Sildenafil Sandoz 50mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SILDENAFIL CITRATE

Available from:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATC code:

G04BE03

INN (International Name):

SILDENAFIL CITRATE 50 mg

Pharmaceutical form:

TABLET

Composition:

SILDENAFIL CITRATE 50 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Withdrawn

Authorization date:

2017-02-01

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 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 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 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 “ches

Summary of Product characteristics

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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 tablet is a light blue, round, slightly dotted
tablet with breaking notch on
one side and debossment “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 tablet is a light blue, round, slightly dotted
tablet with cross breaking
notch on one side and debossment “50” on the other side.
The tablet can be divided into four equal doses.
Only intake of the whole tablet or concomitant intake of two quarters
is covered by posology.
Sildenafil Sandoz 100 mg tablet is a light blue, round, slightly
dotted tablet with cross breaking
notch on both sides and debossment “100” on one side.
The tablet can be divided into four equal doses.
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.
In order for sildenafil to be effective, sexual stimulation is
required.
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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 is taken with food, the onset of