Label: VARDENAFIL HYDROCHLORIDE tablet

Vardenafil works by blocking an enzyme in the body called PDE5, which helps relax certain blood vessels.

Vardenafil Clinical Trials

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 hydrochloride tablets. If you experience these symptoms, stop taking vardenafil hydrochloride tablets and contact a doctor right away. These are not all the side effects of vardenafil hydrochloride tablets. For more information, ask your doctor or pharmacist. HOW SHOULD VARDENAFIL HYDROCHLORIDE TABLETS BE STORED?

Storage Class

Store vardenafil hydrochloride tablets at room temperature between 59–86° F (15–30° C). Keep vardenafil hydrochloride tablets and all medicines out of the reach of children. Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. This leaflet summarizes the most important information about vardenafil hydrochloride tablets. You can ask your doctor or pharmacist for information about vardenafil hydrochloride tablets that is written for health professionals. 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. The most common side effects of vardenafil are listed below. These side effects may vary depending on the form of vardenafil prescribed.

• Vardenafil HCl 10mg is available in tablet form, usually taken orally.
• It’s important to follow your doctor’s instructions precisely for effectiveness.
• Do not use vardenafil if you have a known allergy to similar drugs.
• Alcohol can increase side effects, such as dizziness and low blood pressure.
• Men with pre-existing eye conditions should proceed with caution.
• Keep a record of any side effects experienced to inform your doctor.
• Use of vardenafil should be part of a broader approach to managing ED.
• Check for drug interactions with your pharmacist before starting therapy.
• Certain health conditions may require dose adjustments or caution.
• The medication is not intended for use as a performance enhancer.

Tell your healthcare provider if you have any of these side effects that bother you.

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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. In the U.S., you can report side effects to the FDA at or by calling 800-FDA-1088.

Point	Explanation	Additional Advice
Take as prescribed	Usually 10 mg about 30-60 min before activity	Do not exceed recommended dose
Food interactions	High-fat meals may delay onset	Take on an empty stomach or low-fat meal
Alcohol consumption	May decrease effectiveness or increase side effects	Limit alcohol intake
Report side effects or adverse reactions	Such as vision changes, pain, prolonged erections	Seek medical attention immediately

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 Boxed Warnings

Your doctor may lower your dose or raise your dose, depending on how your body reacts to vardenafil hydrochloride tablets. Call your doctor or emergency room immediately if you accidentally took more vardenafil hydrochloride tablets than prescribed. WHAT ARE THE POSSIBLE SIDE EFFECTS OF VARDENAFIL HYDROCHLORIDE TABLETS? The most common side effects with vardenafil hydrochloride tablets are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness or back pain. Call your doctor if you get a side effect that bothers you or one that will not go away.

Are you currently using Vardenafil (Levitra, Staxyn)?

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 hydrochloride tablets) reported a sudden decrease or loss of vision in one or both eyes. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including vardenafil hydrochloride tablets, and call a doctor right away. 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. 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.

Before taking this medicine

Have low blood pressure or have high blood pressure that is not controlled. Or any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome). Have retinitis pigmentosa, a rare genetic (runs in families) eye disease Have ever had severe vision loss, or if you have an eye condition called non-arteritic anterior ischemic optic neuropathy (NAION). Have a deformed penis shape or Peyronie's disease. Have had an erection that lasted more than 4 hours.

What are the most common side effects of vardenafil?

Have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia. CAN OTHER MEDICATIONS AFFECT VARDENAFIL HYDROCHLORIDE TABLETS? Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take any of the following: Medicines called nitrates (see " What important information should you know about vardenafil hydrochloride tablets?"). In some patients the use of PDE5 inhibitor drugs, including vardenafil hydrochloride tablets, with alpha-blockers can lower blood pressure significantly leading to fainting. 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.

• Vardenafil HCl 10mg can be effective in treating erectile dysfunction symptoms.
• It’s important to avoid unprescribed or counterfeit versions of the drug.
• Consult a healthcare provider for proper diagnosis before starting treatment.
• Discontinue medication and seek medical help if serious side effects occur.
• The medication’s effects depend on proper timing and dosage adherence.
• It’s safe for most men but always needs individual health assessment.
• Mild side effects may diminish over time or with dose adjustment.
• Use caution with other medications that affect blood pressure or blood flow.
• Do not use vardenafil if you are allergic to similar medications like sildenafil.
• Always inform your doctor of any other medications you are taking.

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.

What is the Current Market Landscape for Vardenafil Hydrochloride?

Vardenafil hydrochloride tablets have been shown to be effective in men over the age of 18 years who have erectile dysfunction, including men with diabetes or who have undergone prostatectomy. WHO SHOULD NOT TAKE VARDENAFIL HYDROCHLORIDE TABLETS? Do not take vardenafil hydrochloride tablets if you: Take any medicines called "nitrates" (See " What important information should you know about vardenafil hydrochloride tablets?"). Ask your doctor or pharmacist if you are not sure if any of your medicines are nitrates. Take riociguat, a guanylate cyclase stimulator, a medicine that treats pulmonary arterial hypertension and chronic-throembolic pulmonary hypertension.

How Supplied

Have been told by your healthcare provider to not have sexual activity because of health problems. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. WHAT SHOULD YOU DISCUSS WITH YOUR DOCTOR BEFORE TAKING VARDENAFIL HYDROCHLORIDE TABLETS? Before taking vardenafil hydrochloride tablets, tell your doctor about all your medical problems, including if you: Have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. Ask your doctor if it is safe for you to have sexual activity. 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.

What Are Warnings and Precautions for Vardenafil?

You should contact the prescribing physician if alpha-blockers or other drugs that lower blood pressure are prescribed by another healthcare provider. HOW SHOULD YOU TAKE VARDENAFIL HYDROCHLORIDE TABLETS? Take vardenafil hydrochloride tablets exactly as your doctor prescribes. Your doctor will prescribe the dose that is right for you. If you are older than 65 or have liver problems, your doctor may start you on a lower dose of vardenafil hydrochloride tablets.

Related treatment guides

If you have prostate problems or high blood pressure, for which you take medicines called alpha-blockers, your doctor may start you on a lower dose of vardenafil hydrochloride tablets. If you are taking certain other medicines your doctor may prescribe a lower starting dose and limit you to one dose of vardenafil hydrochloride tablets in a 72-hour (3 days) period. Take 1 vardenafil hydrochloride tablet about 1 hour (60 minutes) before sexual activity. Vardenafil hydrochloride tablets may be taken with or without meals. Do not change your dose of vardenafil hydrochloride tablets without talking to your doctor. If you feel faint or dizzy, lie down. Tell your healthcare provider right away if you have any of the following symptoms of low blood pressure. People who are allergic to any of the following should not take vardenafil.

Vardenafil Warnings/Precautions

WHAT ARE THE INGREDIENTS OF VARDENAFIL HYDROCHLORIDE TABLETS? This Patient Information has been approved by the U.S. Food and Drug Administration. Products cited in vardenafil hydrochloride tablets USPI Vardenafil is commonly used for erectile dysfunction, a condition where you have trouble getting or keeping an erection. Vardenafil may also be used best sex pills for women for other conditions as determined by your healthcare provider. 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 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.

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