Sildenafil STADA 25 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

SILDENAFILCITRAAT 35,1 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 25 mg/stuk

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

G04BE03

INN (Algemene Internationale Benaming):

SILDENAFILCITRAAT 35,1 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 25 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CARMELLOSE NATRIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GLUCOSE 1-WATER ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; KALIUMALUMINIUMSILICAAT (E 555) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MALTODEXTRINE ; NATRIUMSTEARYLFUMARAAT ; POLYDEXTROSE (E 1200) ; PONCEAU 4R ALUMINIUMLAK (E 124) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN, CARMELLOSE NATRIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLUCOSE 1-WATER ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; KALIUMALUMINIUMSILICAAT (E 555) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MALTODEXTRINE ; NATRIUMSTEARYLFUMARAAT ; POLYDEXTROSE (E 1200) ; PONCEAU 4R ALUMINIUMLAK (E 124) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Sildenafil

Product samenvatting:

Hulpstoffen: CARMELLOSE NATRIUM (E 466); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GLUCOSE 1-WATER; HYPROLOSE (E 463); HYPROMELLOSE (E 464); INDIGOKARMIJN ALUMINIUMLAK (E 132); KALIUMALUMINIUMSILICAAT (E 555); LACTOSE 1-WATER; LECITHINE, SOYA (E 322); MALTODEXTRINE; NATRIUMSTEARYLFUMARAAT; POLYDEXTROSE (E 1200); PONCEAU 4R ALUMINIUMLAK (E 124); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); TRIGLYCERIDEN MIDDELLANGE KETEN;

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
SILDENAFIL STADA 25 MG FILMOMHULDE TABLETTEN
SILDENAFIL STADA 50 MG FILMOMHULDE TABLETTEN
SILDENAFIL STADA 100 MG FILMOMHULDE TABLETTEN
Sildenafil
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 is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
contains the active substance sildenafil which belongs
to a group of
medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works
by helping to relax the
blood vessels in your penis, allowing blood to flow into your penis
when you get sexually
excited.
will only help you to get an erection if you are
sexually
stimulated.
is a treatment for adult men with erectile dysfunction,
sometimes known
as impotence. This is when a man cannot get, or keep a hard, erect
penis suitable for sexual
activity.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE
•
If you are allergic to sildenafil, peanut or soya, or any of the other
ingredients of this medicine
(listed in section 6).
•
If you are taking medicines called nitrates, as the combination may
lead to a dangerous fall
in your blood pressure. Tell your doctor if you are taking any of
these medicines which are
often given for relief of angina pectoris (o

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Sildenafil STADA 25 mg, filmomhulde tabletten
Sildenafil STADA 50 mg, filmomhulde tabletten
Sildenafil STADA 100 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 mg film-coated tablet contains 25 mg of sildenafil (as
citrate).
Each 50 mg film-coated tablet contains 50 mg of sildenafil (as
citrate).
Each 100 mg film-coated tablet contains 100 mg of sildenafil (as
citrate).
Excipients with known effect
Each 25 mg film-coated tablet contains 72.888 mg lactose monohydrate,
0.207 mg glucose,
0.0039 mg Ponceau 4R aluminium lake and 0.1125 mg soya lecithin.
Each 50 mg film-coated tablet contains 145.775 mg lactose monohydrate,
0.415 mg glucose,
0.0078 mg Ponceau 4R aluminium lake and 0.2250 mg soya lecithin.
Each 100 mg film-coated tablet contains 291.550 mg lactose
monohydrate, 0.829 mg glucose,
0.0156 mg Ponceau 4R aluminium lake and 0.450 mg soya lecithin.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
25 mg film-coated tablets are light blue pearlescent
film-coated tablets,
round and biconvex in shape with approx. diameter of 8 mm.
50 mg film-coated tablets are light blue pearlescent
film-coated tablets,
round and biconvex in shape with approx. diameter of 10 mm.
100 mg film-coated tablets are light blue pearlescent
film-coated tablets,
round and biconvex in shape with approx. diameter of 12 mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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 to be effective, sexual stimulation is
required.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_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 decr