FULL PRESCRIBING INFORMATION: CONTENTS*

Do not use more of it and do not use it more often than your doctor ordered.

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Sildenafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works. Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection.

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By controlling the enzyme, sildenafil helps to maintain an erection after the penis is stroked. Without physical action to the penis, such as that occurring during sexual intercourse, sildenafil will not work to cause an erection. Sildenafil is also used in both men and women to treat the symptoms of pulmonary arterial hypertension. This is a type of high blood pressure that occurs between the heart and the lungs. When hypertension occurs in the lungs, the heart must work harder to pump enough blood through the lungs. If too much is used, the chance of side effects is increased. This medicine comes with a sildenafil pricing patient information leaflet. Read and follow these instructions carefully before you start using sildenafil and each time you get a refill of your medicine. Ask your doctor if you have any questions. You may take this medicine with or without food. Place the film on top of your tongue.

• The medication is not intended for use by women or children.
• Effectiveness may vary depending on individual health and age.
• Regular exercise and healthy lifestyle can improve outcomes.

It will dissolve in your mouth and can be swallowed with saliva without using water or other liquids.

• Sildenafil 50 mg is used to treat erectile dysfunction in men.
• It works by relaxing blood vessels to increase blood flow.
• Taken about 30-60 minutes before sexual activity.

Shake the bottle well for at least 10 seconds before each use. Remove the cap by pushing it down and twisting it counter-clockwise. Push the plunger of the syringe, then insert the tip into the bottle while holding the bottle upright on a flat surface.

Slowly pull back the plunger until the required dose. If you see air bubbles in the syringe, repeat the steps. Place the tip of the syringe into you or your child's mouth and point it towards the cheek. This medicine usually begins to work for erectile dysfunction within 30 minutes after taking it.

• Sildenafil 50 mg may cause dizziness; avoid driving if affected.
• Combining sildenafil with certain drugs can be dangerous; discuss with your doctor.
• Do not use if you have severe liver or kidney disease.

It continues to work for up to 4 hours, although its action is usually less after 2 hours.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine.

• Sildenafil 50 mg is available by prescription only.
• It may interact with medications containing nitrates.
• Store tablets in a cool, dry place away from children.

If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Proper Use

Sildenafil should never be used in children for erectile dysfunction. In general, sildenafil should not be used for pulmonary arterial hypertension in children, especially for chronic use. Use of sildenafil oral film is not indicated for use in the pediatric population. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sildenafil in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving sildenafil.

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There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. For treatment of erectile dysfunction:For oral dosage form (tablets):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.

8.4 Pediatric Use

The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may sildenafil 5mg for sale change the dose or how often you use one or both of the medicines.

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Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. Alternatively, the medicine may be taken 30 minutes to 4 hours 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. Your doctor may adjust your dose if needed.Children—Use is not recommended.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.

What happens if I overdose?

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Abnormal penis, including a curved penis or birth defects of the penis—Chance of problems occurring may be increased and this medicine should be used with caution in these patients. Arrhythmia (irregular heartbeat, within the last 6 months) or Blood vessel problems (eg, aortic stenosis, idiopathic subaortic stenosis) or Heart attack (within the last 6 months) or Retinitis pigmentosa (an inherited eye disorder) or Stroke (within the last 6 months)—Should not be used in patients with these conditions. Crowded disc or low cup to disc ratio in the eye (an eye disorder) or Hyperlipidemia (high fats in the blood) or Non-arteritic anterior ischemic optic neuropathy or NAION (serious eye condition), history of or Retinitis pigmentosa (an inherited eye disorder) or Smoking—May increase the chance for a serious side effect in the eye called NAION. Stomach ulcer, or history of or—Chance of problems occurring may be increased.

Missed Dose

It is not known if the medicine is safe for use in these patients. The effects may be increased because of slower removal of the medicine from the body. Sickle-cell anemia (blood disorder)—Sildenafil should be used with caution in these patients as problems with prolonged erection of the penis may occur. Pulmonary arterial hypertension (high blood pressure in the lungs) or Pulmonary veno-occlusive disease or PVOD (a type of lung disease)—Use with caution. Use sildenafil exactly as directed by your doctor. Your doctor may adjust your dose as 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. Your doctor may adjust your dose as needed.Children—Use is not recommended. For oral dosage form (tablets):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.Children—Use is not recommended.

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Sildenafil works on the PDE5 enzyme in the lungs to relax the blood vessels. This will increase the supply of blood to the lungs and reduce the workload of the heart. This medicine is available only with your doctor's prescription. This product is available in the following dosage forms: In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make.

Safety Advice

For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Appropriate studies have not been performed on the relationship of age to the effects of sildenafil in children younger than 1 year of age. Safety and efficacy have not been established. 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. 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.