Film-coated tablets
OTC drug

Tadalafil Mensil

product website

Composition

One tablet contains 10 mg of tadalafil.

Indications

Treatment of erectile dysfunction in adult men.

In order for tadalafil to be effective, sexual stimulation is required.

Tadalafil MENSIL 10 mg is not intended for use in women.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed below:

Tablet core:

  • Lactose monohydrate
  • Microcrystalline cellulose
  • Hydroxypropylcellulose
  • Sodium lauryl sulfate
  • Croscarmellose sodium
  • Magnesium stearate


Opadry II Blue 85F30605 coating:

  • Polyvinyl alcohol, partially hydrolysed
  • Titanium dioxide (E 171)
  • Macrogol 3350 and 4000
  • Talc
  • Indigo carmine aluminum lake (E 132)

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, Tadalafil MENSIL is contraindicated in patients taking any form of organic nitrates (see section 4.5).

Tadalafil MENSIL must not be used in men with heart disease for whom sexual activity is inadvisable. When the use of pharmacological treatment is decided by the physician, he should consider the risk of cardiac dysfunction associated with sexual activity in patients with cardiovascular diseases.

Tadalafil is contraindicated in the following cardiovascular disease groups not included in clinical trials:

  • patients with myocardial infarction within the last 90 days,
  • patients with unstable angina or angina occurring during sexual intercourse,
  • patients with a NYHA (New York Heart Association) grade 2 or higher 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 MENSIL is contraindicated in patients who have loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy (NAI). non-arteritic anterior ischemic optic neuropathy (NAION), whether or not related to previous exposure to a PDE5 inhibitor (see section 4.4).

Concomitant use of PDE5 inhibitors, including tadalafil, and drugs that induce guanylyl cyclase, such as riociguat, is contraindicated as it may 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.

Drug information

phone: (+48) 22 742 00 22
informacjaoleku@hasco-lek.pl
Film-coated tablets
OTC drug

Tadalafil Mensil

product website

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.

Drug information

phone: (+48 22) 742 00 22
informacjaoleku@hasco-lek.pl

Composition

One tablet contains 10 mg of tadalafil.

Indications

Treatment of erectile dysfunction in adult men.

In order for tadalafil to be effective, sexual stimulation is required.

Tadalafil MENSIL 10 mg is not intended for use in women.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed below:

Tablet core:

  • Lactose monohydrate
  • Microcrystalline cellulose
  • Hydroxypropylcellulose
  • Sodium lauryl sulfate
  • Croscarmellose sodium
  • Magnesium stearate


Opadry II Blue 85F30605 coating:

  • Polyvinyl alcohol, partially hydrolysed
  • Titanium dioxide (E 171)
  • Macrogol 3350 and 4000
  • Talc
  • Indigo carmine aluminum lake (E 132)

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, Tadalafil MENSIL is contraindicated in patients taking any form of organic nitrates (see section 4.5).

Tadalafil MENSIL must not be used in men with heart disease for whom sexual activity is inadvisable. When the use of pharmacological treatment is decided by the physician, he should consider the risk of cardiac dysfunction associated with sexual activity in patients with cardiovascular diseases.

Tadalafil is contraindicated in the following cardiovascular disease groups not included in clinical trials:

  • patients with myocardial infarction within the last 90 days,
  • patients with unstable angina or angina occurring during sexual intercourse,
  • patients with a NYHA (New York Heart Association) grade 2 or higher 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 MENSIL is contraindicated in patients who have loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy (NAI). non-arteritic anterior ischemic optic neuropathy (NAION), whether or not related to previous exposure to a PDE5 inhibitor (see section 4.4).

Concomitant use of PDE5 inhibitors, including tadalafil, and drugs that induce guanylyl cyclase, such as riociguat, is contraindicated as it may lead to symptomatic hypotension (see section 4.5).