Skip to Content

UK Edition. Click here for US version.

FLUOXETINE 20MG PER 5ML ORAL LIQUID

Active substance(s): FLUOXETINE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet:
Information for the user

Prozac® 20mg per 5ml Oral Liquid
(fluoxetine hydrochloride)
The name of your medicine is Prozac® 20mg per 5ml Oral Liquid, but will be referred to as Prozac
throughout this leaflet.

EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT PROZAC
Prozac treats depression and anxiety disorders. Like all medicines it can have unwanted effects. It is
therefore important that you and your doctor weigh up the benefits of treatment against the possible
unwanted effects, before starting treatment.
Prozac is not for use In children and adolescents under 18. See section 2, ‘Children and adolescents
aged 8 to 18 years’.
Prozac won’t work straight away. Some people taking anti-depressants feel worse before feeling
better. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your
doctor if you haven’t started feeling better. See section 3, ‘How to take Prozac’.
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 Prozac without talking to your doctor. If you stop taking Prozac 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
Prozac may make these feelings worse. See section 4, ‘Possible side effects’.
Taking some other medicines with Prozac can cause problems. You may need to talk to your doctor.
See section 2, ‘Other medicines and Prozac’.
If you are pregnant or planning to get pregnant, talk to your doctor. See section 2, ‘Pregnancy, breastfeeding and fertility’.
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 Prozac is and what it is used for
2. What you need to know before you take Prozac
3. How to take Prozac
4. Possible side effects
5. How to store Prozac
6. Content of the pack and other information

1.

What is Prozac and what is used for

Prozac 20mg per 5ml oral liquid contains the active substance fluoxetine which is one of a group of
medicines called selective serotonin re-uptake inhibitors (SSRI) anti-depressants.
This medicine is used to treat the following conditions:
Adults:
Major depressive episodes
Obsessive-compulsive disorder
Bulimia nervosa: Prozac 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. Prozac should be offered to a child or young person with moderate to
severe major depressive disorder only in combination with psychological therapy.
How Prozac works
Everyone has a substance called serotonin in their brain. People who are depressed or have obsessivecompulsive disorder or bulimia nervosa have lower levels of serotonin than others. It is not fully
understood how Prozac 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 condition
may not go away and may become more serious and more difficult to treat.
You may need to be treated for a few weeks or months to ensure that you are free from symptoms.

2.

What you need to know before you take Prozac

Do not take Prozac if you are:
allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). If you
develop a rash or other allergic reactions (like itching, swollen lips or face or shortness of
breath), stop taking the oral liquid straight away and contact your doctor immediately.
taking other medicines known as irreversible, non-selective monoamine oxidase inhibitors (MAOIs),
since serious or even fatal reactions can occur (e.g. iproniazid used to treat depression).
Treatment with Prozac should only be started at least 2 weeks after discontinuation of an irreversible,
non-selective MAOI.
Do not take any irreversible, non-selective MAOIs for at least 5 weeks after you stop taking Prozac. If
Prozac has been prescribed for a long period and/ or at a high dose, a longer interval needs to be
considered by your doctor.
taking metoprolol (to treat heart failure) because there is an increased risk of your heart beat
becoming too slow.
Warnings and precautions
Talk to your doctor or pharmacist before taking Prozac 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 Prozac might need to be
discontinued.
mania now or in the past; if you have a manic episode, contact your doctor immediately because
Prozac 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 Prozac’);
epilepsy or fits. If you have a fit (seizures) or experience an increase in seizure frequency, contact
your doctor immediately; Prozac might need to be discontinued;
ongoing ECT (electro-convulsive therapy);
ongoing treatment with tamoxifen (used to treat breast cancer) (see ‘Other medicines and Prozac’);
starting to feel restless and cannot sit or stand still (akathisia). Increasing your dose of Prozac 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).
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 anti-depressants, 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
anti-depressant.
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:
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. Prozac 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 Prozac 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 Prozac 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 Prozac 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 Prozac.
Prozac should not be used in the treatment of children under the age of 8 years.
Other medicines and Prozac
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Prozac with:
Certain irreversible, non-selective monoamine oxidase inhibitors (MAOIs), some used to treat
depression. Irreversible, nonselective MAOIs must not be used with Prozac as serious or even fatal
reactions (serotonin syndrome) can occur (see section ‘Do not take Prozac’). Treatment with Prozac
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 Prozac. If Prozac 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.
Prozac may affect the way the following medicines work (interaction):
tamoxifen (used to treat breast cancer); because Prozac 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 anti-depressant 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 serotonin syndrome). Treatment with fluoxetine can be started the day after stopping
treatment with reversible MAOIs but the doctor may wish to monitor you carefully and use a lower
dose of the MAOI-A drug.
mequitazine (for allergies); because taking this drug with Prozac may increase the risk of changes
in the electrical activity of the heart.
phenytoin (for epilepsy); because Prozac may influence the blood levels of this drug, your doctor
may need to introduce phenytoin more carefully and carry out check-ups when given with Prozac.
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
Prozac. 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 anti-depressants,
certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), antimalaria treatment particularly halofantrine or certain antihistamines (astemizole, mizolastine),
because taking one or more of these drugs with Prozac may increase the risk of changes in the
electrical activity of the heart.
anti-coagulants (such as warfarin), NSAID (such as ibuprofen, diclofenac), aspirin and other
medicines which can thin the blood (including clozapine, used to treat certain mental disorders).
Prozac may alter the effect of these medicines on the blood. If Prozac 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 Prozac.
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 Prozac.
anti-depressants such as tricyclic anti-depressants, other selective serotonin reuptake inhibitors
(SSRIs) or bupropion, mefloquine or chloroquine (used to treat malaria), tramadol (used to treat
severe pain) or anti-psychotics such as phenothiazines or butyrophenones; because Prozac may
increase the risk of seizures when taken with these medicines.
flecainide, propafenone, nebivolol or encainide (for heart problems), carbamazepine (for
epilepsy), atomoxetine or tricyclic anti-depressants (for example imipramine, desipramine and
amitriptyline) or risperidone (for schizophrenia); because Prozac may possibly change the blood
levels of these medicines, your doctor may need to lower their dose when administered with Prozac.
Prozac with food, drink and alcohol
You can take Prozac 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.
In babies whose mothers took fluoxetine during the first few months of pregnancy, 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 defect. This increased to about 2 in 100 babies in mothers who took
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.
It is preferable not to use this treatment during pregnancy unless the potential benefit outweighs the
potential risk. Thus, you and your doctor may decide to gradually stop taking Prozac while you are
pregnant or before being pregnant. However, depending on your circumstances, your doctor may suggest
that it is better for you to keep taking Prozac.
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
Psychotropic drugs such as Prozac may affect your judgment or co-ordination. Do not drive or use
machinery until you know how Prozac affects you.
Prozac contains sucrose and ethanol
Prozac contains sucrose. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
The flavouring for this medicinal product contains small amounts of ethanol (alcohol), less than 100mg
per dose (see Section 6).

3.

How to take Prozac

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 medicine than your doctor tells you.
Measure the right amount of medicine using the measuring cup, syringe or a measuring spoon, then drink
it.

Adults:
The recommended dose is:
Depression: The recommended dose is 5ml oral liquid (20mg) 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 15ml oral liquid (60mg) daily. The dose should be
increased carefully to ensure that you receive the lowest effective dose. You may not feel better
immediately when you first start taking your medicine for depression. This is usual because an
improvement in depressive symptoms may not occur until after the first few weeks. Patients with
depression should be treated for at least 6 months.
Bulimia nervosa: The recommended dose is 15ml oral liquid (60mg) daily.
Obsessive-compulsive disorder: The recommended dose is 5ml oral liquid (20mg) 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 15ml oral liquid (60mg) 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 (given as
2.5ml of Prozac). 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. 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 10ml
oral liquid (40mg). The maximum dose is 15ml oral liquid (60mg) daily.
Liver impairment:
If you have a liver problem or are using other medication that might affect Prozac, your doctor may decide
to prescribe a lower dose or tell you to use Prozac every other day.
If you take more Prozac than you should
If you take too much, go to your nearest hospital emergency department (or casualty) or tell your
doctor straight away.
Take the bottle of Prozac with you if you can.
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 Prozac
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 Prozac
Do not stop taking Prozac without asking your doctor first, even when you start to feel better. It is
important that you keep taking your medicine.
Make sure you do not run out of medicine.
You may notice the following effects (withdrawal effects) when you stop taking Prozac: 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.
Most people find that any symptoms on stopping Prozac are mild and disappear within a few weeks. If
you experience symptoms when you stop treatment, contact your doctor.
When stopping Prozac, 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.
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 medicine 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
Prozac 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 side 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 Prozac:
Common (may affect up to 1 in 10 people)
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 heart beat 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 (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
difficulty swallowing
hair loss
increased tendency to bruising
unexplained bruising or bleeding

cold sweat
difficulty passing urine
feeling hot or cold
abnormal liver 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
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
hepatitis
lung problems
sensitivity to sunlight
muscle pain
problems urinating
producing breast milk
Bone fractures – an increased risk of bone fractures has been observed in patients taking this type of
medicines.
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, Prozac
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.
Prozac contains sugar which may be harmful to the teeth.
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.

5.

How to store Prozac

Keep out of the sight and reach of children.
Do not take Prozac after the expiry date which is stated on the pack after ‘Exp’. The expiry date refers to
the last day of that month.
Do not store above 30°C. Protect from light.
Store in the original package.
If you have any other questions please talk to your doctor or pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
If Prozac becomes discoloured or shows any signs of deterioration, seek the advice of your pharmacist.

6.

Content of the pack and other information

What Prozac contains
The active substance is fluoxetine hydrochloride.
Each 5ml of liquid contains 20mg fluoxetine (as hydrochloride).
The other ingredients are benzoic acid, sucrose, glycerol, mint flavour (containing 0.23% alcohol) and
purified water.
What Prozac looks like and contents of the pack
Prozac is available in brown glass bottles containing 70ml oral liquid with dosing pipette.
Manufactured by: Patheon France, 40, boulevard de Champaret, 38300 Bourgoin – Jallieu, France.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit
4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Prozac® 20mg per 5ml Oral Liquid

POM

PL 18799/2137
Leaflet date: 13.04.2016
Prozac is a registered trademark of Lilly group of companies.

Package leaflet:
Information for the user

Fluoxetine 20mg per 5ml Oral Liquid
(fluoxetine hydrochloride)
The name of your medicine is Fluoxetine 20mg per 5ml Oral Liquid, but will be referred to as Fluoxetine
throughout this leaflet.

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 and your doctor weigh up the benefits of treatment against the possible
unwanted effects, before starting treatment.
Fluoxetine is not for use In children and adolescents under 18. See section 2, ‘Children and
adolescents aged 8 to 18 years’.
Fluoxetine won’t work straight away. Some people taking anti-depressants feel worse before feeling
better. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your
doctor if you haven’t started feeling better. See section 3, ‘How to take Fluoxetine’.
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, ‘Other medicines and Fluoxetine’.
If you are pregnant or planning to get pregnant, talk to your doctor. See section 2, ‘Pregnancy, breastfeeding and fertility’.
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 is and what it is used for
2. What you need to know before you take Fluoxetine
3. How to take Fluoxetine
4. Possible side effects
5. How to store Fluoxetine
6. Content of the pack and other information

1.

What is Fluoxetine and what is used for

Fluoxetine 20mg per 5ml oral liquid contains the active substance fluoxetine which is one of a group of
medicines called selective serotonin re-uptake inhibitors (SSRI) anti-depressants.
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 obsessivecompulsive disorder or bulimia nervosa have lower levels of 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 condition
may not go away and may become more serious and more difficult to treat.
You may need to be treated for a few weeks or months to ensure that you are free from symptoms.

2.

What you need to know before you take Fluoxetine

Do not take Fluoxetine if you are:
allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). If you
develop a rash or other allergic reactions (like itching, swollen lips or face or shortness of
breath), stop taking the oral liquid straight away and contact your doctor immediately.
taking other medicines known as irreversible, non-selective monoamine oxidase inhibitors (MAOIs),
since serious or even fatal reactions can occur (e.g. iproniazid used to treat depression).
Treatment with Fluoxetine should only be started at least 2 weeks after discontinuation of an irreversible,
non-selective MAOI.
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 needs to be
considered by your doctor.
taking metoprolol (to treat heart failure) because there is an increased risk of your heart beat
becoming too slow.
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’);
epilepsy or fits. If you have a fit (seizures) or experience an increase in seizure 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).
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 anti-depressants, 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
anti-depressant.
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:
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, nonselective 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, nonselective 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 anti-depressant 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 serotonin syndrome). Treatment with fluoxetine can be started the day after stopping
treatment with reversible MAOIs but the doctor may wish to monitor 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 (for epilepsy); because Fluoxetine may influence the blood levels 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 anti-depressants,
certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), antimalaria 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 ibuprofen, 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, mefloquine 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.
flecainide, propafenone, nebivolol or encainide (for heart problems), carbamazepine (for
epilepsy), atomoxetine or tricyclic anti-depressants (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.
In babies whose mothers took fluoxetine during the first few months of pregnancy, 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 defect. This increased to about 2 in 100 babies in mothers who took
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.
It is preferable not to use this treatment during pregnancy unless the potential benefit outweighs the
potential risk. Thus, you and your doctor may decide to gradually stop taking Fluoxetine while you are
pregnant or before being pregnant. 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 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
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.
Fluoxetine contains sucrose and ethanol
Fluoxetine contains sucrose. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
The flavouring for this medicinal product contains small amounts of ethanol (alcohol), less than 100mg
per dose (see Section 6).

3.

How to take Fluoxetine

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 medicine than your doctor tells you.
Measure the right amount of medicine using the measuring cup, syringe or a measuring spoon, then drink
it.

Adults:
The recommended dose is:
Depression: The recommended dose is 5ml oral liquid (20mg) 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 15ml oral liquid (60mg) daily. The dose should be
increased carefully to ensure that you receive the lowest effective dose. You may not feel better
immediately when you first start taking your medicine for depression. This is usual because an
improvement in depressive symptoms may not occur until after the first few weeks. Patients with
depression should be treated for at least 6 months.
Bulimia nervosa: The recommended dose is 15ml oral liquid (60mg) daily.
Obsessive-compulsive disorder: The recommended dose is 5ml oral liquid (20mg) 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 15ml oral liquid (60mg) 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 (given as
2.5ml of Fluoxetine). 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. 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 10ml
oral liquid (40mg). The maximum dose is 15ml oral liquid (60mg) 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 much, go to your nearest hospital emergency department (or casualty) or tell your
doctor straight away.
Take the bottle of Fluoxetine with you if you can.
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 stop taking Fluoxetine without asking your doctor first, even when you start to feel better. It is
important that you keep taking your medicine.
Make sure you do not run out of medicine.
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.
Most people find that any symptoms on stopping Fluoxetine are mild and disappear 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.
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 medicine 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 side 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
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 (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
difficulty swallowing
hair loss
increased tendency to bruising
unexplained bruising or bleeding

cold sweat
difficulty passing urine
feeling hot or cold
abnormal liver 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
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
hepatitis
lung problems
sensitivity to sunlight
muscle pain
problems urinating
producing breast milk
Bone fractures – an increased risk of bone fractures has been observed in patients taking this type of
medicines.
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. Suicide-related behaviours (suicide attempt and
suicidal thoughts), hostility, mania and nose bleeds were also commonly reported in children.
Fluoxetine contains sugar which may be harmful to the teeth.
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.

5.

How to store Fluoxetine

Keep out of the sight and reach of children.
Do not take Fluoxetine after the expiry date which is stated on the pack after ‘Exp’. The expiry date refers
to the last day of that month.
Do not store above 30°C. Protect from light.
Store in the original package.
If you have any other questions please talk to your doctor or pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
If Fluoxetine becomes discoloured or shows any signs of deterioration, you should seek the advice of
your pharmacist.

6.

Content of the pack and other information

What Fluoxetine contains
The active substance is fluoxetine hydrochloride.
Each 5ml of liquid contains 20mg fluoxetine (as hydrochloride).
The other ingredients are benzoic acid, sucrose, glycerol, mint flavour (containing 0.23% alcohol) and
purified water.
What Fluoxetine looks like and contents of the pack
Fluoxetine is available in brown glass bottles containing 70ml oral liquid with dosing pipette.
Manufactured by: Patheon France, 40, boulevard de Champaret, 38300 Bourgoin – Jallieu, France.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit
4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Fluoxetine 20mg per 5ml Oral Liquid
PL 18799/2137
Leaflet date: 13.04.2016

POM

Expand view ⇕

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.

Hide