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Active substance(s): FLUVOXAMINE MALEATE

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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
• This medicine has been prescribed for you. 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.

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 starting any treatment with
• terfenadine or astemizole to treat allergies such as hay
• tizanidine (used as a muscle relaxant)
• cisapride (used for stomach problems).
If you are taking any of these medicines, DO NOT take
Fluvoxamine, and return to your doctor to discuss your

Talk to your doctor if you are taking any of the following:
• any other antidepressants such as amitriptyline,
clomipramine, imipramine, lithium or tryptophan
• other SSRIs for depression or obsessive-compulsive
1. What Fluvoxamine is and what it is used for
disorders such as fluoxetine
2. What you need to know before you take Fluvoxamine
• St. John’s Wort (Hypericum perforatum), a herbal
3. How to take Fluvoxamine
remedy used for depression
4. Possible side effects
• any benzodiazepines (used to treat anxiety and
5. How to store Fluvoxamine
insomnia) such as midazolam, triazolam, diazepam or
6. Contents of the pack and other information
• any antipsychotic drugs (used to treat mental illnesses)
such as risperidone, chlorpromazine or haloperidol
• antidiabetic agents
• Fluvoxamine belongs to a group of drugs called
• carbamazepine or phenytoin (used to treat epilepsy)
selective serotonin re-uptake inhibitors (SSRIs).
Serotonin is a chemical that, in the brain, passes nerve • clozapine, olanzapine or thioridazine (used to treat
impulses (‘messages’) between nerve cells and may
• theophylline (used to treat asthma and bronchitis)
help to control mood. Fluvoxamine increases the
• propranolol or mexiletine (used to treat high blood
availability of serotonin.
pressure and heart problems)
• Fluvoxamine is used to treat depression or
• ciclosporin (an immunosuppressant) used after organ
obsessive-compulsive disorders.
• tramadol (a painkiller) or methadone (used to treat
severe pain or in the management of drug dependency)
• anticoagulants (used to prevent blood clots) such as
DO NOT take Fluvoxamine if you:
• are allergic (hypersensitive) to fluvoxamine or any of the • ropinirole (used to treat Parkinson’s disease)
other ingredients of this medicine (listed in section 6)
• tacrine (used to treat Alzheimer’s disease)
• are taking any of the medicines listed in the section
• sildenafil (used to treat erectile dysfunction (impotence)).
“DO NOT take Fluvoxamine in combination with:”).
Please tell your doctor or pharmacist if you are taking,
Warnings and precautions
have recently taken or might take any other medicines.
Thoughts of suicide and worsening of your depression
Fluvoxamine with food, drink and alcohol
or anxiety disorder
• DO NOT take alcohol while you are taking
If you are depressed and/or have anxiety disorders you
can sometimes have thoughts of harming or killing
• Fluvoxamine may increase the effects of caffeine, and
yourself. These may be increased when first starting
you should therefore keep your intake of drinks that
antidepressants, since these medicines all take time to
contain caffeine (e.g. coffee, tea, and cola) to a
work, usually about two weeks but sometimes longer.
minimum whilst taking these tablets.
You may be more likely to think like this:
Pregnancy, breast-feeding and fertility
• if you have previously had thoughts about killing or
• Make sure your midwife and/or doctor know you are
harming yourself
on Fluvoxamine. When taken during pregnancy,
• if you are a young adult. Information from clinical trials
particularly in the last 3 months of pregnancy,
has shown an increased risk of suicidal behaviour in
medicines like Fluvoxamine may increase the risk of a
adults aged less than 25 years with psychiatric
serious condition in babies, called persistent
conditions who were treated with an antidepressant.
pulmonary hypertension of the new born (PPHN),
If you have thoughts of harming or killing yourself at any
making the baby breathe faster and appear bluish.
time, contact your doctor or go to a hospital straight
These symptoms usually begin during the first 24
hours after the baby is born. If this happens to your
You may find it helpful to tell a relative or close friend
baby you should contact your midwife and/or doctor
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, Some newborns may also experience other symptoms
such as not being able to sleep or feed properly, being
or if they are worried about changes in your behaviour.
too hot or cold, being sick, crying a lot, stiff or floppy
Use in children and adolescents under 18 years of age
muscles, lethargy, drowsiness, tremors, jitters or fits. If
Fluvoxamine is not normally prescribed for children and
your baby has any of these symptoms when it is born
adolescents under the age of 18 years except for patients
contact your doctor immediately.
with obsessive compulsive disorder. Your doctor may
• Fluvoxamine should not be used if you are
decide that this treatment is appropriate for you or your
Treatment with Fluvoxamine in this age group carries an • If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
increased risk of the following side effects:
doctor for advice before taking this medicine.
• attempts at committing suicide
• suicidal thoughts
Fluvoxamine has been shown to reduce the quality of
• aggression and anger
sperm in animal studies. Theoretically, this could affect
• argumentative behaviour.
fertility, but impact on human fertility has not been
If you have any concerns regarding these side effects or
observed as yet.
worsening of behaviour whilst you or you child are
taking Fluvoxamine please discuss this with your doctor. Driving and using machines
• Fluvoxamine may make you feel sleepy. If you are
The long term safety effects on child or adolescent
affected, DO NOT drive or operate machinery.
development (including their self-image, what they think,
their behaviour and maturity) whilst taking Fluvoxamine Fluvoxamine contains mannitol
• Fluvoxamine tablets contain mannitol which may have
in this age group has not been determined.
a mild laxative effect.
Talk to your doctor before you start to take this medicine
if you:
• have a history of suicidal events or suicide related events
• have history of severe mood swings (hypomania/mania) Always take Fluvoxamine exactly as your doctor has told
you. You should check with your doctor or pharmacist if
• have a history of serotonin syndrome which is
you are not sure.
characterised by coldness, rigidity, muscle spasm,
confusion, extreme agitation, irritability and coma
The tablets should be swallowed preferably with a drink
• are under 18 years of age as Fluvoxamine is not
of water. The recommended dose is:
recommended for treating depression in this age group
• have unstable epilepsy (a history of fits)
• Adults including the elderly
• are being treated with ECT (electro-convulsive therapy)
50 mg or 100 mg taken once daily in the evening.
• have any liver or kidney problems
This may be increased gradually until a dose is found
• have suffered from a heart attack
that is suitable for you.
• are diabetic
The maximum daily dose is 300 mg.
• have a history of bleeding disorders or you regularly
If you are taking more than 150 mg in one day, your
take medicines which increase the risk of bleeding,
medicine should be taken in divided doses.
e.g. aspirin, ibuprofen.



Pharma code 552



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

100 mg Tablets


• Children and adolescents under the age of 18
Fluvoxamine should not be used in children and
adolescents under 18 for the treatment of depression.
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.
If you have kidney or liver problems, your doctor may
start your treatment with a lower dose of Fluvoxamine,
and then monitor your progress.
If you take more Fluvoxamine than you should
If you (or someone else) swallow a lot of the tablets all
together, or if you think a child has swallowed any of the
tablets, contact your nearest hospital casualty
department or your doctor immediately.
An overdose is likely to cause nausea, vomiting,
diarrhoea, sleepiness, dizziness/light-headedness,
changes in heart rhythm and can lead to fits or coma.
Please take this leaflet, any remaining tablets, and the
container with you to the hospital or doctor so that they
know which tablets were consumed.
If you forget to take Fluvoxamine
If you forget to take a tablet, take one as soon as you
remember, unless it is within 12 hours of taking the next
one. DO NOT take a double dose to make up for a forgotten
dose. Take the remaining doses at the correct time.
If you stop taking Fluvoxamine
You should continue to take this medicine for as long as
your doctor tells you. If your doctor decides to stop your
tablets, he/she will reduce the dose gradually.
DO NOT stop taking your tablets suddenly. If you do, you
may suffer from withdrawal symptoms such as
headache, anxiety, nausea and/or vomiting, dizziness,
pins-and-needles, sleep disturbances, visual
disturbances, sweating, shaking, palpitations (awareness
of your heart beating), confusion, diarrhoea, emotional
instability, irritability and agitation.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.



Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Stop taking the tablets and tell your doctor immediately
or go to the casualty department at your nearest hospital
if the following happens:
• an allergic reaction (swelling of the lips, face or neck
leading to severe difficulty in breathing; skin rash or
This is a very serious but rare side effect. You may need
urgent medical attention or hospitalisation.
Tell your doctor immediately if any of the following occur:
• occasionally, thoughts of suicide or self harm may
occur or increase in the first few weeks of treatment
with Fluvoxamine, until the antidepressant effect
becomes apparent. Tell your doctor immediately if you
have any distressing thoughts or experiences.
• a combination of symptoms known as serotonin
syndrome, including a high temperature, muscle
stiffness or twitching, confusion, irritability and
extreme agitation, or neuroleptic malignant syndrome,
which may include fever, sweating, unstable blood
pressure, unresponsive state, autonomic dysfunction
and muscle stiffness; although these conditions only
occur rarely, they can be life-threatening. You may
need to stop taking Fluvoxamine.
• Torsades de pointes, which is a life threatening
irregular heart beat
• bruising or purple patches appear on your skin, or you
vomit blood or pass blood in your stool, or you
become oversensitive to light (rash or itchy skin
following exposure to sunlight)
• a combination of symptoms known as SIADH, causing
tiredness, weakness or confusion and achy, stiff or
uncontrolled muscles.

• headache
• fast heartbeat, palpitations (awareness of your heart
• 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
• spontaneous production of breast milk which is not
due to pregnancy or breast-feeding
• skin sensitivity to sunlight.
Other side effects reported:
• inability to sit still
• weight gain or loss
• low sodium levels in your blood and water retention
• glaucoma
• tingling or numbness
• a change in sense of taste
• inability to have an orgasm.
Side effects related to the treatment for
Obsessive-Compulsive Disorder in children and
• mania (a feeling of elation and over excitement)
• agitation, hyperactivity
• convulsions
• difficulty sleeping, drowsiness
• lack of energy
• indigestion.
An increased risk of bone fractures has been observed in
patients taking this type of medicines.
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.



Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Do not use Fluvoxamine after
the expiry date that is stated on the outer packaging. The
expiry date refers to the last day of that month.
Do not throw away via wastewater or household waste.
Ask your pharmacist how to throw away medicines you
no longer use. These measures will help to protect the



What Fluvoxamine tablets contain:
• The active ingredient is fluvoxamine maleate 50 mg or
100 mg.
• The other ingredients are mannitol, pregelatinised
starch, hydroxypropylcellulose, colloidal silica and
sodium stearyl fumarate. The coating contains
hypromellose, macrogol, polysorbate 80, and the
colourings titanium dioxide (E171), yellow iron oxide
(E172), red iron oxide (E172) and black iron oxide
What Fluvoxamine tablets look like and contents of the
• Fluvoxamine 50 mg Tablets are yellow, film coated
capsule shaped tablets, scored and debossed “93” on
one side (“9” and “3” on either side of the score line)
and “56” on the other side.
• Fluvoxamine 100mg Tablets are pink to light brick, film
coated capsule shaped tablets, scored and debossed
“93” on one side (“9” and “3” on either side of the
score line) and “57” on the other side.
• The 50 mg tablet is available in pack sizes of 20, 30, 50,
60, 100 and 250 tablets, and the 100 mg tablet is
available in pack sizes of 15, 20, 30, 50, 60, 90, 100 and
250 tablets.
Not all pack sizes may be marketed.

Stopping of fluvoxamine, particularly when this is
sudden, can lead to withdrawal symptoms (see section 3, Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company
If you stop taking Fluvoxamine).
responsible for manufacture: TEVA UK Limited,
The following side effects have been reported at the
Eastbourne, BN22 9AG.
approximate frequencies shown:
This leaflet was last revised in March 2015
Common (affecting less than one person in 10 but more
PL 00289/0346-0347
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,
160 x 323

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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.