Sildenafil Clonmel 20 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:

G04BE; G04BE03

INN (International Name):

Sildenafil citrate

Dosage:

20 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Drugs used in erectile dysfunction; sildenafil

Authorization status:

Marketed

Authorization date:

2016-12-02

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILDENAFIL CLONMEL 20MG 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 or pharmacist.
-
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 or pharmacist. 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.
Sildenafil Clonmel brings down blood pressure in the lungs by widening
the blood vessels in the
lungs.
Sildenafil is used to treat adults and children and adolescents from 1
to 17 years old with high blood
pressure in the blood vessels of the lungs (pulmonary arterial
hypertension).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SILDENAFIL CLONMEL
DO NOT TAKE SILDENAFIL CLONMEL IF YOU:

are allergic to sildenafil or any of the other ingredients of this
medicine (listed in section 6)

are taking medicines containing nitrates, or nitric oxide donors such
as amyl nitrate ("poppers").
These medicines are often given for relief of chest pain (or "angina
pectoris").
Sildenafil Clonmel can cause a serious increase in the effects of
these medicines. Tell your doctor
if you are taking any of these medicines. If you are not certain, ask
your doctor or pharmacist

are taking riociguat. This drug is used to

Summary of Product characteristics

Health Products Regulatory Authority
30 August 2022
CRN00CYC7
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sildenafil Clonmel 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Excipient with known effect
Each tablet also contains 58.31 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex, white film-coated tablets with approx. diameter of
7.1 mm and approx. thickness of 3.4 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
Treatment of adult patients with pulmonary arterial hypertension
classified as WHO functional class II and III, to improve
exercise capacity. Efficacy has been shown in primary pulmonary
hypertension and pulmonary hypertension associated with
connective tissue disease.
Paediatric population
Treatment of paediatric patients aged 1 year to 17 years old with
pulmonary arterial hypertension. Efficacy in terms of
improvement of exercise capacity or pulmonary haemodynamics has been
shown in primary pulmonary hypertension and
pulmonary hypertension associated with congenital heart disease (see
section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should only be initiated and monitored by a physician
experienced in the treatment of pulmonary arterial
hypertension. In case of clinical deterioration in spite of Sildenafil
Clonmel treatment, alternative therapies should be
considered.
Posology
_Adults_
The recommended dose is 20 mg three times a day (TID). Physicians
should advise patients who forget to take Sildenafil
Clonmel to take a dose as soon as possible and then continue with the
normal dose. Patients should not take a double dose to
compensate for the missed dose.
_Paediatric population (1 year to 17 years)_
For paediatric patients aged 1 year to 17 years old, the recommended
dose in patients ≤ 20 kg is 10 mg three times a day and
for patients > 20 kg is 20 mg three times