FLUVOXAMINE 50MG TABLETS

Active substance: FLUVOXAMINE MALEATE

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Taking other medicines
DO NOT take Fluvoxamine in combination with:
• antidepressants known as MAOIs
(monoamine oxidase inhibitors) e.g.
phenelzine, moclobemide.
You should not take Fluvoxamine until at
least 14 days after you have stopped taking
an MAOI.
If you stop treatment with Fluvoxamine,
you should wait at least 1 week before
IN THIS LEAFLET:
starting any treatment with a MAOI.
1. What Fluvoxamine is and what it is used for • terfenadine or astemizole to treat allergies
2. Before you take Fluvoxamine
such as hay fever
3. How to take Fluvoxamine
• cisapride (used for stomach problems).
4. Possible side effects
If you are taking any of these medicines, DO
5. How to store Fluvoxamine
NOT take Fluvoxamine, and return to your
6. Further information
doctor to discuss your treatment.
Talk to your doctor if you are taking any of
the following:
• any other antidepressants such as
amitriptyline, clomipramine, imipramine,
• Fluvoxamine belongs to a group of drugs
lithium or tryptophan
called selective serotonin re-uptake
• other SSRIs for depression or
inhibitors (SSRIs). Serotonin is a chemical
obsessive-compulsive disorders such as
that, in the brain, passes nerve impulses
fluoxetine
(‘messages’) between nerve cells and may
• St. John’s Wort (Hypericum perforatum), a
help to control mood. Fluvoxamine
herbal remedy used for depression
increases the availability of serotonin.
• any benzodiazepines (used to treat anxiety
• Fluvoxamine is used to treat depression or
and insomnia) such as midazolam,
obsessive-compulsive disorders.
triazolam, diazepam or alprazolam
• any antipsychotic drugs (used to treat
BEFORE YOU TAKE FLUVOXAMINE
mental illnesses) such as risperidone,
chlorpromazine or haloperidol
DO NOT take Fluvoxamine if you:
• antidiabetic agents
• are allergic (hypersensitive) to fluvoxamine or • carbamazepine or phenytoin (used to treat
any of the other ingredients of this medicine
epilepsy)
• are taking any of the medicines listed in the • clozapine, olanzapine or thioridazine (used
section “DO NOT take Fluvoxamine in
to treat schizophrenia)
combination with:”).
• theophylline (used to treat asthma and
bronchitis)
Take special care with Fluvoxamine
• propranolol or mexiletine (used to treat
Thoughts of suicide and worsening of your
high blood pressure and heart problems)
depression or anxiety disorder
• ciclosporin (an immunosuppressant) used
If you are depressed and/or have anxiety
after organ transplant
disorders you can sometimes have thoughts of
• tramadol (a painkiller) or methadone (used
harming or killing yourself. These may be
to treat severe pain or in the management
increased when first starting antidepressants,
of drug dependency)
since these medicines all take time to work,
usually about two weeks but sometimes longer. • anticoagulants (used to prevent blood
clots) such as warfarin
You may be more likely to think like this:
• if you have previously had thoughts about • ropinirole (used to treat Parkinson’s disease)
• tacrine (used to treat Alzheimer’s disease).
killing or harming yourself
• if you are a young adult. Information from
Please tell your doctor or pharmacist if you
clinical trials has shown an increased risk
are taking or have recently taken any other
of suicidal behaviour in adults aged less
medicines, including medicines obtained
than 25 years with psychiatric conditions
without a prescription.
who were treated with an antidepressant.
Important information about some of the
If you have thoughts of harming or killing
ingredients of Fluvoxamine
yourself at any time, contact your doctor or
• Fluvoxamine tablets contain mannitol
go to a hospital straight away.
which may have a mild laxative effect.
You may find it helpful to tell a relative or
Taking Fluvoxamine with food and drink
close friend that you are depressed or have
an anxiety disorder, and ask them to read this • DO NOT take alcohol while you are taking
Fluvoxamine.
leaflet. You might ask them to tell you if they
• Fluvoxamine may increase the effects of
think your depression or anxiety is getting
caffeine, and you should therefore keep
worse, or if they are worried about changes in
your intake of drinks that contain caffeine
your behaviour.
(e.g. coffee, tea, and cola) to a minimum
Use in children and adolescents under
whilst taking these tablets.
18 years of age
Pregnancy and breast-feeding
Fluvoxamine is not normally prescribed for
• Make sure your midwife and/or doctor know
children and adolescents under the age of 18
you are on Fluvoxamine. When taken during
years except for patients with obsessive
pregnancy, particularly in the last 3 months
compulsive disorder. Your doctor may decide
of pregnancy, medicines like Fluvoxamine
that this treatment is appropriate for you or
may increase the risk of a serious condition
your child.
in babies, called persistent pulmonary
Treatment with Fluvoxamine in this age group
hypertension of the new born (PPHN),
carries an increased risk of the following side
making the baby breathe faster and appear
effects:
bluish. These symptoms usually begin during
• attempts at committing suicide
the first 24 hours after the baby is born. If this
• suicidal thoughts
happens to your baby you should contact
• aggression and anger
your midwife and/or doctor immediately.
• argumentative behaviour.
If you have any concerns regarding these side • Fluvoxamine should not be used if you are
breast-feeding.
effects or worsening of behaviour whilst you
• If you are pregnant, planning to become
or you child are taking Fluvoxamine please
pregnant, ask your doctor for advice before
discuss this with your doctor.
taking any medicine.
The long term safety effects on child or
Fluvoxamine has been shown to reduce the
adolescent development (including their
quality of sperm in animal studies. Theoretically,
self-image, what they think, their behaviour
this could affect fertility, but impact on human
and maturity) whilst taking Fluvoxamine in
fertility has not been observed as yet.
this age group has not been determined.
Driving and using machines
Talk to your doctor before you start to take
• Fluvoxamine may make you feel sleepy. If
this medicine if you:
you are affected, DO NOT drive or operate
• have a history of suicidal events or suicide
machinery.
related events
• have history of severe mood swings
HOW TO TAKE FLUVOXAMINE
(hypomania/mania)
• have a history of serotonin syndrome
Always take Fluvoxamine exactly as your
which is characterised by coldness, rigidity, doctor has told you. You should check with
muscle spasm, confusion, extreme
your doctor or pharmacist if you are not sure.
agitation, irritability and coma
The tablets should be swallowed preferably
• are under 18 years of age as Fluvoxamine
with a drink of water. The usual dose is:

1

WHAT FLUVOXAMINE IS AND
WHAT IT IS USED FOR

2

Pharma code 552 (Main)

3

Obsessive-Compulsive Disorder:
• Adults including the elderly:
50 mg taken once daily in the evening for
the first 3 to 4 days.
This may be increased gradually until a
dose is found that is suitable for you.
The maximum daily dose is 300 mg.
If you are taking more than 150 mg in one
day, your medicine should be taken in
divided doses.
• Children (over 8 years old)
The recommended starting dose is 25 mg
daily.
The dose can be increased by 25 mg every
3 to 4 days until a suitable dose has been
found.
The maximum daily dose is 200 mg.
• Children (under 8 years old):
Fluvoxamine is not recommended for use in
children under 8 years old for the treatment
of Obsessive-Compulsive Disorder.

The following side effects have been reported
at the approximate frequencies shown:
Common (affecting less than one person in 10
but more than one person in 100):
• feeling sick and vomiting (this will usually
pass within the first two weeks of taking
these tablets)
• stomach pain
• loss of appetite, constipation, diarrhoea,
dry mouth, indigestion/heartburn
• headache
• fast heartbeat, palpitations (awareness of
your heart beating)
• lethargy, anxiety, agitation, dizziness,
• difficulty sleeping, nervousness,
sleepiness, shakiness
• sweating or feeling unwell.
Uncommon (affecting less than one person in
100 but more than one person in 1,000):
• low blood pressure on standing
• joint or muscle pain, muscle spasm
• loss of co-ordination, confusion,
hallucinations
• extrapyramidal symptoms (shaking, rigidity,
body restlessness, muscle contractions and
changes in breathing and heart rate)
• delayed ejaculation
• rashes or itching.

Rare (affecting less than one person in 1,000
but more than one person in 10,000):
• liver problems
• convulsions, mania (overactivity, elation or
irritability). If you experience convulsions
you should return to your doctor who may
discontinue your tablets
• inability to sit still
If you have kidney or liver problems, your doctor • spontaneous production of breast milk which
may start your treatment with a lower dose of
is not due to pregnancy or breast-feeding
Fluvoxamine, and then monitor your progress. • weight gain or loss
If you take more Fluvoxamine than you should • low sodium levels in your blood and water
If you (or someone else) swallow a lot of the
retention
tablets all together, or if you think a child has
• skin sensitivity to sunlight.
swallowed any of the tablets, contact your
Very rare (affecting less than one person in
nearest hospital casualty department or your 10,000):
doctor immediately.
• unusual sensations such as burning or
An overdose is likely to cause nausea,
prickling
vomiting, diarrhoea, sleepiness,
• a change in sense of taste
dizziness/light-headedness, changes in heart
• inability to have an orgasm.
rhythm and can lead to fits or coma.
Please take this leaflet, any remaining tablets, An increased risk of bone fractures has been
observed in patients taking this type of
and the container with you to the hospital or
medicines.
doctor so that they know which tablets were
consumed.
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
If you forget to take Fluvoxamine
If you forget to take a tablet, take one as soon please tell your doctor or pharmacist.
as you remember, unless it is within 12 hours
HOW TO STORE FLUVOXAMINE
of taking the next one. DO NOT take a double
dose to make up for a forgotten dose. Take the
Keep out of the reach and sight of children.
remaining doses at the correct time.
Do not store above 30°C. Do not use
If you stop taking Fluvoxamine
You should continue to take this medicine for Fluvoxamine after the expiry date that is
as long as your doctor tells you. If your doctor stated on the outer packaging. The expiry date
refers to the last day of that month.
decides to stop your tablets, he/she will
Medicines should not be disposed of via
reduce the dose gradually.
DO NOT stop taking your tablets suddenly. If you wastewater or household waste. Ask your
do, you may suffer from withdrawal symptoms pharmacist how to dispose of medicines no
such as headache, anxiety, nausea, dizziness, longer required. These measures will help to
protect the environment.
pins-and-needles, and sleep disturbances.

5

If you have any further questions on the use of
this product, ask your doctor or pharmacist.

6

FURTHER INFORMATION

What Fluvoxamine tablets contain:
• The active ingredient is fluvoxamine
maleate 50 mg or 100 mg.
Like all medicines, Fluvoxamine can cause side • The other ingredients are mannitol,
effects, although not everybody gets them.
pregelatinised starch,
Stop taking the tablets and tell your doctor
hydroxypropylcellulose, colloidal silica and
immediately or go to the casualty department at
sodium stearyl fumarate. The coating
your nearest hospital if the following happens:
contains hypromellose, macrogol,
• an allergic reaction (swelling of the lips,
polysorbate 80, and the colourings titanium
face or neck leading to severe difficulty in
dioxide (E171), yellow iron oxide (E172), red
breathing; skin rash or hives).
iron oxide (E172) and black iron oxide (E172).
This is a very serious but rare side effect. You What Fluvoxamine tablets look like and
may need urgent medical attention or
contents of the pack:
hospitalisation.
• Fluvoxamine 50 mg Tablets are yellow, film
Tell your doctor immediately if any of the
coated capsule shaped tablets, scored and
following occur:
debossed “93” on one side (“9” and “3” on
• occasionally, thoughts of suicide or self harm
either side of the score line) and “56” on
may occur or increase in the first few weeks
the other side.
of treatment with Fluvoxamine, until the
• Fluvoxamine 100 mg Tablets are pink to
antidepressant effect becomes apparent.
light brick, film coated capsule shaped
Tell your doctor immediately if you have
tablets, scored and debossed “93” on one
any distressing thoughts or experiences.
side (“9” and “3” on either side of the
• a combination of symptoms known as
score line) and “57” on the other side.
serotonin syndrome, including a high
• The 50 mg tablet is available in pack sizes
temperature, muscle stiffness or twitching,
of 20, 30, 50, 60, 100 and 250 tablets, and
confusion, irritability and extreme agitation,
the 100 mg tablet is available in pack sizes
or neuroleptic malignant syndrome, which
of 15, 20, 30, 50, 60, 90, 100 and 250 tablets.
may include fever, sweating, unstable blood
Not all pack sizes may be marketed.
pressure, unresponsive state, autonomic
dysfunction and muscle stiffness; although Marketing Authorisation Holder and
these conditions only occur rarely, they can Manufacturer
Marketing Authorisation holder and company
be life-threatening. You may need to stop
responsible for manufacture: TEVA UK
taking Fluvoxamine.
Limited, Eastbourne, BN22 9AG.
• Torsades de pointes, which is a life
threatening irregular heart beat
This leaflet was last revised: July 2012
• bruising or purple patches appear on your
skin, or in rare cases an allergic reaction
PL 00289/0346-0347
occurs (itchy, raised rash, stomach pain,
wheezing, swelling of the tongue or throat)
or you become oversensitive to light (rash
or itchy skin following exposure to sunlight).
85106-W
TEVA UK Limited

4

POSSIBLE SIDE EFFECTS

(Bakcup)

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 get serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.




Depression:
• Adults including the elderly
50 mg or 100 mg taken once daily in the
evening.
This may be increased gradually until a
dose is found that is suitable for you.
The maximum daily dose is 300 mg.
If you are taking more than 150 mg in one
day, your medicine should be taken in
divided doses.
• Children and adolescents under the
age of 18
Fluvoxamine should not be used in
children and adolescents under 18 for the
treatment of depression.

Pharma code 552

PACKAGE LEAFLET: INFORMATION
FOR THE USER

is not recommended for treating
depression in this age group
have unstable epilepsy (a history of fits)
are being treated with ECT
(electro-convulsive therapy)
have any liver or kidney problems
have suffered from a heart attack
are diabetic
have a history of bleeding disorders.

Top of page cut-off to middle of registration mark: 44 mm.

FLUVOXAMINE 50 mg AND
100 mg TABLETS

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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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