Granpidam
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
11-04-2023
Charakterystyka produktu
(SPC)
11-04-2023
Sprawozdanie z oceny publicznego
(PAR)
31-01-2017
Składnik aktywny:
sildenafil citrate
Dostępny od:
Accord Healthcare S.L.U.
Kod ATC:
G04BE03
INN (International Nazwa):
sildenafil
Grupa terapeutyczna:
Urologicals
Dziedzina terapeutyczna:
Hypertension, Pulmonary
Wskazania:
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.
Podsumowanie produktu:
Revision: 8
Status autoryzacji:
Authorised
Data autoryzacji:
2016-11-14
Ulotka dla pacjenta
29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GRANPIDAM 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 Granpidam is and what it is used for
2.
What you need to know before you take Granpidam
3.
How to take Granpidam
4.
Possible side effects
5.
How to store Granpidam
6.
Contents of the pack and other information
1.
WHAT GRANPIDAM IS AND WHAT IT IS USED FOR
Granpidam contains the active substance sildenafil which belongs to a
group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors.
Granpidam brings down blood pressure in the lungs by widening the
blood vessels in the lungs.
Granpidam 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 GRANPIDAM
DO NOT TAKE GRANPIDAM
-
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”).
Granpidam 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 (i.e., high
blood pressure in
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Granpidam 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Excipient(s) with known effect
Each tablet also contains 0.2 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White to off white, round shaped, approximately 6.6 mm in diameter,
biconvex, film-coated tablets,
debossed with ‘20’ on one side and plain on 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 Granpidam 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 Granpidam 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
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