Sildenafil STADA 20 mg, filmomhulde tabletten

Țară: Țările de Jos

Limbă: olandeză

Sursă: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredient activ:

SILDENAFILCITRAAT SAMENSTELLING overeenkomend met ; SILDENAFIL

Disponibil de la:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

Codul ATC:

G04BE03

INN (nume internaţional):

SILDENAFILCITRAAT COMPOSITION corresponding to ; SILDENAFIL

Forma farmaceutică:

Filmomhulde tablet

Compoziție:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MALTODEXTRINE ; NATRIUMSTEARYLFUMARAAT ; POLYDEXTROSE (E 1200) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN,

Calea de administrare:

Oraal gebruik

Zonă Terapeutică:

Sildenafil

Rezumat produs:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MALTODEXTRINE; NATRIUMSTEARYLFUMARAAT; POLYDEXTROSE (E 1200); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); TRIGLYCERIDEN MIDDELLANGE KETEN;

Data de autorizare:

2016-11-15

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILDENAFIL STADA 20 MG, FILMOMHULDE TABLETTEN
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 is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
contains the active substance sildenafil which belongs
to a group of
medicines called phosphodiesterase type 5 (PDE5) inhibitors.
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
DO NOT TAKE 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").
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 treat pulmonary arterial
hypertensi

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Sildenafil STADA 20 mg, filmomhulde tabletten
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
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 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 paediatri