Efevelon XL 75mg prolonged-release capsules, hard

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VENLAFAXINE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

N06AX16

INN (International Name):

VENLAFAXINE 75 mg

Pharmaceutical form:

PROLONGED-RELEASE HARD CAPSULE

Composition:

VENLAFAXINE 75 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2009-07-28

Patient Information leaflet

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Dupnitsa
Item number: AAAJ1388
Venlafaxine SR 37.5mg, 75mg, 150mg, PIL, Malta
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, 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.
WHAT IS IN THIS LEAFLET:
1. What Efevelon XL is and what it is used for
2. What you need to know before you take Efevelon XL
3. How to take Efevelon XL
4. Possible side effects
5. How to store Efevelon XL
6. Contents of the pack and other information
1. WHAT EFEVELON XL IS AND WHAT IT IS USED FOR
Efevelon XL is an antidepressant that belongs to a group of medicines
called serotonin and norepinephrine reuptake inhibitors (SNRIs). This
group of medicines is used to treat depression and other conditions
such as anxiety disorders. It is thought that people who are depressed
and/or anxious have lower levels of serotonin and noradrenaline in the
brain. It is not fully understood how antidepressants work, but they
may help by increasing the levels of serotonin and noradrenaline in
the
brain.
Efevelon XL is a treatment for adults with depression. Efevelon XL
is also a treatment f

Summary of Product characteristics

SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Efevelon XL 37.5 mg prolonged-release capsules, hard
Efevelon XL 75 mg prolonged-release capsules, hard
Efevelon XL 150 mg prolonged-release capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[For 37.5 mg strength:]
One capsule contains venlafaxine hydrochloride, equivalent to 37,5 mg
of venlafaxine.
Excipients with known effect:
sucrose max. 46.35 mg
ponceau 4R red (E124) 0.0267 mg
[For 75 mg strength:]
One capsule contains venlafaxine hydrochloride, equivalent to 75 mg of
venlafaxine.
Excipients with known effect:
sucrose max. 92.69 mg
sunset yellow FCF (E110) 0.0006 mg
[For 150 mg strength:]
One capsule contains venlafaxine hydrochloride, equivalent to 150 mg
of venlafaxine.
Excipients with known effect:
sucrose max. 185.38 mg
sunset yellow FCF (E110) 0.0183mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release capsule, hard.
Efevelon XL 37.5 mg prolonged-release capsules, hard:
White to off-white granules in a capsule size “3” with an orange
cap and transparent body.
Efevelon XL 75 mg prolonged-release capsules, hard:
White to off-white granules in a capsule size “1” with a yellow
cap and transparent body.
Efevelon XL 150 mg prolonged-release capsules, hard:
White to off-white granules in a capsule size “0” with a buff cap
and transparent body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Treatment of major depressive episodes.

For prevention of recurrence of major depressive episodes.

Treatment of generalised anxiety disorder.

Treatment of social anxiety disorder

Treatment of panic disorders, with or without agoraphobia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
MAJOR DEPRESSIVE EPISODES
The recommended starting dose for prolonged-release venlafaxine is 75
mg given once daily. Patients
not responding to the initial 75 mg/day dose may benefit from dose
increases up to a maximum dose
of 375 mg/day. Dosage increases can be made at intervals of 2 w