Mysildecard
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
30-06-2023
Fachinformation
(SPC)
30-06-2023
Öffentlichen Beurteilungsberichts
(PAR)
08-12-2016
Wirkstoff:
sildenafil citrate
Verfügbar ab:
Viatris Limited
ATC-Code:
G04BE03
INN (Internationale Bezeichnung):
sildenafil
Therapiegruppe:
Urologicals
Therapiebereich:
Hypertension, Pulmonary
Anwendungsgebiete:
AdultsTreatment 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 populationTreatment 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).
Produktbesonderheiten:
Revision: 7
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2016-09-15
Gebrauchsinformation
30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MYSILDECARD 20 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 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 Mysildecard is and what it is used for
2.
What you need to know before you take Mysildecard
3.
How to take Mysildecard
4.
Possible side effects
5.
How to store Mysildecard
6.
Contents of the pack and other information
1.
WHAT MYSILDECARD IS AND WHAT IT IS USED FOR
Mysildecard contains the active substance sildenafil which belongs to
a group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors.
Mysildecard brings down blood pressure in the lungs by widening the
blood vessels in the lungs.
Mysildecard is used to treat adults and children and adolescents from
1 to 17 years old with high blood
pressure in the blood vessels in the lungs (pulmonary arterial
hypertension).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYSILDECARD
DO NOT TAKE MYSILDECARD:
if you are allergic to sildenafil or any of the other ingredients of
this medicine (listed in
section 6).
if you 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”).
Mysildecard 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.
if you are taking riociguat. This drug is used to treat pulmonary
arterial hypertension
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Mysildecard 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of sildenafil (as citrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
A white, round, biconvex film-coated tablet (approximately 6.5 mm
diameter), debossed with M on
one side of the tablet and SL over 20 on the other side.
_ _
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 Mysildecard 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 Mysildecard 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 a day.
Higher than recommended doses
should not be used in paediatric patients with PAH (see also sections
4.4 and 5
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