Sildenafil Clonmel 50 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sildenafil citrate

Available from:

Clonmel Healthcare Ltd

ATC code:

G04BE03

INN (International Name):

Sildenafil citrate

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

sildenafil

Authorization status:

Not marketed

Authorization date:

2023-12-15

Patient Information leaflet

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 d
ysfunction, 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 p

Summary of Product characteristics

Health Products Regulatory Authority
15 December 2023
CRN00CVSL
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sildenafil Clonmel 50 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 mg film-coated tablet contains 50 mg of sildenafil (as
citrate).
Excipients with known effect
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 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).
_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 impai