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FLUOXETINE 20 MG/5 ML ORAL SOLUTION

Active substance(s): FLUOXETINE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET
Fluoxetine 20 mg/5 ml Oral Solution
Fluoxetine hydrochloride

If you have kidney or liver problems, your doctor may prescribe reduced or less frequent doses for you.

Important things that you need to know about Fluoxetine

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

Fluoxetine 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 Fluoxetine. See section 2.

Taking other medicines with Fluoxetine 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 Fluoxetine is and what it is used for
2.
Before you take Fluoxetine
3.
How to take Fluoxetine
4.
Possible side effects
5.
How to store Fluoxetine
6.
Further information
1.
WHAT FLUOXETINE IS AND WHAT IT IS USED FOR
Fluoxetine 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. Fluoxetine 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 FLUOXETINE
Do not take Fluoxetine if you

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

are taking metoprolol which is used to treat cardiac failure.

are already taking monoamine oxidase inhibitors (MAOIs) or you have finished taking a course of them in the last two weeks. Examples of such MAOIs
include medicines used to treat depression such as nialamide, iproniazide, modobemide, phenelzine, tranylcypromine, isocarboxacid, toloxatone and
also linezolid (an antibiotic).
Treatment with fluoxetine should only be started at least 2 weeks after dicontinuation of an irreversible non-selective MAOI. However, treatment with fluoxetine can
be started the following day after discontinuation of certain reversible MAOIs for e.g. moclobemide, linezolid, methylthioninium (methylene blue). Do not take
MAOI for at least 5 weeks after you stop taking fluoxetine.
Take special care with Fluoxetine 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 Fluoxetine, your doctor
will want to monitor you closely at the start of treatment, or if your dose is changed.

If you have fits (seizures) or experience an increase in seizure frequency, contact your doctor immediately; fluoxetine might need to be discontinued.

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

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

ever had mania or its mild form (hypomania).

heart problems.

low resting heart-rate and/or if you know that you may have salt deletion as a result of prolonged diarrhoea or vomiting, or use of diuretics.

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, Fluoxetine 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 Fluoxetine.

are undergoing ECT (electro-convulsive therapy);

are being treated with tamoxifen (used to treat breast cancer)(see Taking other medicines).

start to feel restless and cannot sit or stand still (akathisia). Increasing your dose of fluoxetine may make this worse.

suffer withdrawal symptoms (see Taking other medicines).

Glaucoma (increased pressure in the eye).

are taking Irreversible non selction (MAOI’s (see section 2).
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. Fluoxetine 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.
Fluoxetine 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.
Fluoxetine may affect the way some medicines work, especially the following:

monoamine oxidase inhibitors (MAOIs) which are used to treat depression. Irreversible nonselective MAOIs must not be used with fluoxetine as serious
fatal reactions (serotonin syndrome) can occur (see section Do not take fluoxetine). Some MAOIs type A for example moclobemide, linezolid,
methylthioninium chloride (methylene blue) type B (selegeline) can be used with fluoxetine provided that your doctor monitors you closely.

metoprolol (which is used to treat heart problems).

tamoxifen (which is used to treat breast cancer).

alcohol.

mequitazine (which is used to treat allergies and rhinitis).

phenytoin (for epilepsy).

medicines that increase the level of serotonin such as lithium, tramadol (a painkiller), tripans (for migraine), tryptophan, selegiline or St. Johns Wort.

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, certain antihistamines (astemizole).

medicines affecting CYP2D6 enzyme such as flecainide, propafenone and nebivol (for heart problems), carbamazepine (for epilepsy), tricyclic
antidepressants (for example imipramine, desipramine and antitriptyline) atomoxetine (for attention deficit and hyperactivity disorders) and risperidine
(for some psychiatric disorders).

cyproheptadine (for treating allergic reactions)

warfarin (used to thin your blood)

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

‘atypical antipsychotics’ (like clozapine, phenothiazines)

NSAIDs such as aspirin or ibuprofen
Taking Fluoxetine with food and drink
You may take Fluoxetine with or without food. You must not drink alcohol while taking Fluoxetine.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breast-feeding.

Fluoxetine 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 Fluoxetine.
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.

If you take more Fluoxetine than you should
If you have taken more Fluoxetine than you should, contact your doctor, pharmacist or nearest hospital casualty department immediately. Symptoms of overdose
include nausea, vomiting, fits, heart problems (including irregular heart beat and cardiac arrest) lung problems and change in mental condition ranging from
agitation to coma.
If you forget to take Fluoxetine
If you miss a dose, DO NOT take a double dose to make up for the forgotten dose, just take your next dose of Fluoxetine at your next dosage time.
If you stop taking Fluoxetine
If you are prescribed other medicines within 5 weeks of stopping your treatment, tell your doctor or pharmacist that you have been taking Fluoxetine.
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, Fluoxetine can cause side effects, although not everybody gets them.
Cases of suicidal ideation and suicidal behaviours have been reported during Fluoxetine 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 Fluoxetine 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.
The following side-effects have also been reported in patients taking fluoxetine:
Very common (may effect more than 1 in 10 people)

difficulty sleeping

headache

diarrhoea, feeling sick

tiredness
Common (may affect up to 1 in 10 people)

not feeling hungry, weight loss

restlessness, poor concentration

feeling more nervous than usual, feeling anxious

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 the way things taste

uncontrollable shaking

blurred vision

rapid and irregular heartbeat sensations

flushing

yawning

Indigestion, being sick

dry mouth

itchy, lumpy rash (hives) or nettle rash (urticaria) itching

excessive sweating

joint pain

passing urine more frequently

feeling shaky or chills

unexplained vaginal bleeding
Uncommon (may affect up to 1 in 100 people)

feeling detached from yourself


abnormally high mood


teeth grinding


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

low blood pressure


difficulty swallowing


increased tendency to bruising


difficulty passing urine


thoughts of suicide or harming yourself


ringing in the ears


vomiting blood or passing blood in your stools

strange thinking
orgasm problems
enlarged pupils
shortness of breath
hair loss
cold sweat
feeling hot or cold
memory impairment
nose bleeds

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

reduction in blood platelets which increases risk of bleeding or bruising

low levels of certain types of white blood cells

seeing or hearing things that are not there

finding it difficult to breath

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

producing breast milk

confusion

aggression

hepatitis

unexplained bruising













low levels of salt in the blood
overactive behaviour or thoughts
agitation
fits
inflammation of a blood vessel
you become more sensitive to the sun than usual
sore throat
stuttering
lung problems
muscle pain
problems passing urine

Not Known (frequency cannot be estimated from the available data)

abnormal liver function test results

feeling dizzy or light-headed when you stand or sit up quickly

difficulty in making voice sounds





burning pain and redness of the skin
reduced sense of touch
burning, tingling mouth

Risk of bone fractures
An increased risk of bone fractures has been observed in patients taking this type of medicine. Most of these side effects are likely to disappear with discontinued
treatment.
In children and adolescents (8 -18 years) – In addition to the possible side effects listed above, fluoxetine may slow growth or possibly delay sexual maturity.
Nose bleeds were also commonly reported in children.
Reporting of side effects
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. By reporting side effects you can help provide more information on the safety of this medicine.
5.
HOW TO STORE FLUOXETINE
Keep out of the sight and reach of children. Do not store above 25˚C. Store in the original container. Once opened, use within 1 month. Do not use Fluoxetine
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 Fluoxetine 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 Fluoxetine looks like and contents of the pack

Fluoxetine is a clear colourless solution with a peppermint odour, and is available in 70 ml amber glass bottles.
Marketing Authorisation Holder and Manufacturer:
This leaflet was last revised in 09/2015.

Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.

PL 04917/0038

Driving and using machines
Fluoxetine should not cause drowsiness or dizziness, but do not drive or operate machinery without advice from your doctor or pharmacist.
Important information about some of the ingredients of Fluoxetine
Fluoxetine contains:

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

Sucrose: Each 5 ml of Fluoxetine 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.
3.
HOW TO TAKE FLUOXETINE
Always take Fluoxetine 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:
For Children and Adolescents
aged 8 to 18 years with depression:

For Children under the age of 8 years:

20 – 60 mg (one to three 5 ml spoonfuls).
Treatment should be started and be supervised by a specialist. The starting dose is 10 mg/day (given as
2.5 ml of Fluoxetine). 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.
Not recommended.
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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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