Fluvoxamine 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluvoxamine maleate

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

N06AB08

INN (International Name):

Fluvoxamine maleate

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030300

Patient Information leaflet

Pharma code 691
TAKING OTHER MEDICINES
DO NOT TAKE FLUVOXAMINE IN COMBINATION WITH:
•
antidepressants known as MAOIs (monoamine
oxidase inhibitors) e.g. phenelzine, moclobemide.
You should not take Fluvoxamine until at least 14 days
after you have stopped taking an MAOI.
If you stop treatment with Fluvoxamine, you should
wait at least 1 week before starting any treatment with
a MAOI.
•
terfenadine or astemizole to treat allergies such as hay
fever
•
tizanidine (used as a muscle relaxant)
•
cisapride (used for stomach problems).
If you are taking any of these medicines, DO NOT take
Fluvoxamine, and return to your doctor to discuss your
treatment.
TALK TO YOUR DOCTOR IF YOU ARE TAKING ANY OF THE FOLLOWING:
•
any other antidepressants such as amitriptyline,
clomipramine, imipramine, lithium or tryptophan
•
other SSRIs for depression or obsessive-compulsive
disorders such as fluoxetine
•
St. John’s Wort_ _(_Hypericum perforatum_), a herbal
remedy used for depression
•
any benzodiazepines (used to treat anxiety and
insomnia) such as midazolam, triazolam, diazepam or
alprazolam
•
any antipsychotic drugs (used to treat mental illnesses)
such as risperidone, chlorpromazine or haloperidol
•
antidiabetic agents
•
carbamazepine or phenytoin (used to treat epilepsy)
•
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
•
tramadol (a painkiller) or methadone (used to treat
severe pain or in the management of drug dependency)
•
anticoagulants (used to prevent blood clots) such as
warfarin
•
ropinirole (used to treat Parkinson’s disease)
•
tacrine (used to treat Alzheimer’s disease)
•
sildenafil (used to treat erectile dysfunction (impotence)).
Please tell your doctor or pharmacist if you are taking,
have recently taken or might take any other medicines.
FLUVOXAMINE WIT

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluvoxamine 100 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: fluvoxamine maleate
Each film-coated tablet contains fluvoxamine as 100 mg of fluvoxamine
maleate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
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 tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Major depressive episode.
•
Obsessive Compulsive Disorder (OCD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Fluvoxamine tablets should be swallowed with water and without
chewing.
_Depression _
_Adults _
The recommended dose is 100 mg daily. Patients should start on 50 or
100 mg, given as a
single dose in the evening. Dosage should be reviewed and adjusted if
necessary within 3 to 4
weeks of initiation of therapy and thereafter as judged clinically
appropriate. Although there
may be an increased potential for undesirable effects at higher doses,
if after some weeks on
the recommended dose insufficient response is seen some patients may
benefit from having
their dose increased gradually up to a maximum of 300 mg a day. Doses
up to 150 mg can be
given as a single dose, preferably in the evening. It is advisable
that a total daily dose of more
than 150 mg is given in 2 or 3 divided doses. Dosage adjustments
should be made carefully
on an individual patient basis, to maintain the patients at the lowest
effective dose.
Patients with depression should be treated for a sufficient period of
at least 6 months to ensure
that they are free from symptoms.
_Children/adolescents _
Fluvoxamine should not be used in children and adolescents under the
age of 18 years for the
treatment of major depressive episode. The efficacy and safety of
fluvoxamine have not been
established in the treatment of paediatric