5 WARNINGS AND PRECAUTIONS

· 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.

What special dietary instructions should I follow?

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. (See “Who Should Not Take Vardenafil Hydrochloride Orally Disintegrating Tablets?”) Tell all your healthcare providers that you take vardenafil hydrochloride orally disintegrating tablets.

Important Disclaimer

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 ed gel 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. Place on the tongue where it will dissolve rapidly.

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

Vardenafil contraindications

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. Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches.

Last Reviewed Date

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. WHAT SHOULD YOU DISCUSS WITH YOUR DOCTOR BEFORE TAKING VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS? The tablet should not be taken with liquid.

How To Get Vardenafil

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 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. 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?

5.10 Combination with Other Erectile Dysfunction Therapies

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. Do not give vardenafil hydrochloride orally disintegrating tablets to other people, even if they have the same symptoms that you have.

Brand Names: Canada

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? Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil film-coated tablets (LEVITRA). 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.

• Vardenafil can cause dizziness or vision changes.
• It is contraindicated if you have severe heart conditions.
• Food, especially high-fat meals, can delay effects.
• Always follow the prescribed dosage instructions.

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.

PCI DSS Compliant

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 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.

Usual Geriatric Dose for:

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? Talk to your doctor to decide if vardenafil hydrochloride orally disintegrating tablets are right for you. 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.

5.8 Hepatic Impairment

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 ceridaviescampaigner co uk 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 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.

• Vardenafil should be stored at room temperature.
• Keep out of reach of children and pets.
• Notify your doctor if you experience priapism.
• Use only the prescribed dose to prevent adverse effects.

If you experience these symptoms, stop taking vardenafil hydrochloride orally disintegrating tablets and contact a doctor right away.

Adverse reactions

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 vardenafil hcl 10mg 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). · Have retinitis pigmentosa, a rare genetic (runs in families) eye disease.

How long before sex should I take vardenafil?

· 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. CAN OTHER MEDICATIONS AFFECT VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS?