Tadalafil 5mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Tadalafil

متاح من:

Sandoz Ltd

ATC رمز:

G04BE08

INN (الاسم الدولي):

Tadalafil

جرعة:

5mg

الشكل الصيدلاني:

Tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: ; GTIN: 5050650147025

خصائص المنتج

OBJECT 1
TADALAFIL SANDOZ 5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 22-Mar-2018 | Sandoz
Limited
1. Name of the medicinal product
Tadalafil Sandoz 5 mg Film-coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 5 mg tadalafil.
Excipient(s) with known effect
Each tablet contains 88 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
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.
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.
Treatment of the signs and symptoms of benign prostatic hyperplasia in
adult males.
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 mg 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.
_Benign prostatic hyperplasia in adult men_
The recommended dose is 5 mg, taken at approximately the same time
every day with or without food.
For