Tadalafil Mylan
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
30-06-2022
Charakterystyka produktu
(SPC)
30-06-2022
Sprawozdanie z oceny publicznego
(PAR)
19-12-2014
Składnik aktywny:
tadalafil
Dostępny od:
Mylan Pharmaceuticals Limited
Kod ATC:
G04BE08
INN (International Nazwa):
tadalafil
Grupa terapeutyczna:
Urologicals
Dziedzina terapeutyczna:
Erectile Dysfunction
Wskazania:
Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required.Tadalafil Mylan is not indicated for use by women.
Podsumowanie produktu:
Revision: 15
Status autoryzacji:
Authorised
Data autoryzacji:
2014-11-21
Ulotka dla pacjenta
61
B. PACKAGE LEAFLET
62
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TADALAFIL MYLAN 2.5 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 Tadalafil Mylan is and what it is used for
2.
What you need to know before you take Tadalafil Mylan
3.
How to take Tadalafil Mylan
4.
Possible side effects
5.
How to store Tadalafil Mylan
6.
Contents of the pack and other information
1.
WHAT TADALAFIL MYLAN IS AND WHAT IT IS USED FOR
Tadalafil Mylan is a treatment for adult men with erectile
dysfunction. This is when a man cannot get, or
keep a hard, erect penis suitable for sexual activity. Tadalafil has
been shown to significantly improve the
ability of obtaining a hard erect penis suitable for sexual activity.
Tadalafil Mylan contains the active substance tadalafil which belongs
to a group of medicines called
phosphodiesterase type 5 inhibitors. Following sexual stimulation
Tadalafil Mylan works by helping the
blood vessels in your penis to relax, allowing the flow of blood into
your penis. The result of this is
improved erectile function. Tadalafil Mylan will not help you if you
do not have erectile dysfunction.
It is important to note that tadalafil does not work if there is no
sexual stimulation. You and your partner will
need to engage in foreplay, just as you would if you were not taking a
medicine for erectile dysfunction.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TADALAFIL MYLAN
DO NOT TAKE TADALAFIL MYLAN
-
if you are allergic to tadalafil or any of the other ingredie
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Mylan 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg tadalafil.
_Excipient with known effect:_
Each film-coated tablet contains 29.74 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
A light yellow, film-coated, round, biconvex tablet (5.1 ± 0.3 mm)
debossed with ‘M’ on one side of the
tablet and ‘TL over 1’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective, sexual stimulation is
required.
Tadalafil Mylan is not indicated for use by women.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult men_
In general, the recommended dose is 10 mg taken prior to anticipated
sexual activity and with or without
food.
In those patients in whom tadalafil 10 mg does not produce an adequate
effect, 20 mg might be tried.
It may be taken at least 30 minutes prior to sexual activity.
The maximum dose frequency is once per day.
Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual
activity and it is not recommended for
continuous daily use.
In patients who anticipate a frequent use of tadalafil (i.e., at least
twice weekly) a once daily regimen with
the lowest doses of tadalafil might be considered suitable, based on
patient choice and the physician’s
judgement.
In these patients the recommended dose is 5 mg taken once a day at
approximately the same time of day. The
dose may be decreased to 2.5 mg once a day based on individual
tolerability.
The appropriateness of continued use of the daily regimen should be
reassessed periodically.
3
Special populations
_Elderly men_
Dose adjustments are not required in elderly patients.
_Men with renal impairment_
Dose adjustments are not required in patients with mild to moderate
renal impairment. For patients with
severe renal impairment 10 mg is t
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