Adcirca (previously Tadalafil Lilly)
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
20-09-2023
Charakterystyka produktu
(SPC)
20-09-2023
Sprawozdanie z oceny publicznego
(PAR)
12-05-2023
Składnik aktywny:
tadalafil
Dostępny od:
Eli Lilly Nederland B.V.
Kod ATC:
G04BE08
INN (International Nazwa):
tadalafil
Grupa terapeutyczna:
Urologicals
Dziedzina terapeutyczna:
Hypertension, Pulmonary
Wskazania:
AdultsTreatment 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 populationTreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III.
Podsumowanie produktu:
Revision: 17
Status autoryzacji:
Authorised
Data autoryzacji:
2008-10-01
Ulotka dla pacjenta
47
B. PACKAGE LEAFLET
48
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADCIRCA 20 MG FILM-COATED TABLETS
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 of the 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 ADCIRCA is and what it is used for
2.
What you need to know before you take ADCIRCA
3.
How to take ADCIRCA
4.
Possible side effects
5
How to store ADCIRCA
6.
Contents of the pack and other information
1.
WHAT ADCIRCA IS AND WHAT IT IS USED FOR
ADCIRCA contains the active substance tadalafil.
ADCIRCA 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 ADCIRCA
DO NOT TAKE ADCIRCA
-
if you are allergic to tadalafil or any of the other ingredients (see
section 6).
-
if you are taking any form of nitrates such as amyl nitrite, used in
the treatment of chest pain.
ADCIRCA has been shown to increase the effects of these medicines. If
you are taking any
form of nitrate or are unsure tell your doctor.
-
if you have ever had loss of vision – a condition described as
“stroke of the eye” (non-arteritic
anterior ischemic optic neuropathy - NAION).
-
if you have had a heart attack in the last 3 months.
-
if you have low blood pressure.
-
if you are taking riociguat. This medicine is used to treat
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ADCIRCA 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each film-coated tablet contains 20 mg tadalafil.
Excipient with known effect
Each film-coated tablet contains 233 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Orange and almond shaped film-coated tablets of 12.09 mm x 7.37 mm,
marked "4467" on one side.
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.
3
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 available 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 ADCIRCA in children aged between 6 months to < 2
years has not been
established. Therefore, ADCIRCA is not recommended in this age subset.
_Delayed dose, m
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