Sildenafil Clonmel 50 mg film-coated tablets

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Beszerezhető a:

Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary E91 D768, Ireland

ATC-kód:

G04BE03

INN (nemzetközi neve):

SILDENAFIL CITRATE 50 mg

Gyógyszerészeti forma:

FILM-COATED TABLET

Összetétel:

SILDENAFIL CITRATE 50 mg

Recept típusa:

POM

Terápiás terület:

UROLOGICALS

Engedélyezési státusz:

Authorised

Engedély dátuma:

2023-11-30

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
SILDENAFIL CLONMEL 25 MG FILM-COATED TABLETS
SILDENAFIL CLONMEL 50 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 Sildenafil Clonmel is and what it is used for
2. What you need to know before you take Sildenafil Clonmel
3. How to take Sildenafil Clonmel
4. Possible side effects
5. How to store Sildenafil Clonmel
6. Contents of the pack and other information
1. WHAT SILDENAFIL CLONMEL IS AND WHAT IT IS USED FOR
Sildenafil Clonmel contains the active substance sildenafil, which
belongs to a group of medicines
called phosphodiesterase type 5 (PDE5) 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
Clonmel will only help you to get an erection if you are sexually
stimulated.
Sildenafil Clonmel 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 CLONMEL
DO NOT TAKE SILDENAFIL CLONMEL
•
If you are allergic to sildenafil, peanut or soya, 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 pe

Termékjellemzők

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Sildenafil Clonmel 25 mg film-coated tablets
Sildenafil Clonmel 50 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 mg film-coated tablet contains 25 mg of sildenafil (as
citrate).
Each 50 mg film-coated tablet contains 50 mg of sildenafil (as
citrate).
Excipients with known effect
Each 25 mg film-coated tablet contains 69.2 mg lactose, 0.2 mg
glucose, 0.004 mg Ponceau
4R aluminium lake, 0.1 mg soya lecithin.
Each 50 mg film-coated tablet contains 138.5 mg lactose, 0.4 mg
glucose, 0.008 mg Ponceau
4R aluminium lake, 0.2 mg soya lecithin.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Sildenafil Clonmel 25 mg film-coated tablets are round, biconvex,
light blue pearlescent film-
coated tablets with diameter of approximately 8 mm.
Sildenafil Clonmel 50 mg film-coated tablets are round, biconvex,
light blue pearlescent film-
coated tablets with diameter of approximately 10 mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sildenafil Clonmel 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 Clonmel 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 Sildenafil Clonmel 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).
Page 2 of 13
_Renal impairment _
The dosing recommendations described in ‘Use in adults’ apply t