TRO-SILDENAFIL 100mg tablets film-coated

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

sildenafil (sildenafil citrate)

Dostopno od:

S Kant Healthcare LTD

Koda artikla:

G04BE03

INN (mednarodno ime):

sildenafil (sildenafil citrate)

Odmerek:

100mg

Farmacevtska oblika:

tablets film-coated

Enote v paketu:

(4/1x4/) in blister, (30) box

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2018-05-29

Lastnosti izdelka

SUMMARY PRODUCT
CHARACTERISTICS
for:
TRO-SILDENAFIL
100 mg
film-coated Tablets
TROGE
®
Register-Nr. HRB 35614
DEPARTMENT FOR SCIENTIFIC RESEARCH AND PRODUCT DEVELOPMENT
DEPARTMENT FOR INTERNATIONAL REGULATORY AFFAIRS
– March2017 –
PRODUCT:
TRO-SILDENAFIL 100 MG
film-coated tablets
SUMMARY OF PRODUCT CHARACTERISTICS
TROGE MEDICAL GMBH · HAMBURG · GERMANY
1.
NAME OF THE MEDICINAL PRODUCT
TRO-SILDENAFIL 100 mg
film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg Sildenafil (in form of Sildenafil citrate)
Excipients with known effect
Each tablet contains 170 mg of lactose as monohydrate
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
_Film-coated tablets for oral use. _
Description: TRO-SILDENAFIL 100 mg film-coated tablets are blue
coloured
and diamond shaped. They are embossed with “100” on one side and
plain on
the other side.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
TRO-SILDENAFIL 100 mg film-coated tablets is indicated in adult men
with
erectile dysfunction, which is the inability to achieve or maintain a
penile
erection sufficient for satisfactory sexual performance.
In order for TRO-SILDENAFIL 100 mg film-coated tablets to be
effective,
sexual stimulation is required.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
This strength is not suitable for dosages below 100 mg.
PRODUCT:
TRO-SILDENAFIL 100 MG
film-coated tablets
SUMMARY OF PRODUCT CHARACTERISTICS
TROGE MEDICAL GMBH · HAMBURG · GERMANY
Other medicinal products of Sildenafil in adequate strength are
available.
_Use in Adults _
The recommended dose is 50 mg taken as needed approximately one hour
before sexual activity. Based on efficacy and tolerability, the dose
may be
increased to 100 mg or decreased to 25 mg. The maximum recommended
dose
is 100 mg. The maximum recommended dosing frequency is once per day.
If
TRO-SILDENAFIL 100 mg film-coated tablets is taken with food, the
onset
of activity may be delayed compared to the fasted state (see section
5.2).
Special