Sildenafil 100mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Sildenafil citrate

Tilgjengelig fra:

Hameln Pharmaceuticals Ltd

ATC-kode:

G04BE03

INN (International Name):

Sildenafil citrate

Dosering :

100mg

Legemiddelform:

Tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 07040500; GTIN: 5016386009037

Informasjon til brukeren

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
Sildenafil 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 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
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 cause a potentially dangerous
decrease 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 the drugs known as
NITRIC
OXIDE DONORS such as amyl nitrite (“poppers”) as the
combination may also lead to a potentially dangerous
decrease in your blood pressure.
• If you are taking
RIOCIGUAT
. This drug is used to
treat pulmonary arterial hypertension (i.e., high blood
pressure in the lungs) and chronic thromboembolic
pulmonary hypertension (i.e., high blood pressure in
the lungs secondary to blood clots). PDE5 inhibitors,
such as sildenafil have been shown to increase the
hypotensive effects of this medicine. If you are taking
riociguat or are unsure tell your doctor.
• If you have a
SEVERE HEART
or
LIVER
problem.
• If you have recently had a
STROKE
or a
HEART ATTACK
,
or if you have
LOW BLOOD PRESSURE
.

Preparatomtale

OBJECT 1
SILDENAFIL-HAMELN 100 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 08-Jul-2016 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Sildenafil-hameln 100 mg film-coated tablets
2. Qualitative and quantitative composition
Sildenafil 100 mg: Each tablet contains 140.48 mg of sildenafil
citrate, equivalent to 100 mg of sildenafil.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Sildenafil 100 mg film-coated tablets are blue, oval and biconvex with
break-mark on both sides. The
tablet can be divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of 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 50 mg taken as needed 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 once daily. 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:_
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 eff