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FLUOXETINE 20MG/5ML ORAL SOLUTION
Active substance(s): FLUOXETINE HYDROCHLORIDE / FLUOXETINE HYDROCHLORIDE / FLUOXETINE HYDROCHLORIDE
Package leaflet: Information for the user
20 mg/5 ml Oral Solution
EIGHT IMPORTANT THNGS YOU NEED TO KNOW ABOUT PROZEP
Prozep 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.
Prozep is not for use in children and adolescents under 18. See section 2, Children and adolescents aged 8 to 18 years.
Prozep 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 Prozep.
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 Prozep without talking to your doctor. If you stop taking Prozep 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 Prozep may make these feelings worse.
See section 4, Possible side-effects.
Taking some other medicines with Prozep 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, breast-feeding and fertility.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Prozep is and what it is used for
2. What you need to know before you take Prozep
3. How to take Prozep
4. Possible side effects
5. How to store Prozep
6. Contents of the pack and other information
1. What Prozep is and what it is used for
Prozep contains the active substance fluoxetine, which is one of a
group of medicines called selective serotonin re-uptake inhibitors
This medicine is used to treat the following conditions:
• Major depressive episodes
• Obsessive-compulsive disorder
• Bulimia nervosa: Prozep 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. Prozep
should be offered to a child or young person with moderate to
severe major depressive disorder only in combination with
How Prozep 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 Prozep 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 Prozep
Do not take Prozep 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 irreversible non-selective
monoamine oxidase inhibitors (MAOIs) since serious or even fatal
reactions can occur (e.g. iproniazid used to treat depression).
Treatment with Prozep should only be started at least 2 weeks after
discontinuation of an irreversible, non-selective MAOI.
Do not take any irreversible, non-selective MAOIs for at least 5 weeks
after you stop taking Prozep. If Prozep has been prescribed for a long
period and/or at a high dose, a longer interval needs to be
considered by your doctor.
• taking metoprolol (to treat heart failure) because there is an
increased risk of your heart beat becoming too slow.
Warnings and precautions
Talk to your doctor or pharmacist before taking Prozep 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 Prozep might need to be discontinued.
• mania now or in the past; if you have a manic episode, contact your
doctor immediately because Prozep might need to be discontinued;
• history of bleeding disorders or appearance of bruises or unusual
• ongoing treatment with medicines that thin the blood (see ‘Other
medicines and Prozep’);
• epilepsy or fits. If you have a fit (seizures) or experience an increase in
seizure frequency, contact your doctor immediately; Prozep might
need to be discontinued;
• ongoing ECT (electro-convulsive therapy);
• ongoing treatment with tamoxifen (used to treat breast cancer) (see
‘Other medicines and Prozep’);
• starting to feel restless and cannot sit or stand still (akathisia).
Increasing your dose of Prozep 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
• glaucoma (increased pressure in the eye).
Thoughts of suicide and worsening of your depression or anxiety
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
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 close friend or relative 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
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
Prozep 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 Prozep 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 Prozep 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 Prozep 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 Prozep.
Prozep should not be used in the treatment of children under the age
of 8 years.
Other medicines and Prozep
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Some medicines may be affected by Prozep or they may affect how
well Prozep will work.
Do not take Prozep with:
• Certain irreversible, non-selective monoamine oxidase inhibitors
(MAOIs), some used to treat depression. Irreversible, non-selective
MAOIs must not be used with Prozep as serious or even fatal
reactions (serotonin syndrome) can occur (see section ‘Do not take
Prozep’). Treatment with Prozep should only be started at least 2
weeks after discontinuation of an irreversible, non-selective MAOI
(for instance tranylcypromine). Do not take any irreversible,
non-selective MAOIs for at least 5 weeks after you stop taking
Prozep. If Prozep 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.
Prozep may affect the way the following medicines work (interaction):
• tamoxifen (used to treat breast cancer); because Prozep may change
the blood levels of this drug, resulting in the possibility of a
reduction in the effect of tamoxifen, your doctor may need to
consider prescribing a different anti-depressant treatment.
• monoamine oxidase inhibitors A (MAOI-A) including
moclobemide, linezolid (an antibiotic) and methylthioninium
chloride (also called methylene blue, used for the treatment of
medicinal or chemical product induced methaemogobinaemia) 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 Prozep
may increase the risk of changes in the electrical activity of the heart.
• phenytoin (for epilepsy); because Prozep 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 Prozep.
• 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 Prozep.
Your doctor will carry out more frequent check-ups.
• medicines that may affect the heart’s rhythm, e.g. Class IA and III
antiarrhythmics, anti-psychotics (e.g. phenothiazine derivatives,
pimozide, haloperidol), tricyclic anti-depressants, 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 Prozep 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). Prozep
may alter the effect of these medicines on the blood. If Prozep
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
• 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 Prozep.
• 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 Prozep may increase the risk of seizures when taken with
• flecainide, propafenone, nebivolol or encainide (for heart
problems), carbamazepine (for epilepsy), atomoxetine or tricyclic
anti- depressants (for example imipramine, desipramine and
amitriptyline) or risperidone (for schizophrenia); because Prozep
may possibly change the blood levels of these medicines, your
doctor may need to lower their dose when administered with
Prozep with food, drink and alcohol
You can take Prozep 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.
Talk to your doctor as soon as possible if you are pregnant, if you
might be pregnant, or if you are 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. It is preferable
not to use this treatment during pregnancy unless the potential
benefit outweighs the potential risk. You and your doctor may decide
that it is better for you to gradually stop taking Prozep while you are
pregnant. However, depending on your circumstances, your doctor
may suggest that it is better for you to keep taking Prozep.
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
new born (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
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 has been shown to reduce the quality of sperm in animal
studies. Theoretically, this could affect fertility, but impact on human
fertility has not been observed as yet.
Driving and using machines
Psychotropic drugs such as Prozep may affect your judgment or
co-ordination. Do not drive or use machinery until you know how
Prozep affects you.
Prozep contains sorbitol and castor oil
Prozep contains sorbitol. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before
taking this medicinal product.
Prozep contains castor oil.
This may cause stomach upset and diarrhoea.
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.
• Take the solution with or without food, whichever you prefer.
• You should not drink alcohol whilst taking this medicine.
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: The recommended dose is 15 ml oral solution (60 mg)
• 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.
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 Prozep). After 1 to 2 weeks,
your doctor may increase the dose to 20 mg/day (5 ml).
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.
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.
If you have a liver problem or are using other medication that might
affect Prozep, your doctor may decide to prescribe a lower dose or tell
you to use Prozep every other day.
If you take more Prozep 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 Prozep 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 Prozep
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
• Taking your medicine at the same time each day may help you to
remember to take it regularly.
If you stop taking Prozep
• Do not stop taking Prozep without asking your doctor first, even
when you start to feel better. It is important that you keep taking
• Make sure you do not run out of medicine.
You may notice the following effects (withdrawal effects) when you
stop taking Prozep: 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
Most people find that any symptoms on stopping Prozep are mild and
disappear within a few weeks. If you experience symptoms when you
stop treatment, contact your doctor.
When stopping Prozep, your doctor will help you to reduce your dose
slowly over one or two weeks – this should help reduce the chance of
If you have any further questions on the use of this product, 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
• 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 Prozep 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
The following side effects have also been reported in patients taking
Common (may affect up to 1 in 10 people)
• not feeling hungry, weight loss
• nervousness, anxiety
• restlessness, poor concentration
Continued over page
• feeling tense
• 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 heart-beat 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
• memory impairment
• enlarged (dilated) pupils
• ringing in the ears
• low blood pressure
• shortness of breath
• nose bleeds
• difficulty swallowing
• hair loss
• increased tendency to bruising
• unexplained bruising or bleeding
• cold sweat
• difficulty passing urine
• feeling hot or cold
• abnormal liver test results
Rare (may affect up to 1 in 1,000 people)
• low levels of salt in the blood
• reduction in blood platelets, which increases risk of bleeding or
• reduction in white blood cell count
• untypical wild behaviour
• panic attacks
• vasculitis (inflammation of a blood vessel)
• rapid swelling of the tissues around the neck, face, mouth and/or
• pain in the tube that takes food or water to your stomach
• 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
In children and adolescent (8-18 years): In addition to the possible side
effects listed above, Prozep 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.
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 Prozep
• Keep this medicine out of the sight and reach of children.
• Do not take this medicine after the expiry date which is stated on the
bottle label and on the carton. The expiry date refers to the last day
of that month.
• Do not use after one month from first opening the bottle.
• Do not store above 25°C. Store in the original container.
• Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Prozep contains
• The active substance is fluoxetine hydrochloride. Each 5 ml of liquid
contains 20 mg fluoxetine (as hydrochloride).
• Other ingredients are: glycerol, sorbitol (E420), hydrogenated
polyoxyl castor oil, benzoic acid, peppermint flavour and purified
water. (See end of Section 2 for further information on sorbitol and
What Prozep looks like and contents of the pack
Prozep is a clear, colourless liquid with the odour of peppermint.
It is available in amber glass bottles of 70 ml with a tamper evident
child resistant closure.
Marketing Authorisation Holder
Chemidex Pharma Ltd., Chemidex House, Egham Business Village,
Crabtree Road, Egham, Surrey, TW20 8RB.
Famar Nederland BV, Industrieweg 1, 5531 AD Bladel, The Netherlands.
This leaflet was last revised in
'Prozep', 'Chemidex' and Chemidex logo are registered trademarks of
Chemidex Pharma Ltd.
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.