Tadalafil 20mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Tadalafil

Διαθέσιμο από:

Sandoz Ltd

Φαρμακολογική κατηγορία (ATC):

G04BE08

INN (Διεθνής Όνομα):

Tadalafil

Δοσολογία:

20mg

Φαρμακοτεχνική μορφή:

Tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 07040500; GTIN: 5050650147049 5050650147056

Αρχείο Π.Χ.Π.

OBJECT 1
TADALAFIL SANDOZ 20 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 26-Mar-2018 | Sandoz
Limited
1. Name of the medicinal product
Tadalafil Sandoz 20 mg Film-coated Tablets
2. Qualitative and quantitative composition
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.
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 can be divided into equal halves.
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.
Tadalafil is indicated in adults for the treatment of pulmonary
arterial hypertension (PAH) classified as
WHO functional class II and III, to improve exercise capacity (see
section 5.1).
Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to
collagen vascular disease.
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
appro