Blugral 50 mg film-coated tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Sildenafil citrate

Tilgængelig fra:

Niche Generics Limited

ATC-kode:

G04BE; G04BE03

INN (International Name):

Sildenafil citrate

Dosering:

50 milligram(s)

Lægemiddelform:

Film-coated tablet

Recept type:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Drugs used in erectile dysfunction; sildenafil

Autorisation status:

Not marketed

Autorisation dato:

2013-01-11

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
BLUGRAL 25 MG FILM-COATED TABLETS
BLUGRAL 50 MG FILM-COATED TABLETS
BLUGRAL 100 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 Blugral is and what it is used for
2. What you need to know before you take Blugral
3. How to take Blugral
4. Possible side effects
5. How to store Blugral
6. Contents of the pack and other information
1. WHAT BLUGRAL IS AND WHAT IT IS USED FOR
Blugral contains the active substance sildenafil which belongs to a
group of medicines
called phosphodiesterase type 5 (PDE 5) 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. Blugral will only help you to get an erection if you are
sexually stimulated.
Blugral 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 BLUGRAL
DO NOT TAKE BLUGRAL:
■ 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 or pharmacist.
■ if you are using any of

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Blugral 50 mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50mg tablet contains 50mg of sildenafil (as citrate)
Excipient with known effect: lactose monohydrate 134.46mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Blue rounded diamond-shaped, biconvex, film-coated tablets, marked
“U” debossed on one side and “50” on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Blugral 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 Blugral 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 Blugral
is taken with food, the onset of activity may
be delayed compared to the fasted state (see section 5.2).
Special population
_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
impairment (creatinine clearance <30 mL/min) a 25
mg dose should be considered. Based on efficacy and tolerability, the
dose may be increased step-wise to 50 mg up to
100 mg as necessary.
_Hepatic impairment:_
Since sildenafil clearance is reduced in patients with hepatic
impairment (e.g. cirrhosis) a 25 mg dose should be
considered. Based on efficacy and tolerability, the dose may be
increased step-wise to 50 mg up to 100 mg as
necessary.
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