Sildenafil 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sildenafil citrate

Available from:

Zentiva

ATC code:

G04BE03

INN (International Name):

Sildenafil citrate

Dosage:

50mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07040500; GTIN: 5000283656371

Patient Information leaflet

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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

Summary of Product characteristics

OBJECT 1
SILDENAFIL 50MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 15-Mar-2016 | Zentiva
1. Name of the medicinal product
Sildenafil Zentiva 50mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 50mg of sildenafil (as 70.24mg
sildenafil citrate).
Excipients with known effect: each sildenafil 50mg film-coated tablet
contains 3.72mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Blue coloured round, biconvex, scored approx. 9.00mm in diameter
film-coated tablets debossed with 125
on one side and J on the other side with the score line. The tablet
can be divided into 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.
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 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 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 25 mg dose should be considered. Based on efficacy and
tolerability, the dose may be increased
step-wise to 50mg up to 100 mg as necess