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PROZAC 20 MG/5 ML ORAL LIQUID

Active substance(s): FLUOXETINE

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PATIENT INFORMATION LEAFLET

2190
20.08.15[10]

Prozac® 20mg/5ml oral liquid
(fluoxetine hydrochloride)
This medicine is known as Prozac 20mg/5ml oral liquid but will be
referred to as Prozac or Prozac oral liquid throughout the 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, 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.
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 are pregnant or planning to get pregnant, talk to your doctor.
See section 2, Pregnancy and breastfeeding.
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.
In this leaflet:
1. What Prozac oral liquid is and what it is used for
2. What you need to know before you take Prozac oral liquid
3. How to take Prozac oral liquid
4. Possible side effects
5. How to store Prozac oral liquid
6. Content of the pack and other information
1. What Prozac oral liquid is and what it is used for
Prozac 20mg/5ml oral liquid contains the active substance fluoxetine
which is one of a group of medicines called selective serotonin re-uptake
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
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 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 oral liquid
Do not take Prozac if you are:
 allergic to fluoxetine or any of the other ingredients of this medicines
(see 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 non-selective monoamine oxidase
inhibitors or reversible monoamine oxidase inhibitors type A (MAOIs),
since serious or even fatal reactions can occur. Examples of such
MAOIs include medicines used to treat depression such as nialamide,
iproniazide, moclobemide, phenelzine, tranylcypromine, isocarboxazid,
toloxatone and also linezolid (an antibiotic) and methylthioninium
chloride also called methylene blue (used to treat medicinal or
chemical induced methaemogobinaemia).
Treatment with 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)).
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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Prozac if any of the
following applies to you:
 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 discontinued;














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);
heart problems;
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);
glaucoma (increased pressure in the eye);
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”);
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.

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
















Certain monoamine oxidase inhibitors (MAOIs), some used to treat
depression. Non-selective 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.
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.
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, mizolastine)
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 Prozac.
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.

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 and 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 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.
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
Prozac may affect your judgment or co-ordination. Do not drive or use
machinery without advice from your doctor or pharmacist.
Prozac contains sucrose and ethanol
Prozac oral liquid 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 oral liquid
Always take Prozac exactly as your doctor or pharmacist has told you.
You should 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 (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 15ml oral liquid (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 15ml oral liquid (60 mg)
daily.
 Obsessive-compulsive disorder: The recommended dose is 5ml oral
liquid (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 15ml oral liquid (60 mg) daily.
If no improvement is noted within 10 weeks, your doctor will reconsider
your treatment.
Use in Children and adolescents aged 8 to 18 years with depression:
Treatment should be started and be supervised by a specialist. The
starting dose is 10mg/day (given as 2.5ml of Prozac oral liquid). 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 (40 mg).The maximum dose
is 15ml oral liquid (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 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, Prozac 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.



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 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 function test results

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

 low levels of salt in the blood
 reduction in blood platelets, which increases risk of bleeding or bruising
 untypical wild behavior
 hallucinations
 agitation
 panic attacks
 confusion
 stuttering
 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 behaviors (suicide attempt and suicidal
thoughts), hostility, mania and nose bleeds were also commonly reported
in children.
Prozac oral liquid 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 oral liquid
Keep out of the sight and reach of children.
Do not take Prozac after the expiry date which is stated on the pack.
Do not store above 30°C.
If you have any other questions please talk to your doctor or pharmacist.
If your doctor decides to stop treatment, return any left-over medicine to a
pharmacist. Only keep this if your doctor tells you to.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to
do.
Medicines should not be disposed of via wastewater or household waste.
These measures will help to protect the environment.
6. Content of the pack and other information
What Prozac contains
The active substance is fluoxetine hydrochloride.
Each 5ml of oral liquid contains 20mg fluoxetine (as the hydrochloride).
Other ingredients are: benzoic acid, sucrose, glycerol, mint flavour
(contains 0.23% alcohol) and purified water
What Prozac looks like and contents of the pack
Prozac is available in a brown glass bottle containing 70 ml clear
colourless oral liquid with peppermint odour and tamper evident seal. The
pack has a plastic measuring oral syringe
Manufacturer and Product Licence holder
Prozac is manufactured by Patheon France, 40 boulevard de champaret
38300 Bourgion-Jallieu, France and procured from the EU by Product
Licence holder Tenolol Ltd., 5 Sandridge Close, Harrow, HA1 1XD.
Repackaged by Servipharm Ltd
POM

PL 30900/2190

This leaflet was last updated on 20.08.15[10]
Prozac® is a registered trademark of Lilly and Co.

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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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