doctor monitors you closely.
metoprolol, used to treat heart failure (see also, “Do not take Fluoxetine”).
lithium (used to treat bipolar disorder), tryptophan (used to treat mental illness), selegiline (used for
Parkinson’s disease), the herbal remedy St. John’s wort (used to treat depression), tramadol (a painkiller) or medicines known as ‘triptans’ (e.g. sumatriptan, zolmitriptan) used to treat migraine; there
is an increased risk of serotonin syndrome when these medicines are taken with fluoxetine
blood-thinning medicine (e.g. warfarin)
medicine for epilepsy (e.g. phenytoin or carbamazepine)
medicine for pain and inflammation like acetylsalicylic acid and nonsteroidal anti-inflammatory
drugs (NSAIDs) (e.g. aspirin, ibuprofen)
certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine)
anti-malarial treatment particularly halofantrine
astemizole, mequitazine, cyproheptadine or mizolastine (antihistamines, used to treat allergic
reactions)
medicines used to treat heart problems (e,g, flecainide, propafenone, nebivolol),
diuretics (water tablets), medicines used to treat high blood pressure
medicines that affect the heart’s rhythm e.g. Class IA and III antiarrhythmics, tricyclic
antidepressants, antipsychotic drugs (e.g. pimozide, haloperidol, risperidone)
tamoxifen (used to treat breast cancer)
atomoxetine (used to treat attention-deficit hyperactivity disorder, ADHD)
desmopressin, used to treat certain hormone problems that affect urination.
medicines that can increase the chance of seizures, such as other SSRI antidepressants (e.g.
sertraline, citalopram, paroxetine), certain medicines for mental illness called phenothiazines (e.g.
perphenazine, chlorpromazine), certain medicines for mental illness called butyrophenones (e.g.
benperidol, haloperidol), mefloquine or chloroquine (for malaria), or bupropion (for depression or
nicotine dependence).
Fluoxetin Mylan with food, drink and alcohol
The tablets may be taken with or between meals.
The combination of Fluoxetin Mylan and alcohol is not recommended.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Pregnancy
In babies whose mothers took fluoxetine 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
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 knows you are on 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 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.
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 breastfeed 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
Fluoxetin Mylan 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 totake Fluoxetin Mylan
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Fluoxetin Mylan dispersible tablets can be dissolved in a glass of water, or swallowed whole.
Adults
Depression, obsessive thoughts and obsessive actions (OCD):
The recommended dose is 20 mg - 60 mg daily
Your doctor will review and adjust your dosage if necessary within 3 to 4 weeks of the start of treatment.
The dose should be increased carefully to ensure that you receive the lowest effective dose.
Bulimia nervosa:
The recommended dose is 60 mg daily
Use in children and adolescents aged 8 years and above with moderate to severe depression
Treatment should be started and be supervised by a specialist. The starting dose is 10 mg a day (given as
2.5 ml of fluoxetine liquid). After 1 to 2 weeks, your doctor may increase the dose to 20 mg a 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 should review
the need for continuing treatment beyond 6 months. If you have not improved within 9 weeks, your
doctor will reassess your treatment.
Patients with liver problems
If you suffer from liver impairment, the dosage may be reduced by your doctor.
If you take more Fluoxetin Mylan than you should
If you have taken too much of this medicine you should contact your doctor or a hospital.
Signs of overdose: Nausea, vomiting, seizures, anxiety, restlessness, excessive cheerfulness, impaired heart
function (e.g. arrhythmia and cardiac arrest) and impaired breathing.
If you forget to take Fluoxetin Mylan
If you forget to take a dose, take your next dose the next day at the usual time. Do not take a double dose
to make up for a forgotten tablet.
If you stop taking Fluoxetin Mylan
Do not discontinue the treatment without consulting your doctor, even when you start to feel better.
If you stop taking Fluoxetin Mylan, withdrawal reactions can occur, e.g. sleep disturbances (vivid dreams,
nightmares, inability to sleep), feeling restless or agitated, unusual tiredness or weakness, nausea,
vomiting, shakiness, dizziness, headache, anxiety and abnormal sensation of the skin such as numbness,
tingling, pricking or burning (paraesthesia). These disorders are mild and temporary.
When your doctor decides you should stop taking Fluoxetin Mylan, he/she may choose to reduce the dose
gradually over a number of weeks. If you experience side effects when the dose is reduced, your doctor
may decide to reduce the dose more slowly.
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 experience any of the following side effects, stop taking your tablets and either tell your
doctor immediately or go to your nearest hospital emergency department:
Uncommon (may affect up to 1 in 100 people):

thoughts of harming or killing yourself at any time (see section 2 ‘Thoughts of suicide and worsening
of your depression or anxiety disorder’)
Rare (may affect up to 1 in 1,000 people):

an allergic reaction. Such reactions may appear in the form of anaphylaxis (a severe form of allergic
reaction) with symptoms such as:
rash
swollen face, tongue and/or pharynx, difficulty in swallowing, hives and difficulties in
breathing (angioedema)
sudden wheezing, fainting or difficulties in swallowing
fever, rapid swelling of the tissues around the neck, face, mouth and/or throat, skin rash,
enlargement of the lymph nodes (serum sickness).

fits (convulsion)

disturbances in heart rhythm called QT prolongation (delayed conduction of electrical signals which
can be seen on an ECG, an electrical recording of the heart). In some people this can develop into a
potentially serious heart condition known as Torsades de pointes. This can result in a very fast
heartbeat causing a sudden loss of consciousness

restlessness and an inability to sit or stand still, you may have akathisia; increasing your dose of

Fluoxetin Mylan may make you feel worse.high fever, muscle twitching, confusion and anxiety.
These symptoms could be a sign of so called “serotonin syndrome”

skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler
area, with dark ring around the edge) (erythema multiforme), widespread rash with blisters and
peeling skin, particularly around the body surface, mouth, nose, eyes and genitals (toxic epidermal
necrolysis, Stevens-Johnson syndrome)

prolonged and painful erection
Other possible side effects
Very common (may affect more than 1 in 10 people):

difficulty sleeping (insomnia)

headache

diarrhoea

feeling sick (nausea)

tiredness (fatigue), feeling unusually weak
Common (may affect up to 1 in 10 people):

loss of appetite, 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 (including nightmares)

tiredness or sleepiness

dizziness

change in taste

uncontrollable shaking movements

blurred vision

rapid and irregular heartbeat sensations

flushing

yawning








indigestion, vomiting
dry mouth
rash, hives (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

memory problems

strange thinking

abnormally high mood

ringing in the ears

nose bleeds

orgasm problems

teeth grinding

muscle twitching, involuntary movements or problems with balance or coordination

enlarged (dilated) pupils

low blood pressure

shortness of breath

difficulty swallowing,

abdominal bleeding

hair loss

increased tendency to bruising

cold sweat

pain when passing urine

feeling hot or cold

generally feeling unwell/abnormal
Rare (may affect up to 1 in 1,000 people):

a lower than normal level of sodium in the blood, which may make you feel weak and confused with
aching of muscles. This may be due to inappropriate ADH secretion, a hormone that causes the body
to retain water and dilute the blood, reducing the amount of sodium

frequent infections with fever, chills, sore throat or mouth ulcers (reduced number of white blood
cells)

lung problems, scarring and thickening in the lungs with shortness of breath

liver disease with the following signs; feeling or being sick, loss of appetite, feeling generally unwell,
fever, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine

low levels of salt in the blood

untypical wild behaviour

seeing, feeling or hearing things that are not there (hallucinations )

agitation

panic attacks

confusion

stuttering or stammering

inflammation of a blood vessel (vasculitis)

widening of blood vessels

pain in the tube that takes food or water to your stomach











sensitivity to sunlight
producing breast milk
high prolactin levels in the blood
increase in liver enzymes seen in a blood test
sore throat and discomfort when swallowing
muscle pain
bruising
unexplained bruising or bleeding
difficulty passing urine
problems urinating
bleeding from the mucosal lining of areas such as the mouth and nose
Not known (frequency cannot be estimated from the available data)
Bone fractures - An increased risk of bone fractures has been observed in patients taking this type of
medicine.
Side effects 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. Suicide-related behaviours (suicide attempt and suicidal thoughts), hostility, mania and nose
bleeds were also commonly reported in children.
Reporting 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 national reporting system listed in
Appendix V. By reporting side effects, you can help provide more information on the safety of this
medicine.
5.
How to store Fluoxetin Mylan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the
last day of that month.
Do not store above 25°C
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 to protect the environment.
6.
Contents of the pack and other information
What Fluoxetin Mylan contains:
The active substance is fluoxetine hydrochloride equivalent to 20 mg of fluoxetine.
The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, maize starch, crospovidone,
saccharin sodium, magnesium stearate and peppermint powder.
What Fluoxetin Mylan looks like and contents of the pack
Your medicine is a dispersible tablet; it is a white, oval-shaped tablet marked “FL|20” on one side and “G”
on the other.
Your medicine is available in plastic bottles of 30, 100, 250 and 500 tablets or in blisters containing 7, 12,
14, 28 and 30 tablets, as well as blisters of 30x1 and 100x1 unit-dose tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
[To be completed nationally]
Manufacturer
[To be completed nationally]
This leaflet was last revised in July 2015