Silvasta

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Sildenafil citrate 35.12mg equivalent to 25 mg sildenafil;  ;  

Disponível em:

Douglas Pharmaceuticals Limited

DCI (Denominação Comum Internacional):

Sildenafil citrate 35.12 mg (equivalent to 25 mg sildenafil)

Dosagem:

25 mg

Forma farmacêutica:

Tablet

Composição:

Active: Sildenafil citrate 35.12mg equivalent to 25 mg sildenafil     Excipient: Croscarmellose sodium Hypromellose Indigo carmine Lactose monohydrate Macrogol 6000 Magnesium stearate Microcrystalline cellulose Povidone Titanium dioxide

Unidades em pacote:

Blister pack, PVC/PVDC aluminium, 1 tablet

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

Mylan Laboratories Limited

Indicações terapêuticas:

Sildenafil is indicated for the treatment of erectile dysfunction in adult males.

Resumo do produto:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC aluminium - 1 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC aluminium - 2 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC aluminium - 4 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC aluminium - 8 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC aluminium - 12 tablets - 36 months from date of manufacture stored at or below 25°C

Data de autorização:

2010-07-12

Folheto informativo - Bula

CONSUMER MEDICINE INFORMATION
1
SILVASTA®
_sildenafil citrate _
25 mg, 50 mg and 100 mg film-coated tablets
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING SILVASTA.
This
leaflet
answers
some
common
questions
about Silvasta. It does not contain all the available
information. It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor
has weighed the risks of you taking Silvasta against
the benefits they expect it will have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY
NEED TO READ IT AGAIN.
WHAT SILVASTA IS USED FOR
Silvasta 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.
Silvasta belongs to a group of medicines called
phosphodiesterase type 5 inhibitors. It works by
relaxing the blood vessels in your penis when you
are sexually excited. This allows blood to flow into
your penis, allowing you to get an erection in the
natural way. Silvasta will work only if you are
sexually excited. Silvasta will not increase your sex
drive. Silvasta is not for use in women.
This
medicine
is
available
with
a
doctor’s
prescription or from a trained pharmacist without
a doctor’s prescription if you meet certain criteria.
ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
SILVASTA
HAS
BEEN
PRESCRIBED FOR YOU.
BEFORE YOU TAKE SILVASTA
_WHEN YOU MUST NOT TAKE IT _
YOU MUST NOT TAKE SILVASTA IF YOU ARE TAKING ANY
NITRATE MEDICATION. It may lead to a severe drop in
your blood pressure, which may be difficult to
treat. 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. Nitrates
can include glyceryl trinitrate (tablets, patches,
ointment, oral sprays or injection) or isosorbide

Características técnicas

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Silvasta® 25 mg film-coated tablets
Silvasta® 50 mg film-coated tablets
Silvasta® 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Silvasta 25 mg tablet contains 35.12 mg of sildenafil citrate
(equivalent to 25 mg sildenafil).
Each Silvasta 50 mg tablet contains 70.24 mg of sildenafil citrate
(equivalent to 50 mg sildenafil).
Each Silvasta 100 mg tablet contains 140.48 mg of sildenafil citrate
(equivalent to 100 mg
sildenafil).
EXCIPIENT(S) WITH KNOWN EFFECT
Silvasta 25 mg, 50 mg and 100 mg tablets contain lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Silvasta tablets are blue elliptical, biconvex, film-coated tablets.
SILVASTA 25 MG TABLET is marked “SL25” on one side.
SILVASTA 50 MG TABLET is marked “SL50” on one side.
SILVASTA 100 MG TABLET is marked “SL100” on one side.
Do not halve tablet. Dose equivalence when the tablet is divided has
not been established.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Sildenafil is indicated for the treatment of erectile dysfunction in
adult males.
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSE
_ADULTS _
The recommended starting dose is 50 mg taken approximately one hour
before sexual activity.
Based on efficacy and toleration, 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
2 | P a g e
once per day. If sildenafil is taken with food, the onset of activity
may be delayed compared to
the fasted state (refer to section 5.2).
_SPECIAL POPULATIONS _
Elderly population
Since sildenafil clearance is reduced in elderly patients, a first
dose of 25 mg should be
considered. Based on efficacy and toleration, the dose may be
increased to 50 mg and 100 mg.
Renal impairment
The dosing recommendations for adults should be followed for patients
with mild to moderate
renal impairment (Clcr = 30–80 mL/min). Since sildenafil clearance
is reduced in patie