Maxigra Drive film-coated tablets 20 mg blister 1 pc.

• active ingredient: tadalafil;
• 1 tablet contains 20 mg of tadalafil;
• excipients:
• tablet core: lactose monohydrate, microcrystalline cellulose, povidone K 30, poloxamer, sodium lauryl sulfate, croscarmellose sodium, colloidal anhydrous silicon dioxide, magnesium stearate;
• shell: polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, iron oxide yellow (E 172), iron oxide red (E 172).

Hypersensitivity to tadalafil or any other component of the drug.

Tadalafil should not be used in men with heart disease for whom sexual activity is undesirable. Physicians should consider the potential cardiac risk of sexual activity in patients with a history of cardiovascular disease.

Tadalafil is contraindicated in patients with loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy (NAPION), whether or not this was related to previous exposure to PDE5 inhibitors.

The most commonly reported adverse reactions in the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain, and myalgia, the incidence of which increased with increasing tadalafil dose. Adverse reactions were of short duration and generally mild to moderate in severity. Most cases of headache with daily tadalafil occurred within the first 10–30 days after initiation of treatment.

For oral use.

Erectile dysfunction in adult men.

The recommended dose is 10 mg before anticipated sexual activity, regardless of food intake. Patients in whom tadalafil 10 mg does not produce an adequate effect may be given a 20 mg dose.

The drug can be taken 30 minutes before sexual activity.

The maximum recommended frequency of administration is once a day.

Benign prostatic hyperplasia in adult men.

For daily use, the recommended dose is 5 mg/day at approximately the same time each day, without regard to meals. For the treatment of adult men with erectile dysfunction and symptoms of benign prostatic hyperplasia, the recommended dose for daily use is 5 mg/day at approximately the same time each day. For patients who cannot tolerate tadalafil 5 mg/day for the treatment of benign prostatic hyperplasia, alternative therapy should be considered, as the efficacy of tadalafil 2.5 mg/day for the treatment of benign prostatic hyperplasia has not been evaluated.

Use during pregnancy or breastfeeding

Maxigra Drive is not indicated for use in women.

Maxigra Drive should not be used during breastfeeding.

Children

There are no data on the use of tadalafil in children for the treatment of erectile dysfunction.

Ability to influence reaction speed when driving vehicles or other mechanisms

Tadalafil has negligible influence on the ability to drive and use machines. Although the frequency of reports of dizziness in clinical trials with placebo and in clinical trials with tadalafil was similar, patients should be aware of how Maxigra Drive affects them before driving or operating machinery.

Symptoms: With a single use of tadalafil in doses up to 500 mg by healthy volunteers and with multiple use of tadalafil in patients up to 100 mg per day, undesirable effects were similar to those observed with lower doses of the drug.

Treatment: In case of overdose, standard symptomatic therapy should be used if necessary. Hemodialysis had no significant effect on the elimination of tadalafil.

Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.