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FLUVOXAMINE 50 MG FILM COATED TABLETS

Active substance(s): FLUVOXAMINE MALEATE

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Package leaflet: Information for the user
Fluvoxamine 50 mg & 100 mg tablets
fluvoxamine maleate












Fluvoxamine 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.
Fluvoxamine should not be used to treat depression in children and adolescents under 18. See
section 2, Use in Children and adolescents under 18.
Fluvoxamine 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 Fluvoxamine without talking to your doctor. If you stop taking Fluvoxamine
suddenly or miss a dose, you may get withdrawal effects. See Section 3, How to take Fluvoxamine.
If you feel restless and feel like you can't sit or stand still, tell your doctor. Increasing the dose of
Fluvoxamine may make these feelings worse.
Taking some other medicines with Fluvoxamine 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. What Fluvoxamine is and what it is used for
2. Before you take Fluvoxamine
3. How to take Fluvoxamine
4. Possible side effects
5. How to store Fluvoxamine
6. Further information
1. What Fluvoxamine is and what it is used for

Fluvoxamine belongs to a group of medicines called selective serotonin re-uptake inhibitors (SSRQ.
Fluvoxamine contains a substance called Fluvoxamine. This is an antidepressant. It is used to treat
depression (major depressive episode).
Fluvoxamine can also treat people who have obsessive compulsive disorder (OCD).
2. Before you take Fluvoxamine
Do not take Fluvoxamine 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 MAOQ may be used
with Fluvoxamine provided the doctor can monitor you closely. Your doctor will advise you how you
should begin taking Fluvoxamine 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 Fluvoxamine 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 Fluvoxamine')
If any of the above applies to you, your doctor will tell you whether it is safe for you to start taking
Fluvoxamine.
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 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
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 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 Fluvoxamine 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.
If your doctor has prescribed Fluvoxamine 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 develop or
worsen when patients under 18 are taking Fluvoxamine.
Also, it is not known whether taking Fluvoxamine under the age of 18 years can affect growth, maturation
or development of intelligence or behaviour in the long term.
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.
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
Fluvoxamine since this may result in an increase of undesirable effects. If you are already taking St



John's Wort when you start on Fluvoxamine, 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 Fluvoxamine.
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. Fluvoxamine 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 Fluvoxamine with food and drink



Do not drink alcohol if you are taking this medicine. This is because alcohol works together with
Fluvoxamine 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 Fluvoxamine
How much Fluvoxamine to take
Always take Fluvoxamine 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.
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 Fluvoxamine


Swallow the tablets with water. Do not chew them.

The tablet can be divided into equal halves. You can break the tablets in half if your doctor has advised
you to
How long does it take to work?
Fluvoxamine 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 Fluvoxamine 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 Fluvoxamine 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 Fluvoxamine 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
Fluvoxamine, 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').
If you experience any symptoms on stopping the treatment, contact your doctor.
If you take more Fluvoxamine than you should
If you or someone else takes too much Fluvoxamine (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 drowsy 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 Fluvoxamine
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 Fluvoxamine 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 Fluvoxamine, 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 Fluvoxamine and contact your doctor immediately.
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.
Stopping of fluvoxamine (particularly when abrupt) commonly leads to withdrawal symptoms (see
section 3 withdrawal symptoms).
Sometimes patients feel slightly sick as Fluvoxamine 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.
Side effects specifically related to Fluvoxamine
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

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)
• 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 Oncreased pressure in eye)
• dilated pupils
• increase in the hormone prolactin (a hormone that supports milk production in a nursing mother)
• weight changes
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)
• Drowsy (somnolence)
• Indigestion
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 Website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.

Also, it is not known whether taking Fluvoxamine under the age of 18 years can affect growth, maturation
or development of intelligence or behaviour in the long term.
5. How to store Fluvoxamine
• Keep out of the sight and reach 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. Contents of the pack and other information

What Fluvoxamine 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 Fluvoxamine looks like and contents of the pack
The Fluvoxamine 50 mg tablet is film-coated, white to off white, round and marked "291" on both sides
of the score line.
The Fluvoxamine 100 mg tablet is film-coated, white to off-white, oval and marked "313" on both sides
of the score line.
Fluvoxamine 50 mg is available in packs of 5, 10, 20, 30, 50, 60, 90, 100 and 250 tablets.
Fluvoxamine 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.

The marketing authorisation holder is
Abbott Laboratories Ltd.,
Abbott House, Vanwall Business Park,
Vanwall Road, Maidenhead, Berkshire, SL6 4XE, UK.
Fluvoxamine is made by
Mylan Laboratories SAS
Route de Belleville
Lieu-dit Maillard
01400 Châtillon-sur-Chalaronne
France
This medicinal product is authorized in the Member States of the EEA under the following names:
France Fluvoxamine
United Kingdom Fluvoxamine
Date of Revision: 10/2017

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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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