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FAVERIN 50MG FILM-COATED TABLETS

Active substance(s): FLUVOXAMINE MALEATE / FLUVOXAMINE MALEATE / FLUVOXAMINE MALEATE

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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 d
­ evelop or worsen
when patients under 18 are taking Faverin.
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
­depression 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 ­doctor 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.
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.
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 de­pression (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 ­applies
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) sometimes prescribed
to treat depression or anxiety, including linezolid
(an antibiotic which is also an MAOI).
Treatment with fluvoxamine should only be
started at least 2 weeks after discontinuation of
an irreversible MAOI. However treatment with
fluvoxamine after discontinuation of certain
reversible MAOIs can be started the following
day. In exceptional cases linezolid (an antibiotic
MAOI) may be used with fluvoxamine provided
the doctor can monitor you closely. Your doctor
will advise you how you should begin taking
Faverin once you have stopped taking the MAOI.
• You are taking tizanidine, a medicine often
used as a muscle relaxant
• You are breast-feeding
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 ­common pain
killers
• you have diabetes
• you are having treatment with electro­convulsive
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 anti­depressant 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
­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
psychatric conditions who were treated with an
antidepressant.
If you have thoughts of harming or killing yourself at
­ ospital
any time, contact your doctor or go to a h
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 de­pression
in people aged under 18 years.
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.

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 ­listed 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. F
­ averin
should not be taken together with terfenadine.
• sildenafil, used to treat erectile dysfunction
• 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 ­already
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,
particularly in the last 3 months of pregnancy,
­
medicines like fluvoxamine may increase the risk of a
serious condition in babies, called persistent
­pulmonary 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 ­properly, being too 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.
The treatment for obsessive compulsive ­disorder:
• Start with 50 mg daily, preferably in the
evening.
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.
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):
Start with 25 mg (half a tablet) per day, preferably
at bedtime. Your doctor may increase the dose
every 4 – 7 days in 25 mg increments as tolerated
until an ­effective dose is achieved.
The highest daily dose is 200 mg.
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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.

• micturition disorders (such as the need to
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)
• glaucoma (increased pressure in eye)
• dilated pupils
• increase in the hormone prolactin (a hormone
that supports milk production in a nursing
mother)
• weight changes

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 / intense dreams
• 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 s­evere
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’).

An increased risk of bone fractures has been ­observed
in patients taking this type of medicine.
Side effects related to the treatment for OCD, in
children and adolescents, no frequencies are given:
• Hypomania ( a feeling of elation and over
excitement)
• Agitation
• Convulsions
• Difficulty sleeping (insomnia)
• Lack of energy (asthenia)
• Hyperactivity (hyperkinesia)
• Feeling drowsy (somnolence)
• Indigestion
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects
directly via the national reporting system. By reporting
side effects you can help provide more information
on the safety of this medicine.
In the UK:
The Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
In Ireland:
Reports may be made via freepost, to the following
address:
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
In Malta:
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
5.

• 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 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 l­imited to,
nausea, vomiting, diarrhoea and feeling d
­ rowsy or
dizzy. Cardiac events (slow or fast heartbeat, low blood
pressure), liver problems, convulsions (fits) and coma
have also been reported.
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.
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.

How to store Faverin

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 ­fumarate,
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 offwhite, 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 Manu­facturer
The marketing authorisation holder is
Mylan Products Ltd,
Station Close, Potters Bar, Herts, EN6 1TL, UK
Faverin is made by Mylan Laboratories SAS, Route
de Belleville, Lieu dit ­Maillard, 01400 Châtillon-surChalaronne, France.
For further information in the UK contact:
Mylan Products Ltd,
Station Close, Potters Bar, Herts, EN6 1TL, UK
For further information in Ireland contact:
Mylan IRE Healthcare Limited, Newenham Court,
Northern Cross,
Malahide Road,
Dublin 17.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria Floxyfral

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.

Belgium Floxyfral

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

Finland Fevarin

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.

Germany Fevarin

Side effects specifically related to Faverin
Common side effects:
• agitation
• anxiety
• constipation
• diarrhoea
• difficulty sleeping
• dizziness
• dry mouth
• faster heart beat
• feeling drowsy (lethargy)
• feeling unwell (malaise)
• headache
• indigestion
• loss of appetite
• nervousness
• stomach pain
• sweating
• tremor
• muscle weakness (asthenia)
• vomiting

Denmark Fevarin

France Floxyfral

Greece Dumyrox
Ireland Faverin
Italy Dumirox
Luxembourg Floxyfral
Norway Fevarin
Portugal Dumyrox
Spain Dumirox
Sweden Fevarin
The Netherlands Fevarin
United Kingdom Faverin
This leaflet was last revised in January 2017.

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-excite­ment)
• sensitivity to sunlight
• unexpected milk flow
Other side effects reported:
• akathisia (restlessness)
• abnormal taste
• anorgasmy (failure to achieve orgasm)
• for female patients: disorders with menstruation
(monthly bleeding)
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Expand Transcript

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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