Description
Tadalafil Maxigra is a medicinal product containing tadalafil as the active substance. The medicine is intended for adult men with erectile dysfunction.
Composition
Film-coated tablets. Each tablet contains 10 mg of tadalafil. Excipient with known effect: lactose monohydrate. Each film-coated tablet contains 153.8 mg of lactose monohydrate.
Posology and Method of Administration
Tadalafil Maxigra tablets are for oral use in men only. The tablets should be swallowed whole with a small amount of water. They may be taken with or without food.
The recommended dose of Tadalafil Maxigra is one 10 mg tablet taken prior to anticipated sexual activity. The medicine should be taken at least 30 minutes before sexual activity. Its effect may last up to 36 hours after dosing. For on-demand use only. Do not use more than once per week. Do not take more than one tablet.
Pharmacological Action
Tadalafil belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Following sexual stimulation, it helps relax blood vessels and allows increased blood flow to the penis, thereby improving erectile function.
Indications
Tadalafil Maxigra is indicated for adult men with erectile dysfunction, a condition characterized by the inability to achieve or maintain an erection sufficient for satisfactory sexual activity.
Contraindications
Do not use Tadalafil Maxigra:
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if you are allergic to tadalafil or any of the excipients
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if you are taking nitrates, such as:
• nitroglycerin (Glycerol trinitrate) – e.g., Nitrocard, Nitromint, Sustonit, Nitroderm, Minitran
• isosorbide mononitrate – e.g., Effox, Isosorbide Mononitrate Vitabalans, Isosorbide Mononitrate Accord, Mono Mack, Mononit, Monosan, Olicard retard
• isosorbide dinitrate – e.g., Sorbonit
These medicines are commonly used for angina pectoris. Tadalafil Maxigra has been shown to potentiate the hypotensive effects of these agents. -
if you are taking medicines or substances that release nitric oxide (e.g., amyl nitrite “poppers”), as concomitant use may cause dangerous hypotension
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if you have severe heart disease or have had a myocardial infarction within the last 90 days
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if you have had a stroke within the past 6 months
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if you have low blood pressure or uncontrolled hypertension
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if you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION)
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if you are taking riociguat (e.g., Adempas) for pulmonary hypertension, as PDE5 inhibitors enhance its hypotensive effect
Information on excipients:
Tadalafil Maxigra contains lactose and sodium. If you have been told you have an intolerance to certain sugars, consult your doctor before taking this product.
This medicine contains less than 1 mmol (23 mg) sodium per tablet and is considered “sodium-free.”
Possible Side Effects
Like all medicines, this product may cause side effects, although not everybody gets them. They are usually mild to moderate.
Stop taking the medicine and seek immediate medical attention if you experience:
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allergic reactions including rash (uncommon)
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chest pain — do not take nitrates; seek immediate help (uncommon)
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priapism — a prolonged and possibly painful erection (rare). If an erection lasts more than 4 hours, contact a doctor immediately, as permanent damage may occur
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sudden loss of vision (rare), distorted or blurred central vision (frequency not known)
Other reported adverse effects include:
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Common (≤1/10): —
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Uncommon (≤1/100): fainting, seizures, transient memory loss, eyelid swelling, eye redness, sudden hearing decrease or loss, urticaria, penile bleeding, haematospermia, increased sweating
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Rare (≤1/1,000): myocardial infarction, stroke (mostly in men with pre-existing cardiac risk factors), partial or complete visual impairment, migraine, facial swelling, severe allergic reactions including angioedema, severe skin rashes, ocular vascular disorders, arrhythmia, angina pectoris, sudden cardiac death
Dizziness has been reported more frequently in men over 75 years taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years.
Warnings and Precautions
Read the package leaflet carefully before use. If in doubt, consult your doctor or pharmacist.
Sexual activity can pose a cardiac risk in patients with heart disease. Inform your doctor if you have cardiovascular problems.
Before taking the medicine, inform your doctor if you have:
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sickle-cell anaemia
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multiple myeloma
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leukaemia
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anatomical penile deformities
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severe hepatic or renal impairment
The efficacy of Tadalafil Maxigra has not been established in patients:
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after pelvic surgery
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after radical prostatectomy without nerve-sparing procedures
Discontinue treatment and seek immediate medical advice if sudden vision loss or visual disturbance occurs.
Hearing impairment or sudden hearing loss has been reported. If this occurs, stop treatment and consult a doctor.
Do not use Tadalafil Maxigra together with other oral or topical treatments for erectile dysfunction, nor with sildenafil-based pulmonary hypertension therapies.
Do not use sildenafil-containing medicines (e.g., Maxigra Go, Maxigra Max, Sildenafil PPH, Viagra) within 48 hours of taking Tadalafil Maxigra.
Do not use the medicine if erectile dysfunction is not diagnosed.
Men taking alpha-blockers (e.g., doxazosin, prazosin, terazosin) may experience dizziness or faintness due to hypotension. Stable dosing of the alpha-blocker is recommended before starting tadalafil.
If symptoms of hypotension occur (dizziness, light-headedness, presyncope):
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lie down or sit until symptoms resolve
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drinking water, fresh air, or leg-crossing may help
Avoid sudden changes in posture.
Consult your doctor if you are taking antihypertensive medicines.
Interactions with Other Medicinal Products
Inform your doctor or pharmacist about any medicines you are taking or have recently taken.
Do not take Tadalafil Maxigra with nitrates or nitric oxide donors, as this may cause severe hypotension.
Tadalafil may interact with:
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alpha-blockers
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antihypertensive agents
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riociguat
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5-alpha-reductase inhibitors (dutasteride, finasteride)
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ketoconazole (oral)
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protease inhibitors (ritonavir, saquinavir)
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antiepileptics (phenobarbital, phenytoin, carbamazepine)
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antibiotics (rifampicin, erythromycin, clarithromycin)
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itraconazole
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other ED treatments
Pregnancy and Breast-Feeding
Tadalafil Maxigra is not intended for use in women.
Use in Children and Adolescents
Tadalafil Maxigra is not indicated for individuals under 18 years of age.
Effects on Ability to Drive and Use Machines
Dizziness has been reported in some men taking tadalafil. Assess your response before driving or operating machinery.
