Tadalafil 20 mg Centrafarm, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TADALAFIL

Beschikbaar vanaf:

Centrafarm B.V.

ATC-code:

G04BE08

INN (Algemene Internationale Benaming):

TADALAFIL

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Tadalafil

Product samenvatting:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 0-WATER; LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2017-11-29

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL 20 MG CENTRAFARM, 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 [Product Νame] is and what it is used for
2. What you need to know before you take [Product Νame]
3. How to take [Product Νame]
4. Possible side effects
5. How to store [Product Νame]
6. Contents of the pack and other information
1. WHAT [PRODUCT ΝAME] IS AND WHAT IT IS USED FOR
[Product Νame] contains the active substance tadalafil.
[Product Νame] is a treatment for pulmonary arterial hypertension in
adults.
It 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 [PRODUCT ΝAME]
DO NOT TAKE [PRODUCT NAME] 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 – a condition described as “stroke of
the eye” (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 dru

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Tadalafil 20 mg Centrafarm, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg tadalafil.
Excipient with known effect
Each 20 mg tablet contains 312 mg of lactose anhydrous and 3 mg of
lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
Yellow coloured, caplet shaped, biconvex, film-coated tablet, with a
length of 13.5 mm and a
width of 6.6 mm. Film-coated tablets are debossed with “T 20” on
one side and plain on the
other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
[Product Name] 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 (2 x 20 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