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PROZAC 20MG/5ML ORAL LIQUID

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Patient Information Leaflet
Prozac® 20mg/5ml Oral Liquid
(fluoxetine hydrochloride)
EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT
PROZAC
Your medicine is called Prozac 20mg/5ml Oral Liquid but will be
referred to as Prozac throughout the remainder of the leaflet.
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 the 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.
• 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Prozac is and what it is used for
2. Before you take Prozac
3. How to take Prozac
4. Possible side effects
5. How to store Prozac
6. Further information
1. What Prozac is and what it is used for
Prozac contains fluoxetine which is one of a group of medicines
called selective serotonin reuptake inhibitor (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.
2. Before you take Prozac
Do not take Prozac if you are:
• allergic (hypersensitive) to fluoxetine or any of the other
ingredients of Prozac (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 used to treat depression, 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 MAOIs
include nialamide iproniazide, selegeline, moclobemide,
phenelzine, tranylcypromine, isocarboxazid and toloxatone.
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)
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.
Take special care with Prozac
Tell your doctor 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;

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
‘Taking other medicines’);

ongoing treatment with tamoxifen (used to treat breast cancer)
(see ‘Taking other medicines’);

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.
Use in 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines (up to 5 weeks ago) including
medicines obtained without prescription.
Prozac may affect the way some other medicines work
(interaction), especially the following:

Certain monoamine oxidase inhibitors (MAOIs, used to treat
depression). Non-selective MAOIs and MAOIs type A
(moclobemide) 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) . 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).









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.

Taking Prozac with food and drink

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
Ask your doctor or pharmacist for advice before taking any
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.
Important information about some of the ingredients of Prozac
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 100mg per dose (see Section 6).
3. How to take Prozac
Always take Prozac exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
The instructions will also be on the label on the pack. 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 usual 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 (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
(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.
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.

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 Prozac, 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.

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.

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.

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

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.

Very common (seen in more than 1 in every 10 patients)

insomnia

headache

diarrhoea, feeling sick (nausea)

fatigue

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.

Common (seen in 1 to 10 in every 100 patients)

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 (seen in 1 to 10 in every 1,000 patients)

feeling detached from yourself

strange thinking

abnormally high mood

orgasm problems

teeth grinding

muscle twitching, involuntary movements or problems with
balance or co-ordination

enlarged (dilated) pupils

low blood pressure

shortness of breath

difficulty swallowing

hair loss

increased tendency to bruising

cold sweat

difficulty passing urine

feeling hot or cold
Rare (seen in 1 to 10 in every 10,000 patients)

low levels of salt in the blood

untypical wild behaviour

hallucinations

agitation

panic attacks

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

sensitivity to sunlight

producing breast milk
Very rare (seen in less than 1 to 10,000 patients)

reduction in blood platelets, which increases risk of bleeding or
bruising
Other (frequency cannot be estimated)

thoughts of suicide or harming yourself

memory impairment

lung problems

hepatitis, abnormal liver function test results

muscle pain

problems urinating

confusion

stuttering

nose bleeds

ringing in the ears

unexplained bruising or bleeding
Bone fractures - an increased risk of bone fractures has been
observed in patients taking this type of medicines.
If you have any of the symptoms listed and they bother you, or last
for some time, tell your doctor or a pharmacist.
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. Nose bleeds were also commonly
reported in children.

Prozac oral liquid contains sugar which may be harmful to the
teeth.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
5. How to store Prozac
Keep out of the reach and sight of children.
Do not store above 30°C.
Do not take after the expiry date shown on the bottle.
If you have any other question 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 your medicine shows any signs of deterioration or discolouration
speak to your pharmacist for advice.
6. Further information
Each 5ml contains 20mg of the active ingredient fluoxetine (as
hydrochloride).
Also contains benzoic acid, glycerol, sucrose, mint flavour and
purified water.
Prozac is a clear, colourless, mint odoured liquid, in an amber glass
bottle and a measuring syringe.
Prozac is available in bottles of 70ml.
PL 20774/1003

Prozac 20mg/5ml Oral Liquid

POM

Manufactured by Patheon France, 40, boulevard de Champaret,
38300 Bourgoin – Jallieu, France. Procured from within the EU.
Product Licence Holder: Quadrant Pharmaceuticals Ltd, Lynstock
House, Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by
Maxearn Ltd, Bolton, BL6 4SA.
th
Leaflet revision date 10 October 2012

Prozac is a registered trademark of Eli Lilly and company.
PP5/1003/V7

Expand Transcript

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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