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FLUVOXAMINE 100 MG FILM-COATED TABLETS

Active substance(s): FLUVOXAMINE MALEATE / FLUVOXAMINE MALEATE

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PATIENT INFORMATION LEAFLET


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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 treatments
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 the age of 18 years”.
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 “Other medicines and Fluvoxamine”.
If you are pregnant or planning to get pregnant, talk to your doctor. See section 2 “Pregnancy,
breastfeeding and fertility”.










Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please 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 illness 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.
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1

What Fluvoxamine is and what it is used for
What you need to know before you take Fluvoxamine
How to take Fluvoxamine

What Fluvoxamine is and what
it is used for

Fluvoxamine belongs to a group of medicines called
Selective Serotonin Re-uptake Inhibitor (SSRI)
antidepressants. SSRI’s work by increasing the levels of
the chemical serotonin in the brain.
Serotonin is a neurotransmitter (a messenger that
carries signals between nerve cells in the brain). After
carrying a message, serotonin is usually reabsorbed by
the nerve cells (this is known as “reuptake”). SSRIs
work by blocking (“inhibiting”) reuptake, enabling more
serotonin to pass further messages between nearby
nerve cells.
Fluvoxamine is used to treat the following:
• Depressive illness (major depressive episodes)
• Anxiety disorder (Obsessive-Compulsive Disorder
[OCD])

2

What you need to know before
you take Fluvoxamine

Do not take Fluvoxamine if:
• You are allergic (hypersensitive) to Fluvoxamine,
other SSRI antidepressants or any of the other
ingredients of this medicine (see section 6 “Contents
of the pack and other information”).
• You are taking tizanidine, a muscle relaxant (see
“Other medicines and Fluvoxamine” section)
• You are taking Monoamine Oxidase Inhibitors
(MAOIs), medicines used to treat depression.
Treatment with Fluvoxamine can be started 2 weeks
after discontinuing treatment with an irreversible
MAOI, or the following day after discontinuing
treatment with a reversible MAOI (e.g. moclobemide,
linezolid). At least 1 week should elapse between
discontinuing treatment with Fluvoxamine and
starting treatment with any MAOI.
Warnings and precautions
Talk to your doctor before taking Fluvoxamine:
• If you are diabetic as the dose of your diabetic
medicine may need to be adjusted.
• If you suffer from liver or kidney disorders, as you
should start on a low dose and be carefully
monitored.
• If you start to feel restless and cannot sit or stand still
(akathisia). This is most likely to occur within the first
few weeks of treatment. If you develop these
symptoms, increasing the dose may be detrimental
and it may be necessary to review the use of
Fluvoxamine.
• If you have recently had a heart attack (myocardial
infarction).
• If you have a history of convulsive disorders.
Fluvoxamine should be discontinued. Treatment with
Fluvoxamine should be avoided if you have unstable
epilepsy. If your epilepsy is controlled you should be
carefully monitored. Treatment with Fluvoxamine
should be discontinued if fits (seizures) occur or if
frequency increases.
• If you have a history of mania feeling/being elated or
over-excited), which causes unusual behaviour. If
you have a manic phase treatment with Fluvoxamine
may need to be discontinued.
• If you have a history of bleeding disorders or if you
are taking medicines which may increase the risk of
bleeding (see “Other medicines and Fluvoxamine”):
o Medicines used to treat mental health problems
(anti-psychotics)
o Phenothiazines, medicines used to treat serious
mental and emotional disorders and also severe
nausea (feeling sick) and vomiting (being sick)
o Most tricyclic antidepressants, medicines used
to treat depression
o Aspirin, a medicine used to treat mild to
moderate pain, to reduce fever or inflammation
o Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs), medicines used to treat certain
rheumatic disorders
• If you are receiving ECT (Electro-Convulsive
Therapy) treatment.
• If you are taking serotonergic medicines
(antidepressants) and/or neuroleptic (anti-psychotic)
medicines as on rare occasions, development of
serotonin syndrome or neuroleptic malignant
syndrome have occurred (see ‘Other medicines and
Fluvoxamine” section). As these syndromes may
result in potentially life-threatening conditions,
treatment with Fluvoxamine should be discontinued if
such symptoms (fever (hyperthermia), muscle
stiffness, involuntary muscle twitching (myoclonus),
confusion, irritability, extreme agitation, delirium and
coma) should occur.
• If you are taking linezolid (an antibiotic which is a
reversible relatively weak non-selective MAOI – see
“Other medicines and Fluvoxamine” section). In
exceptional circumstances linezolid can be given in
combination with Fluvoxamine but you should be
closely monitored.
• If you are at risk of abnormally low levels of salt
(sodium) in the blood (hyponatremia), particularly if
you are an older person.
• If you have or at risk of increased pressure in the eye
(glaucoma) as Fluvoxamine can cause dilation of the
pupils (mydriasis).
• If you are taking terfenadine or astemizole,
medicines used to treat allergic conditions (see
“Other medicines and Fluvoxamine” section).
• If you are taking cisapride, a medicine used to treat
gastrointestinal disorders (see “Other medicines and
Fluvoxamine” section).
• If you are an older person, your dose of Fluvoxamine
should be increased more slowly and with extra
caution.
Withdrawal symptoms (following discontinuation of
treatment with Fluvoxamine)
See section 3 “If you stop taking Fluvoxamine” and
section 4 “Possible side effects".
The risk of withdrawal symptoms may be dependent on
the duration and dose of treatment and the rate of dose
reduction.
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

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Possible side effects
How to store Fluvoxamine
Contents of the pack and other information

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.
Use in children and adolescents under the age of 18
years:
Fluvoxamine should not be used in the treatment of
children and adolescents under the age of 18 years,
except for patients over 8 years with
Obsessive-Compulsive Disorder (OCD). Patients under
the age of 18 years are at an increased risk of
suicide-related behaviours (suicide attempt and suicidal
thoughts) and hostility (predominantly aggression,
oppositional behaviour and anger) when treated with
antidepressants. If a decision to treat with Fluvoxamine
is taken, the patient should be carefully monitored for
the appearance of suicidal symptoms. Additionally,
limited evidence is available concerning long-term effect
on safety in children and adolescents, including effects
on growth, puberty and mental, emotional and
behavioural developments.
Other medicines and Fluvoxamine
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including those obtained without a prescription. This
includes herbal medicines.
Medicines which may interact with or be affected by
Fluvoxamine:
• Monoamine Oxidase Inhibitors (MAOIs), medicines
used to treat depression (see “Do not take
Fluvoxamine” section)
• Selective Serotonin Reuptake Inhibitors, medicines
used to treat depression
• Lithium, a medicine used to treat mood disorders
(antipsychotic)
• Tryptophan, a dietary supplement
• Medicines used to treat migraines and cluster
headaches (triptans)
• Tramadol, a pain-relieving medicine
• St. John’s Wort, a herbal remedy used to treat
depression
• Medicines used to treat depression e. g.
clomipramine, imipramine, amitriptyline (tricyclic
antidepressants). A decrease in the dose of these
medicines should be considered if treatment with
Fluvoxamine is started
• Medicines used to treat mental health disorders e.g.
clozapine, olanzapine, quetiapine, thioridazine
(neuroleptics). A decrease in the dose of these
medicines should be considered if treatment with
Fluvoxamine is started
• Tizanidine, a muscle relaxant
• Tacrine, a medicine used to treat mild to moderate
dementia
• Theophylline, a medicine used to treat breathing
disorders
• Methadone, a synthetic opiate used as a treatment
for opioid dependency
• Mexiletine and propranolol, medicines used to treat
heart disorders
• Ropinirole, a medicine used to treat Parkinson’s
Disease
• Caffeine (see “Taking Fluvoxamine with food and
drink and alcohol” section)
• Phenytoin, carbamazepine, medicines used to treat
and prevent fits (seizures)
• Terfenadine, astemizole, medicines used to treat
allergic conditions
• Cisapride, a medicine used to treat gastrointestinal
disorders
• Sildenafil, a medicine used to treat erectile
dysfunction
• Ciclosporin, a medicine used to reduce the body’s
immunity when receiving organ transplant
• Medicines used to calm and relieve anxiety disorders
e.g. triazolam, midazolam, alprazolam and diazepam
(benzodiazepines). The dose of these
benzodiazepines should be reduced during
co-administration with Fluvoxamine
• Warfarin, a medicine used to thin the blood
(anticoagulant) as the risk of haemorrhage may
increase
Taking Fluvoxamine with food and drink and alcohol
• It is not recommended to drink alcohol whilst taking
Fluvoxamine.
• You should lower your intake of caffeine-containing
beverages (tea, coffee, cola etc) when taking
Fluvoxamine as adverse effects like shakiness
(tremor), feeling your heartbeat (palpitations), feeling
sick (nausea), restlessness and difficulty in sleeping
(insomnia) may occur.
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 for advice before taking this medicine.
Pregnancy
Fluvoxamine should not be used if you are pregnant
unless your clinical condition requires treatment with
Fluvoxamine.
When taking Fluvoxamine during pregnancy, particularly
in the last months of pregnancy, there is an increased
risk of the development of a very serious condition in
babies, called Persistent Pulmonary Hypertension in the
Newborn (PPHN). This occurs when the baby does not
change over from foetal to normal newborn circulation
which decreases the baby’s supply of oxygen.
Isolated cases of withdrawal symptoms in newborn
children have been reported following the use of
Fluvoxamine at the end of pregnancy.
Following treatment with Fluvoxamine during the last 3
months of pregnancy, some newborns have
experienced feeding and/or breathing difficulties, fits
(seizures), temperature instability, low blood sugar
levels (hypoglycaemia), shakiness (tremor), abnormal
muscle tone, jitteriness, abnormal blue discoloration of
the skin (cyanosis), irritability, a lack of energy (lethargy),
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sleepiness or drowsiness (somnolence), being sick
(vomiting), difficulty in sleeping and constant crying and
may require prolonged hospitalisation.



Breast-feeding
If you are breast-feeding, Fluvoxamine should not be
taken as Fluvoxamine is passed into breast milk.




Fertility
Fluvoxamine should not be used if you are attempting to
conceive a baby unless your clinical condition requires
treatment with Fluvoxamine.
Driving and using machines
Fluvoxamine may cause sleepiness or drowsiness
(somnolence). If symptoms are experienced, it may be
necessary to avoid driving or operating machinery or
pursuing any activity in which full attention is required.
Fluvoxamine contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.






Lack of voluntary co-ordination of muscle
movements [unsteadiness or clumsiness] (ataxia)
Medicine-induced movement disorders
(Extrapyramidal Symptoms [EPS])
Confusional stage
Seeing or hearing things that are not real
(hallucinations)
Delayed ejaculation
Skin disorders (rash, severe itching [pruritis])

Rare side effects (may affect up to 1 in 1000 people)
• Liver function disorders
• Fits (convulsions)
• Feeling/being elated or over-excited, which causes
unusual behaviour (mania)
• Milky secretion from the breasts not due to
breast-feeding (galactorrhoea)
• Abnormal sensitivity of the skin to sunlight
(photosensitivity)

Other side effects (frequency not known)
• Bleeding from the stomach, gums or bottom
(gastrointestinal haemorrhage)
• Bruising (ecchymosis)
How to take Fluvoxamine
• Skin rash caused by small blood vessels bleeding
into the skin (purpura)
Always take Fluvoxamine exactly as your doctor
• Syndrome of Inappropriate Anti-Diuretic Hormone
has told you. You should check with your doctor or
secretion (SIADH). Anti-Diuretic Hormone (ADH) is
pharmacist if you are not sure.
produced by the brain and is stored in & released by
• The tablets should be swallowed without chewing
the pituitary gland. ADH controls how your body
and with water.
releases and conserves water. SIADH occurs when
• The score line on the tablet is only to facilitate
ADH is produced somewhere other than the brain,
breaking for ease of swallowing and not to divide the
which makes it difficult for your body to get rid of
tablet into equal doses.
excess water. This causes a build-up of fluids as
well as abnormally low sodium levels
Depression
• Abnormally high levels of prolactin in the blood
Adults:
(hyperprolactinaemia)
• The recommended dose is 100mg daily.
• Abnormally low levels of salt (sodium) in blood
• The starting dose is 50mg or 100mg, given as a
(hyponatremia)
single dose in the evening.
• Weight gain or loss
• Your dose should be reviewed and adjusted if
• Serotonin syndrome (a group of symptoms together
necessary within 3 to 4 weeks of starting treatment
e.g. abnormally high body temperature, rigidity,
with Fluvoxamine.
muscle spasms, confusion, irritability, agitation)
• It is recommended to increase the dose gradually
• Neuroleptic malignant syndrome-like effects (a
until an effective dose is reached. The usual effective
group of symptoms together e.g. rigidity, fever,
dose is 100mg daily.
sweating, high blood pressure, agitation, delirium,
• If after some weeks on the recommended dose,
coma)
insufficient response has been achieved, the dose
• Tingling or numbness in the hands or feet
may be increased gradually up to 300mg daily.
(paraesthesia)
• Doses up to 150mg can be given as a single dose,
• Taste disturbances
preferably in the evening. Doses above 150mg
• Extreme restlessness accompanied by an increase
should be given in 2 or 3 divided doses.
in muscle spasms, tremors and twitching
• Treatment should be continued for at least 6 months
(psychomotor restlessness) or restlessness
after recovery from a depressive episode. A dose of
(akathisia)
100mg daily may be sufficient for this use.
• Increased pressure in the eye (glaucoma)
Children and adolescents under the age of 18 years: • Dilation of the pupil of the eye (mydriasis)
• Connective tissue and bone disorders
Fluvoxamine should not be used for the treatment of
• Bone fractures
major depressive episodes in children and adolescents
• Difficulty reaching orgasm even after sexual
under the age of 18 years of age (see “Warnings and
stimulation (anorgasmia)
precautions” section).
• Menstrual disorders including lack of menstrual
Obsessive-Compulsive Disorders (OCD)
periods (amenorrhea), extremely light menstrual
Adults:
blood flow (hypomenorrhea), bleeding from the
• The recommended starting dose is 50mg per day for
uterus between menstrual periods (metrorrhagia),
3-4 days.
abnormally heavy and prolonged menstrual period
• The effective dose is usually between 100mg and
at regular intervals (menorrhagia)
300mg per day.
• Urinary (micturition) disorders including urinary
• If after some weeks on the recommended dose,
retention, incontinence, frequent need to urinate
insufficient response has been achieved, the dose
(pollakiuria), a need to wake and pass urine at night
may be increased gradually up to a maximum of
(nocturia) and repeated inability to control urination
300mg per day.
(enuresis)
• Doses up to 150mg can be given as a single dose,
• In children and adolescents with Obsessive
preferably in the evening. A total daily dose of more
Compulsive Disorder (OCD), reported adverse
than 150mg should be given in 2 or 3 divided doses.
effects included difficulty in sleeping (insomnia),
• If no improvement is observed within 10 weeks,
general weakness (asthenia), restlessness
treatment with Fluvoxamine should be reconsidered.
(agitation), abnormal amount of uncontrolled
muscular action (hyperkinesia), sleepiness or
Children and adolescents under the age of 18 years:
drowsiness (somnolence), indigestion (dyspepsia)
• The starting dose is 25mg per day.
and feeling over-excited (hypomania). Convulsions
• Increase every 4-7 days in 25mg increments until an
have also been reported
effective dose is achieved.
• The maximum dose in children should not exceed
Withdrawal symptoms
200mg per day.
Discontinuation of Fluvoxamine (particularly when
• It is advisable that a total daily dose of more than
abrupt) commonly leads to withdrawal symptoms.
50mg should be given in two divided doses. If the
Dizziness, sensory disturbances (including tingling or
two divided doses are not equal, the larger dose
numbness in the hands or feet [paraesthesia], visual
should be given at bedtime.
disturbances and electric shock sensations), sleep
disturbances (including difficulty in sleeping [insomnia]
Patients with liver and/or kidney disorders
and intense dreams), restlessness (agitation) and
You should start on a low dose and be carefully
anxiety, irritability, confusion, emotional instability,
monitored.
feeling sick (nausea) and/or being sick (vomiting) and
diarrhoea, sweating and palpitations, headache and
Withdrawal symptoms (following discontinuation of
tremor are the most commonly reported.
treatment with Fluvoxamine)
Generally these symptoms are mild to moderate,
See “If you stop taking Fluvoxamine” section and
however, in some patients they may be severe and/or
section 4 “Possible side effects".
prolonged.
They usually occur within the first few days of
If you take more Fluvoxamine than you should
discontinuing treatment. Generally, these symptoms
If you accidentally take too many tablets, contact your
usually resolve within 2 weeks, though in some patients
doctor or nearest hospital emergency department
they may be prolonged (2-3 months or more).
immediately for advice. Remember to take this leaflet
It is therefore advised to discontinue treatment
or any remaining tablets with you.
Symptoms of overdose include: feeling sick (nausea), gradually over a period of several weeks or months.
being sick (vomiting), diarrhoea, sleepiness or
Reporting of side effects
drowsiness (somnolence), dizziness, faster heartbeat
If you get any side effects, talk to your doctor or
(tachycardia), slower heartbeat (bradycardia), low blood
pharmacist. This includes any possible side effects not
pressure (hypotension), liver function disturbances, fits
listed in this leaflet. You can also report side effects
(convulsions) and coma.
directly via the internet at
www.mhra.gsi.gov.uk/yellowcard. By reporting side
If you forget to take Fluvoxamine
effects you can help provide more information on the
Take it as soon as you remember, unless it is nearly
safety of this medicine.
time for your next dose. If you miss a dose, do not take
a double dose to make up for a forgotten dose.

3

If you stop taking Fluvoxamine
• It is important to keep taking Fluvoxamine for as long
as your doctor has told you to.
• Abrupt discontinuation should be avoided.
• When stopping treatment with Fluvoxamine the dose
should be gradually reduced over a period of at least
1 or 2 weeks in order to reduce the risk of withdrawal
reactions (see section 4 “Possible side effects").
• If intolerable symptoms occur following a decrease in
the dose or upon discontinuation of treatment of
Fluvoxamine, then resuming the previously
prescribed dose may be considered or continuing to
decrease the dose, but at a more gradual rate.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, Fluvoxamine can cause side effects,
although not everybody gets them.
Seek medical advice immediately if you develop the
following symptoms:
• Distressing thoughts of harming yourself or
committing suicide
• Allergic reactions; swelling of the face, throat or
tongue, fever, difficulty in breathing, dizziness
• Swelling of the deeper layers of the skin caused by
a build-up of fluid (angioneurotic oedema)
Common side effects (may affect up to 1 in 10
people)
• General weakness (asthenia)
• Generally feeling unwell (malaise)
• Feeling your heartbeat (palpitations)
• Faster heartbeat (tachycardia)
• Abdominal pain
• Constipation
• Diarrhoea
• Dry mouth
• Indigestion (dyspepsia)
• Feeling sick (nausea). This usually diminishes within
the first 2 weeks of treatment
• Being sick (vomiting)
• Restlessness (agitation)
• Dizziness
• Headache
• Difficulty in sleeping (insomnia)
• Nervousness
• Sleepiness or drowsiness (somnolence)
• Shakiness (tremor)
• Anxiety
• Sweating, excessive sweating (hyperhidrosis)
• Loss of appetite (anorexia)
Uncommon side effects (may affect up to 1 in 100
people)
• Low blood pressure when changing position
(postural hypotension)
• Pain or swelling in the joints (arthralgia)
• Muscle pain (myalgia)

5







How to store Fluvoxamine

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the carton/blister after EXP. The expiry
date refers to the last day of that month.
Do not store above 25°C. Store in the original
package in order to protect from light and moisture.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These
measures will help to protect the environment.

6

Contents of the pack and other
information

What Fluvoxamine contains
• Each 50mg tablet contains 50mg of fluvoxamine
maleate
• Each 100mg tablet contains 100mg of fluvoxamine
maleate
The other ingredients are: lactose monohydrate,
mannitol, maize starch, hypromellose, polyethylene
glycol 4000, pregelatinized starch, sodium stearyl
fumarate, colloidal anhydrous silica, titanium dioxide
(colouring agent E 171)
What Fluvoxamine look like and contents of the
pack:
• Fluvoxamine 50mg are white, biconvex, round,
scored, film-coated tablets with a diameter 8.8 9.2mm and height of 3.6 - 4.1mm
• Fluvoxamine 100mg are white, biconvex, round,
scored, film-coated tablets with a diameter 11.8 12.2mm and height of 4.8 – 5.2mm
Fluvoxamine is available in:
Fluvoxamine tablets are available in packs of 15, 20, 30,
40, 50, 60, 90, or 100 tablets.
Not all pack sizes may be marketed.
Product Licence Numbers:
Fluvoxamine 50mg Tablets: PL 11311/0488
Fluvoxamine 100mg Tablets: PL 11311/0489
Marketing Authorisation Holder:
Tillomed Laboratories Ltd
3 Howard Road
Eaton Socon
St. Neots
Cambridgeshire
PE19 8ET
United Kingdom
Manufacturer:
Salutas Pharma GMBH
Otto-von-Guericke-Allee 1
D-39179 Barleben
Germany
This leaflet was last revised in February 2015
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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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