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FLUOXETINE SYRUP ORAL SOLUTION (IVAX)

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PATIENT INFORMATION LEAFLET
Prozit 20 mg/5 ml Oral Solution
Fluoxetine hydrochloride
Important things that you need to know about Prozit

Your doctor has prescribed Prozit because it is a treatment for depression, bulimia nervosa or obsessive compulsive disorders.

Prozit won’t work straight away. Some people taking antidepressants feel worse before feeling better. Your doctor should see you regularly during
your course of treatment. Tell your doctor if you haven’t started feeling better.

If you are pregnant or could get pregnant you should talk to your doctor before taking Prozit. See section 2.

Taking other medicines with Prozit can cause problems. You may need to talk to your doctor. See section 2.

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 hospital straight away.
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.
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.
In this leaflet:
1.
What Prozit is and what it is used for
2.
Before you take Prozit
3.
How to take Prozit
4.
Possible side effects
5.
How to store Prozit
6.
Further information
1.
WHAT PROZIT IS AND WHAT IT IS USED FOR
Prozit belongs to a group of medicines called antidepressants. It is used to treat the following conditions:
Adults:

major depressive episodes

bulimia nervosa

obsessive compulsive disorder
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. Prozit 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 PROZIT
Do not take Prozit if you

are allergic (hypersensitive) to fluoxetine or any of the other ingredients of Prozit (see Section 6 and end of Section 2).

have epilepsy which is not controlled by medicine, or a condition which causes convulsions (fits).

are already taking monoamine oxidase inhibitors (MAOIs) or you have finished taking a course of them in the last two weeks.
Take special care with Prozit and tell your doctor if you have:

ever had suicidal thoughts or want to harm yourself. Depression is associated with an increased risk of suicidal thoughts, self harm and suicide. The
risk persists until your condition improves. Since it can take 3-4 weeks before your illness improves following treatment with Prozit, your doctor will
want to monitor you closely at the start of treatment, or if your dose is changed.

epilepsy which is controlled by medicine. You will need to be carefully monitored.

liver or kidney problems. A low dose of Prozit may be appropriate for you.

diabetes, as your dose may need to be adjusted, as Prozit contains sucrose.

ever had mania or its mild form (hypomania).

heart problems.

bleeding or blood clotting problems which may be controlled by medicine.

are taking medicines that thin the blood.

begun to experience 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, Prozit might need to be discontinued.

a rare hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

alcoholism. You must not consume alcohol while taking Prozit.
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. Prozit 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.
Prozit 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 a prescription.
Prozit may affect the way some medicines work, especially the following:

monoamine oxidase inhibitors (MAOIs) which are used to treat depression

flecainide, encainide (for heart problems)

vinblastine (for cancer)

carbamazepine or phenytoin (for epilepsy)

tricyclic antidepressants (like lithium or tryptophan)

warfarin (used to thin your blood)

diuretics (water tablets that help you pass more urine), especially if you are elderly

medicines known as ‘serotonergic drugs’ which are pain killers like tramadol or sumatriptan

‘atypical antipsychotics’ (like clozapine, phenothiazines)

NSAIDs such as aspirin or ibuprofen

the herbal remedy called St. John’s Wort, which is used to treat depression

receiving ECT (electroconvulsive therapy)
Taking Prozit with food and drink
You may take Prozit with or without food. You must not drink alcohol while taking Prozit.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast-feeding.

Prozit can be used during pregnancy but caution should be exercised, especially during late pregnancy or just prior to the onset of labour.

Fluoxetine is excreted into 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 Prozit.
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
Prozit should not cause drowsiness or dizziness, but do not drive or operate machinery until you are sure how this medicine affects you.
Important information about some of the ingredients of Prozit
Prozit contains:

Ethanol: Each 5 ml of Prozit contains small amounts of ethanol (alcohol), but less than 100 mg per dose.

Sucrose: Each 5 ml of Prozit contains 3 g of sucrose. If taken according to the dosing recommendations, it can supply up to 12 g of sucrose daily.
If you have an intolerance to some sugars (which may be inherited), contact your doctor before taking this medicinal product. This should also
be taken into account if you have diabetes mellitus.
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3.

HOW TO TAKE PROZIT

Always take Prozit exactly as your doctor has told you. You should check with your doctor if you are not sure.
The usual dose to be taken by mouth is:
For Adults and the Elderly:
Depression :

20 mg (one 5 ml spoonful) per day. The daily dose must not exceed 80 mg per day.

Bulimia nervosa:

60 mg (three 5 ml spoonfuls) per day.

Obsessive compulsive disorder:

20 – 60 mg (one to three 5 ml spoonfuls).

For Children and Adolscents 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 Prozit). After 1 to 2 weeks, your doctor may increase the
dose to 20 mg/day. The dose should be increased to ensure that you receive the lowest
effective dose. Lower weight children may need lower doses. Your doctor will review
the need for continuing treatment beyond 6 months, and treatment will be reassessed
if no improvement is seen.

For Children under the age of 8 years:

Not recommended.

If you have kidney or liver problems, your doctor may prescribe reduced or less frequent doses for you.
If you take more Prozit than you should
If you have taken more Prozit than you should, contact your doctor or pharmacist immediately.
If you forget to take Prozit
If you miss a dose, DO NOT take a double dose to make up for the forgotten dose, just take your next dose of Prozit at your next dosage time.
If you stop taking Prozit
If you are prescribed other medicines within 5 weeks of stopping your treatment, tell your doctor or pharmacist that you have been taking Prozit.
Common withdrawal symptoms are: dizziness, headache, pins and needles, anxiety, feeling sick, sleep disturbances, feeling restless or agitated, unusual
tiredness or weakness and tremors (shakiness).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Prozit can cause side effects, although not everybody gets them.
Cases of suicidal ideation and suicidal behaviours have been reported during Prozit therapy or early after treatment discontinuation.
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.
You should STOP using Prozit and contact your doctor immediately if you experience a rare allergic reaction, including swelling of the skin and
rashes, difficulty breathing, loss of consciousness, and fever or shock.
Contact your doctor if you experience the following:

fever accompanied by faster breathing, sweating, muscle stiffness or sleepiness.
You should contact your doctor if any of these side effects occur :

difficulty in passing urine

needing to go to the toilet more often

changes in sexual performance

prolonged erection

production of breastmilk

hair loss

blurred vision

yawning

unexplained bruising or bleeding

hot flushes or excessive sweating

feeling dizzy when you stand up

muscle pain or joint pain

thoughts of harming or killing yourself
In addition, contact your doctor if any of the following side effects become persistent (some of these may be due to your condition itself):

chills

sensitivity to sunlight

stomach upsets such as diarrhoea

indigestion

dry mouth

sore throat and/or difficulty swallowing

feeling sick

headache

being sick

dizziness

extreme restlessness

shortness of breath

change in taste of food

unusual dreams or sleep problems

changes in appetite or weight loss

fatigue

unusually high moods

uncontrollable movements

fits

agitation or anxiety

nervousness or panic attacks

lack of concentration or confusion

hallucinations

feeling of loss of self identity

changes in liver function (detected by blood tests)

hepatitis (inflammation of the liver possibly causing yellowing of the skin and whites of the eyes)
Blood sodium levels may fall in some patients, particularly if you are elderly or taking water tablets. This may make you feel weak, confused and drowsy.
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 PROZIT
Keep out of the reach and sight of children. Do not store above 25˚C. Store in the original container. Once opened, use within 1 month.
Do not use Prozit after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month.
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.
6.
FURTHER INFORMATION
What Prozit contains:

The active substance is: fluoxetine hydrochloride; each 5 ml contains 20 mg fluoxetine

The other ingredients are: sucrose, glycerol (E422), peppermint soluble, ethanol, benzoic acid (E210), hydrochloric acid, sodium hydroxide,
purified water.
What Prozit looks like and contents of the pack

Prozit is a clear colourless solution with a peppermint odour, and is available in 70 ml amber glass bottles.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
PL 04917/0038
This leaflet was last revised in 07/2012.
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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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