Label: VARDENAFIL tablet, orally disintegrating

6.1 Clinical Studies Experience
What is vardenafil?
6.2 Postmarketing Experience
Warnings & Precautions
5.1 Cardiovascular Effects

Place on the tongue where it will dissolve rapidly.

The onset of vardenafil 10 mg is typically 30-60 minutes.
It can last up to 4-5 hours in some users.
Vardenafil is contraindicated with certain heart medications.
Use caution if you have a history of hypotension.
The tablet may cause mild gastrointestinal upset.
Do not consume large amounts of alcohol when taking vardenafil.
Inform your doctor if you experience sudden hearing loss.
Use only as directed by your healthcare provider.
Discontinue if you experience persistent erection issues.
The medication does not increase sexual desire.

The tablet should be taken whole and not crushed or split.

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

The tablet should not be taken with liquid.

6.1 Clinical Studies Experience

(See “Who Should Not Take Vardenafil Hydrochloride Orally Disintegrating Tablets?”) Tell all your healthcare providers that you take vardenafil hydrochloride orally disintegrating tablets. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took vardenafil hydrochloride orally disintegrating tablets. 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.

Mechanism of Action

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. Speak to your doctor about ways to guard against sexually transmitted diseases. · Serve vardenafil cost as a male form of birth control. Vardenafil hydrochloride orally disintegrating tablets are only for men with ED.

Pregnancy and breastfeeding

Vardenafil hydrochloride orally disintegrating tablets must be used only under a doctor’s care. HOW DOES VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS WORK? 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? Call your doctor or emergency room immediately if you accidentally took more vardenafil hydrochloride orally disintegrating tablets than prescribed.

Product	Dosage	Quantity + Bonus	Price
Kamagra Polo	100 mg	272 + 12 Pills	622.94€ 593.28€
Kamagra Oral Jelly	100 mg	21 Sachets	95.92€ 91.35€
Levitra Professional	20mg	10 Pills	62.37€ 59.40€
Cialis Soft Tabs	20mg	180 + 8 Pills	353.17€ 336.35€
Levitra Professional	20mg	90 + 2 Pills	304.49€ 289.99€
Levitra Generic	60mg	180 + 10 Pills	501.43€ 477.55€
Viagra Soft Tabs	100mg	120 + 8 Pills	232.21€ 221.15€
Levitra Generic	60mg	20 Pills	81.30€ 77.43€
Kamagra	100mg	360 + 6 Pills	839.95€ 799.95€
Apcalis SX Oral Jelly	20mg	30 + 5 Sachets	141.84€ 135.09€
Levitra Generic	10mg	60 + 6 Pills	112.98€ 107.60€
Cialis Generic	20mg	120 + 8 Pills	188.15€ 179.19€
Kamagra Soft Tabs	100mg	120 + 6 Pills	311.78€ 296.93€
Kamagra Soft Tabs	100mg	12 Pills	57.55€ 54.81€
Cialis Generic	10mg	90 + 6 Pills	146.17€ 139.21€
Kamagra Gold	100 mg	60 + 4 Pills	201.34€ 191.75€
Kamagra Polo	100mg	120 + 6 Pills	327.15€ 311.57€

If you receive vardenafil hydrochloride orally disintegrating tablets in a blisterpack, examine the blisterpack before use.

What is vardenafil?

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. 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.

Which drugs interact with vardenafil?

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. · 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.

Does vardenafil interact with foods or drinks?

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. Ask your doctor if it is safe for you to have sexual activity. · 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). Do not use if blisters are torn, broken, or missing. WHAT ARE THE POSSIBLE SIDE EFFECTS OF VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?

Storage Condition	Recommended Temperature	Humidity	Additional Notes
Standard Storage	15-30°C (59-86°F)	< 70%	Keep away from light
Protect from moisture	-	Keep in a dry place	Keep in original container
Keep out of reach of children	-	-	Safety measure

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.

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.

Call your doctor if you get a side effect that bothers you or one that will not go away.

Vardenafil 10 mg is a selective phosphodiesterase type 5 inhibitor.
It can improve the ability to achieve an erection.
Maintain open communication with your healthcare provider.
Use with caution in elderly patients.
Report any unusual side effects promptly.
The medication should not be used recreationally.
Not recommended for use with certain antihypertensives.
Effectiveness depends on correct timing and dosage.
Avoid taking if you have severe liver disease.
Always read the patient information leaflet.

Vardenafil hydrochloride orally disintegrating tablets may uncommonly cause: · An erection that won’t go away (priapism).

6.2 Postmarketing Experience

It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. 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.Call your doctor for medical advice about side effects. 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 TABLETSMedicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use vardenafil hydrochloride orally disintegrating tablets for a condition for which it was not prescribed.

Navigating the MS Therapy Explosion: Strategies for Proactive Initiation and Smart Treatment Switching

Do not give vardenafil hydrochloride orally disintegrating tablets to other people, even if they have the same symptoms that you have. It may harm them.This leaflet summarizes the most important information about vardenafil hydrochloride orally disintegrating tablets. If you would like more information, talk with your healthcare provider. If you do not understand the information, or have questions, talk with your doctor or pharmacist. WHAT IMPORTANT INFORMATION SHOULD YOU KNOW ABOUT VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?

What are the serious side effects of vardenafil?

Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil film-coated tablets (LEVITRA). Vardenafil hydrochloride orally disintegrating tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. With a sudden drop in blood pressure, you could get dizzy, faint, or have a heart attack or stroke. Vardenafil hydrochloride orally disintegrating tablets contain phenylalanine which can be harmful to people who have phenylketonuria. Do not take vardenafil hydrochloride orally disintegrating tablets if you: · Take any medicines called “nitrates” (often used to control chest pain, also known as angina) · Use recreational drugs called “poppers” like amyl nitrate and butyl nitrate. Priapism must be treated as soon as possible or lasting damage can happen to your penis including the inability to have erections.

Warnings & Precautions

· 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. · Have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia.

What is the dosage for vardenafil?

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. 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 cenforce d 160 hydrochloride orally disintegrating tablets. Patients taking alpha-blockers should not initiate vardenafil therapy with vardenafil hydrochloride orally disintegrating tablets.

Report Problems to the Food and Drug Administration

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. · 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. · Color vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green.

5.1 Cardiovascular Effects

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. 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. 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.

Region	Average Price (per tablet)	Availability	Notes
North America	$2 - $5	Widely available	Prescription required
Europe	€2 - €4	Available at pharmacies	Generic options common
Asia	$1 - $3	Readily available	Often lower cost
Africa	$2 - $4	Varies by country	May require import or special order

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.