Country: Israel
Language: English
Source: Ministry of Health
TADALAFIL
ELI LILLY ISRAEL LTD, ISRAEL
G04BE08
FILM COATED TABLETS
TADALAFIL 5 MG
PER OS
Required
LILLY S.A., SPAIN
TADALAFIL
TADALAFIL
For the treatment of erectile dysfunction in adult men.Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)Treatment of ED and the signs and symptoms of BPH (ED/BPH)
2023-05-31
I CIALTB A 12 Page 1 of 8 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a physician’s prescription only_ _ Cialis 10 mg Cialis 20 mg Coated tablets Coated tablets Composition: Composition: Each tablet contains: Each tablet contains: Tadalafil 10 mg to be used_ “ON DEMAND”_ Tadalafil 20 mg to be used_ “On Demand”_ Cialis 2.5 mg Cialis 5 mg Coated tablets Coated tablets Composition: Composition: Each tablet contains: Each tablet contains: Tadalafil 2.5 mg for _“Once-a-Day”_ use Tadalafil 5 mg for _“Once-a-Day”_ use Inactive ingredients and allergens in the preparation: See Chapter 2 Section “important information about some of the ingredients of this medicine” and Chapter 6 “Additional information”. Read the entire leaflet carefully before using this medicine. This leaflet contains concise information about this medicine. If you have any additional questions, contact your doctor or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It might harm them even if their illness seems to be the same as yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Cialis 2.5, 10 and 20 mg is indicated for the treatment of erectile dysfunction in men. Cialis 5 mg is indicated for: The treatment of erectile dysfunction in men. The treatment of symptoms of benign prostatic hyperplasia (BPH). The treatment of men with erectile dysfunction and symptoms of benign prostatic hyperplasia (BPH). Therapeutic group: Urologicals, drugs used in erectile dysfunction. Cialis contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. I CIALTB A 12 Page 2 of 8 Erectile dysfunction is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Cialis has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. Following sexual stimulation, Cialis works by helping the Read the complete document
X CIALTB A 11 Page 1 of 15 1. NAME OF THE MEDICINAL PRODUCT CIALIS 2.5 mg film-coated tablets CIALIS 5 mg film-coated tablets CIALIS 10 mg film-coated tablets CIALIS 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each 2.5 mg tablet contains 2.5 mg tadalafil. Each 5 mg tablet contains 5 mg tadalafil. Each 10 mg tablet contains 10 mg tadalafil. Each 20 mg tablet contains 20 mg tadalafil. Excipient with known effect Each 2.5 mg coated tablet contains 87 mg lactose (as monohydrate). Each 5 mg coated tablet contains 121 mg lactose (as monohydrate). Each 10 mg coated tablet contains 170 mg lactose (as monohydrate). Each 20 mg coated tablet contains 233 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). The 2.5 mg tablets are light orange-yellow and almond shaped, marked "C 2 ½" on one side. The 5 mg tablets are light yellow and almond shaped, marked "C 5" on one side. The 10 mg tablets are light yellow and almond shaped, marked “C 10” on one side. The 20 mg tablets are yellow and almond shaped, marked “C 20” on one side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of erectile dysfunction in adult men. In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required. X CIALTB A 11 Page 2 of 15 CIALIS 5 mg for once daily use is also indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). CIALIS 5 mg for once daily use is also indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). CIALIS 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 max Read the complete document