Description
Maxigra Max film-coated tablets are a medicinal product indicated for the management of erectile dysfunction, also referred to as impotence. The product is intended for adult men.
Composition
Active substance: sildenafil.
Each tablet contains 50 mg of sildenafil (as sildenafil citrate).
Excipients:
Tablet core: mannitol (E421), crospovidone (type A), povidone (K30), colloidal anhydrous silica, maize starch, magnesium stearate, sodium lauryl sulfate.
Film coating: hypromellose, macrogol 6000, titanium dioxide, talc, indigo carmine aluminium lake (E132).
Dosage and Administration
This medicine should always be used exactly as described in the patient information leaflet or as advised by a doctor or pharmacist. In case of any doubt, medical advice should be sought.
If the patient has previously taken medicinal products containing sildenafil at a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, Maxigra Max 50 mg should only be used if a 25 mg dose of sildenafil did not produce a satisfactory effect (i.e., an erection sufficient for sexual intercourse).
Maxigra Max must not be taken more than once daily.
Do not take Maxigra Max concomitantly with any other medicinal products containing sildenafil.
Take the tablet approximately one hour before planned sexual activity.
Swallow the tablet whole with a glass of water.
If the effect appears too strong or too weak, the patient should consult a doctor or pharmacist. Maxigra Max will only enable an erection in the presence of sexual stimulation.
The onset of action varies between individuals and usually occurs between 30 minutes and 1 hour. The onset may be delayed if the tablet is taken with a heavy meal.
Mechanism of Action
Maxigra Max contains sildenafil, a phosphodiesterase type 5 (PDE5) inhibitor. It works by enhancing vasodilation in the corpus cavernosum, increasing blood flow to the penis during sexual stimulation. Maxigra Max facilitates an erection only in response to sexual arousal.
Indications
Treatment of erectile dysfunction in adult men.
Contraindications
Do not use Maxigra Max if:
-
the patient is allergic to sildenafil or any of the excipients;
-
the patient is taking nitric oxide donors or nitrate-containing medicines, as concomitant use may cause a dangerous drop in blood pressure;
This includes:
– nitroglycerin (e.g., Nitrocard, Nitromint, Sustonit, Nitroderm, Minitran),
– isosorbide mononitrate (e.g., Effox, Mononit, Monosan),
– isosorbide dinitrate (e.g., Sorbonit),
– pentaerythritol tetranitrate (e.g., Pentaerythritol compositum). -
the patient uses nitric oxide-releasing agents such as amyl nitrite (“poppers”);
-
the patient is taking riociguat (e.g., Adempas) for pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension;
-
the patient has severe cardiac or hepatic impairment;
-
the patient has had a recent stroke or myocardial infarction, or has hypotension;
-
the patient has hereditary retinal degenerative disorders such as retinitis pigmentosa;
-
the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).
Adverse Reactions
Like all medicines, this product may cause side effects, although not everyone will experience them.
Side effects are usually mild to moderate and transient.
Seek immediate medical assistance and discontinue Maxigra Max if any of the following occur:
-
Allergic reaction (uncommon): wheezing, difficulty breathing, dizziness, swelling of eyelids, face, lips or throat.
-
Chest pain (uncommon):
– stop sexual activity,
– sit upright and try to relax,
– do not take nitrates. -
Prolonged and sometimes painful erection lasting more than 4 hours (rare) – seek immediate medical attention.
-
Sudden decrease or loss of vision (rare).
-
Severe skin reactions (rare): blistering, peeling, swelling of skin, lesions on mouth, genitals, eyes, fever.
-
Seizures (rare).
Other adverse reactions:
Very common:
• headache.
Common:
• nausea, flushing, hot flushes, dyspepsia,
• visual disturbances (colour tinge, blurred vision),
• nasal congestion, dizziness.
Uncommon:
• vomiting, rash, eye irritation, photophobia, tearing,
• palpitations, tachycardia, hypertension, hypotension,
• myalgia, somnolence, paraesthesia, tinnitus,
• dry mouth, sinus congestion, rhinitis,
• abdominal pain, gastro-oesophageal reflux,
• haematuria, limb pain, epistaxis, fatigue.
Rare:
• syncope, stroke, myocardial infarction, arrhythmias, transient ischemic attacks,
• throat tightness, lip numbness,
• retinal bleeding, diplopia,
• reduced visual acuity, ocular edema, floaters, halos,
• priapism-related bleeding, haematospermia, nasal dryness, nasal swelling,
• irritability, sudden hearing loss.
Warnings and Precautions
Discuss use of Maxigra Max with a doctor or pharmacist if the patient has:
-
sickle cell anaemia,
-
leukemia,
-
multiple myeloma,
-
anatomical penile deformities (e.g., Peyronie’s disease),
-
severe cardiovascular disease (physician must assess if sexual activity is safe),
-
peptic ulcer disease,
-
bleeding disorders (e.g., haemophilia).
Discontinue use and seek medical advice immediately if sudden visual impairment occurs.
Do not use Maxigra Max with other oral or topical erectile dysfunction treatments.
Do not combine Maxigra Max with sildenafil-containing therapy for pulmonary arterial hypertension or other PDE5 inhibitors (e.g., tadalafil).
Interactions
Inform a doctor or pharmacist of all medicines currently being taken, recently taken, or planned to be taken.
Pregnancy and Breast-Feeding
Maxigra Max is not intended for use by women.
Paediatric Population
Not indicated for individuals under 18 years of age.
Driving and Use of Machines
Maxigra Max may cause dizziness or visual disturbances. Before driving or operating machinery, patients should assess their individual response to the medicinal product.
