Sildenafil Upjohn 25mg film-coated Tablets

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

SILDENAFIL

Beschikbaar vanaf:

Viatris Hellas Ltd 253-255, Mesogion Avenue, 154 51 Neo Psychiko, Athens,, Greece

ATC-code:

G04BE03

INN (Algemene Internationale Benaming):

SILDENAFIL 25 mg

farmaceutische vorm:

FILM-COATED TABLET

Samenstelling:

SILDENAFIL 25 mg

Prescription-type:

POM

Therapeutisch gebied:

UROLOGICALS

Autorisatie-status:

Authorised

Autorisatie datum:

2011-03-18

Bijsluiter

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B. PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILDENAFIL UPJOHN 25 MG, 50 MG OR 100 MG FILM-COATED TABLETS
sildenafil citrate
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 Upjohn is and what it is used for
2.
What you need to know before you take Sildenafil Upjohn
3.
How to take Sildenafil Upjohn
4.
Possible side effects
5.
How to store Sildenafil Upjohn
6.
Contents of the pack and other information
1.
WHAT SILDENAFIL UPJOHN IS AND WHAT IT IS USED FOR
Sildenafil Upjohn contains the active substance sildenafil (as
citrate), 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. This
medicine will only help you to get an erection if you are sexually
stimulated.
This medicine 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 UPJOHN
DO NOT TAKE SILDENAFIL UPJOHN
−
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 angin

Productkenmerken

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Sildenafil Upjohn 25 mg film-coated tablets
Sildenafil Upjohn 50 mg film-coated tablets
Sildenafil Upjohn 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil (as citrate)
Excipient with known effect: Lactose (as monohydrate)
0.9 mg per 25 mg tablet
1.7 mg per 50 mg tablet
3.5 mg per 100 mg tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
25 mg: White to off-white, rounded diamond-shaped tablets, of
dimensions 9.2 x 6.7 mm, marked
“25”on one side.
50 mg: White to off-white, rounded diamond-shaped tablets, of
dimensions 11.2 x 8.1 mm, marked
“50” on one side.
100 mg: White to off-white, rounded diamond-shaped tablets, of
dimensions 14.1 x 10.2 mm,
marked “100” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 Upjohn 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
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per day. If Sildenafil Upjohn is taken with food, the onset of
activity may be delayed compared to
the fasted state (see section 5.2).
Special populations
_Elderly _
Dosage adjustments are not required in elderly patients (≥ 65 years
old).
_Renal impairment _
The dosing recommendations described in ‘Use in adults’ apply to
patients with mild to moderate
renal impairment (creatinine clearance = 30 - 80 mL/min).
Since sildenafil clearance is reduced in patients with severe renal