Country: Netherlands
Language: Dutch
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TADALAFIL 5 mg/stuk
G.L. Pharma GmbH Schlossplatz 1 A-8502 LANNACH (OOSTENRIJK)
G04BE08
TADALAFIL 5 mg/stuk
Filmomhulde tablet
CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Tadalafil
Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 0-WATER; LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); TALK (E 553 B); TITAANDIOXIDE (E 171);
2017-01-25
PACKAGE LEAFLET: INFORMATION FOR THE USER GEROCILAN 5 MG FILMOMHULDE TABLETTEN 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 Gerocilan is and what it is used for 2. What you need to know before you take Gerocilan 3. How to take Gerocilan 4. Possible side effects 5. How to store Gerocilan 6. Contents of the pack and other information 1. WHAT GEROCILAN IS AND WHAT IT IS USED FOR Gerocilan contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Gerocilan 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 obtain- ing a hard erect penis suitable for sexual activity. Following sexual stimulation Gerocilan 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. Gerocilan will not help you if you do not have erectile dysfunction. It is important to note that Gerocilan 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 HYPER- PLASIA . This is when the prostate gland gets bigger with age. Symptoms include difficulty in start Read the complete document
1 . NAME OF THE MEDICINAL PRODUCT Gerocilan 5 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Gerocilan 5 mg: Each film-coated tablet contains 5 mg tadalafil. Excipient with known effect: Each 5 mg tablet contains 78.125 mg of lactose and 0.7 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Gerocilan 5 mg: Yellow colored, caplet shaped, biconvex, film coated tablet, debossed with “T 5” on one side and plain on the other, with nominal dimensions 8.2 mm x 4.1 mm. 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. Gerocilan 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 Gerocilan (i.e., at least twice weekly) a once daily regimen with the lowest doses of Gerocilan 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 recommended doses are not all possible using this product however tadalafil is available in a dosage lower than 5 mg. The appropriateness of continued use of the daily regimen should be re Read the complete document