FAVERIN 100MG FILM-COATED TABLETS

Active substance: FLUVOXAMINE MALEATE

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When taking this type of medicine, people under
18 have an increased risk of side effects such
as  attempting suicide, thoughts about suicide
and hostility, such as aggression, oppositional
behaviour and anger.

In this leaflet:
1.
2.
3.
4.
5.
6.
1.

What Faverin is and what it is used for
Before you take Faverin
How to take Faverin
Possible side effects
How to store Faverin
Further information
What Faverin is and what it is used for

Faverin belongs to a group of medicines called
selective serotonin re-uptake inhibitors (SSRI).
Faverin contains a substance called fluvoxamine.
This is an antidepressant. It is used to treat de­
pression (major depressive episode).
Faverin can also treat people who have obsessive
compulsive disorder (OCD).
2.

Before you take Faverin

Do not take Faverin if any of the following
a
­ pplies to you:
• You are allergic (hypersensitive) to fluvoxamine or any of the other tablet ingredients
(see section 6 ‘Further information’)
• You are taking medicines called monoamine
oxidase inhibitors (MAOI), or have taken
them in the last two weeks. Your doctor will
advise you how you should ­ egin taking
b
Faverin once you have stopped taking the
MAOI. This medicine is sometimes prescribed to treat de­ ression or anxiety.
p
• You are taking tizanidine, a medicine often
used as a muscle relaxant
• You are breast-feeding

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If any of the above apply to you, do not take
Faverin and talk to your doctor.
Take special care
Talk to your doctor or a pharmacist before taking
your medicine if:
• you recently had a heart attack
• you are pregnant, or could be pregnant
• you have epilepsy
• you have a history of bleeding problems
or if you regularly use medicines which
increase the risk of bleeding, such as
c
­ ommon pain killers
• you have diabetes
• you are having treatment with electro­
convulsive therapy (ECT)
• you ever had mania (a feeling of elation or
over-excitement)

• you have liver or kidney problems
• you have high pressure in your eyes
(glaucoma)
• you are less than 18 years old (See also
section 3 ‘How to take Faverin’)
If any of the above applies to you, your doctor will
tell you whether it is safe for you to start taking
Faverin.
Occasionally, thoughts of restlessness, for
e
­ xample, you cannot sit or stand still (akathisia)
may occur or may increase during the first few
weeks of treatment with Faverin, until the anti­
depressant effect has worked.
Tell your doctor immediately if you experience
these symptoms. Then a dosage adjustment may
be helpful.
Thoughts of suicide and worsening of your
d
­ epression 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:
–  you have previously had thoughts about
If
killing or harming yourself.
–  you are a young adult. Information from
If
clinical trials has shown an increased risk of
suicidal behaviour in adults aged less than
25 years with psychatric 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
h
­ ospital 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.
Tell your doctor immediately if you have any
distressing thoughts or experiences.
Use in children and adolescents under 18 years
of age
Children and adolescents under 18 years should
not take this medicine, unless they are being
treated for obsessive compulsive disorder (OCD).
This is because Faverin is not used to treat de­
pression in people aged under 18 years.

Also, it is not known whether taking Faverin under
the age of 18 years can affect growth, maturation
or development of intelligence or behaviour in the
long term.
Are you taking any other medicines?
• You should not start to take the herbal
remedy St John’s Wort while you are being
treated with Faverin since this may result
in an increase of undesirable effects. If you
are already taking St John’s Wort when
you start on Faverin, stop taking the St
John’s Wort and tell your doctor at your
next visit.
• If you have been taking a medicine to treat
depression or anxiety within the last two
weeks, or you suffer from schizophrenia,
check with your doctor or a pharmacist.
Your doctor or pharmacist will check if you are
taking other medicines to treat your depression or
related conditions, these may include:













benzodiazepines
tricyclic antidepressants
neuroleptic or anti-psychotics
lithium
tryptophan
monoamine oxidase inhibitors (MAOI) such
as moclobemide.
• Selective serotonin reuptake inhibitors
(SSRI) such as citalopram

Your doctor will tell you if it is safe for you to start
taking Faverin.
You should also tell your doctor or pharmacist if
you have been taking any of the medicines ­ isted
l
below:
• aspirin (acetylsalicylic acid) or aspirin-like
medicines, used to treat pain and inflammation (arthritis)
• ciclosporin, used to reduce the activity of
the immune system
• methadone, used to treat pain and withdrawal symptoms
• mexiletine, used to treat abnormal heart
rhythms
• phenytoin or carbamazepine, used to treat
epilepsy
• propranolol, used to treat high blood pressure and heart conditions

• ropinirole, for Parkinson’s disease.
• a ‘triptan’, used to treat migraines, such
as sumatriptan
• terfenadine, used to treat allergies. ­ averin
F
should not be taken together with terfenadine.
• theophylline, used to treat asthma and
bronchitis

• tramadol, a pain-killer
• warfarin, nicoumalone or any other drug
used to prevent blood clots
If you are taking or have recently taken any of the
medicines in the above list and you have not
a
­ lready discussed these with your doctor, go
back to your doctor and ask what you should do.
Your dose may need to be changed or you may
need to be given a different medicine.
Please tell your doctor or pharmacist if you are
taking or have taken any other medicines, including medicines obtained without a prescription.
This includes herbal medicines.
Taking Faverin with food and drink
• Do not drink alcohol if you are taking this
medicine. This is because alcohol works
together with Faverin and will make you
sleepy and unsteady.
• If you normally drink a lot of tea, coffee
and soft drinks with caffeine in them, you
may have symptoms such as your hands
shaking, feeling sick, fast heart rate (palpitations), restlessness and difficulty sleeping (insomnia). If you lower how much
caffeine you drink, these symptoms might
disappear.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
Pregnancy
There is only limited experience concerning the
use of fluvoxamine during pregnancy. Do not take
fluvoxamine if you are pregnant unless your
doctor considers it absolutely necessary. If you
are currently taking fluvoxamine and are planning to become pregnant or to father a child,
please consult with your physician to decide
if an alternative medication is necessary or
­appropriate.
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.
Make sure your midwife and/or doctor know you
are on fluvoxamine. When taken during pregnancy,
p
­ articularly in the last 3 months of pregnancy,
medicines like fluvoxamine may increase the risk
of a serious condition in babies, called persistent
p
­ ulmonary 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.
You should not discontinue treatment with fluvoxamine abruptly. If you are taking fluvoxamine in the
last 3 months of pregnancy, your baby might have
some other symptoms when it is born in addition
to having trouble breathing or bluish skin, such as
not being able to sleep or feed ­ roperly, being too
p
hot or cold, being sick, crying a lot, stiff or floppy
muscles, lethargy, drowsiness, tremors, jitters or
fits. If your baby has any of these symptoms when
it is born contact your doctor immediately.
Breast-feeding
Fluvoxamine passes into breast milk. There is a risk
of an effect on the baby. Therefore, you should
discuss the matter with your doctor, and he/she will
decide whether you should stop breast-feeding or
stop the therapy with fluvoxamine.
Driving and using machines
You can drive and use machines while you are
taking this treatment, so long as this medicine
does not make you sleepy.
3.

How to take Faverin

How much Faverin to take
Always take Faverin as your doctor has told you
to.
You should check with your doctor or pharmacist
if you are not sure.
Usual starting dose for adults (18 years and
older):
The treatment for depression:
• Start with 50 or 100 mg daily, taken in the
evening.
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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 become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

If your doctor has prescribed Faverin for someone
under 18 years and you want to discuss this,
please go back to your doctor. You should tell your
doctor if any of the symptoms listed above ­ evelop
d
or worsen when patients under 18 are taking
Faverin.

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50 mg and 100 mg film-coated tablets
fluvoxamine maleate
• Faverin treats depression and Obsessive
Compulsive Disorder (OCD). Like all
medicines it can have unwanted effects.
It is therefore important that you and your
doctor weigh up the benefits of treatment
against the possible unwanted effects,
before starting treatment.
• Faverin should not be used to treat
d
­ epression in children and adolescents
under 18. See section 2, Use in Children
and adolescents under 18.
• Faverin won’t work straight away. Some
people taking antidepressants feel worse
before feeling better. Your doctor should
see you regularly during your course of
treatment. Tell your doctor if you haven’t
started feeling better.
• Some people who are depressed or anxious think of harming or killing themselves. If you start to feel worse, or think
of harming or killing yourself, see your
d
­ octor or go to a hospital straight away.
• Don’t stop taking Faverin without talking
to your doctor. If you stop taking Faverin
suddenly or miss a dose, you may get
withdrawal effects. See Section 3, How to
take Faverin.
• If you feel restless and feel like you can’t
sit or stand still, tell your doctor. Increasing the dose of Faverin may make these
feelings worse.
• Taking some other medicines with
Faverin can cause problems. You may
need to talk to your doctor. See section 2,
Are you taking any other medicines.
• If you are pregnant or planning to get
pregnant, talk to your doctor. See section
2, Pregnancy and breastfeeding.

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The highest daily dose that is recommended is
300 mg.
If your doctor advises you to take more than
150 mg per day, do not take them all at once; ask
your doctor when you should take them.
The usual dose for children and adolescents
with obsessive compulsive disorder – OCD
(8 years and older is):

S
 tart with 25 mg (half a tablet) per day. Your
doctor may increase the dose every 4 – 7 days
in 25 mg increments as tolerated until an
e
­ ffective dose is achieved.

The highest daily dose is 200 mg.
If your doctor advises you to take more than 50 mg
per day, do not take them all at once; ask your
doctor when you should take them. If the dose is
not divided equally, the larger dose should be
taken at night.
Children and adolescents under the age of 18
should not take this medicine to treat depression.
This medicine should be prescribed for children
or adolescents for Obsessive Compulsive Disorder
(OCD) only.
How to take Faverin
• Swallow the tablets with water. Do not
chew them.
You can break the tablets in half if your doctor has
advised you to
How long does it take to work?
Faverin may take a little time to start working.
Some patients do not feel better in the first 2 or
3 weeks of treatment.
Keep taking your tablets until your doctor tells you
to stop. Even when you start feeling better, your
doctor may want you to carry on taking the tablets
for some time, for at least six months to make sure
that the medication has worked completely.
Do not stop taking Faverin too quickly.
You may suffer from withdrawal symptoms such as:

• agitation and anxiety

• confusion

• diarrhoea

• difficulty sleeping

• dizziness

• emotional instability

• headaches

• irritability

• nausea and/or vomiting

• palpitations (faster heartbeat)
• sensory disturbance (such as electric
shock sensations or visual disturbances)

• sweating

• tremors
When stopping Faverin your doctor will help you
to reduce your dose slowly over a number of
weeks or months, this should help reduce the
chance of withdrawal effects. Most people find
that any symptoms on stopping Faverin are mild
and go away on their own within two weeks. For
some people, these symptoms may be more severe, or go on for longer.
If you get withdrawal effects when you are coming
off your tablets your doctor may decide that you
should come off them more slowly. If you get
s
­ evere withdrawal effects when you stop taking
Faverin, please see your doctor. He or she may
ask you to start taking your tablets again and come
off them more slowly (see section 4 ‘Possible Side
Effects’).

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If you experience any symptoms on stopping the
treatment, contact your doctor.
If you take more Faverin than you should
If you or someone else takes too much Faverin
(an overdose), talk to a doctor or go to a hospital
straight away. Take the medicine pack with you.
Symptoms of overdose include, but are not ­imited
l
to, nausea, vomiting, diarrhoea and feeling ­ rowsy
d
or dizzy. Cardiac events (slow or fast heartbeat,
low blood pressure), liver problems, convulsions
(fits) and coma have also been reported.
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If you forget to take Faverin
If you miss a tablet, wait until the next dose is due.
Do not try to make up for the dose you have
missed.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines Faverin can cause side effects
(unwanted effects or reactions), but not everyone
gets them.
Frequencies of the observed side effects are
defined as:
very common affects more than 1 user in 10
common

affects 1 to 10 users in 100

uncommon

affects 1 to 10 users in 1,000

rare

affects 1 to 10 users in 10,000

very rare

affects less than 1 user in 10,000

not known

frequency cannot be estimated
from the available data

Side effects related to this type of medicine
Occasionally, thoughts of suicide or self harm
may occur or may increase in the first few weeks
of treatment with Faverin, until the antidepressant
effect has worked.
Tell your doctor immediately if you have any
distressing thoughts or experiences.












feeling unwell (malaise)
headache
indigestion
loss of appetite
nervousness
stomach pain
sweating
tremor
muscle weakness (asthenia)
vomiting

Uncommon side effects:
• allergic skin reactions (including swelling
of face, lip or tongue, rash or itching)

• confusion

• delayed ejaculation

• dizziness when standing up too quickly

• hallucinations

• lack of co-ordination

• muscle or joint pain
Rare side effects:

• convulsions

• liver complaints
• mania (a feeling of elation or over-excite­
ment

• sensitivity to sunlight

• unexpected milk flow
Other side effects reported:

• akathisia (restlessness)

• abnormal taste

• anorgasmy (failure to achieve orgasm)

• or female patients: disorders with menf
struation (monthly bleeding)

•  icturition disorders (such as the need to
m
urinate frequently during the day and/or
the night, the sudden lack of control over
urination during the day and/or the night,
or the lack of ability to urinate)

• paraesthesia (tingling or numbness)

•  ilated pupils
d

• ncrease in the hormone prolactin (a hori
mone that supports milk production in a
nursing mother)

• weight changes
An increased risk of bone fractures has been
o
­ bserved in patients taking this type of medicines.
Side effects related to the treatment for OCD,
in children and adolescents, no frequencies are
given:
• Mania (a feeling of elation and over excitement)

• Agitation

• Convulsions

• Difficulty sleeping (insomnia)

• Lack of energy (asthenia)

• Hyperactivity (hyperkinesia)

• Drowsy (somnolence)

• Indigestion
If any of the side effects become serious, or if you
notice any side effects that are not listed in this
leaflet, please tell your doctor or pharmacist.
5.

How to store Faverin

• Keep out of the reach and sight of
­children.
• Do not use the tablets after the expiry date
(EXP) which is printed on the carton and
blister pack.
• Do not store above 25°C.
If your doctor stops your treatment, return any
unused tablets to a pharmacist.
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 Faverin 50 mg/100 mg contains
The active substance is fluvoxamine maleate. Each
50 mg tablet contains 50 mg of fluvoxamine
maleate. Each 100 mg tablet contains 100 mg of
fluvoxamine maleate.
The other ingredients are: mannitol (E421), maize
starch, pregelatinized starch, sodium stearyl
f
­ umarate, colloidal anhydrous silica, hypromellose,
macrogol 6000, talc and titanium dioxide (E171).
What Faverin looks like and contents of the
pack
The Faverin 50 mg tablet is film-coated, white to
off-white, round and marked “291” on both sides
of the score line.
The Faverin 100 mg tablet is film-coated, white to
off-white, oval and marked “313” on both sides of
the score line.
Faverin 50 mg is available in packs of 5, 10, 20,
30, 50, 60, 90, 100 and 250 tablets.
Faverin 100 mg is available in packs of 15, 20, 30,
50, 60, 90, 100, 120 or 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manu­
facturer
The marketing authorisation holder is Abbott
Healthcare Products Limited, Mansbridge Road,
West End, Southampton, SO18 3JD, UK.
Faverin is made by Abbott Healthcare SAS, Route
de Belleville, Lieu dit ­ aillard, 01400 ChâtillonM
sur-Chalaronne, France.
For further information in the UK contact:
Abbott Healthcare Products Limited,
Mansbridge Road, West End,
Southampton, SO18 3JD, UK.
TEL: 023 8046 7000
For further information in Ireland contact:
Abbott Laboratories Ireland Ltd.,
4051 Kingswood Drive,
Citywest Business Campus,
Dublin 24,
Ireland
014691500

If you have several symptoms at the same time
you might have one of the following rare conditions:
• Serotonin syndrome: if you have sweating,
muscle stiffness or spasms, instability,
confusion, irritability or extreme agitation.
• Neuroleptic malignant syndrome: if you
have stiff muscles, high temperature, confusion and other related symptoms.
• SIADH: if you feel tired, weak or confused
and have achy, stiff or uncontrolled muscles.
Stop taking Faverin and contact your doctor
immediately.

This medicinal product is authorised in the
Member States of the EEA under the following
names:

If unusual bruising or purple patches appear on
your skin or you vomit blood or pass blood in your
stool, contact your doctor for advice.

Greece Dumyrox

Stopping of fluvoxamine (particularly when abrupt)
commonly leads to withdrawal symptoms (see
section 3 withdrawal symptoms).

Italy Dumirox

Sometimes patients feel slightly sick as Faverin
begins to work. Although the feeling of sickness
is unpleasant, it should soon pass if you keep
taking your tablets as prescribed. This may take
a few weeks.

Austria Floxyfral
Belgium Floxyfral
Denmark Fevarin
Finland Fevarin
France Floxyfral
Germany Fevarin

Ireland Faverin

Luxembourg Floxyfral
Norway Fevarin
Portugal Dumyrox
Spain Dumirox
Sweden Fevarin

Side effects specifically related to Faverin

The Netherlands Fevarin

Common side effects:

• agitation

• anxiety

• constipation

• diarrhoea

• difficulty sleeping

• dizziness

• dry mouth

• faster heart beat

• feeling drowsy (lethargy)

United Kingdom Faverin

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If you don’t start to feel better after a couple of
weeks, talk to your doctor, who will advise you.
He or she may decide to increase the dose
­gradually.












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The treatment for obsessive compulsive disorder:
­
• Start with 50 mg daily, preferably in the
evening.

This leaflet was last revised in November 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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