Drug Ingredient Information
FLUOXETINE-60MG
FLUOXETINE
| Information for
patients
|
| Drug Information |
Fluoxetine contains fluoxetine which is one of a group of medicines called selective serotonin re-
uptake inhibitor (SSRI) antidepressants.
This medicine is used to treat the following conditions:
Adults:
•
•
•
Major depressive episodes
Obsessive-compulsive
Bulimia nervosa: Fluoxetine is used alongside psychotherapy for the reduction of binge-eating
and purging
Children and adolescents aged 8 years and above:
•
2.
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. |
| Drug Alert |
| Alert |
if you are:
allergic (hypersensitive) to fluoxetine or any of the other ingredients of Fluoxetine.
If you develop a rash or other allergic reactions (like itching, swollen lips or face
or shortness of breath), stop taking the capsules 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. |
| Before Consuming
the Medicine
|
| Avoid Drug |
Do not take Fluoxetine if you are:
•
•
allergic (hypersensitive) to fluoxetine or any of the other ingredients of Fluoxetine.
If you develop a rash or other allergic reactions (like itching, swollen lips or face
or shortness of breath), stop taking the capsules 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 Fluoxetine should only be started 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 Fluoxetine . If Fluoxetine has been
prescribed for a long period and/or at a high dose, a longer interval needs to be considered by
your doctor. |
| Drug Special Care |
Tell your doctor if any of the following applies to you:
•
•
•
•
have epilepsy or fits (seizures) or experience an increase in seizure frequency, contact
your doctor immediately; Fluoxetine might need to be discontinued.
mania now or in the past; if you have a manic episode, contact your doctor immediately
because Fluoxetine 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
•
•
•
•
•
are taking diuretics (water tablets), especially if you are elderly;
are having ECT (electro-convulsive therapy) treatment;
have a history of bleeding disorders or you develop bruises or unusual bleeding;
are taking medicines that thin the blood (see ‘Taking other medicines’).
start 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.
• have 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 kil ing 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. 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
Additionally, only limited information concerning the long-term safety of Fluoxetine on growth,
puberty, mental, emotional and behavioural development in this age group is available. Despite
this, your doctor may prescribe Fluoxetine for patients under 18 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 Fluoxetine 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 Fluoxetine .
Fluoxetine should not be used in the treatment of children under the age of 8 years. |
| Drug Drug Interactions |
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.
Fluoxetine may affect the way some other medicines work (interaction), especially the following:
•
•
•
•
•
•
•
Certain MAO-inhibitors (used to treat depression). Non-selective MAO-inhibitors and
MAO-inhibitors type A (moclobemide) must not be used with Fluoxetine as serious or even
fatal reactions (serotonin syndrome) can occur (see section “Do not take Fluoxetine ”). Some
MAO-inhibitors type B (selegeline) can be used with Fluoxetine provided that your doctor
monitors you closely.
lithium, tryptophan; there is an increased risk of serotonin syndrome when these drugs are
taken with Fluoxetine . Your doctor will carry out more frequent check-ups.
phenytoin (for epilepsy); because Fluoxetine 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 Fluoxetine .
clozapine (used to treat certain mental disorders), 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 Fluoxetine
may possibly change the blood levels of these medicines, your doctor may need to lower
their dose when administered with Fluoxetine .
warfarin or other medicines used to thin the blood; Fluoxetine may alter the effect of these
medicines on the blood. If Fluoxetine 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 Fluoxetine since this may result in an increase in side effects. If you are already taking St
John’s wort when you start on Fluoxetine , stop taking St John’s wort and tell your doctor at
your next visit. |
| Drug Pregnancy Interaction |
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 Fluoxetine while you are pregnant. However, depending on your
circumstances, your doctor may suggest that it is better for you to keep taking Fluoxetine .
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. |
| Drug Breast feeding Interaction |
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. |
| Drug Machinery Interaction |
Fluoxetine may affect your judgment or co-ordination. Do not drive or use machinery without advice
from your doctor or pharmacist. |
| Drug More Information |
You can take Fluoxetine with or without food, whatever you prefer.
• You should avoid alcohol while you are taking this medicine. |
| How to take the
Medicine
|
| Consumption Info |
|
| Drug quanitty |
Adults:
The usual dose is:
•
•
•
Depression: The recommended dose is 1 capsule (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 3 capsules (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 3 capsules (60 mg) daily.
OCD: The recommended dose is 1 capsule (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 3 capsules (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 Fluoxetine 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. Your doctor will review the need for
continuing treatment beyond 6 months, and treatment will be reassessed if no improvement is
seen
Elderly:
Your doctor will increase the dose with more caution and the daily dose should generally not
exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) daily.
Liver impairment:
If you have a liver problem or are using other medication that might affect Fluoxetine , your doctor
may decide to prescribe a lower dose or tell you to use Fluoxetine every other day. |
| Drug Dose |
Always take Fluoxetine 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 capsules than your doctor tells you.
Swallow the capsules with a drink of water. Do not chew the capsules. |
| Excess Drug Consumption |
If you take too many capsules, go to your nearest hospital emergency department (or
casualty) or tell your doctor straight away.
Take the pack of Fluoxetine 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 |
| Forgot Drug Consumption |
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 |
| Stop Drug Consumption |
Do not stop taking Fluoxetine 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 capsules.
You may notice the following effects when you stop taking Fluoxetine : 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 Fluoxetine are mild and disappear within a few
weeks. If you experience symptoms when you stop treatment, contact your doctor.
When stopping Fluoxetine , 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 Fluoxetine , ask your doctor or pharmacist. |
| Possible Side
Effects
|
| General Information |
Like all medicines, Fluoxetine can cause side effects, although not everybody gets them.
•
•
•
If you get a rash or allergic reaction such as itching, swollen lips/tongue or
wheezing/shortness of breath, stop taking the capsules 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 Fluoxetine 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. |
| Common Drug Side Effects |
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. |
| Rare Drug Side Effects |
If you have any of the following symptoms and they bother you, or last for some time, tell your
doctor or a pharmacist.
• Whole body - chills, sensitivity to sunlight, weight loss.
• Digestive system - diarrhoea and stomach upsets, vomiting, indigestion, difficulty
swallowing or a change in taste, or a dry mouth. Abnormal liver function has been
reported rarely, with very rare cases of hepatitis.
• Nervous system - headache, sleep problems or unusual dreams, dizziness, poor
appetite, tiredness, abnormally high mood, uncontrollable movements, fits, extreme
restlessness, hallucinations, untypical wild behaviour, confusion, agitation, anxiety,
nervousness, not being able to concentrate or think properly, panic attacks; or thoughts
of suicide or harming yourself.
• Urogenital system and reproductive disorders - difficulty passing urine or passing
urine too frequently, poor sexual performance, prolonged erections, and producing
breastmilk.
• Respiratory System - sore throat, shortness of breath. Lung problems (including
inflammatory processes of varying histopathology and/or fibrosis) have been reported
rarely.
• Bone fractures - an increased risk of bone fractures has been observed in patients
taking this type of medicines.
• Other - hair loss, yawning, blurred vision, unexplained bruising or bleeding, sweating, hot
flushes, feeling dizzy when you stand up, or joint or muscle pain, low levels of sodium in
the blood.
Most of these side effects are likely to disappear with continued treatment.
In children and adolescents (8-18 years) – Fluoxetine may slow growth or possibly delay sexual
maturity.
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. |
| Very Rare Drug Side Effects |
|
| Drug Side Effects Symptoms |
|
| How to Store the
Medicine
|
| How to Store the Medicine |
Keep out of the reach and sight of children.
Do not take Fluoxetine after the expiry date which is stated on the pack.
Do not store your capsules 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 capsules to a pharmacist. Only keep
them if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste. These measures will
help to protect the environment |
|
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