Afagra 50,100

Afagra 50 & 100

Sildenafil (as citrate)

Film-coated tablets 50 and 100 mg

This medicine has been prescribed for your current condition. Therefore, refrain from using it in similar cases or recommending it to others.

General Guidelines:

Consult your doctor before taking this medicine in the following cases:

• In case of allergy to this medicine, other medicines, or any other substances such as foods, preservatives, dyes, etc.
• In case of suffering from heart disease, severe hepatic and renal impairment, hypotension, sickle cell anemia, priapism, leukemia, a history of stroke or myocardial infarction, active stomach ulcer, and retinal disorders.

Use in Pregnancy and Lactation:

Sildenafil should not be used during pregnancy and lactation unless advised by a specialist.

Warnings:

• Sildenafil potentiates the hypotensive effects of nitrates. Sildenafil is contraindicated in patients undergoing treatment with nitrates such as nitroglycerin and isosorbide dinitrate.
• If chest pain occurs during or after sexual activity, since this reaction is not common, the patient should be placed in a semi-sitting position and rest, and nitrates should not be used to treat chest pain.
• Sildenafil should not be used in men for whom sexual activity is inadvisable (e.g., patients with severe cardiovascular disorders such as unstable angina or severe heart failure).
• Concurrent use of sildenafil with drugs known as protease inhibitors, such as HIV treatments, should be done under a doctor’s consultation.
• Sildenafil is contraindicated in patients who have lost vision in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION).
• In the event of any sudden visual defect, sildenafil should be stopped and a doctor must be consulted immediately.
• If an erection lasts longer than 4 hours, immediate medical attention is required.
• Caution should be exercised when prescribing sildenafil to patients using alpha-blockers (terazosin, prazosin, etc.), as concurrent use may lead to symptomatic hypotension in a small number of susceptible individuals.
• The use of sildenafil in patients with pulmonary veno-occlusive disease (PVOD) is not recommended.
• In patients with hepatic impairment and severe renal impairment, as well as those taking strong cytochrome P450 3A4 inhibitors like erythromycin, itraconazole, ketoconazole, and ritonavir, sildenafil plasma concentrations increase eightfold compared to healthy individuals. Since higher plasma concentrations may increase the incidence of adverse effects, the initial dose of sildenafil in these patients should be 25 mg.
• Sildenafil may have a minor influence on the ability to drive and use machines. Since dizziness and altered vision have been reported in clinical trials with sildenafil, patients should be aware of how they react to sildenafil before driving or operating machinery.
• Sildenafil should not be used concurrently with other oral or topical treatments for erectile dysfunction.
• Sildenafil is usually not prescribed for children and individuals under 18 years of age.

Dosage:

The exact dosage for each patient is determined by the attending physician. However, the usual dosage is as follows:

For the treatment of erectile dysfunction:

• Adults: 50 mg orally, as needed, 1 hour before sexual activity. The dose can be increased up to 100 mg per day.
• Elderly: 25 mg orally, as needed, 1 hour before sexual activity.

For the treatment of pulmonary hypertension:

• Adults: 20 mg orally, prescribed 3 times a day.

Administration:

• Swallow the tablet whole with a glass of water.
• Taking sildenafil with a heavy meal may delay the onset of action.
• Concurrent consumption of this medicine with alcoholic beverages can temporarily impair an erection.
• Sildenafil should not be taken more than once a day without a doctor’s prescription.
• Taking too much sildenafil may cause unwanted side effects. Doses above 100 mg do not increase efficacy.
• The tablet can be divided into equal halves for easier swallowing, but the dose should not be altered by doing so.

Side Effects:

Every medicine, alongside its desired therapeutic effects, may also cause some unwanted side effects. Inform your doctor if any of the following occur.

Important side effects that require medical notification if they occur:

• Common or very common: Alopecia, anemia, anxiety, cough, diarrhea, fluid retention, gastrointestinal problems, headache, increased risk of infection, insomnia, nausea, night sweats, pain, skin reactions, tremors, vasodilation, visual disturbances.
• Uncommon: Arrhythmia, chest pain, drowsiness, eye disorders, dry and inflamed eyes, fatigue, feeling hot, gynecomastia, bleeding, hypertension, hypotension, muscle pain, numbness, palpitations, sinus congestion, tinnitus, dizziness, vomiting.
• Rare or very rare: Acute coronary syndrome, atherosclerotic retinopathy, cerebrovascular insufficiency, glaucoma, hematospermia, hearing impairment, irritability, optic neuropathy, decreased oral sensation, priapism, retinal occlusion, scleral discoloration, seizures, severe skin reaction, sudden cardiac death, syncope, throat tightness.

Storage Conditions:

• Store the medicine below 30°C, protected from light and moisture.
• Keep the medicine out of the reach of children.
• Do not use this medicine after the expiry date printed on the carton. On the blister, it is stated after the expiry date term, which refers to the last day and month of the medicine’s expiration.
• To protect the environment, do not dispose of any medicines via wastewater or household waste.

Dosage Forms and Packaging:

This medicine is manufactured and supplied as 50 and 100 mg sildenafil (as citrate) film-coated tablets in boxes of 10 by Afashimi Pharmaceutical Company.

References: USP DI, BNF 2020