Pays: Suède
Langue: suédois
Source: Läkemedelsverket (Medical Products Agency)
tadalafil
Zentiva k.s.
G04BE08
tadalafil
5 mg
Filmdragerad tablett
laktosmonohydrat Hjälpämne; natriumlaurilsulfat Hjälpämne; tadalafil 5 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 14 tabletter; Blister, 28 tabletter
Godkänd
2017-07-13
PACKAGE LEAFLET: INFORMATION FOR THE USER [INVENTED NAME] 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 [Invented name] is and what it is used for 2. What you need to know before you take [Invented name] 3. How to take [Invented name] 4. Possible side effects 5. How to store [Invented name] 6. Contents of the pack and other information 1. WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR [Invented name] contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. [Invented name] 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 the prostate gland gets bigger w Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT [Invented name] 5 mg 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. [Invented name] 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 [Invented name] (i.e., at least twice weekly) a once daily regimen with the lowest doses of [Invented name] 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. As <[Invented name]> is not available as 2.5 mg film-coated tablets, other suitable formulations should be checked for their availability Lire le document complet