FLUVOXAMINE MALEATE TABLETS BP 50MG

Active substance: FLUVOXAMINE MALEATE

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Fluvoxamine Maleate BP 100 mg
Tablets

Package Leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Fluvoxamine Maleate Tablets BP 50 mg and 100 mg
Active substance: 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 Maleate BP 50 mg and 100 mg is and what it is used for
Before you take Fluvoxamine Maleate BP 50 mg and 100 mg
How to take Fluvoxamine Maleate BP 50 mg and 100 mg
Possible side effects
How to store Fluvoxamine Maleate BP 50 mg and 100 mg
Further information

What Fluvoxamine Maleate BP 50 mg and 100 mg is and what it is
used for
Fluvoxamine belongs to a specific group of antidepressants called selective
serotonin reuptake inhibitors (SSRIs). Low levels of serotonin in the brain are
associated with depression and other related conditions. Fluvoxamine increases
serotonin levels.
Fluvoxamine is used to treat major depressive episodes and obsessive compulsive
behaviour (Obsessive Compulsive Disorder).

2.

Before you take Fluvoxamine Maleate BP 50 mg and 100 mg
Do not take Fluvoxamine Maleate BP (50 mg and 100 mg) if you:

Fluvoxamine Maleate BP 100 mg
Tablets

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are allergic (hypersensitive) to fluvoxamine or any of the other ingredients
of Fluvoxamine (see section 6, What fluvoxamine contains)
are taking other medicines to treat depression called irreversible monoamine
oxidase inhibitors (MAOIs) or if you have taken them within the last 2 weeks.

At least one week should pass between stopping fluvoxamine and starting a therapy
with MAOIs.
Take special care with Fluvoxamine Maleate BP (50 mg and 100 mg)
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 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 disorder is getting worse, or if they
are worried about changes in your behaviour.
Check if one of the warnings listed below applies to you or applied to you in the
past. Contact your doctor if you:







constantly feel the need to move and cannot sit or stand still. Fluvoxamine can
cause these symptoms. Your doctor may decide to stop treatment with
fluvoxamine.
suffer from liver or kidney problems. Your doctor may lower the dose of
fluvoxamine.
experience symptoms such as feeling sick, loss of appetite or yellowing of the
skin (jaundice). Fluvoxamine can increase the liver enzymes in your blood,
causing these symptoms. Your doctor may decide to stop fluvoxamine
treatment.
suffer from diabetes. The dose of anti-diabetic medicines may need to be
adjusted while taking fluvoxamine.
suffer or have suffered from fits (uncontrolled or controlled epilepsy).

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experience high fever possibly combined with jerks, stiffness, confusion,
agitation. These symptoms may indicate a serious neurological disorder
(neuroleptic malignant syndrome or serotonin syndrome) caused by the use
of fluvoxamine. You should contact your doctor immediately.
have a history of bleeding or blood clotting disorders. Fluvoxamine may
cause bleeding abnormalities of the skin.
suffer or have suffered from irritable mood, manic thoughts with or without
symptoms of mental illness (mania/hypomania). Your doctor may recommend
stopping the use of fluvoxamine.
have suffered from a heart attack (myocardial infarction).
are receiving electrocompulsive therapy (ECT). There is limited information on
the use of this therapy together with fluvoxamine.

Use in children and adolescents under 18 years of age
Children under the age of 18 years should not take fluvoxamine for the treatment of
depression. The risk of suicidal-thoughts and aggressive behaviour in children and
adolescents under the age of 18 years is increased by the use of fluvoxamine.
Fluvoxamine may be used to treat obsessive compulsive behaviour in children and
adolescents under the age of 18 years only if carefully monitored by a doctor.
Taking other medicines
Other medicines may be affected by fluvoxamine. They, in turn, may affect how
well fluvoxamine works. Fluvoxamine can interact with:







reversible or irreversible monoamine oxidase inhibitors (MAOIs), which
are medicines use to treat depression.
clomipramine, imipramine, amitriptyline, medicines known as tricyclic
anti-depressants. Fluvoxamine increases the amount of these medicines in
your blood.
olanzepine and clozapine and other anti-psycothic medicines. Fluvoxamine
increases the amount of these medicines in your blood.
medicines for which dose-monitoring is required such as tacrine, a
medicine used for Alzheimer’s disease, theophylline, a medicine used for
bronchial asthma, methadone, mexiletine, a medicine used for severe heart
irregularity, carbamazide, a medicine used for epilepsy, phenytoin, a
medicine used for epilepsy, and cyclosporin, a medicine used to prevent
rejection of an organ tranplantation. Your doctor will adjust the dose of
these medicines if you are taking fluvoxamine.
lithium, a medicine used for depression. This medicine may increase the
effect of fluvoxamine.

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warfarin, a medicine used for heart and vascular diseases. Fluvoxamine
may increase the amount of these medicines in the blood which can slow
blood clotting.
thioridazine, a medicine used for mental and emotional disturbances. The
use of this medicine with fluvoxamine raises a small risk of heart disorders .
propanolol, a medicine used for heart problems. Fluvoxamine may increase
the amount of this medicine in the blood.
ropinirol, a medicine used for Parkinson’s disease. Fluvoxamine may
increase the amount of this medicine in the blood.
benzodiazepines, which are tranquilizers or sedatives. Fluvoxamine
increases the amount of these medicines in the blood.
terfenadine, a medicine used for hay fever, astemizole, used for hay fever
and allergic skin reactions, and cisapride, used for digestive disorders.
Fluvoxamine increases the amount of these medicines in the blood with a
consequent increased risk of heart disorders.
Other medicines that influence serotonin levels (such as triptans, SSRIs
and St John’s Wort preparations). These medicines may increase the effect
of fluvoxamine.

Please tell your doctor pharmacist if you are taking or have recently taken any of
the medicines listed above or any other medicines, including medicines obtained
without prescription.
Taking Fluvoxamine Maleate BP (50 mg and 100 mg) with food and drink
Food does not affect Fluvoxamine.
You should reduce your intake of caffeinated beverages such as coffee while taking
fluvoxamine. Fluvoxamine can increase some effects of caffeine; you could
experience shaking, feeling your heartbeat, feeling sick, feeling restless and
difficulty spleeping.
You should not drink alcohol while taking fluvoxamine.
Pregnancy, breast-feeding and fertility
Inform your doctor if you are pregnant or if you are planning to get pregnant. He
will decide if you can take fluvoxamine.
Make sure your midwife and/or doctor know you are on Fluvoxamine Maleate BP.
When taken during pregnancy, particularly in the last 3 months of pregnancy,
medicines like Fluvoxamine Maleate BP 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

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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.
You should not breast-feed while taking fluvoxamine as it can pass to your baby
through the mother’s milk.
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
No effect on the ability to drive or operate machinery has been associated with the
use of fluvoxamine. However, since fluvoxamine can cause sleepiness, caution is
recommended when driving or using operating machines.

3.

How to take Fluvoxamine Maleate BP 50 mg and 100 mg
Always take fluvoxamine exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
You should swallow the tablets whole with water. Do not crush or chew them. You
can take Fluvoxamine with or without food.
DOSAGE
Depression
Adults
The recommended dose is 100 mg daily. You will start with 50 mg or 100 mg taken
as a single dose in the evening. The dose can then be adjusted gradually within 3 to
4 weeks to a maximum of 300 mg a day. Doses up to 150 mg can be taken as a
single dose in the evening. Doses above 150 mg should be taken in 2 or 3 divided
doses.
You should take fluvoxamine for at least 6 months, even if you already feel better,
to ensure you are free from symptoms.
Children and adolescents
Children and adolescents under the age of 18 years should not take fluvoxamine for
the treatment of depression.

Fluvoxamine Maleate BP 100 mg
Tablets

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Obsessive compulsive disorders
Adults
The recommended dose is between 100 - 300 mg daily. You will start with a dose
of 50 mg per day. The dose can be increased gradually up to a maximum of 300 mg
a day. Doses up to 150 mg can be taken as a single dose in the evening. Doses
above 150 mg should be taken in 2 or 3 divided doses.
Children over 8 years and adolescents
In children over 8 years of age the recommended starting dose is 25 mg per day.
The dose can be gradually increased to a maximum of 200 mg per day. Doses above
50 mg should be taken in 2 divided doses, with the larger dose at bedtime.
Children under the age of 8 years should not take fluvoxamine.
Patients with liver or kidney disorders
You will start on a low dose and your doctor will closely monitor your response to
fluvoxamine to adjust the dose when necessary.
If you take more Fluvoxamine Maleate BP (50 mg and 100 mg) than you
should
Contact your doctor or pharmacist immediately. Take this leaflet and the remaining
tablets with you to show your doctor or pharmacist.
If you take more fluvoxamine than you should, you may experience symptoms such
as feeling sick, vomiting, diarrhoea, sleepiness and dizziness. Heart problems such
as a fast or low heartbeat, low blood pressure, liver function disturbances, fits may
also occur.
Your doctor may empty you stomach or give you activated charcoal to minimise the
effect of the overdose. You will need to be carefully monitored for at least 5 days as
some side effects can occur with delay.
If you forget to take Fluvoxamine Maleate (50 mg and 100 mg)
Do not take a double dose to make up for a forgotten dose. Just take the next dose at
the usual time.
If you stop taking Fluvoxamine Maleate 50 mg and 100 mg
You may experience withdrawal symptoms if you suddenly stop taking this
medicine. These symptoms include dizziness, sleeping disturbances (including
difficulty sleeping and intense dreams), feeling sick, headache and weakness.
Sometimes also numbness, agitation and inability to have an orgasm can occur.

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Possible side effects
Like all medicines, Fluvoxamine can cause side effects, although not everybody
gets them.
Feeling sick, sometimes accompanied by vomiting, is the most frequently observed
symptom when you take fluvoxamine. This side effect usually diminishes within the
first two weeks of treatment.
Allergic skin reactions (including swelling of face or throat, lip or tongue, rash or
itching) can occur. Please contact immediately your doctor if these symptoms
occur.
Common (occurring in more than 1 in 100, but in less than 1 in 10 people)
Feeling of weakness, headache, malaise; feeling your heartbeat/faster heartbeat;
abdominal pain, loss of appetite, constipation, diarrhoea, dry mouth, indigestion;
agitation, anxiety, dizziness, difficulty in sleeping, nervousness, sleepiness, shaking;
sweating.
Uncommon (occurring in more than 1 in 1,000, but in less than 1 in 100 people)
Feeling dizzy or faint, especially when getting up from a lying or sitting position
(postural hypotension); joint pain, muscle pain; difficulty in controlling movements,
confusion, abnormal movements (extrapyramidal symptoms), hallucinations;
abnormal (delayed) ejaculation.; rash, pruritus, serious allergic reaction which
causes swelling of nose and throat.
Rare (occurring in more than 1 in 10,000, but in less than 1 in 1,000 people)
Abnormalities of the liver; fits, feeling elated or overexcited which causes unusual
behaviour (mania), restlessness; excessive spontaneous flow of milk
(galactorrhoea); sensitivity to light (photosensitivity).
Other side effects (frequency unknown):
Weight gain and loss have been reported.
Rarely, serotonin syndrome, neuroleptic malignant syndrome-like events,
hyponatremia (an electrolyte disturbance) and SIADH (a disease causing
abnormalities of anti-diuretic hormone excretion) have been reported (Please see
Section 2, “Before you take”).
An increased risk of bone fractures has been observed in patients taking this type of
medicines.
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.

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5.

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How to store Fluvoxamine Maleate 50 mg and 100 mg BP
Keep out of the reach and sight of children.
Do not use Fluvoxamine after the expiry date [EXP] which is printed on the outer
carton box and on each blister. The first two digits indicate the month and the last
four digits indicate the year. The expiry date refers to the last day of that month.
Fluvoxamine should be stored in its original package below 25 °C.
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 contains
The active substance is fluvoxamine maleate (50 mg or 100 mg). The other
ingredients are: maize starch, colloidal anhydrous silica, pregelatinised starch,
sodium stearyl fumarate, mannitol, polyethylene glycol 6,000, talc, titanium dioxide
(E171) and methyl hydroxypropyl cellulose.
What Fluvoxamine looks like and contents of the pack
The tablets are round, biconvex, scored, white to off-white film coated tablets
imprinted “FLM 50” or “FLM 100” on one side.
They are supplied in blister packs of 28, 30, 56 and 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

Fluvoxamine Maleate BP 100 mg
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Package Leaflet
Manufacturer(s):
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Distributed by:
IVAX Pharmaceuticals UK, Royal Docks, London E16 2QJ, UK.
National registration number:
PL 14048/0001, Fluvoxamine Maleate Tablets BP 50 mg. [POM]
PL 14048/0002; Fluvoxamine Maleate Tablets BP 100 mg. [POM]
This leaflet was last approved in 09/2012.

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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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