Sildenafil Sandoz 25mg tablets

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

SILDENAFIL CITRATE

Dostupno od:

1 A Pharma GmbH

ATC koda:

G04BE03

INN (International ime):

SILDENAFIL CITRATE

Farmaceutski oblik:

TABLET

Sastav:

SILDENAFIL CITRATE 25 milligram(s)

Tip recepta:

POM

Područje terapije:

UROLOGICALS

Status autorizacije:

Authorised

Datum autorizacije:

2017-02-01

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
SILDENAFIL SANDOZ 25 MG TABLETS
SILDENAFIL SANDOZ 50 MG TABLETS
SILDENAFIL SANDOZ 100 MG 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 of the side effects, talk to your doctor, pharmacist or
nurse. This includes
and possible side effects not listed in this leaflet.. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Sildenafil Sandoz is and what it is used for
2.
What you need to know before you take Sildenafil Sandoz
3.
How to take Sildenafil Sandoz
4.
Possible side effects
5.
How to store Sildenafil Sandoz
6.
Contents of the pack and other information
1.
WHAT SILDENAFIL SANDOZ IS AND WHAT IT IS USED FOR
Sildenafil Sandoz 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 Sandoz will only help you to get an erection if
you are sexually
stimulated.
Sildenafil Sandoz 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 SANDOZ
DO NOT TAKE SILDENAFIL SANDOZ
-
if you are allergic to sildenafil or any 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”).

Svojstava lijeka

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Sildenafil Sandoz 25 mg tablets
Sildenafil Sandoz 50 mg tablets
Sildenafil Sandoz 100 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_Sildenafil Sandoz 25 mg tablets _
Each tablet contains 25 mg of sildenafil (as citrate).
_Sildenafil Sandoz 50 mg tablets _
Each tablet contains 50 mg of sildenafil (as citrate).
_Sildenafil Sandoz 100 mg tablets _
Each tablet contains 100 mg of sildenafil (as citrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
_Sildenafil Sandoz 25 mg tablets _
Sildenafil Sandoz 25 mg tablet is a light blue round slightly dotted
tablet, with breaking notch on
one side and embossment “25” on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
_Sildenafil Sandoz 50 mg tablets _
Sildenafil Sandoz 50 mg tablet is a light blue round slightly dotted
tablet, with cross breaking
notch on one side and embossment “50” on the other side.
The tablet can be divided into equal quarters.
Only intake of the whole tablet or concomitant intake of two quarters
is covered by posology.
_Sildenafil Sandoz 100 mg tablets _
Sildenafil Sandoz 100 mg tablet is a light blue round slightly dotted
tablet, with cross breaking
notch on both sides and embossment “100” on one side.
The tablet can be divided into equal quarters.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sildenafil is indicated in adult men with erectile dysfunction, which
is the inability to achieve or
maintain a penile erection sufficient for satisfactory sexual
performance.
Page 2 of 15
In order for sildenafil 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 m