10 OVERDOSAGE

Stop taking vardenafil and get help right away if you have sudden vision loss in one or both eyes. Sudden hearing loss has been reported after taking vardenafil.

This may occur along with dizziness and ringing in the ears. Stop taking vardenafil and get help right away if you have sudden hearing loss or suddenly have trouble hearing as well as usual. Vardenafil may cause a rare, dangerous heart rhythm problem called QT prolongation. Some people may have a higher risk of this, including people born with long QT syndrome and those taking certain medicines for heart rhythm problems. Tell your healthcare provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Vardenafil may cause a mild and temporary drop in blood pressure. You may be at a higher risk if you have certain health conditions or take blood pressure medicines.

Pricing & Options

The most common side effects of vardenafil are listed below. These side effects may vary depending on the form of vardenafil prescribed. Tell your healthcare provider if you have any of these side effects that bother you. Stuffy or runny nose, or inflamed sinuses There may be other side effects of vardenafil that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine.

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In the U.S., you can report side effects to the FDA at or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at or by calling 866-234-2345. While less common, the most serious side effects of vardenafil are described below, along with what to do if they happen. Vardenafil may cause allergic reactions, which can be serious. Stop taking vardenafil and get help right away if you have any of the following symptoms of a serious allergic reaction. If you feel lady era tablets faint or dizzy, lie down. Tell your healthcare provider right away if you have any of the following symptoms of low blood pressure.

• Vardenafil is used to treat erectile dysfunction in men.
• It works by increasing blood flow to the penis.
• Vardenafil is marketed under the brand name Levitra.
• The drug typically takes effect within 25-60 minutes.

People who are allergic to any of the following should not take vardenafil.

Any of the ingredients in the specific product dispensed Your pharmacist can tell you all of the ingredients in the specific vardenafil products they stock.

• Vardenafil is available in tablet form, usually 5-20 mg.
• It is designed to be taken as needed, not regularly.
• Effects may vary based on age and health condition.
• Always follow your healthcare provider’s instructions.

Vardenafil should not be taken while you are using certain other medicines. Before taking vardenafil, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details. Do not take vardenafil unless it has been prescribed to you by a healthcare provider. Do not share vardenafil with other people, even if they have the same condition as you. Keep vardenafil out of the reach of children. Do not chew, cut, or crush vardenafil orally disintegrating tablets.

• Vardenafil is part of phosphodiesterase inhibitors.
• It may interact with certain blood pressure medications.
• The drug is usually effective within 30 minutes.
• Store vardenafil in a cool, dry place away from children.

Sexual activity can put extra strain on your heart, which may be unsafe for people with certain health problems, such as a recent heart attack. Talk to your healthcare provider to see if your heart is strong enough for sex.

• Vardenafil is available by prescription only.
• Common side effects include headache and flushing.
• It should be taken on an empty stomach for best results.
• Do not combine vardenafil with nitrates.

If you feel chest pain, dizziness, or nausea during sex, stop and contact your healthcare provider right away.

7.2 Effect of Other Drugs on Vardenafil

This leaflet summarizes the most important information about vardenafil hydrochloride orally disintegrating tablets. You can ask your doctor or pharmacist for information about vardenafil hydrochloride orally disintegrating tablets that is written for health professionals. For more information call Alembic Pharmaceuticals Limited at 1-866-210-9797. WHAT ARE THE INGREDIENTS OF VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS? Phenylketonurics: Vardenafil hydrochloride orally disintegrating tablets contain 1.403 mg phenylalanine per tablet.

Other Interactions

Products cited in vardenafil hydrochloride orally disintegrating tablets USPI LEVITRA is a registered trademark of Bayer AG and is used under license by GlaxoSmithKline. Invirase or Fortavase (saquinavir mesylate) is a trademark of Roche Laboratories Inc. Vardenafil is commonly used for erectile dysfunction, a condition where you have trouble getting or keeping an erection. Vardenafil may also be used for other conditions as determined by your healthcare provider. Vardenafil works by blocking an enzyme in the body called PDE5, which helps relax certain blood vessels.

What should I do if I miss a dose of vardenafil?

This increases blood flow to the penis when aroused, making it easier to get and keep an erection. 2.5 mg, 5 mg, 10 mg, 20 mg oral tablets Vardenafil should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Do not remove an orally disintegrating tablet from the blister pack until ready to take it. Do not take if the blister pack is damaged or missing. Vardenafil does not protect against sexually transmitted infections, including HIV.

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Swelling of the face, lips, mouth, tongue, or throat Itching, skin rash, or pale red bumps on the skin called hives Vardenafil may cause an unwanted erection that is persistent, painful, and that may occur without sexual arousal. Permanent damage to the penis may occur if priapism is not treated quickly. Stop taking vardenafil and get emergency help if you have any of the following symptoms of priapism. Erection lasting for more than four hours Erection that is unrelated to sexual stimulation Vardenafil can cause mild, temporary vision changes such as seeing a blue tint, abnormal colors, blurry vision, or sensitivity to light. Though rare, some people have reported permanent vision loss. Vardenafil belongs to a group of medicines, known as phosphodiesterase-5 (PDE-5) inhibitors, which are used to treat erectile dysfunction or pulmonary arterial hypertension. You should not take more than one PDE-5 inhibitor medicine. Medicines in this group include avanafil (Stendra), sildenafil (Viagra, Revatio, and others), tadalafil (Cialis and others), and vardenafil (Levitra, Staxyn). Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if vardenafil is right for you. In particular, make sure that you discuss any of the following.

Phenylalanine is found in vardenafil oral tablets and vardenafil orally disintegrating tablets. This substance can be harmful to people with PKU. Tell your healthcare provider if you have PKU.

5.4 Effects on the Eye

Call your doctor if you get a side effect that bothers you or one that will not go away. Vardenafil hydrochloride orally disintegrating tablets may uncommonly cause: · An erection that won’t go away (priapism). Priapism must be treated as soon as possible or lasting damage can happen to your penis including the inability to have erections. · Color vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green. In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including vardenafil) reported a sudden decrease or loss of vision in one or both eyes.

What should I do if I accidentally take too much vardenafil?

If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, and call a doctor right away. Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including vardenafil. If you experience these symptoms, stop taking vardenafil hydrochloride orally disintegrating tablets and contact a doctor right away. These are not all the side effects of vardenafil hydrochloride orally disintegrating tablets. For more information, ask your doctor or pharmacist.

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You may report side effects to FDA at 1-800-FDA 1088. HOW SHOULD VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING Tablets BE STORED? · Store vardenafil hydrochloride orally disintegrating tablets at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. · Keep vardenafil hydrochloride orally disintegrating tablets and all medicines out of the reach of children. GENERAL INFORMATION ABOUT VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. They can suggest a different treatment option for you. Tell your healthcare provider if you have any of the following. Heart problems, such as heart rhythm problems, chest pain, or heart failure Heart attack, stroke, or heart surgery within the past six months High blood pressure that is still too high despite taking medicines for it Peyronie's disease, or a penis with an abnormal curve or shape An erection lasting longer than four hours A blood disorder, such as sickle cell anemia An inherited eye disease called retinitis pigmentosa Vision loss, or a problem with the nerve between your eyes and brain (optic nerve) Health conditions or factors that raise the risk of optic nerve problems, such as diabetes, high cholesterol, smoking, being older than 50, or having a “crowded disc,” which is something an eye doctor may see during an eye exam Pulmonary veno-occlusive disease, a condition where blood vessels in the lungs are blocked People who can become pregnant are not usually prescribed vardenafil. It is not known if or how vardenafil could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. People who can breastfeed are not usually prescribed vardenafil. It is not known if vardenafil passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Grapefruit or grapefruit juice can raise vardenafil levels in your body, which can increase the risk of side effects. Vardenafil orally disintegrating tablets should not be taken with water or liquids. Let it dissolve on your tongue without crushing it. There are no known interactions between vardenafil and alcohol. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.