Dapoxem 60 Tablets

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Dapoxetine Hydrochloride

Available from:

MSN Laboratories Private Limited , INDIA

ATC code:

Other urologicals incl. Antispasmodics

INN (International Name):

Dapoxetine Hydrochloride

Dosage:

60

Pharmaceutical form:

Tablets

Manufactured by:

MSN Laboratories Private Limited (Formulations Division), , INDIA

Product summary:

Physical description: Grey coloured, round, biconvex, film-coated tablets with plain surface on both sides.; Local technical representative: Reddy's Pharma Limited (6041)

Authorization status:

Registered/Compliant

Authorization date:

2023-03-02

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
DAPOXEM 30/ 60
Dapoxetine
film-coated tablets
30 mg/ 60 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains
Dapoxetine Hydrochloride equivalent to Dapoxetine 30 mg/ 60 mg
Product contains Lactose.
For the full list of excipients, see section 6.1.
_3._
_ _
PHARMACEUTICAL FORM
Film-coated tablet.
_Dapoxetine Tablets 30 _
_mg _
Grey colored, round, biconvex, film coated tablets with plain surface
on both sides.
_Dapoxetine Tablets 60 mg _
Grey colored, round, biconvex, film coated tablets with plain surface
on both sides.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dapoxetine Tablets is indicated for the treatment of premature
ejaculation (PE) in adult men
aged 18 to 64 years.
•
Dapoxetine Tablets should only be prescribed to patients who meet all
the following
criteria:
•
An intravaginal ejaculatory latency time (IELT) of less than two
minutes; and
•
Persistent or recurrent ejaculation with minimal sexual stimulation
before, on, or
shortly after penetration and before the patient wishes; and
•
Marked personal distress or interpersonal difficulty as a consequence
of PE; and
•
Poor control over ejaculation; and
•
A history of premature ejaculation in the majority of intercourse
attempts over the
prior 6 months.
Dapoxetine Tablets should be administered only as on-demand treatment
before anticipated
sexual activity. Dapoxetine Tablets should not be prescribed to delay
ejaculation in men who
have not been diagnosed with PE.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult men (aged 18 to 64 years) _
The recommended starting dose for all patients is 30 mg, taken as
needed approximately 1
to 3 hours prior to sexual activity. Treatment with Dapoxetine Tablets
should not be initiated
with the 60 mg dose.
Dapoxetine Tablets is not intended for continuous daily use.
Dapoxetine Tablets should be
taken only when sexual activity is anticipated. Dapoxetine Tablets
must not be taken more
frequently than once every 24 hours.
If the individual