RECENT MAJOR CHANGES

This includes prescription or sildenafil online ireland nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Along with its needed effects, a medicine may cause some unwanted effects.

Storage Condition	Details	Recommended Temperature
Temperature	Store in a cool, dry place	20-25°C
Container	Keep in original packaging to prevent moisture	Airtight container
Light Exposure	Protect from direct sunlight	Yes
Expiry Date	Check before use	Typically 2-3 years

Although not all of these side effects may occur, if they do occur they may need medical attention.

5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease

Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Store mixed oral liquid in the refrigerator. Throw away any unused mixed Revatio® oral liquid after 60 days.

Dosage for erectile dysfunction (ED)

It is important that you tell all of your doctors that you take sildenafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took sildenafil. Do not use this medicine if you are also using a nitrate medicine, often used to treat angina or high blood pressure. Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite). Do not use this medicine if you also use riociguat (Adempas®). Check with your doctor immediately if any of the following side effects occur: burning feeling in the chest or stomach burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings decrease in amount of urine or the frequency of urination dizziness or lightheadedness, especially when getting up suddenly from a lying or sitting position dryness, redness, scaling, or peeling of the skin increase in the size of the pupil redness, burning, or swelling of the eyes redness, itching, or tearing of the eyes seeing shades of colors differently than before swelling of the face, hands, feet, or lower legs unusual feeling of burning or stinging of the skin Some side effects may occur that usually do not need medical attention.

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These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: pain or tenderness around the eyes and cheekbones diarrhea or stomach cramps (severe or continuing) numbness or tingling of the hands, legs, or feet redness, soreness, swelling, or bleeding of the gums sensation of motion, usually whirling, either of one's self or of one's surroundings sexual problems in men (continuing), including failure to experience a sexual orgasm sores in the mouth and on the lips Other side effects not listed may also occur in some patients.

Interaction	Effect	Management Tips
Nitrates	Severe hypotension, danger to life	Avoid combination
Alpha-blockers	Risk of hypotension	Use with caution, monitor blood pressure
CYP3A4 inhibitors	Increased sildenafil levels, risk of side effects	Dose adjustments may be needed
Other PDE-5 inhibitors	Increased risk of adverse effects	Use separate medications

If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects.

5.7 Priapism

Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may adjust your dose if needed. Adults 65 years of age and older—25 mg as a single dose no more than once a day, 1 hour before sexual intercourse. For oral dosage form (film):Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may adjust your dose as needed.

What should I do if I accidentally use too much sildenafil?

For treatment of pulmonary arterial hypertension:For oral dosage forms (suspension or tablets):Adults—20 milligrams (mg) 3 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 80 mg 3 times a day.Children 1 year of age and older weighing 45 kilograms (kg) or more—20 mg 3 times a day. However the dose is usually not more than 40 mg 3 times a day.Children 1 year of age and older weighing 20 to 45 kg—20 mg 3 times a day.Children 1 year of age and older weighing 20 kg or less—10 mg 3 times a day.Children younger than 1 year of age—Use and dose must be determined by your doctor. For oral dosage forms (suspension or tablets):Adults—20 milligrams (mg) 3 times a day. You may report side effects to the FDA at 1-800-FDA-1088.

6. Adverse Reactions/Side Effects

Adults—20 milligrams (mg) 3 times a day. However, the dose is usually not more than 80 mg 3 times a day. Children 1 year of age and older weighing 45 kilograms (kg) or more—20 mg 3 times a day. However the dose is usually not more than 40 mg 3 times a day. Children 1 year of age and older weighing 20 to 45 kg—20 mg 3 times a day.

How does sildenafil work (mechanism of action)?

Children 1 year of age and older weighing 20 kg or less—10 mg 3 times a day. Children younger than 1 sildenafil 25 mg tablets year of age—Use and dose must be determined by your doctor. For oral dosage forms (suspension or tablets): If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. NDC Code(s): 68071-3862-1, 68071-3862-5, 68071-3862-6, 68071-3862-9 If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S.

Proper Use

If you will be taking this medicine for pulmonary arterial hypertension, your doctor will want to check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. If you take sildenafil for pulmonary arterial hypertension, do not take Viagra®, Vibrique™ or other PDE5 inhibitors, including tadalafil (Cialis®) or vardenafil (Levitra®). If you take too much sildenafil or take it together with these medicines, the chance for side effects will be higher. It is important to tell your doctor about any heart problems you have now or may have had in the past.

Pulmonary hypertension

This medicine can cause serious side effects in patients with heart problems. If you experience a prolonged or painful erection for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis. If you experience a sudden loss of vision in one or both eyes, contact your doctor immediately. Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. Approval:1998RECENT MAJOR CHANGESWarnings and Precautions, Effects on the Eye ( 5.3) 08/2017INDICATIONS AND USAGESildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). (1)DOSAGE AND ADMINISTRATIONFor most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.

• Sildenafil tablets 125 mg are manufactured by various brands.
• Always verify the authenticity of medication sources.
• Use only FDA-approved or certified pharmacies.
• Cost can vary based on brand and location.
• Generic versions are typically more affordable.
• Beware of counterfeit sildenafil products.
• Read customer reviews before purchasing online.
• Consult your doctor about the best brand for you.

However, Sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity ( 2.1)Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg ( 2.1)Maximum recommended dosing frequency is once per day ( 2.1)DOSAGE FORMS AND STRENGTHSTablets: 25 mg, 50 mg and 100 mg ( 3)CONTRAINDICATIONSAdministration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form.

16. How is Sildenafil Oral Suspension supplied

If you already use medicine for high blood pressure (hypertension), sildenafil could make your blood pressure go too low. Call your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly, sweating, or unusual tiredness or weakness. This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this. Do not take other medicines unless they have been discussed with your doctor. Sildenafil citrate was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2)Known hypersensitivity to sildenafil or any component of tablet ( 4.2)Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3)WARNINGS AND PRECAUTIONSPatients should not use sildenafil citrate if sexual activity is inadvisable due to cardiovascular status ( 5.1)Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil citrate with caution in patients predisposed to priapism ( 5.2)Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION).

• Sildenafil tablets 125 mg are available by prescription only.
• They work by inhibiting the PDE5 enzyme.
• Do not mix sildenafil with alcohol to avoid adverse effects.
• Use with caution if you have heart or liver conditions.
• Sildenafil may interact with certain antibiotics.
• Be aware of potential side effects like flushing.
• Take sildenafil about 30-60 minutes before activity.
• Avoid using grapefruit juice while on sildenafil.

Sildenafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a” crowded” optic disc may also be at an increased risk of NAION. ( 5.3)Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4)Caution is advised when Sildenafil citrate is co-administered with alpha- blockers or anti-hypertensives. Concomitant use may lead to hypotension ( 5.5)Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.

Use Case	Description	Typical Dosage	Onset of Action	Duration
Erectile Dysfunction	Helps achieve and maintain erections during sex	125 mg	30-60 minutes	Up to 4-6 hours
Pulmonary Hypertension	Relieves high blood pressure in lung arteries	125 mg	15-30 minutes	4-6 hours
Off-Label Uses	Potential uses in other vascular conditions	Varies	Varies	Varies

In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased.

• Common side effects include headaches and facial flushing.
• Less common effects may include nasal congestion or upset stomach.
• Do not use sildenafil if allergic to it or similar drugs.
• Pregnant women should consult a healthcare provider before use.
• Be aware of the signs of allergic reactions.
• Sildenafil may also be indicated for certain heart conditions.
• Emergency services should be contacted if adverse reactions occur.
• Keep a record of any side effects experienced.

Decrease in Sildenafil citrate dosage is recommended ( 2.4, 5.6)ADVERSE REACTIONSMost common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1).To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or INTERACTIONSSildenafil citrate can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2)With concomitant use of alpha blockers, initiate sildenafil citrate at 25 mg dose ( 2.3)CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase Sildenafil citrate exposure ( 2.4, 7.4, 12.3)Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4, 5.6)Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg ( 2.4, 7.4)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 5/2026 Warnings and Precautions, Effects on the Eye ( 5.3) 08/2017 Sildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).