Label: VARDENAFIL tablet, orally disintegrating

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.

Do erectile dysfunction medicines increase sexual desire?

· Take riociguat, a guanylate cyclase stimulator, a medicine that treats pulmonary arterial hypertension and chronic-throembolic pulmonary hypertension. · 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 ORALLY DISINTEGRATING TABLETS? Before taking vardenafil hydrochloride orally disintegrating 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.

Pulmonary Arterial Hypertension (Orphan)

Ask your doctor if it is safe for you to have sexual activity. · Have low blood pressure or have best ed treatments 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). 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.

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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.

Are erectile dysfunction medicines safe?

The tablet should not be taken with liquid. Call your doctor or emergency room immediately if you accidentally took more vardenafil hydrochloride orally disintegrating tablets than prescribed. If you receive vardenafil hydrochloride orally disintegrating tablets in a blisterpack, examine the blisterpack before use. Do not use if blisters are torn, broken, or missing. WHAT ARE THE POSSIBLE SIDE EFFECTS OF VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?

What are the serious side effects of vardenafil?

The most common side effects with vardenafil hydrochloride orally disintegrating tablets are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness, and back pain. 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 vardenafil oral 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. For more information, ask your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA 1088.

Parameter	Result	Notes
Absorption Time	30-60 minutes	Time to peak plasma concentration (Tmax)
Bioavailability	~15%	Percentage of dose reaching systemic circulation
Half-life	4-5 hours	Duration of effect
Metabolism	Liver (CYP3A4 enzyme)	Mainly via hepatic pathways
Excretion	Feces (~60%), Urine (~20%)	Primary routes

HOW SHOULD VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING Tablets BE STORED?

Brand Name	Manufacturer	Formulation Type	Price Range	Notes
Levitra	Bayer	Tablet	Moderate	Widely used
Staxyn	Bayer	Orally disintegrating tablet	Similar price	Alternative formulation
Generic Vendors	Multiple	Tablet	Lower	Cost-effective option

· 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.

Pregnancy & Lactation

When a man is sexually stimulated, his body’s normal physical response is to increase blood flow to his penis. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away. WHO CAN TAKE VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS? Talk to your doctor to decide if vardenafil hydrochloride orally disintegrating tablets are right for you. Vardenafil hydrochloride orally disintegrating tablets have been shown to be effective in men over the age of 18 years who have erectile dysfunction, including men with diabetes.

Prevention & Wellness

WHO SHOULD NOT TAKE VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS? Do not take vardenafil hydrochloride orally disintegrating tablets if you: · Take any medicines called “nitrates” (see “What important information should you know about vardenafil hydrochloride orally disintegrating tablets?”). Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm. Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Ask your doctor or pharmacist if you are not sure if any of your medicines are nitrates. GENERAL INFORMATION ABOUT VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS Medicines are sometimes prescribed for conditions other than those described in patient information leaflets.

• Vardenafil is ineffective without sexual arousal.
• It does not protect against sexually transmitted infections.
• Avoid excessive mental or physical exertion while on medication.
• Consult a healthcare professional if unsure about interactions.
• Don't take vardenafil if you've had recent heart attack.
• Use with caution if you have a bleeding disorder.
• Medication may cause a temporary drop in blood pressure.
• Avoid using if you have a known hypersensitivity.
• The pill should be taken as part of a treatment plan.
• Keep track of how you respond to the medication.

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?

• Vardenafil 10 mg tablets treat erectile dysfunction in men.
• The medication works by increasing blood flow to the penis.
• Take vardenafil 10 mg about 30 minutes before activity.
• It can be taken with or without food, but high-fat meals may delay effects.
• Maximum recommended dose is one tablet per 24 hours.
• Vardenafil may cause side effects like headache or flushing.
• Do not use vardenafil if you take nitrates for chest pain.
• Consult a doctor before using vardenafil if you have heart problems.
• Store vardenafil tablets at room temperature, away from moisture.
• Alcohol can increase side effects of vardenafil.

Phenylketonurics: Vardenafil hydrochloride orally disintegrating tablets contain 1.403 mg phenylalanine per tablet. 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.

How to Use

WHAT ARE VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS? Vardenafil hydrochloride orally disintegrating tablets are a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men. ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. Vardenafil hydrochloride orally disintegrating tablets may help a man with ED get and keep an erection when he is sexually excited. Vardenafil hydrochloride orally disintegrating tablets does not: · Protect a man or his partner from sexually transmitted diseases, including HIV.

Professional resources

Speak to your doctor about ways to guard against sexually transmitted diseases. · Serve as a male form of birth control. Vardenafil hydrochloride orally disintegrating tablets are only for men with ED. Vardenafil hydrochloride orally disintegrating tablets must be used only under a doctor’s care. HOW DOES VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS WORK? Vardenafil works by blocking an enzyme in the body called PDE5, which helps relax certain blood vessels.

Warnings & Precautions

· Patients 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 ORALLY DISINTEGRATING TABLETS? Take vardenafil hydrochloride orally disintegrating tablets exactly as your doctor prescribes. Doses should be taken at least 24 hours apart. · If you have prostate problems or high blood pressure, for which you take medicines called alpha-blockers, you should not start treatment for erectile dysfunction with vardenafil hydrochloride orally disintegrating tablets.

Vardenafil Side Effects

Your doctor may prescribe a lower dose of vardenafil film-coated tablet. Take 1 vardenafil hydrochloride orally disintegrating tablet about 1 hour (60 min) before sexual activity. Vardenafil hydrochloride orally disintegrating tablets may be taken with or without meals. Place on the tongue where it will dissolve rapidly. The tablet should be taken whole and not crushed or split. This increases blood flow to the penis when aroused, making it easier to get and keep an erection.

• Vardenafil 10 mg should not be used with certain medications.
• Grapefruit or grapefruit juice may have interactions.
• Inform your doctor about all health conditions before use.
• The medication may cause vision changes or sensitivity.
• Do not use vardenafil if you have liver or kidney issues.
• The pill helps achieve and maintain an erection.
• Follow prescribed dosage to avoid complications.
• Not effective as an aphrodisiac without sexual stimulation.
• Avoid using recreational drugs along with vardenafil.
• Regular medical check-ups are recommended during use.

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.

5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 Inhibitors

· Have a deformed penis shape or Peyronie’s disease. · Have had an erection that lasted more than 4 hours. · Have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia. CAN OTHER MEDICATIONS AFFECT VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS? Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

What should I tell my healthcare provider before taking vardenafil?

Especially tell your doctor if you take any of the following: · Medicines called nitrates (see “What important information should you know about vardenafil hydrochloride orally disintegrating tablets?”). Patients taking these drugs should not use vardenafil hydrochloride orally disintegrating tablets. Patients taking alpha-blockers should not initiate vardenafil therapy with vardenafil hydrochloride orally disintegrating tablets. Patients taking alpha-blockers who have previously used vardenafil film-coated tablets may switch to vardenafil hydrochloride orally disintegrating tablets at the advice of their healthcare provider. In some patients the use of PDE5 inhibitor drugs, including vardenafil hydrochloride orally disintegrating tablets, with alpha-blockers can lower blood pressure significantly leading to fainting. 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.

• Some users may experience mild flickering vision episodes.
• The efficacy of vardenafil varies between individuals.
• The medication is available in various dosage forms.
• Always follow the specific instructions provided.
• Avoid taking vardenafil with high-fat meals to speed absorption.
• Do not take vardenafil if allergic to its ingredients.
• The drug may cause a temporary burning sensation.
• Use caution in patients with a history of priapism.
• Avoid combining vardenafil with certain herbal supplements.
• Consult your doctor about any ongoing health treatments.

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

Country	Regulatory Authority	Approval Status	Notes
United States	FDA	Approved for ED	Prescription required
European Union	EMA	Approved	Prescription required
Canada	Health Canada	Approved	Prescription required
Australia	TGA	Approved	Prescription required

Stuffy or runny nose, or inflamed sinuses There may be other side effects of vardenafil that are not listed here.