Qizerz 20 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TADALAFIL 20 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

G04BE08

INN (Algemene Internationale Benaming):

TADALAFIL 20 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 12 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Tadalafil

Product samenvatting:

Hulpstoffen: CROSPOVIDON (E 1202); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MACROGOL 3350; NATRIUMLAURILSULFAAT (E 487); NATRIUMSTEARYLFUMARAAT; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 12 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2017-02-23

Bijsluiter

Sandoz B.V.
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Qizerz 20 mg, filmomhulde tabletten
RVG 1181661
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1.3.1.3 Leaflet
Januari 2024
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
QIZERZ 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 [Nationally completed name] is and what it is used for
2. What you need to know before you take [Nationally completed name]
3. How to take [Nationally completed name]
4. Possible side effects
5. How to store [Nationally completed name]
6. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] contains the active substance tadalafil.
[Nationally completed name] is a treatment for pulmonary arterial
hypertension in adults and in
children aged 2 years and above.
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.
_Other suitable formulations, such as an oral suspension, should be
checked for their availability for _
_administration to paediatric patients who require 20 mg and are not
able to swallow tablets. _
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME] IF YOU:
-
are allergic to tadalafil or any of the other ingredients of this
medicine (listed in section 6).
Sandoz B.V.
Page 2/7
Qizerz 20 mg, filmomhulde tabletten

Productkenmerken

Sandoz B.V.
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RVG 118161
v11
1.3.1.1 Summary of product characteristics
Januari 2024
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Qizerz 20 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of tadalafil.
_ _
Excipient with known effect
Each film-coated tablet contains 335.4 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Ochre to yellow, oval shaped film-coated tablet of approximately 15 x
9 mm. On one side debossed
with “20”. The other side of the tablet is bi-scored.
The tablet can be divided into equal halves and/or quarters.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
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.
Paediatric population
Treatment of paediatric patients aged 2 years and above with pulmonary
arterial hypertension (PAH)
classified as WHO functional class II and II.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should only be initiated and monitored by a physician
experienced in the treatment of
PAH.
Posology
_Adults _
The recommended dose is 40 mg (2 x 20 mg film-coated tablets) taken
once daily.
Sandoz B.V.
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RVG 118161
v11
1.3.1.1 Summary of product characteristics
Januari 2024
_Paediatric population (age 2 years to 17 years) _
The recommended once daily doses based on age and weight categories in
paediatric patients are
shown below.
PAEDIATRIC PATIENT’S AGE AND/OR WEIGHT
RECOMMENDED DAILY DOSE AND DOSING REGIMEN
Age ≥ 2 years old
Body weight ≥ 40 kg
Body weight < 40 k
40 mg (two 20 mg tablets) once daily
20 mg (one 20 mg tablet or 10 mL of oral
suspension (OS), 2 mg/mL tadalafil*) once daily
*
Other suitable formulations, such