Maxon Active (3x8tablets) = 24 tablets

Composition:

Each film-coated tablet contains 25 mg of sildenafil as citrate sildenafil.

Each 25 mg film-coated tablet contains 1.63 mg lactose monohydrate.

For a full list of excipients, see section 6.1.

Indications:

MAXON ACTIVE is indicated for use in adult men with erectile dysfunction, ie an inability to obtain or maintain an erection of the penis sufficient to undergo sexual intercourse.

Sexual stimulation is required for effective treatment of MAXON ACTIVE.

Contraindications:

Hypersensitivity to the active substance or to any of the excipients listed in

point 6.1.

Due to the effect of sildenafil on metabolic changes in which nitric oxide and nitric oxide are involved

cyclic guanosine monophosphate (cGMP) (see section 5.1) potentiates hypotensive action

nitrates. Concomitant use of sildenafil with releasing agents is contraindicated

nitric oxide (such as amyl nitrite) or nitrates in any form.

Concomitant use of PDE5 inhibitors, including sildenafil, and cyclase-stimulants

guanyl, such as riociguat, is contraindicated, because it can lead to symptomatic

hypotension (see section 4.5).

Medicinal products intended for the treatment of erectile dysfunction, including sildenafil should not

use in men whose sexual activity is not indicated (eg patients with severe

diseases of the cardiovascular system, such as unstable angina or severe angina

heart failure).

MAXON ACTIVE is contraindicated in patients who have lost their sight in one eye as a result of non-arteritic anterior ischemic optic neuropathy (NAION), irrespective of whether it was affected or not was related to previous PDE5 inhibitor exposure (see section 4.4).

The safety of sildenafil in the following groups of patients has not been studied:

severe liver failure, hypotension (blood pressure <90/50 mmHg), after a recent history

stroke or myocardial infarction, and with inherited degenerative changes in the retina,

such as retinitis pigmentosa (a small proportion of these patients are genetically conditioned

abnormalities of retinal phosphodiesterase). The use of sildenafil in these patients is

contraindicated.

Side effects:

Summary of the safety profile

The safety profile of sildenafil was based on data on 9,570 patients in 74 double-blind and placebo-controlled clinical studies. The most common side effects reported by patients taking sildenafil in clinical trials were headache, flushing, indigestion, stuffy nose, dizziness, nausea, flushing, blurred vision, blue vision, and

blurred vision.

Data on adverse reactions collected as part of the safety monitoring

pharmacotherapy after admission of sildenafil is for more than 10 years.

Because not all side effects are reported to the responsible entity and

entered into the safety database, it is not possible to reliably determine

frequency of occurrence of these activities.

Tabulated list of adverse reactions

The following table lists all medically relevant adverse events whose incidence exceeds the incidence of analogous events in patients taking placebo in clinical trials. These activities were grouped according to the organ systems in which they were found and the frequency of their occurrence (very frequent (≥1 / 10), frequent (≥1 / 100 to <1/10), uncommon (≥1 / 1000 to <1/100) and rare (≥1 / 10,000 to <1/1000).

In addition, medically relevant adverse events that occurred after the introduction of sildenafil were listed as adverse events with an unknown incidence.

Within each frequency grouping, adverse reactions are listed in order of decreasing seriousness.

Dosage

Use in adults

The recommended dose is 25 mg sildenafil taken depending on needs about an hour before planned sexual activity. The use of the medicinal product is not recommended more frequently than once a day. If MAXON ACTIVE is taken with food, the onset of action of the medicinal product may be delayed compared to taking the fasted medicinal product (see section 5.2).

If the doctor decides about the use of pharmacological treatment, he may recommend a dose of 50 mg sildenafil, taken as needed, approximately one hour before planned sexual activity. Depending on the efficacy and tolerance of the medicinal product, your doctor may increase the dose to 100 mg or reduce to 25 mg.

Special populations of patients

Elderly patients

Dosage adjustment in elderly patients is not required (≥ 65 years).

Patients with impaired renal function

The dosage recommendations described under ‘Use in adults’ also apply to patients with mild or moderate renal impairment (creatinine clearance 30 – 80 ml / min).

In patients with severe renal impairment (creatinine clearance <30 ml / min), due to decreased sildenafil clearance, a 25 mg dose should be considered.

In the case when the doctor decides about the use of pharmacological treatment, depending on the efficacy and tolerance of the medicinal product, the dose may be gradually increased by the doctor to 50 mg, up to a maximum of 100 mg (if necessary).

Patients with impaired liver function

In patients with hepatic impairment (eg cirrhosis), a 25 mg dose should be considered due to decreased sildenafil clearance.

In the case when the doctor decides about the use of pharmacological treatment, depending on the efficacy and tolerance of the medicinal product, the dose may be gradually increased by the doctor to 50 mg, up to a maximum of 100 mg (if necessary).

Children and youth

MAXON ACTIVE is not indicated for people under 18 years of age.

Use in patients taking other medicinal products

If a physician decides to use a pharmacological treatment, a dose of 25 mg should be considered for patients who are co-administered with CYP3A4 inhibitors (see section 4.5). The exception is ritonavir, which is not recommended for concomitant use with sildenafil (see section 4.4).

In order to reduce the risk of orthostatic hypotension in patients taking alpha-blocker medication, the condition of such patients should be stabilized before starting treatment with sildenafil. If a physician decides about the use of pharmacological treatment, the initiation of therapy with 25 mg sildenafil should be considered (see sections 4.4 and 4.5).