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FLUOXETINE LIQUID 20MG/5ML

Active substance(s): FLUOXETINE HYDROCHLORIDE

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276 LEAFLET Prozac Liquid 20160419

The following side effects have also been reported in patients taking
Prozac:

-

pain in the tube that takes food or water to your stomach

-

hepatitis

Common (may affect up to 1 in 10 people)

-

lung problems

-

not feeling hungry, weight loss

-

sensitivity to sunlight

-

nervousness, anxiety

-

muscle pain

-

restlessness, poor concentration

-

problems urinating

-

feeling tense

-

producing breast milk

-

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

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

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.

-

sleep problems, unusual dreams, tiredness or sleepiness

-

dizziness

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

EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT
PROZAC

-

change in taste

Prozac treats depression and anxiety disorders.

-

uncontrollable shaking movements

-

blurred vision

-

rapid and irregular heartbeat sensations

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.

-

flushing

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

-

yawning

Reporting of side effects

Prozac is not for use In children and adolescents under 18. See
section 2, Children and adolescents aged 8 to 18 years.

-

indigestion, vomiting

-

dry mouth

-

rash, urticaria, itching

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

-

excessive sweating

-

joint pain

-

passing urine more frequently

-

unexplained vaginal bleeding

5. How to store Prozac

-

feeling shaky or chills



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

By reporting side effects, you can help provide more information on
the safety of this medicine.



Do not store above 30 C.

Uncommon (may affect up to 1 in 100 people)



Store in the original container to protect from light.

-

feeling detached from yourself



-

strange thinking

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

-

abnormally high mood



-

orgasm problems

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.

-

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



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

-

abnormal liver test results



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.

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





PROZAC® LIQUID
FLUOXETINE LIQUID 20mg/5ml
(fluoxetine hydrochloride)

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.

Treatment with Prozac should only be started at least 2 weeks after
discontinuation of an irreversible, non-selective MAOI.

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
medicines.

If you have any further questions, ask your doctor or
pharmacist.

-

-



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.

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.



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

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.



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;

4. Possible side effects



ongoing ECT (electro-convulsive therapy);

5. How to store Prozac



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).

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

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

6. Content of the pack and other information

-

low levels of salt in the blood

Product Licence holder

-

reduction in blood platelets, which increases risk of bleeding or
bruising

-

reduction in white blood cell count

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

-

untypical wild behaviour

Manufacturer

-

hallucinations

-

agitation

-

panic attacks

-

confusion

-

stuttering

Leaflet revision date: 19 April 2016

-

aggression

Prozac is a registered trade mark of Eli Lilly & Co, USA.

-

fits

Children and adolescents aged 8 years and above:

-

vasculitis (inflammation of a blood vessel)



-

rapid swelling of the tissues around the neck, face, mouth
and/or throat

POM PL 08747/0276

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.



What Prozac contains

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

Do not take Prozac if you are:

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.

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

What Prozac looks like and contents of the pack

2. What you need to know before you take Prozac

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).

-

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
sucrose.

You may need to be treated for a few weeks or months to ensure
that you are free from symptoms.



-



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.

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 solution.

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.

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

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.

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.

If you are pregnant or planning to get pregnant, talk to your
doctor. See section 2, Pregnancy, breast-feeding and fertility.



How Prozac works



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.

6. Further information

moderate to severe major depressive disorder only in
combination with psychological therapy.

PACKAGE LEAFLET: INFORMATION FOR THE USER

1. What is Prozac oral solution and what it is used for
Prozac 20 mg per 5 ml contains the active substance fluoxetine
which is one of a group of medicines called selective serotonin reuptake inhibitors (SSRI) antidepressants.
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.
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

Thoughts of suicide and worsening of your depression or
anxiety disorder.
If you are depressed and/or have anxiety disorders you can
sometimes have thoughts of harming or killing yourself. These may
be increased when first starting antidepressants, since these

medicines all take time to work, usually about two weeks but
sometimes longer.



You may be more likely to think like this:
-

If you have previously had thoughts about killing or harming
yourself.

-

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



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



Children and adolescents aged 8 to 18 years:
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, non-selective 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, nonselective 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 antidepressant treatment.
 monoamine oxidase inhibitors A (MAOI-A) including
moclobemide, linezolid (an antibiotic) and methylthioninium
chloride (also called methylene blue, used for the treatment of
medicinal or chemical product induced methemoglobinemia):
due to the risk of serious or even fatal reactions (called
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 checkups.
medicines that may affect the heart’s rhythm, e.g. Class IA and
III antiarrhythmics, antipsychotics (e.g. phenothiazine
derivatives, pimozide, haloperidol), tricyclic antidepressants,
certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin,
erythromycin IV, pentamidine), anti-malaria 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
ibruprofen, 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 antidepressants (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.

Breast-feeding

If you forget to take Prozac

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.



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.

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.

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

Psychotropic drugs such as Prozac may affect your judgment or coordination. Do not drive or use machinery until you know how
Prozac affects you.
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.

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.



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.

3. How to take Prozac

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.

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 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.



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.

Pregnancy

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.

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.

The flavouring for this medicinal product contains small amounts of
ethanol (alcohol), less than 100 mg per dose (see Section 6).

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.
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.



Driving and using machines

Prozac with food, drink and alcohol


If you stop taking Prozac

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.

Use in children and adolescents aged 8 to 18 years with
depression:
Treatment should be started and be supervised by a specialist. The
starting dose is 10 mg/day (given as 2.5 ml of Prozac oral solution).
After 1 to 2 weeks, your doctor may increase the dose to 20
mg/day. The dose should be increased carefully to ensure that you
receive the lowest effective dose. Lower weight children may need
lower doses. If there is a satisfactory response to treatment, your
doctor will review the need for continuing treatment beyond 6
months. If you have not improved within 9 weeks, your doctor will
reassess your treatment.
Elderly:
Your doctor will increase the dose with more caution and the daily
dose should generally not exceed 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 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 have any of the above side effects, you should tell your
doctor immediately.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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