TADALAFIL ACTAVIS 5 Milligram Film Coated Tablet

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

TADALAFIL

Inapatikana kutoka:

Actavis Group PTC ehf

ATC kanuni:

G04BE08

INN (Jina la Kimataifa):

TADALAFIL

Kipimo:

5 Milligram

Dawa fomu:

Film Coated Tablet

Dawa ya aina:

Product subject to prescription which may not be renewed (A)

Eneo la matibabu:

Drugs used in erectile dysfuntion

Idhini hali ya:

Authorised

Idhini ya tarehe:

2016-06-24

Taarifa za kipeperushi

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL ACTAVIS 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 Actavis is and what it is used for
2.
What you need to know before you take Tadalafil Actavis
3.
How to take Tadalafil Actavis
4.
Possible side effects
5.
How to store Tadalafil Actavis
6.
Contents of the pack and other information
1.
WHAT TADALAFIL ACTAVIS IS AND WHAT IT IS USED FOR
Tadalafil Actavis contains the active substance tadalafil which
belongs to a group of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil Actavis 5 mg 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 has been shown to significantly improve the
ability of obtaining a hard
erect penis suitable for sexual activity. Following sexual stimulation
tadalafil 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 will not help you if you
do not have erectile
dysfunction. It is important to note that tadalafil 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 as you would if you were not taking a medicine for erectile
dysfunction.
-
urinary symptoms associated with a common condition called BENIGN
PROSTATIC HYPERPLASIA.
This is when th

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tadalafil Actavis 5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg tadalafil.
Excipient with known effect:
Each coated tablet contains 123 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
5 mg film
-
coated tablets are: Pale yellow, oval shape, film
-
coated tablets, debossed with ‘5’ on one side and plain on
the other side. The tablet is 10 mm x 6.0 mm in diameter and 3.3 –
3.9 mm in thickness.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective_ FOR THE TREATMENT OF ERECTILE
DYSFUNCTION_, sexual stimulation is required.
Treatment of the signs and symptoms of benign prostatic hyperplasia in
adult males.
Tadalafil Actavis is not indicated for use by women.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Erectile dysfunction in 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 Actavis (i.e.,
at least twice weekly) a once daily regimen with the
lowest doses of Tadalafil Actavis 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.
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