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VARDELENA 10mg Vardenafil oral dispersible tablet
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VARDELENA

VARDELENA
10mg Vardenafil oral dispersible tablet
 
Prescription drug.
Read the leaflet carefully before using.
Keep this medicine out of the sight and reach of children.
Immediately notify your doctor or pharmacist of adverse reactions encountered when using medicine.
 

INGREDIENTS AND CONTENT
Each tablet contains:
Active ingredientst:
Vardenafil hydrochloride trihydrate equivalent to Vardenafil...............10 mg
Excipients just enough:Lactose anhydrous, mannitol 160C, aspartam, crospovidon XL, silica K200, natri stearyl fumarat, banana flavor.
DESCRIPTION ABOUT PRODUCT
Tablets are white, circular shape, beveled, 2flat surfaces, one surface with “HERA” word, the other with grooves, intact edge and walls.
PACKAGING:Box of 1 blister x 4 Tablets.
WHAT IS THE MEDICINE USED FOR
Vardelena contains vardenafil, in a group of drugs called phosphodiesterase 5 enzym (PDE 5) inhibitors. Used in the treatment of impotence in men, a type of pathology in which patients have difficulty in inadquate or does not maintain an erection state.
At least 1 in 10 men have problems with inadquate or does not maintain an erection state for some time. This may be due to physical or psychological causes, or a combination of both. Regardless of what the cause is, the muscle and blood vessels do not keep blood enough to penile the male in a stiff and maintain such state. 
Vardelena only works when you have sexual stimulation. Vardelena reduces the activity of natural active ingredients – active substances that lose erectile function in the body.  Vardelena maintains an erection state sufficiently long enough for you have satisfactory sexual activity.
HOW TO TAKE  THIS MEDICINE AND DOSAGE
Always take the medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
Take Vardelena for 25 to 60 minutes before having sex. With sexual stimulation you can achieve an erection within 25 minutes up to 4 or 5 hours after taking Vardelena.
  - Do not take the pill out of the blister until you are prepare to drink. Use dry hand to gently press the tablet from the blisters on the palms. Do not crush the pill.
  - Put the whole tablet in the mouth, above the tongue, where the tablet will dissolve for a new seconds, then swallow it with saliva. Drugs dispersed in the mouth do not drink with water.
Do not take Vardenafil oral dispersible tablet with others dose of vardenafil.
Do not take Vardelena more than once a day.
Tell your doctor if you think Vardelena too strong or too weak. Doctor may recommend another dose for you, depending on the individual.
 WHEN TO USE THIS DRUG
  - Take Vardelena for 25 to 60 minutes before having sex.
  - Take the medication as prescribed by your doctor.
WHEN SHOULD NOT TAKE THIS MEDICINE?
  - If you are allergic to Vardenafil or any of the ingredients. Signs of allergy including itching, swelling of the face or lips and difficulty breathing.
  - If you are taking the drugs contain nitrates, such as glycerol trinitrate for treating angina or nitro, such as amyl nitrite. Taking these medications together with Vardelena can seriously affect your blood pressure.
  - If you are taking ritonavir or indinavir, medicines to treat HIV.
  - If you are over 75 years of age and are taking ketoconazole oritraconzole, medication for fungal infections.
  - If you have severe heart or liver problems
  - If you have Hemodialysis
  - If you have a recent stroke or heart attack
  - If you have or have had low blood pressure
  - If your family has a history of eye degeneration (eg: retinitis pigmentosa).
  - If you have ever had a situation related to blindness due to visual never damage from not providing enough blood and is known to be the neuropathy (NAION).
  - If you are taking Riociguat. This drug is used to treat pulmonary hypertension (ie: high blood pressure in the lungs) and chronic pulmonary hypertension derived from thromboembolism (secondary pulmonary hypertension from clots). PDE5 inhibitors, such as Vardelena shown an increase in the antihypertensive effect of this drug. Talk to your doctor if you are not sure.
UNDESIRABLE EFFECTS
Like other drugs, Vardelena can cause some undesirable effects, although not all patients will experience it. Most of these side effects are usually mild or moderate.
Partial, sudden, temporary or permanent loss of vision in one or both eyes has been observed in patients. Stop using drug and contact your doctor immediately.
Decreased or hearing loss is also reported.
Undesirable effects include:
Very common (> 1/10 patients)
  - Headache
Frequently (1/10 patients)
  - Dizziness
  - Blush
  - Stuffy nose or runny nose
  - Undigested
Less common (1/100 patients)
  - Skin or muscle tissue, including: facial swelling, lips and throat.
  - Sleep disorders
  - Numbness and tactile reduction
  - Sleepy
  - Impact on vision: red eye, affect on color, eye pain or discomfort, sensitivity to light.
  - Tinnitus
  - The heart beats fast
  - Shortness of breath
  - Stuffy nose
  - Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, nausea, dry mouth
  - Increased live enzyms in the blood
  - Itchy skin, redness
  - Back or muscle pain: increased creatinin phosphokinase in blood, muscle stiffness
  - Prolonged erection
  - Uncomfortable
Rare (1/1000 patients)
  - Eye infections
  - Allergic reaction
  - Worry
  - Fainting
  - Forgetful
  - Convulsions
  - Increased eye pressure, increased tears
  - Effects on the heart (such as heart attack, arrhythmia, angina)
  - High or low blood pressure
  - Epistaxis
  - Effects on blood test results when assessing liver function
  - Skin sensitive to light
  - Pain when erection
  - Chest pain
Very rare (< 1/1000 patients)
  - Blood in the urine
  - Bleeding in the penis
  - Blood in semen
Report on undersirable effects
If you experience any undersirable effects, notify your doctor or pharmacist immediately. Include undersirable effects that appear in addition to the signs list above.  
WHAT MEDICATIONS OR FOODS SHOULD AVOID WHEN TAKINGTHIS MEDICINE
Inform your doctor or pharmacist if you are taking or have used other medicines, including over the counter medicines. This is extremely important when treating on or more drugs at the same time can enhance or weaken the effects of the drug.
Some medications can cause serious problems, especially:
  - Nitrate, the drug treatment angina, ornitric oxid, as amyl nitrit. Taking these medications together with Vardelena can seriously affect your blood pressure. Inform your doctor before using.
  - Drugs to treat arrhythmias, such as quinidin, procainamid, amiodaroneor sotalol.
  - Ritonavir or indinavir, medicines for HIV. Inform your doctor before taking the medicine.
  - Ketoconazole or itraconazol, macrolide antibiotics.
  - Erythromycin, or clarithromycin, macrolide antibiotics.
  - Alpha channel blockers, high blood pressure medications and prostatic hypertrophy  (such as benign prostatic adenomas).
  - Riociguat.
Do not use Vardelena oral dispersible tablets in combination with other treatments for erectile dysfunction.
With food and water
  - You can take dispersible tablets in the mouth of Vardelena with or without food, but do not use it with any liquid including water.
  - Do not drink grape juice when using Vardelena, as it may interfere with normal effects of the drug.
  - Drinking alcohol can make erections worse.
WHAT TO DO WHEN ONE TIME FORGETS TO TAKE MEDICINE 
Do not take the missed dose and do not take double dose to make up for forgotten dose. Instead, continue as usual with the normal dose and check with your doctor.
IF YOU STOP THE DRUG
See a doctor for advice when you want to stop taking medicine.
If you have any questions, ask your doctor or pharmacist.
STORAGE
Store in a cool, dry place, temperature below 30oC.
SIGNS AND SYMPTOMS OF OVERDOSE
Inform your doctor/pharmacist immediately if you notice any abnormalities.
WHAT TO DO WHEN OVERDOSE IS RECOMMENDED
People who take Vardelena overdose may be have unwanted effects or severe back pain. Inform your doctor immediately if you use oversode.
See a doctor for advice if you have any questions.
THINGS TO TAKE CAUTION WHEN TAKING THIS DRUG
Talk to your doctor, pharmacist or nurse before taking Vardelena.
  - If you have heart problems. This will be dangerous when you have sex.
  - If you have abnormal heart rhythm (heart rhythm disturbance) or genetic heart disease that affects your electrocardiogram.
  - If you have a physical problem that affects the shape of your penis, including: La Peyronie disease
  - If you have prolonged erection problems (priapism syndrome), including sickle cell disease, multipe myeloma and leukemia.
  - If you have a stomach ulcer.
  - If you have bleeding disorders (such as coagulopathy).
  - If you are on another difficult erection problem.
  - If you suddenly get blurred or blind, stop taking Vardelena and contact with your doctor immediately.
Use for children and adolescents:
Not indicated for children or adolescents under 18 years old.
Use in pregnant women and nursing mothers:
Woman do not use Vardelena.
Impact on the ability to drive or operate machinery:
Vardelena can cause dizziness or affect vision. If you feel dizzy or if your vision is affected after using Vardelena, you can’t drive or operate machinery.
Vardelena contains aspartam:
Aspartam is a source of phenylalanine, and can be harmful to patients with disorders known as phenyceton.
 WHEN TO CONSULT A DOCTOR, PHARMACIST
When you have any unwanted effects of the drug, no treatment response or symptoms become worse. Consult your doctor or pharmacist for more information.
SHELF LIFE: 24 months from date of manufacture.
Manufactured by:
HERA BIOPHARMACEUTICAL CO. LTD.
Lot A17, Tu Ha Industrial zone, Tu Ha Ward, Huong Tra Town, Thua Thien Hue Province, Viet Nam