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TEVA FLUVOXAMINE 100MG TABLETS

Active substance(s): FLUVOXAMINE MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Teva Fluvoxamine 50 mg & 100 mg Tablets
fluvoxamine maleate
Read all of this leaflet carefully before you start taking this medicine because it containes
important information for you.
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 only. Do not pass it on to others. It may harm them,
even if their signs of illnes 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.
What is in this leaflet:
1.
What Teva Fluvoxamine 50 mg & 100 mg Tablet is and what it is used for
2.
What you need to know before you take Teva Fluvoxamine 50 mg & 100 mg Tablet
3.
How to take Teva Fluvoxamine 50 mg & 100 mg Tablet
4.
Possible side effects
5.
How to store Teva Fluvoxamine 50 mg & 100 mg Tablet
6.
Contents of the pack and other information
1.

WHAT TEVA FLUVOXAMINE 50 mg & 100 mg Tablet IS AND WHAT IT IS USED
FOR

Fluvoxamine belongs to a group of drugs called selective serotonin re-uptake inhibitors (SSRIs).
Serotonin is a chemical that, in the brain, passes nerve impulses (‘messages’) between nerve cells and
may help to control mood. Fluvoxamine increases the availability of serotonin.
Fluvoxamine tablets are used to treat the symptoms of depression or obsessive-compulsive disorder.
Ask your doctor or pharmacist if you need additional information.
2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEVA FLUVOXAMINE 50 mg
& 100 mg Tablet

Do not take Teva Fluvoxamine 50 mg & 100 mg Tablet
if you are allergic to fluvoxamine maleate or any of the other ingredients of this medicine
(listed in section 6).
if you breast-feeding
if you are taking, or have taken in the past two weeks, any monoamine oxidase inhibitors (used
to treat depression) such as phenelzine, moclobemide or 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 Teva
Fluvoxamine 50 mg & 100 mg Tablet once you have stopped taking the MAOI.

-

if you are taking tizanidine, a medicine often used as a muscle relaxant

Warnings and precautions
Talk to your doctor or pharmacist before taking Teva Fluvoxamine 50 mg & 100 mg Tablet:
if you recently suffered from a heart attack
if you are pregnant or could be pregnant
if you have a history of fits or you are taking carbamazepine or phenytoin (used to treat
epilepsy)
if you have any liver or kidney problems
if you are taking aspirin or any non-steroidal anti-inflammatory drugs (usually taken to relieve
pain, inflammation and/or stiffness) such as naproxen or ibuprofen
If you are taking tramadol (a painkiller) or methadone (used to treat severe pain or in the
management of drug dependency)
if you have a history of bleeding disorders or if you are taking any anticoagulants (used to
prevent blood clots) such as warfarin or acenocoumarol
if you are being treated with electroconvulsive therapy (ECT)
if you ever had mania (a feeling of elation or over-excitement)
if you are diabetic
if you have high pressure in your eyes (glaucoma)
you are less than 18 years old (See also section 3 ‘How to take Teva Fluvoxamine 50 mg &
100 mg Tablet)
Occasionally, thoughts of restlessness, for example, you cannot sit or stand still (akathisia) may occur
or may increase during the first few weeks of treatment with Teva Fluvoxamine, 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 themselves. 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 young adults (less than 25 years old) 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 or anxiety is getting worse, or if they are worried about changes in your behaviour.
Don’t stop taking Teva Fluvoxamine 50 mg & 100 mg Tablet without talking to your doctor. If
you stop taking Teva Fluvoxamine 50 mg & 100 mg Tablet suddenly or miss a dose, you may get
withdrawal effects. See Section 3, How to take Teva Fluvoxamine 50 mg & 100 mg Tablet.
Other medicines and Teva Fluvoxamine 50 mg & 100 mg Tablet
Tell your doctor or pharmacist if you are taking have recently taken or might take any other
medicines:
aspirin (acetylsalicylic acid) or aspirin-like medicines, used to treat pain and inflammation
(arthritis)

clozapine, olanzapine or thioridazine (used to treat schizophrenia)
theophylline (used to treat asthma and bronchitis)
propranolol or mexiletine (used to treat high blood pressure and heart problems)
ciclosporin (an immunosuppressant) used after organ transplant
terfenadine or astemizole to treat allergies
any medicine used to treat migraines e.g. sumatriptan or rizatriptan
ropinirole (used to treat Parkinson’s disease)
tacrine (used to treat Alzheimer’s disease)
any benzodiazepines (used to treat anxiety and insomnia) such as midazolam, diazepam or
alprazolam
any antipsychotic drugs (used to treat mental illnesses) such as risperidone, chlorpromazine or
haloperidol
any other antidepressants such as amitriptyline, clomipramine, imipramine, lithium, tryptophan,
monoamine oxidase inhibitors (MAOI) such as moclobemide or selective serotonin reuptake
inhibitors (SSRI) such as citalopram
St. John’s Wort (Hypericum perforatum), a herbal remedy used for depression
methadone, used to treat pain and withdrawal symptoms
phenytoin or carbamazepine, used to treat epilepsy
tramadol, a pain-killer
warfarin or any other drug used to prevent blood clots
sildenafil, used to treat erectile dysfunction
Teva Fluvoxamine 50 mg & 100 mg Tablet with drink and alcohol
Fluvoxamine may increase the effects of alcohol, and you should therefore avoid alcohol while taking
these tablets.

Fluvoxamine may increase the effects of caffeine, and you should therefore keep your intake of
drinks that contain caffeine (e.g. coffee, tea and cola) to a minimum whilst taking these tablets.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy
Make sure your midwife and/or doctor know you are on Teva Fluvoxamine 50 mg & 100 mg Tablet.
When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Teva
Fluvoxamine 50 mg & 100 mg Tablet 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.

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.
Fertility
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.
Driving and using machines
Your tablets may make you feel sleepy. If affected do not drive or operate machinery until you are
used to these tablets.
3.

HOW TO TAKE TEVA FLUVOXAMINE 50 mg & 100 mg Tablet

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Your doctor has decided the dose which is suited to you.
The tablets should be swallowed with a drink of water.
The score line is only there to help break the tablet if you have difficulty swallowing it whole.
The usual dosage instructions are given below:
Depression:
Adults (including the Elderly):
The recommended starting dose is 50 mg or 100 mg taken once daily in the evening. 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.
Use in children and adolescents
Not recommended.
Fluvoxamine should normally not be used for children and adolescents under 18 years except for
patients with obsessive-compulsive disorder. Also, you should know that patients under 18 have an
increased risk of side-effects such as 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 for patients under 18 because he/she decides that this is in
their best interests. If your doctor has prescribed fluvoxamine 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. Also, the long-term
safety effects concerning growth, maturation and cognitive and behavioural development of
fluvoxamine in this age group have not yet been demonstrated.
Obsessive-Compulsive Disorder:
Adults (including the Elderly):
The recommended starting dose is 50 mg taken once daily 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. 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.
Use in children
Children (over 8 years old):

The recommended starting dose is 25 mg daily. The dose can be increased by 25 mg every 4 to 7 days
until a suitable dose has been found. The maximum daily dose is 200 mg.
Children (under 8 years old):
Not recommended.
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 Teva Fluvoxamine 50 mg & 100 mg Tablet than you should
If you or someone else swallows 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 can cause nausea, vomiting, diarrhoea, sleepiness, dizziness/light-headedness, changes
in heart rhythm and can lead to fits or coma.
If you forget to take Teva Fluvoxamine 50 mg & 100 mg Tablet
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. Never take two doses together. Take the remaining doses at the correct time.
If you stop taking Teva Fluvoxamine 50 mg & 100 mg Tablet
Sometimes fluvoxamine takes a little time to start working and it may be 2-3 weeks before you start
to feel better. Do not stop taking your tablets suddenly. If you do, you may suffer from withdrawal
symptoms such as headache, nausea and/or vomiting, dizziness, pins-and-needles, visual
disturbances, sweating, tremors, palpitations (faster heartbeat), confusion, diarrhoea, difficulty
sleeping, emotionala instability, irritability, agitation and anxiety. Most people find that any
symptoms on stopping Teva Fluvoxamine 50 mg & 100 mg Tablet 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 your
doctor decides to stop your tablets, he/she will reduce the dose gradually.
If you experience any symptoms on stopping the treatment, contact your doctor.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Feeling sick and sometimes vomiting. This will almost always pass if you keep taking your tablets.
If bruising or purple patches appear on your skin, or you vomit blood or pass blood in your stool; or
in rare cases an allergic reaction occurs (itchy, raised rash, stomach pain, wheezing, swelling of the
tongue or throat) or you become oversensitive to light (rash or itchy skin following exposure to
sunlight), tell your doctor.
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.
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 Teva Fluvoxamine 50 mg & 100 mg Tablet and contact your doctor immediately.

Stopping of fluvoxamine (particularly when abrupt) commonly leads to withdrawal symptoms.
Common side effects (affects 1 to 10 users in 100):
• 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
• shakiness
• muscle weakness (asthenia)
• vomiting
Uncommon side effects (affects 1 to 10 users in 1,000):
• 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 (affects 1 to 10 users in 10,000):
• convulsions
• liver complaints
• mania (a feeling of elation or over-excitement)
• sensitivity to sunlight
• unexpected milk flow
Other side effects reported (frequency cannot be estimated from the available data):
• akathisia (restlessness)
• abnormal taste
• anorgasmy (failure to achieve orgasm)
• for female patients: disorders with menstruation (monthly bleeding)
• micturition disorders (such as the need to urinate frequently during the day and/or the night, the
sudden lack of control over urinating during the day nad/or the night, or the lack of ability to urinate)
• paraesthesia (tingling or numbness)
• weight gain or loss
• low sodium levels in your blood
• glaucoma (eye disease)
• dilated pupils

• withdrawal syndrome (see section 3 How to take Teva Fluvoxamine 50 mg & 100 mg Tablet)
• increase in the hormon prolactin (a hormone that supports milk production in a nursing mother)
An increased risk of bone factures has been observed in patients taking this type of medicines.
Side effects related to the treatment for obsessive-compulsive disorder, in children and
adolescents:
• Mania (a feeling of elation and over excitement)
• Agitation
• Convulsions
• Difficulty sleeping (insomnia)
• Lack of energy (asthenia)
• Hyperactivity (hyperkinesia)
• Drowsy (somnolence)
• Indigestion
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
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: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5.

HOW TO STORE TEVA FLUVOXAMINE 50 mg & 100 mg Tablet

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the outside of the packaging. Do not store
above 25 ºC. Store in the original package. Do not transfer them to another container. This medicine
is for you ONLY, do not give it to anyone else. Unless your doctor tells you to, do not keep these
tablets for longer than you need.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Teva Fluvoxamine 50 mg & 100 mg Tablet contains
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The active substance is 50 mg or 100 mg fluvoxamine maleate
The other ingredients are mannitol, starch, hydroxypropylcellulose, colloidal silica and sodium
stearyl fumarate. The coating contains hypromellose, macrogol, polysorbate, and the
colourings titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and black
iron oxide (E172).

What Teva Fluvoxamine 50 mg & 100 mg Tablet looks like and contents of the pack
50 mg - yellow, film-coated capsule shaped tablet, scored and debossed with “93” on one side (“9”
and “3” on either side of the score-line) and “56” on the other side.

100 mg - pink to light brick, film coated capsule shaped tablet, scored and debossed with “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. See outer packaging or
the pharmacy label for contents i.e. the number of tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Teva pharma B.V. Swensweg 5, 2031 GA Haarlem, The
Netherlands.
Manufacturer: Teva UK Ltd, Eastbourne, BN22 9AG
This leaflet was last revised in October 2015
PL 14776/0051
PL 14776/0052

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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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