Talmanco (previously Tadalafil Generics)
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
09-11-2023
Charakterystyka produktu
(SPC)
09-11-2023
Sprawozdanie z oceny publicznego
(PAR)
13-06-2017
Składnik aktywny:
tadalafil
Dostępny od:
Viatris Limited
Kod ATC:
G04BE08
INN (International Nazwa):
tadalafil
Grupa terapeutyczna:
Urologicals
Dziedzina terapeutyczna:
Hypertension, Pulmonary
Wskazania:
Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Podsumowanie produktu:
Revision: 8
Status autoryzacji:
Authorised
Data autoryzacji:
2017-01-09
Ulotka dla pacjenta
22
B. PACKAGE LEAFLET
23
Package leaflet: Information for the patient
Talmanco 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 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 Talmanco is and what it is used for
2.
What you need to know before you take Talmanco
3.
How to take Talmanco
4.
Possible side effects
5.
How to store Talmanco
6.
Contents of the pack and other information
1.
What Talmanco is and what it is used for
Talmanco contains the active substance tadalafil.
Talmanco 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 Talmanco
Do not take Talmanco:
-
if you are allergic to tadalafil or any of the other ingredients of
this medicine (listed in
section 6).
-
if you 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.
-
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 pulmona
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Talmanco 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 237.9 mg lactose (234.5 mg as
anhydrous and 3.4 mg as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
A white, film-coated, round, biconvex, bevelled edge tablet
(approximately 10.7 mm diameter)
debossed with ‘M’ on one side of the tablet and ‘TA20’ on the
other side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Talmanco 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.
Elderly
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 tadalafil is not recommended
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