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Assessed against the UK PIL dated Feb 2014
Common (may affect up to 1 in 10 people)


muscle pain


not feeling hungry, weight loss


problems urinating

nervousness, anxiety


producing breast milk


restlessness, poor concentration


feeling tense

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


decreased sex drive or sexual problems (including difficulty
maintaining an erection for sexual activity)


sleep problems, unusual dreams, tiredness or sleepiness




change in taste


uncontrollable shaking movements


blurred vision


rapid and irregular heartbeat sensations






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 function test results
Rare (may affect up to 1 in 1,000 people)

By Caroline McDermott at 11:23 am, Aug 11, 2015

276 LEAFLET Prozac Liquid 20150602



Prozac oral liquid contains sugar which may be harmful to the teeth.

Your medicine is known as Prozac Liquid or Fluoxetine Liquid
20mg/5ml; it will be referred to as Prozac or Prozac Oral Liquid
throughout this leaflet.
Prozac treats depression and anxiety disorders.

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:
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. How to store Prozac


Do not store above 30 C.

Store in the original container to protect from light.

Do not use after the expiry date printed on the carton or bottle

If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

This leaflet does not contain the complete information about
your medicine. If you have any questions, or are not sure about
anything, ask your doctor or pharmacist, who has access to
additional information.

6. Further information

Children and adolescents aged 8 years and above:

(fluoxetine hydrochloride)

Most of these side effects are likely to disappear with continued
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.


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
Prozac is not for use In children and adolescents under 18. See
section 2, Use in children and adolescents aged 8 to 18 years.
Prozac 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 weeks after you first start
treatment. Tell your doctor if you haven’t started feeling better. See
section 3, How to take Prozac oral liquid.
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.

How Prozac 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 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 solution 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).

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, Taking other
If you are pregnant or planning to get pregnant, talk to your
doctor. See section 2, Pregnancy and breastfeeding.

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.

Treatment with Prozac should only be started at least 2 weeks after
discontinuation of an irreversible MAOI (for instance
However, treatment with fluoxetine can be started the following day
after discontinuation of certain reversible MAOIs (for instance
moclobemide, linezolid, methylthioninium chloride (methylene

What Prozac contains

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Each 5ml of liquid contains 20mg of the active ingredient
fluoxetine as the hydrochloride.


Keep this leaflet. You may need to read it again.


Prozac also contains the following inactive ingredients: benzoic
acid, sucrose, glycerol, mint flavour (containing 0.23% alcohol)
and purified water. Each 5ml spoonful contains 3 grams of

If you have any further questions, ask your doctor or


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.

Warnings and precautions

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.

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;

mania now or in the past; if you have a manic episode, contact
your doctor immediately because Prozac might need to be

diabetes (your doctor may need to adjust your dose of insulin or
other antidiabetic treatment);

What Prozac looks like and contents of the pack

It is a clear liquid which has no colour and smells of mint.

Prozac is available in an amber bottle, with a tamper-evident
cap, containing 70ml or 140ml of liquid, and an oral syringe for
measuring the dose.


low levels of salt in the blood


reduction in blood platelets, which increases risk of bleeding or


untypical wild behaviour






panic attacks






Prozac is manufactured by Patheon France. 40, boulevard de
Champaret, 38300 Bourgoin-Jallieu, France.




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




lung problems
sensitivity to sunlight

What is in this leaflet:

Do not take any 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.

Talk to your doctor or pharmacist before taking Prozac if any of the
following applies to you:

1. What Prozac is and what it is used for
2. What you need to know before you take Prozac

Product Licence holder

3. How to take Prozac

Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX

4. Possible side effects

liver problems (your doctor may need to adjust your dosage);

5. How to store Prozac

heart problems;

6. Contents of the pack and other information

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);

1. What Prozac is and what it is used for

glaucoma (increased pressure in the eye);

Prozac contains the active substance fluoxetine which is one of a
group of medicines called selective serotonin re-uptake inhibitors
(SSRI) antidepressants.

ongoing treatment with diuretics (water tablets), especially if
you are elderly;

ongoing ECT (electro-convulsive therapy);

history of bleeding disorders or appearance of bruises or
unusual bleeding;

ongoing treatment with medicines that thin the blood (see
“Other medicines and Prozac”);

ongoing treatment with tamoxifen (used to treat breast cancer)
(see “Other medicines and Prozac”);

This medicine is used to treat the following conditions:

POM PL No. 08747/0276
Leaflet revision date: 2 June 2015
Prozac is a registered trade mark of Eli Lilly & Co, USA S053
276 LEAFLET Prozac Liquid 20150602

Major depressive episodes

Obsessive-compulsive disorder

Bulimia nervosa: Prozac is used alongside psychotherapy for
the reduction of binge-eating and purging

starting to feel restless and cannot sit or stand still (akathisia).
Increasing your dose of Prozac may make this worse;
appearance of fever, muscle stiffness or tremor, changes in
your mental state like confusion, irritability and extreme
agitation; you may suffer from the so-called “serotonin
syndrome” or “neuroleptic malignant syndrome”. Although this
syndrome occurs rarely it may result in potentially life
threatening conditions; contact your doctor immediately,
since Prozac might need to be discontinued.

tramadol (a painkiller) or triptans (for migraine); there is an
increased risk of hypertension (raised blood pressure).

medicines that may affect the heart’s rhythm, e.g. Class IA and
III antiarrhythmics, antipsychotics (e.g. fentiazine
derviatives, pimozide, haloperidol), tricyclic antidepressants,
certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin,
erythromycin IV, pentamidine), anti-malaria treatment
particularly halofantrine, certain antihistamines (astemizole,

Thoughts of suicide and worsening of your depression or
anxiety disorder.
If you are depressed and/or have anxiety disorders you can
sometimes have thoughts of harming or killing yourself. These may
be increased when first starting antidepressants, since these
medicines all take time to work, usually about two weeks but
sometimes longer.

You may be more likely to think like this:

If you have previously had thoughts about killing or harming


If you are a young adult. Information from clinical trials has
shown an increased risk of suicidal behaviour in adults aged
less than 25 years with psychiatric conditions who were treated
with an antidepressant.

If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you
are depressed or have an anxiety disorder, and ask them to read
this leaflet. You might ask them to tell you if they think your
depression or anxiety is getting worse, or if they are worried about
changes in your behaviour.

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.

flecainide or encainide (for heart problems), carbamazepine
(for epilepsy), tricyclic antidepressants (for example
imipramine, desipramine and amitriptyline); because Prozac
may possibly change the blood levels of these medicines, your
doctor may need to lower their dose when administered with
tamoxifen (used to treat breast cancer), because Prozac may
change the blood levels of this drug and a reduction of the
effect of tamoxifen cannot be excluded, your doctor may need
to consider different antidepressant treatments.
warfarin, NSAID or other medicines which can thin the blood
(including clozapine, used to treat certain mental disorders, and
aspirin); 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.
You should not start to take the herbal remedy St John’s wort
while you are being treated with Prozac since this may result in
an increase in side effects. If you are already taking St John’s
wort when you start on Prozac, stop taking St John’s wort and
tell your doctor at your next visit.

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.

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

Driving and using machines

If you forget to take Prozac

Prozac may affect your judgment or co-ordination.

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.

Do not drive or use machinery without advice from your doctor or
Prozac contains sucrose and ethanol
Prozac oral solution 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 100 mg 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.
The recommended dose is:

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
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.
Prozac may affect the way some other medicines work (interaction),
especially the following:

Certain monoamine oxidase inhibitors (MAOIs), some used
to treat depression. Nonselective MAOIs and MAOIs type A
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 MAOI (for
instance tranylcypromine). However, treatment with fluoxetine
can be started the following day after discontinuation of certain
reversible MAOIs (for instance moclobemide, linezolid,
methylthioninium chloride (methylene blue)). Some MAOIs type
B (selegeline) can be used with Prozac provided that your
doctor monitors you closely.
lithium, tryptophan; there is an increased risk of serotonin
syndrome when these drugs are taken with Prozac. Your doctor
will carry out more frequent check-ups.

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.

Bulimia nervosa: The recommended dose is 15 ml oral
solution (60 mg) daily.

Obsessive-compulsive disorder: The recommended dose is
5 ml oral solution (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 15 ml oral solution (60 mg) daily. If no
improvement is noted within 10 weeks, your doctor will
reconsider your treatment.

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 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 Prozac while you are pregnant. However, depending on
your circumstances, your doctor may suggest that it is better for you
to keep taking Prozac.
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.
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.

Depression: The recommended dose is 5 ml oral solution (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 15 ml oral solution (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 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.

Use in Children and adolescents aged 8 to 18 years with
Treatment should be started and be supervised by a specialist. The
starting dose is 10 mg/day (given as 2.5 ml of Prozac oral liquid).
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.

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 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.

Your doctor will increase the dose with more caution and the daily
dose should generally not exceed 10 ml oral solution (40 mg). The
maximum dose is 15 ml oral solution (60 mg) 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 have any of the above side effects, you should tell your
doctor immediately.

If you take more Prozac than you should

The following side effects have also been reported in patients taking

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.

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.