Tadalafil – 1 A Pharma 20 mg film-coated tablets

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Malta Medicines Authority

Δραστική ουσία:

TADALAFIL

Διαθέσιμο από:

1 A Pharma GmbH

Φαρμακολογική κατηγορία (ATC):

G04BE08

INN (Διεθνής Όνομα):

TADALAFIL

Φαρμακοτεχνική μορφή:

FILM-COATED TABLET

Σύνθεση:

TADALAFIL 20 milligram(s)

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

UROLOGICALS

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2016-11-30

Φύλλο οδηγιών χρήσης

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TADALAFIL – 1 A PHARMA 2.5 MG FILM-COATED TABLETS
TADALAFIL – 1 A PHARMA 5 MG FILM-COATED TABLETS
TADALAFIL – 1 A PHARMA 10 MG FILM-COATED TABLETS
TADALAFIL – 1 A PHARMA 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 Tadalafil – 1 A Pharma is and what it is used for
2. What you need to know before you take Tadalafil – 1 A Pharma
3. How to take Tadalafil – 1 A Pharma
4. Possible side effects
5. How to store Tadalafil – 1 A Pharma
6. Contents of the pack and other information
1. WHAT TADALAFIL – 1 A PHARMA IS AND WHAT IT IS USED FOR
Tadalafil – 1 A Pharma contains the active substance tadalafil which
belongs to a group of medicines
called phosphodiesterase type 5 inhibitors.
Tadalafil – 1 A Pharma
2.5 MG, 5 MG, 10 MG AND 20 MG
film-coated tablets is used to treat adult men
with
ERECTILE DYSFUNCTION.
This is when a man cannot get, or keep a hard, erect penis suitable
for sexual activity.
Tadalafil – 1 A Pharma has been shown to significantly improve the
ability of obtaining a
hard erect penis suitable for sexual activity.
Following sexual stimulation Tadalafil – 1 A Pharma 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 – 1 A Pharma will not help you if you
do not have erectile
dysfunction. It is important to note that Tadalafil – 1 A Pharma for
the tr

Αρχείο Π.Χ.Π.

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil – 1 A Pharma 2.5 mg film-coated tablets
Tadalafil – 1 A Pharma 5 mg film-coated tablets
Tadalafil – 1 A Pharma 10 mg film-coated tablets
Tadalafil – 1 A Pharma 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TADALAFIL – 1 A PHARMA 2.5 MG FILM-COATED TABLETS
Each film-coated tablet contains 2.5 mg tadalafil.
Excipient(s) with known effect
Each tablet contains 44 mg lactose monohydrate.
TADALAFIL – 1 A PHARMA 5 MG FILM-COATED TABLETS
Each film-coated tablet contains 5 mg tadalafil.
Excipient(s) with known effect
Each tablet contains 88 mg lactose monohydrate.
TADALAFIL – 1 A PHARMA 10 MG FILM-COATED TABLETS
Each film-coated tablet contains 10 mg tadalafil.
Excipient(s) with known effect
Each tablet contains 177 mg lactose monohydrate.
TADALAFIL – 1 A PHARMA 20 MG FILM-COATED TABLETS
Each film-coated tablet contains 20 mg tadalafil.
Excipient(s) with known effect
Each tablet contains 353 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
TADALAFIL – 1 A PHARMA 2.5 MG FILM-COATED TABLETS
Ochre to yellow, round shaped film coated tablet of approximately 5 mm
in diameter. On one side
debossed with “2.5” and plain on the other side.
TADALAFIL – 1 A PHARMA 5 MG FILM-COATED TABLETS
Ochre to yellow, oval shaped film coated tablet of approximately 8 x 4
mm. On one side debossed
with “5” and plain on the other side.
Page 2 of 16
TADALAFIL – 1 A PHARMA 10 MG FILM-COATED TABLETS
Ochre to yellow, oval shaped film coated tablet of approximately 11 x
7 mm. On one side debossed
with “10”. The other side of the tablet is plain.
TADALAFIL – 1 A PHARMA 20 MG FILM-COATED TABLETS
Ochre to yellow, oval shaped film coated tablet of approximately 14 x
8 mm. On one side scored and
debossed with “2” on the left side of the score and with “0”
on the right side of the score. The other
side of the tablet is plain.
The tablet