Tadalafil Sandoz 2.5 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TADALAFIL

Available from:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATC code:

G04BE08

INN (International Name):

TADALAFIL 2.5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

TADALAFIL 2.5 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Withdrawn

Authorization date:

2016-11-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TADALAFIL SANDOZ 2.5 MG FILM-COATED TABLETS
TADALAFIL SANDOZ 5 MG FILM-COATED TABLETS
TADALAFIL SANDOZ 10 MG FILM-COATED TABLETS
TADALAFIL SANDOZ 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 Sandoz is and what it is used for
2. What you need to know before you take Tadalafil Sandoz
3. How to take Tadalafil Sandoz
4. Possible side effects
5. How to store Tadalafil Sandoz
6. Contents of the pack and other information
1. WHAT TADALAFIL SANDOZ IS AND WHAT IT IS USED FOR
Tadalafil Sandoz contains the active substance tadalafil which belongs
to a group of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil Sandoz
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 Sandoz has been shown to significantly improve the ability
of obtaining a hard erect
penis suitable for sexual activity.
Following sexual stimulation Tadalafil Sandoz 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 Sandoz will not help you if you do not
have erectile dysfunction. It
is important to note that Tadalafil Sandoz for the treatment of
erectile dysfunction does not
work if there is no sexual stimulation. You and your partner will need
to engage in foreplay,
just

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Sandoz 2.5 mg film-coated tablets
Tadalafil Sandoz 5 mg film-coated tablets
Tadalafil Sandoz 10 mg film-coated tablets
Tadalafil Sandoz 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg of tadalafil.
Excipient with known effect
Each tablet contains 41.9 mg of lactose (as monohydrate).
Each film-coated tablet contains 5 mg of tadalafil.
Excipient with known effect
Each tablet contains 83.8 mg of lactose (as monohydrate).
Each film-coated tablet contains 10 mg of tadalafil.
Excipient with known effect
Each tablet contains 167.7 mg of lactose (as monohydrate9.
Each film-coated tablet contains 20 mg of tadalafil.
Excipient with known effect
Each tablet contains 335.4 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_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.
_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.
_10 mg film-coated tablets _
Ochre to yellow, oval shaped film-coated tablet of approximately 11 x
6 mm. On one side debossed
with “10”. The other side of the tablet is plain.
_20 mg film-coated tablets _
Ochre to yellow, oval shaped film-coated tablet of approximately 15 x
9 mm. On one side debossed
with “20”. The other side of the tablet is bi-scored.
The tablet can be divided into equal halves and/or quarters.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tadalafil Sandoz 2.5 mg, 5 mg, 10 mg and 20 mg film-coated tablets:
Treatment of erectile dysfunction in adult males. In order for
tadalafil to be effective for the treatment
of erectile dysfunction, sexual stimulation is required.
Tadalafil Sandoz 5 mg film-coated tablets:
Treatment of the