Tadalafil Stada 20 mg, filmomhulde tabletten

Država: Nizozemska

Jezik: nizozemski

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

Aktivni sastojci:

TADALAFIL

Dostupno od:

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

INN (International ime):

TADALAFIL

Farmaceutski oblik:

Filmomhulde tablet

Sastav:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Administracija rute:

Oraal gebruik

Datum autorizacije:

2020-06-18

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL STADA 20 MG, FILMOMHULDE TABLETTEN
TADALAFIL
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 Tadalafil Stada is and what it is used for
2. What you need to know before you take Tadalafil Stada
3. How to take Tadalafil Stada
4. Possible side effects
5. How to store Tadalafil Stada
6. Contents of the pack and other information
1. WHAT TADALAFIL STADA IS AND WHAT IT IS USED FOR
Tadalafil Stada contains the active substance tadalafil. It is used
for the treatment of
pulmonary arterial hypertension in adults.
Tadalafil Stada belongs to a group of medicines called
phosphodiesterase type 5 (PDE5)
inhibitors which work by helping the blood vessels around your lungs
relax, improving the
flow of blood into your lungs. The result of this is an improved
ability to do physical activity.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TADALAFIL STADA
DO NOT TAKE TADALAFIL STADA IF YOU:
•
are allergic to tadalafil or any of the other ingredients of this
medicine (listed in section 6)
•
are taking any form of nitrates such as amyl nitrite, used in the
treatment of chest pain.
Tadalafil has been shown to increase the effects of these medicines.
If you are taking any
form of nitrate or are unsure tell your doctor
•
have ever had loss of vision – also known as “eye stroke”
(non-arteritic anterior ischaemic
optic neuropathy - NAION)
•
have had a heart attack in the last 3 months
•
have low blood pressure
•
are taking riociguat. This drug is used

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Tadalafil Stada 20 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg tadalafil.
Excipient with known effect
Each 20 mg tablet contains 232.6 mg of lactose (as lactose
monohydrate) and 2.2 mg
sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
Yellow, round, biconvex, film-coated tablets with cross line on both
sides, white at the cross
section with 10.1 ± 0.2 mm diameter
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tadalafil Stada is indicated in adults for the treatment of pulmonary
arterial hypertension
(PAH) classified as WHO functional class II and III, to improve
exercise capacity (see section
5.1).
Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to
collagen vascular
disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment
should
only
be
initiated
and monitored
by
a
physician
experienced
in
the
treatment of PAH.
Posology
The recommended dose is 40 mg taken once daily with or without food.
Special populations
_Elderly patients _
Dose adjustments are not required in elderly patients.
_Renal impairment _
In patients with mild to moderate renal impairment a starting dose of
20 mg once per day is
recommended. The dose may be increased to 40 mg once per day, based on
individual
efficacy and tolerability. In patients with severe renal impairment
the use of tadalafil is not
recommended (see sections 4.4 and 5.2).
_Hepatic impairment _
Due to limited clinical experience in patients with mild to moderate
hepatic cirrhosis (Child-
Pugh Class A and B), following single doses of 10 mg, a starting dose
of 20 mg once per day
may be considered. If tadalafil is prescribed, a careful individual
benefit/risk evaluation
should be undertaken by the prescribing physician. Patients with
severe hepatic cirrhosis
(Child-Pugh
Class
C)
have
not
been
studied
and
therefore
dosing
of
tadalaf