TADALAFIL-TEVA FC TABLET 5MG

দেশ: সিঙ্গাপুর

ভাষা: ইংরেজি

সূত্র: HSA (Health Sciences Authority)

সক্রিয় উপাদান:

Tadalafil

থেকে পাওয়া:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

এটিসি কোড:

G04BE08

ফার্মাসিউটিকাল ফর্ম:

TABLET, FILM COATED

রচনা:

Tadalafil 5 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

Prescription Only

Manufactured by:

TEVA PHARMA, S.L.U.

অনুমোদন অবস্থা:

ACTIVE

অনুমোদন তারিখ:

2023-10-13

পণ্য বৈশিষ্ট্য

TADALAFIL–TEVA FC TABLET
1.
NAME OF THE MEDICINAL PRODUCT
TADALAFIL-TEVA FC TABLET 5MG
TADALAFIL-TEVA FC TABLET 20MG
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each tablet contains 5mg or 20mg tadalafil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
5 mg tablet: Ochre to yellow, oval shaped film coated tablet. On
one side debossed with “5” and plain on the other side. Length:
8.1 mm, width: 4.1mm.
20 mg tablet: Ochre to yellow, oval shaped film coated tablet. On
one side bi-scored and the other side debossed with “20”. Length:
15.0 mm, width: 9.0 mm. The tablet can be divided into two or
four equal doses.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction (ED) in adult males. In order
for tadalafil to be effective for the treatment of ED, sexual
stimulation is required.
Treatment of the signs and symptoms of benign prostatic
hyperplasia (BPH). If Tadalafil is used with finasteride to initiate
BPH treatment, such use is recommended for up to 26 weeks.
Treatment of erectile dysfunction and the signs and symptoms of
benign prostatic hyperplasia (ED/BPH).
Tadalafil is not indicated for use by women.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Erectile Dysfunction
Tadalafil for Use as Needed
The recommended dose is 10mg taken prior to anticipated sexual
activity. In those patients in whom tadalafil 10mg does not
produce an adequate effect, the maximum dose is 20mg and the
maximum dosing frequency is once per day. It may be taken from
30 minutes to 36 hours prior to sexual activity. Tadalafil 10mg
and 20mg is intended for use prior to anticipated sexual activity
and it is not recommended for continuous daily use.
Tadalafil for Once 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 starting dose is 2.5m