Pulmopresil 20 mg Filmdragerad tablett

国家: 瑞典

语言: 瑞典文

来源: Läkemedelsverket (Medical Products Agency)

有效成分:

sildenafilcitrat

可用日期:

Teva B.V.

ATC代码:

G04BE03

INN（国际名称）:

sildenafil citrate

剂量:

20 mg

药物剂型:

Filmdragerad tablett

组成:

laktosmonohydrat Hjälpämne; sildenafilcitrat 28,1 mg Aktiv substans

处方类型:

Receptbelagt

產品總結:

Förpacknings: Blister, 30 tabletter; Blister, 90 tabletter; Blister, 100 tabletter

授权状态:

Godkänd

授权日期:

2016-12-16

资料单张

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PULMOPRESIL 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 Pulmopresil is and what it is used for
2.
What you need to know before you take Pulmopresil
3.
How to take Pulmopresil
4.
Possible side effects
5.
How to store Pulmopresil
6.
Contents of the pack and other information
1.
WHAT PULMOPRESIL IS AND WHAT IT IS USED FOR
Pulmopresil contains the active substance sildenafil which belongs to
a group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors.
Pulmopresil brings down blood pressure in the lungs by widening the
blood vessels in the lungs. Pulmopresil
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 PULMOPRESIL
DO NOT TAKE PULMOPRESIL
-
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 (such as nicorandil),
or nitric oxide donors such as
amyl nitrite (“poppers”). These medicines are often given for
relief of chest pain (or “angina
pectoris”). Pulmopresil 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.,

产品特点

1
1.
NAME OF THE MEDICINAL PRODUCT
Pulmopresil 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 contains 49.9 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex film-coated tablets of 6.5 mm, marked
“SL20” on one 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 Pulmopresil treatment,
alternative therapies should be considered.
Posology
_Adults_
The recommended dose is 20 mg three times a day. Physicians should
advise patients who forget to
take Pulmopresil 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
2
5.1). The 20 mg tablet should not b