Dapoxetine Ibn Al Haytham tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

dapoxetine

Available from:

IBN AL-Haytham Pharma Industries Co.

ATC code:

G04BX14

INN (International Name):

dapoxetine

Dosage:

30mg

Pharmaceutical form:

tablets film-coated

Units in package:

(4/2x2/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-11-17

Patient Information leaflet

Patient Leaflet:
Patient Information on
DAPOXETINE IBN AL HAYTHAM
Film Coated Tablets
Adults use only
Please read all of this leaflet carefully before taking this medicine,
it contains important
information.
• Please keep this leaflet; you might need to read it again
• Talk to your prescribing doctor or pharmacist for additional
information or consultation
• If symptoms worsen, consult your doctor immediately.
• Where any side effect becomes serious or you have noticed any side
effects not listed in this
Patient Leaflet, please talk to your doctor or pharmacist.
THE FOLLOWING INFORMATION IS PROVIDED IN THIS PATIENT LEAFLET:
1. What DAPOXETINE IBN AL HAYTHAM is and what it is used for
2. What you need to know before you take DAPOXETINE IBN AL HAYTHAM
3. How to use DAPOXETINE IBN AL HAYTHAM
4. Possible side effects
5. How to store DAPOXETINE IBN AL HAYTHAM
6. More detailed information
1. WHAT DAPOXETINE IBN AL HAYTHAM IS AND WHAT IT IS USED FOR
DAPOXETINE IBN AL HAYTHAM contains an active substance called
‘dapoxetine’. This
belongs to a group of medicines called ‘selective serotonin reuptake
inhibitors’ (SSRIs).
Dapoxetine may also be known as a ‘urological’ medicine.
Dapoxetine increases the time it takes to ejaculate and can improve
the control over the
ejaculation. This may reduce the frustration or worry about fast
ejaculation.
Dapoxetine is used to treat premature ejaculation in adult men aged 18
to 64 years.
Premature ejaculation is when a man ejaculates with little sexual
stimulation and before
the man wants. This can cause problems for the man and may cause
problems in sexual
relationships.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAPOXETINE IBN AL HAYTHAM
DO NOT TAKE DAPOXETINE IBN AL HAYTHAM IF:

you are allergic to dapoxetine or any of the other ingredients of this
medicine (listed
in section 6)

you have heart problems, such as heart failure or problems with the
heart rhythm

you have a history of fainting

you have ever had mania (symptoms include feeling over−excited,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
DAPOXETINE IBN AL HAYTHAM 30 MG film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains dapoxetine hydrochloride equivalent
to 30 mg dapoxetine.
Excipient with known effect: Lactose. Each 30 mg tablet contains
116.25 mg of
lactose. For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM:
Film-coated tablet
The 30 mg film-coated tablets are green
, oval,
biconvex, film-coated tablet, with score-line on
one side. Length 12.0 mm (±5.0%), width 6.0 mm (±5.0%).
4. CLINICAL PARTICULARS:
4.1- THERAPEUTIC INDICATIONS:
DAPOXETINE IBN AL HAYTHAM 30 MG is indicated for the treatment of
premature ejaculation (PE) in
adult
men aged 18 to 64 years.
DAPOXETINE IBN AL HAYTHAM 30 MG should only be prescribed to patients
who meet all the
following criteria:
• An intravaginal ejaculatory latency time (IELT) of less than two
minutes.
• Persistent or recurrent ejaculation with minimal sexual
stimulation before, on, or shortly after
penetration and before the patient wishes.
• Marked personal distress or interpersonal difficulty as a
consequence of PE.
• Poor control over ejaculation.
• A history of premature ejaculation in the majority of intercourse
attempts over the prior 6
months. DAPOXETINE IBN AL HAYTHAM 30 MG should be administered only as
on-demand
treatment before anticipated sexual activity.
DAPOXETINE IBN AL HAYTHAM 30 MG 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 IBN AL
HAYTHAM 30 MG should not be
initiated with the 60 mg dose.
DAPOXETINE IBN AL HAYTHAM 30 MG is not intended for continuous daily
use. DAPOXETINE
IBN AL HAYTHAM 30 MG should be taken only when sexual activity is
anticipated and must not
be ta