Tadalafil Genericon tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

tadalafil

Available from:

Genericon Pharma Gesellschaft m.b.H.

ATC code:

G04BE08

INN (International Name):

tadalafil

Dosage:

20mg

Pharmaceutical form:

tablets film-coated

Units in package:

(4/1x4/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2023-07-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL GENERICON 20 MG FILM-COATED TABLETS
Active substance: Tadalafil
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 Tadalafil Genericon is and what it is used for
2.
What you need to know before you take Tadalafil Genericon
3.
How to take Tadalafil Genericon
4.
Possible side effects
5
How to store Tadalafil Genericon
6.
Contents of the pack and other information
1.
WHAT TADALAFIL GENERICON IS AND WHAT IT IS USED FOR
Tadalafil Genericon is a treatment for adult men with erectile
dysfunction. This is when a man
cannot get, or keep a hard, erect penis suitable for sexual activity.
Tadalafil has been shown to
significantly improve the ability of obtaining a hard, erect penis
suitable for sexual activity.
Tadalafil Genericon contains the active substance tadalafil which
belongs to a group of medicines
called phosphodiesterase type 5 inhibitors (PDE5 inhibitors).
Following sexual stimulation Tadalafil Genericon works by helping the
blood vessels in your penis
to relax, allowing the flow of blood into your penis. The result of
this is improved erectile function.
Tadalafil Genericon will not help you if you do not have erectile
dysfunction.
It is important to note that Tadalafil Genericon does not work if
there is no sexual stimulation.
You and your partner will need to engage in foreplay, just as you
would if you were not taking a
medicine for erectile dysfunction.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TADALAFIL GENERICON
DO NOT TAKE TADALAFIL

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Genericon 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of tadalafil.
Excipient with known effect:
Each film-coated tablet contains 265 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Yellow coloured, oval shaped, one side scored and other side debossed
with “T 20” biconvex film-
coated tablet of 13.90 x 7.20 mm. The tablet can be divided into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective, sexual stimulation is
required.
Tadalafil Genericon is not indicated for use by women.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult men _
In general, the recommended dose is 10 mg taken prior to anticipated
sexual activity and with or
without food.
In those patients in whom tadalafil 10 mg does not produce an adequate
effect, 20 mg might be tried. It
may be taken at least 30 minutes prior to sexual activity.
The maximum dose frequency is once per day.
Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual
activity and it is not recommended
for continuous daily use.
In patients who anticipate a frequent use of Tadalafil Genericon (i.e.
at least twice weekly) a once daily
regimen with the lowest doses of Tadalafil Genericon might be
considered suitable, based on patient
choice and the physician’s judgement.
In these patients the recommended dose is 5 mg taken once a day at
approximately the same time of
day. The dose may be decreased to 2.5 mg once a day based on
individual tolerability.
The appropriateness of continued use of the daily regimen should be
reassessed periodically.
Special populations
_Elderly men _
Dose adjustments are not required in elderly patients.
_Men with renal impairment _
Dose adjustments are not required in patients with mild to moderate
renal impairme