Sildenafil Teva

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

sildenafil

Διαθέσιμο από:

Teva B.V. 

Φαρμακολογική κατηγορία (ATC):

G04BE03

INN (Διεθνής Όνομα):

sildenafil

Θεραπευτική ομάδα:

Drugs used in erectile dysfunction

Θεραπευτική περιοχή:

Erectile Dysfunction

Θεραπευτικές ενδείξεις:

Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Sildenafil Teva to be effective, sexual stimulation is required.,

Περίληψη προϊόντος:

Revision: 17

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2009-11-30

Φύλλο οδηγιών χρήσης

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILDENAFIL TEVA 25
MG FILM-COATED TABLETS
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sildenafil Teva is and what it is used for
2.
What you need to know before you take Sildenafil Teva
3.
How to take Sildenafil Teva
4.
Possible side effects
5.
How to store Sildenafil Teva
6.
Contents of the pack and other information
1.
WHAT SILDENAFIL TEVA IS AND WHAT IT IS USED FOR
Sildenafil Teva 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. Sildenafil Teva will only
help you to get an erection if you are sexually stimulated.
Sildenafil Teva 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 SILDENAFIL TEVA
DO NOT TAKE SILDENAFIL TEVA
−
If you are allergic to sildenafil 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 (or “chest pain”). If you are
not certain, ask your doctor

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sildenafil Teva 25 mg film-coated tablets
Sildenafil Teva 50 mg film-coated tablets
Sildenafil Teva 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sildenafil Teva 25 mg film-coated tablets
Each tablet contains sildenafil citrate equivalent to 25 mg of
sildenafil.
Sildenafil Teva 50 mg film-coated tablets
Each tablet contains sildenafil citrate equivalent to 50 mg of
sildenafil.
Sildenafil Teva 100 mg film-coated tablets
Each tablet contains sildenafil citrate equivalent to 100 mg of
sildenafil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Sildenafil Teva 25 mg film-coated tablets
White, oval-shaped film-coated tablets, engraved with ‘S 25’ on
one side, and plain on the other side.
Sildenafil Teva 50 mg film-coated tablets
White, oval-shaped film-coated tablets, engraved with ‘S 50’ on
one side, and plain on the other side.
Sildenafil Teva 100 mg film-coated tablets
White, oval-shaped film-coated tablets, engraved with ‘S 100’ on
one side, and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sildenafil Teva 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 Sildenafil Teva to be effective, sexual stimulation is
required.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_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 Sildenafil Teva is taken with food, the onset of activity may
be delayed compared to the fasted
state (see section 5.2).
_ _
3
Special populations
_ _
_Elderly _
Dosage adjustments are not required in elderly patients (≥ 65