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FLUVOXAMINE 100 MG FILM-COATED TABLETS

Active substance(s): FLUVOXAMINE MALEATE

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PATIENT INFORMATION LEAFLET

Fluvoxamine 50mg, 100mg Tablets
(Fluvoxamine maleate)
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1
2
3
4
5
6

1

What Fluvoxamine 50mg, 100mg Tablets is and what it is used for
Before you take Fluvoxamine 50mg, 100mg tablets
How to take Fluvoxamine 50mg, 100mg Tablets
Possible side effects
How to store Fluvoxamine 50mg, 100mg Tablets.
Further information

What Fluvoxamine 50mg, 100mg
Tablets is and what it is used for

Fluvoxamine 50mg, 100mg Tablets is an antidepressant
that influences the central nervous system.
Fluvoxamine 50mg, 100mg Tablets is used for:
 depressive illness (major depressive episodes)
 obsessive thoughts and obsessive actions
(obsessive compulsive disorders).

2

Before you take Fluvoxamine
50mg, 100mg Tablets

Do not take Fluvoxamine 50mg, 100mg Tablets
 If you are allergic (hypersensitive) to fluvoxamine or
any of the other ingredients in the product.
 If you are taking or have recently taken a medicine
that belongs to the group of monoamine oxidase
(MAO) inhibitors (medicines to treat depression or
Parkinson’s disease), or if you are going to use such
medicine within the next week. Depending on the
type of MAO-inhibitor you must wait for up to two
weeks before you can start taking Fluvoxamine
50mg, 100mg Tablets (see ”Taking other medicines”).
Take special care with Fluvoxamine 50mg, 100mg
Tablets
 If you have diabetes control of blood sugar may be
disturbed, especially in the early stages of treatment.
The dose of your insulin or the anti-diabetic medicines
that you take by mouth may need to be adjusted.
 If you have reduced liver or kidney function you must
tell your doctor, because it may be necessary to
prescribe a lower dose for you.
 If you have recently had a heart attack.
 If epileptic seizures (convulsions) occur during
treatment, Fluvoxamine 50mg, 100mg Tablets
should be discontinued. If you already suffer from
epilepsy and the frequency of seizures increases
during treatment, Fluvoxamine 50mg, 100mg Tablets
should also be discontinued.
 If you have or have had episodes of overactive
behaviour or thoughts (mania).
 If you have a history of bleeding disorder e.g.
cutaneous bleeding abnormalities, gynaecological or
bleeding from the stomach or if you use medicines
which possibly increase tendency to bleed (see
section “Taking other medicines”).
 If you are receiving electric shock treatment.
Use of Fluvoxamine 50mg, 100mg Tablets can be
connected with the development of a condition of
inner restlessness and inability to sit or stand still.
This is most likely to occur in the first weeks of
treatment. Increasing the dose can worsen such
symptoms.
 If you develop some or all of the following symptoms:
high fever, rigidity, sudden jerks of the muscles,
confusion, irritability, extreme agitation, rapid
fluctuations in heart beat or breathing rate. If you
notice these symptoms, contact your doctor
immediately, because you may have something
called serotonin-syndrome. Concomitant use of
certain other medicines may enhance the risk of this
syndrome (see “Taking other medicines”).
 If you are at risk of a decreased sodium level in the
blood (hyponatraemia) e.g. from concomitant
medications. Hyponatraemia has been reported
rarely during treatment with Fluvoxamine 50mg,
100mg Tablets, predominantly in the elderly.
If you are an eldery patient. Your doctor will increase
your dose of Fluvoxamine 50mg, 100mg Tablets more
slowly and with extra caution.
Withdrawal symptoms
After the end of therapy, withdrawal symptoms
commonly occur, particularly if Fluvoxamine 50mg,
100 mg Tablets are discontinued abruptly (see section
4. “Possible side effects”).
The risk of withdrawal symptoms may be dependent on
several factors including the duration of therapy and
dosage and the rate of dose reduction.
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 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 is
getting worse, or if they are worried about changes in
your behaviour.
Children and adolescents of less than 18 years of age
Fluvoxamine 50mg, 100mg Tablets should normally not
be used for children and adolescents under 18 years,
except for patients over 8 years with obsessive
compulsive disorders. Also, you should know that
patients under 18 have an increased risk of side-effects
such suicide attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional behaviour and
anger) when they take this class of medicines. Despite
this, your doctor may prescribe Fluvoxamine 50mg,
100mg Tablets for patients under 18 because he/she
decides that this is in their best interests. If your doctor
has prescribed Fluvoxamine 50mg, 100mg Tablets 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 Fluvoxamine 50mg, 100mg
Tablets. Also, the long-term safety effects concerning
growth, maturation and cognitive and behavioural
development of Fluvoxamine 50mg, 100mg Tablets in
this age group have not yet been demonstrated.

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Taking other medicines
Certain other medicines can affect or be affected by
Fluvoxamine 50mg, 100mg Tablets. Please ask your
doctor for advice if you are taking:
 Medicines that belong to the group of MAO inhibitors
(MAOI).
If your doctor changes your medicine from a MAOI
to Fluvoxamine 50mg, 100mg Tablets, there must be
an interval of
at least 2 weeks after stopping an irreversible
MAOI (e. g. selegiline)
one day after stopping a reversible MAOI
(e.g. moclobemide)
Therapy with any MAOI should not be started for at
least 1 week after stopping intake of Fluvoxamine
50mg, 100mg Tablets.
 Other medicine for depression: other serotonin reuptake inhibitors.
 Medicines containing lithium (antipsychotic) or the
dietary supplement tryptophan.
 Medicines against migraine (triptane).
 Tramadol (pain-killer).
 Herbal remedy St.John’s Wort (Hypericum
perforatum).
Concomitant use of above mentioned medicinal
products may e. g. lead to serotonine syndrome or
neuroleptic malignant syndrome (see “Do not take
Fluvoxamine 50mg, 100mg Tablets” and “Take special
care with Fluvoxamine 50mg, 100mg Tablets”).
 Other medicine for depression: tricyclic
antidepressants (e. g. clomipramine, imipramine,
amitriptyline)
 Neuroleptics such as clozapine, olanzapine or
thioridazine (used to treat schizophrenia).
 Tizanidine for treatment of muscle disorders. The
duration and intensity of its effect may be increased,
correlated with increased blood pressure and heart
rate.
 Tacrine (used to treat dementia), Theophylline (used
to treat asthma and bronchitis), Methadon
(commonly used to treat drug dependence) and
Mexiletine (used to treat heart disorders).
 Propranolol (against high blood pressure).
 Ropinirole (used to treat Parkinson’s Disease).
 Caffeine (found in tea or coffee). The consumption of
high quantities of caffeine-containing beverages
should be avoided.
 Phenytoin (used to treat epilepsy or certain heart
rhythm disorders)
 Terfenadine, astemizole (used to treat allergic
reaction) or cisapride (for gastrointestinal disorders).
Concomitant use with Fluvoxamine 50mg, 100mg
Tablets can lead to disorders of heart rate and these
medicinal products should therefore not be used
simultaneously.
 Ciclosporin (used after organ transplant).
 Carbamazepine (used to treat epilepsy).
 Benzodiazepines such as triazolam, midazolam,
alprazolam and diazepam (uses include treatment of
anxiety and epilepsy).
Fluvoxamine 50mg, 100mg Tablets may increase the
blood levels of above mentioned medicinal products,
which can result in adverse effects. Your doctor may
need to adjust the dose of the above mentioned
products.
 Anti-inflammatory medicines/painkillers (e.g.
ibuprofen, diclofenac) and acetylsalicylic acid.
Warfarin (to prevent blood clotting) and other
medcines known to effect blood clotting, e. g.
antipsychotics and tricyclic antidepressants.
Concomitant use of above mentioned medicinal
products may lead to increased/prolonged bleeding
(see “Take special care with Fluvoxamine 50mg, 100mg
Tablets“).
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Taking Fluvoxamine 50mg, 100mg Tablets with food
and drink
Drink: The film-coated tablets should be swallowed with
water.
Alcohol: You should avoid consumption of alcohol
during therapy with Fluvoxamine 50mg, 100mg Tablets.
Pregnancy and breast-feeding
There is only limited data available regarding use of
fluvoxamine in pregnant women. Therefore Fluvoxamine
50mg, 100mg Tablets should be used with caution
during pregnancy. If Fluvoxamine 50mg, 100mg Tablets
is used at the end of pregnancy the newborn child may
suffer from withdrawal symptoms.
Make sure your midwife and/or doctor know you are on
Fluvoxamine. When taken during pregnancy, similar
drugs (SSRIs) may increase the risk of a serious
condition in babies, called persistent pulmonary
hypertension of the new born (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.
Fluvoxamine passes into breast milk. Therefore do not
take Fluvoxamine 50mg, 100mg Tablets while breastfeeding.
Fluvoxamine 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.
Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
In individual cases, the ability to drive and use machines
can be reduced.
Fluvoxamine 50mg, 100mg Tablets can cause
somnolence as an undesirable effect. Therefore patients
should be aware of this at the start of treatment.
Important information about some of the ingredients
of Fluvoxamine 50mg, 100mg Tablets
Fluvoxamine 50mg, 100mg Tablets contain lactose.
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.
continued....
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3

How to take Fluvoxamine 50mg,
100mg Tablets

Always take Fluvoxamine 50mg, 100mg Tablets exactly
as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The film-coated tablets should be swallowed without
chewing and with water.
The usual dose is:

Nervous system disorders
Common: sleepiness, sleep disturbances, feeling
nervous, trembling, headache, dizziness, restlessness
Uncommon: movement disorders, difficulty in
co-ordinating movement and impaired tension of
muscles
Rare: convulsions
Cardiac disorders
Common: increased heart rate or palpitations

Major depressive episodes
Adults:
Starting dose: 1 or 2 tablets (50mg fluvoxamine
maleate) or ½ or 1 tablet (100 mg) taken as a single
dose in the evening. Your doctor may increase the dose
gradually until an effective dose is reached.
Usual effective daily dose: 2 tablets (50mg
fluvoxamine maleate) or 1 tablet (100 mg). Your doctor
will adjust the dose to your individual response.
A daily dose in excess of 3 tablets (50mg fluvoxamine
maleate) or 1 ½ tablets (100mg) should be divided into
several doses.
Maximum dose: 6 (50mg fluvoxamine maleate) or 3
tablets (100mg), daily.
Children and adolescents of less than 18 years of
age
Fluvoxamine 50mg, 100mg Tablets should not be used
in children and adolescents of less than 18 years of age
(see “Take special care with Fluvoxamine 50mg, 100mg
Tablets”).
Obsessive-compulsive disorders
Adults:
Starting dose: 1 tablet (50mg fluvoxamine maleate) or
½ tablet (100 mg) per day for 3-4 days .
Your doctor may increase the dose gradually until an
effective dose is reached.
Usually effective dose: 2-6 tablets (50 mg fluvoxamine
maleate) or 1-3 tablets (100 mg) per day.
Maximum daily dose: 6 tablets (50mg fluvoxamine
maleate) or 3 tablets (100mg).
The tablets should be taken preferably in the evening as
a single dose. A daily dose in excess of 3 tablets (50 mg
fluvoxamine maleate) or 1 ½ tablets (100 mg) should be
taken in 2 or 3 divided doses.
Children and adolescents over 18 years of age
For children over 8 years and adolescents the starting
dose is ½ tablet (50 mg fluvoxamine maleate) per day.
Your doctor will increase the dose every 4-7 days in ½
tablet (50 mg fluvoxaine maleate) as tolerated until an
effective dose is achieved.
A total daily dose of more than 1 tablet (50 mg
fluvoxamine maleate) or ½ tablet (100mg) should be
given in two divided doses. If doses are not equal, the
larger dose should be given at bedtime.
Maximum dose: 4 tablets (50mg fluvoxamine maleate)
or 2 tablets (100mg).
Patients with hepatic and renal insufficiency should
commence treatment at a low dose.
Duration of treatment
The duration depends on the course of the disease
and is determined by your doctor.
Major depressive episodes
It may take a few weeks or more until you start
feeling better. After the symptoms have disappeared
treatment should be continued for at least 6 month.
Obsessive-compulsive disorders
If no improvement is observed after 10 weeks your
doctor may decide to stop prescribing Fluvoxamine for
you. If you respond well to Fluvoxamine, your doctor will
most likely continue treatment with Fluvoxamine. He/she
will then periodically reassess the need for treatment.
Before terminating treatment, gradual dose reduction is
to be taken into consideration.
If you take more Fluvoxamine 50mg, 100mg Tablets
than you should
If you have taken too much Fluvoxamine 50mg, 100mg
Tablets you should contact your doctor or a hospital.
Symptoms of overdose:
Nausea, vomiting and diarrhoea, sleepiness, dizziness,
rapid heart beat, slow heart beat and low blood pressure,
liver function disturbances, seizures and coma.
If you forget to take Fluvoxamine 50mg, 100mg
Tablets
Do not take a double dose to make up for a forgotten
dose. Continue intake as prescribed by your doctor.
If you stop taking Fluvoxamine 50mg, 100mg
Tablets
Please speak with your doctor if you want to
terminate or interrupt treatment.
Withdrawal symptoms may occur when you stop taking
Fluvoxamine 50mg, 100mg Tablets (see section 4
“Possible side effects"). Since the risk of withdrawal
symptoms is higher when you stop taking Fluvoxamine
50mg, 100mg Tablets abruptly, your doctor will gradually
reduce the dose over a period of at least 1–2 weeks.
If intolerable withdrawal symptoms occur after dose
reduction or discontinuation of the medicinal product,
inform your doctor. He/she may consider to decrease
your dose in smaller steps.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, Fluvoxamine 50mg, 100mg Tablets
can cause side effects, although not everybody gets
them.
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.
Frequencies are defined as:
Very common: in more than 1 of 10 patients
Common: in more than 1 of 100, but in less than 1 of
10 patients
Uncommon: in more than 1 of 1000, but in less than 1
of 100 patients.
Rare: in more than 1 of 10,000 , but less than 1 of 1000
patients
Very rare: in less than 1 of 10,000 patients
Frequency not known: frequency cannot be estimated
from the available data
Psychiatric disorders:
Common: anxiety
Uncommon: confusion, hallucinations
Rare: episodes of overactive behaviour or thoughts
(mania)
Frequency not known: Suicidal thoughts and thus
related behaviour (see section “Take special care with
Fluvoxamine 50mg, 100 mg Tablets”)

Product Name
Strength / Form
Type
Dimensions
Typefaces
Rev #
Last updated
No. of Colours

Fluvoxamine
50 & 100mg Tablets
PIL
165 mm x 550 mm
Font SansSerif − Min. Text 8pt
Til−Ver.5.1s
28/06/12
Pantone Black CVC

Vascular disorders:
Uncommon: low blood pressure (when changing
posture from lying to standing)
Gastrointestinal disorders:
Very common: nausea
Common: abdominal pain, digestive disorders (a
feeling of pressure in the stomach, bloating, loss of
appetite), constipation, diarrhoea, vomiting, dry mouth
Hepato-biliary disorders:
Rare: liver function disorders
Skin and subcutenous tissue disorders:
Common: sweating
Uncommon: allergic skin reactions such as rash,
itching, swelling
Rare: sensitivity to light
Reproductive system and breast disorders:
Uncommon: delayed ejaculation
Rare: milky secretion from the breast gland
(galactorrhoea)
Musculoskeletal disorders:
Uncommon: joint pain, muscle pain
Other side effects
Weight gain or weight loss.
An increased risk of bone fractures has been observed
in patients taking this type of medicines.
Common: weakness, feeling sick
Rare: serotonin syndrome, neuroleptic-malignant
syndrome, hyponatremia and abnormal bleeding (see
also “Taking other medicines” and “Take special care
with Fluvoxamine 50mg, 100mg Tablets”),
Very rare: taste abnormalities, sensation of pins and
needles, failure to experience orgasm.
Withdrawal symtoms
After the end of therapy commonly occur, particularly
Fluvoxamine 50mg, 100mg Tablets are discontinued
abruptly. The risk of withdrawal symptoms may be
dependent on the duration of therapy and dosage and
the rate of dose reduction.
Dizziness, sensory disturbances (including tingling in
arms and legs and electric shock sensation), sleep
disturbances (including intense dreams), inner
restlessness or anxiety, nausea, tremor, confusion,
sweating, headache, diarrhoea, palpitations, emotional
instability, irritability, and visual disturbances have been
reported. Most of these symptoms are mild to moderate,
however, in some patients they may also be severe in
intensity. They usually occur within the first few days of
discontinuing treatment. Generally, these symptoms are
self-limiting and spontaneously resolve within 2 weeks,
though in some individuals they may be prolonged. It is
therefore advised to discontinue treatment gradually by
stepwise reduction in the dose over a period of several
weeks or months.

5

How to store Fluvoxamine 50mg,
100mg Tablets

Keep out of the reach and sight of children.
Do not store above 25 °C.
Keep the blister in the carton, in order to protect from
light and moisture.
Do not use Fluvoxamine 50mg, 100mg Tablets after the
expiry date which is stated on the carton and the blister.
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 Fluvoxamine 50mg, 100mg Tablets contains
 The active substance is 50mg, or 100 mg
fluvoxamine maleate in 1 film-coated tablet.
 The other ingredients are:
Lactose monohydrate, mannitol, maize starch,
hypromellose, polyethylene glycol 4000,
pregelatinized starch, sodium stearyl fumarate,
colloidal anhydrous silica, titanium dioxide (colouring
agent E 171)
What Fluvoxamine 50mg, 100mg Tablets look like
and contents of the pack
Fluvoxamine 50mg, 100mg Tablets are white, biconvex,
round film-coated tablets with a score.
The tablets are packed in blisters in a carton containing
15, 20, 30, 40, 50, 60, 90, and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Tillomed Laboratories Ltd
3 Howard Road,
Eaton Socon
St. Neots
Cambridgeshire
PE19 8ET
United Kingdom

Manufacturer
Salutas Pharma GMBH
Otto-von-Guericke-Allee 1,
D-39179 Barleben,
Germany
Product Licence Number:
Fluvoxamine 50mg Tablets:
PL 11311/0488
Fluvoxamine 100mg Tablets:
PL 11311/0489

Date of last revision: June 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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