Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tadalafil
Sandoz Ltd
G04BE08
Tadalafil
10mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040500; GTIN: 5050650147032
OBJECT 1 TADALAFIL SANDOZ 10 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 22-Mar-2018 | Sandoz Limited 1. Name of the medicinal product Tadalafil Sandoz 10 mg Film-coated Tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 10 mg tadalafil. Excipient(s) with known effect Each tablet contains 177 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 11 x 7 mm. On one side debossed with “10”. 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. 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 adult men being treat Διαβάστε το πλήρες έγγραφο