Ciastad 20 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TADALAFIL 20 mg/stuk

Beschikbaar vanaf:

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

ATC-code:

G04BE08

INN (Algemene Internationale Benaming):

TADALAFIL 20 mg/stuk

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 ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), 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
CIASTAD 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 [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 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.
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 ta

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ciastad 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 312 mg of lactose 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
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 III.
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 (two x 20 mg film-coated tablets) taken
once daily.
_ _
_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 kg
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
*
Oral suspension is recommended for administration to paediatric
patients who require
20 mg and are not able to swallow tablets.
For patients < 2 years old no PK or efficacy data are available from
clinical trials. The most
appropriate dose of tadalafil in children aged between 6 months to < 2
years has no