Sildenafil 25mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Sildenafil citrate

Disponible des:

Zentiva

Codi ATC:

G04BE03

Designació comuna internacional (DCI):

Sildenafil citrate

Dosis:

25mg

formulario farmacéutico:

Tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 07040500; GTIN: 5000283656388

Informació per a l'usuari

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Package leaflet: Information for the user
SILDENAFIL 25MG
FILM-COATED TABLETS
SILDENAFIL 50MG
FILM-COATED TABLETS
SILDENAFIL 100MG
FILM-COATED TABLETS
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, please
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 is and what it is used for
2. What you need to know before you take
sildenafil
3. How to take sildenafil
4. Possible side effects
5. How to store sildenafil
6. Contents of the pack and other information
1.What sildenafil is and what it is used for
The name of your medicine is Sildenafil
25mg, 50mg or 100mg film-coated tablets
(referred to as sildenafil throughout this
leaflet).
Sildenafil 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. Sildenafil will only
help you to get an erection if you are
sexually stimulated.
Sildenafil 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
Do not take sildenafil
- If you are taking medicines called nitrates,
as the combination may lead to a danger-
ous 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

Fitxa tècnica

OBJECT 1
SILDENAFIL 25MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 06-Mar-2014 | Zentiva
1. Name of the medicinal product
Sildenafil Zentiva 25mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 25mg of sildenafil (as 35.12mg
sildenafil citrate).
Excipients with known effect: each sildenafil 25mg film-coated tablet
contains 1.86 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Blue coloured round, biconvex, approx. 7.20mm in diameter film-coated
tablets debossed with 124 on
one side and J on the other side
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.
4.2 Posology and method of administration
Posology
_Use in adults:_
The recommended dose is 50mg taken as needed approximately one hour
before sexual activity. Based on
efficacy andtolerability, the dose may be increased to 100mg or
decreased to 25mg. The maximum
recommended dose is 100mg. The maximum recommended dosing frequency is
once per day. If
sildenafil is taken with food, the onset of activity may be delayed
compared to the fasted state (see section
5.2).
Special populations
_Elderly patients_
Dosage adjustments are not required in elderly patients (≥65 years
old).
_Patients with 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 25mg dose should be considered. Based on efficacy
andtolerability, the dose may be increased
step-wise to 50mg up to 100mg as necessary.
_Patients with hepatic impairment:_
Since sildenafil clearance is reduced