Each film-coated tablet contains 5 mg, 10 mg or 20 mg tadalafil. Excipient with known effect: 115.84 mg or 463.36 mg of lactose as monohydrate.
5 mg – Treatment of erectile dysfunction in adult men.
In order for tadalafil to be effective, sexual stimulation is required.
Treatment of the symptoms of benign prostatic hyperplasia in adult men.
20 mg – Treatment of erectile dysfunction in adult men.
In order for tadalafil to be effective, sexual stimulation is required.
Treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and
III to improve exercise capacity in adults (see section 5.1).
Efficacy of the product has been shown in idiopathic PAH
(IPAH) and in PAH related to
collagen vascular disease.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of Tadalafil Hasco to patients who are using any form of organic nitrate is contraindicated (see section 4.5).
Tadalafil Hasco must not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.
The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated:
patients with myocardial infarction within the last 90 days,
patients with unstable angina or angina occurring during sexual intercourse,
patients with New York Heart Association
Class 2 or greater heart failure in the last 6 months,
patients with uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension,
patients with a stroke within the last 6 months.
Tadalafil Hasco is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy
(NAION), regardless of whether this episode was in connection or not with previous phosphodiesterase 5 (PDE5) inhibitor exposure (see section 4.4).
The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase
stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic
hypotension (see section 4.5).
This is a drug. For safety, use it according to the package insert and only when necessary. If in doubt, consult your doctor or pharmacist.
phone: (+48 22) 742 00 22
informacjaoleku@hasco-lek.pl
Each film-coated tablet contains 5 mg, 10 mg or 20 mg tadalafil. Excipient with known effect: 115.84 mg or 463.36 mg of lactose as monohydrate.
5 mg – Treatment of erectile dysfunction in adult men.
In order for tadalafil to be effective, sexual stimulation is required.
Treatment of the symptoms of benign prostatic hyperplasia in adult men.
20 mg – Treatment of erectile dysfunction in adult men.
In order for tadalafil to be effective, sexual stimulation is required.
Treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and
III to improve exercise capacity in adults (see section 5.1).
Efficacy of the product has been shown in idiopathic PAH
(IPAH) and in PAH related to
collagen vascular disease.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of Tadalafil Hasco to patients who are using any form of organic nitrate is contraindicated (see section 4.5).
Tadalafil Hasco must not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.
The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated:
patients with myocardial infarction within the last 90 days,
patients with unstable angina or angina occurring during sexual intercourse,
patients with New York Heart Association
Class 2 or greater heart failure in the last 6 months,
patients with uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension,
patients with a stroke within the last 6 months.
Tadalafil Hasco is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy
(NAION), regardless of whether this episode was in connection or not with previous phosphodiesterase 5 (PDE5) inhibitor exposure (see section 4.4).
The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase
stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic
hypotension (see section 4.5).
Przedsiębiorstwo Produkcji
Farmaceutycznej
Hasco-Lek S.A.
st. Żmigrodzka 242e
51-131 Wroclaw
phone: (+48) 71 352 95 22
fax: (+48) 71 352 76 36
hasco@hasco-lek.pl
