FAVERIN 50 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-04-2024
Summary of Product characteristics
(SPC)
19-04-2024
Active ingredient:
FLUVOXAMINE MALEATE
Available from:
Abbott Healthcare Products Ltd
INN (International Name):
FLUVOXAMINE MALEATE
Dosage:
50 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
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
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Faverin 50 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg fluvoxamine maleate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex, scored, white to off-white film coated tablets imprinted '291' on both sides of the score.
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
_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 (see section 5.1). 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_
Faverin 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 Faverin have not bee
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