Generic Name: Vardenafil Oral Jelly
Brand Name: Valif Oral Jelly 20mg
Dosage Form: Oral Jelly
Strength: Each sachet contains Vardenafil 20mg
Package: 7 sachets per box
Manufacturer: Ajanta Pharma Ltd

Ingredients

Active Ingredient:
Vardenafil 20mg

Inactive Ingredients:
Water, glycerin, gelatin, food flavoring, sweeteners, and other pharmaceutical excipients.

Indications

Valif Oral Jelly is indicated for the treatment of male erectile dysfunction (ED).

It helps men achieve and maintain an erection sufficient for satisfactory sexual activity when sexual stimulation is present.

Dosage and Administration

Recommended Dose

Take one sachet (20mg) as needed before sexual activity.

Recommended Timing

Take approximately 25 minutes to 1 hour before sexual activity.

Maximum Dose

• Do not exceed 20mg within 24 hours.

• Do not use more than once daily.

How to Take

• Tear open the sachet and squeeze the oral jelly directly into the mouth.

• It can be taken with or without food.

• Avoid taking it immediately after a heavy or high-fat meal, as fatty foods may delay absorption.

Onset of Action

The effect usually begins within:

25–60 minutes (individual response may vary).

Duration of Effect

The effect generally lasts:

Approximately 4–5 hours, and in some individuals may last up to 8 hours.

Sexual stimulation is required for the medication to work.

Important Notes

• Vardenafil does not automatically cause an erection.

• Sexual stimulation is required to activate its effect.

• Do not combine with nitrate medications such as:

• Nitroglycerin

• Isosorbide mononitrate

• Other nitrate-containing drugs

Combining these medicines may cause a dangerous drop in blood pressure.

Contraindications (Who Should Not Use Valif Oral Jelly)

Do not use Vardenafil if you:

1. Are taking nitrate medications

Including:

• Nitroglycerin

• Isosorbide mononitrate

• Isosorbide dinitrate

• Amyl nitrite (“poppers”)

This combination may cause life-threatening hypotension.

2. Have an allergy

Do not use if you are allergic to:

• Vardenafil

• Any ingredient contained in the product

3. Have severe cardiovascular conditions

Including:

• Recent heart attack (within the last 6 months)

• Recent stroke

• Unstable angina

• Severe heart rhythm disorders

• Severe heart failure (NYHA Class III–IV)

4. Blood pressure problems

Do not use if:

• Severe low blood pressure
  (systolic blood pressure <90 mmHg)

• Uncontrolled high blood pressure
  (systolic blood pressure >170 mmHg)

5. Eye disorders

Avoid use if you have:

• Non-arteritic anterior ischemic optic neuropathy (NAION)

• Retinitis pigmentosa or inherited retinal disorders

6. Conditions associated with prolonged erections

Including:

• Penile deformities

• Peyronie's disease

• Sickle cell anemia

• Multiple myeloma

• Leukemia

Warnings and Precautions

For Adult Men Only

This product is not intended for:

• Women

• Children

• Adolescents

Priapism (Prolonged Erection)

If an erection lasts:

More than 4 hours

seek emergency medical attention immediately.

Delayed treatment may result in permanent damage to penile tissue and permanent loss of erectile function.

Sudden Vision or Hearing Loss

Rare cases of:

• Sudden hearing loss

• Vision loss

• Blurred vision

• Visual field changes

have been reported.

Stop using the medication and seek medical advice immediately if these symptoms occur.

Cardiovascular Risk

Sexual activity itself may increase cardiovascular stress.

Patients with heart disease should evaluate their cardiovascular condition before use.

Stop sexual activity and seek medical help if symptoms occur, such as:

• Chest pain

• Severe dizziness

• Nausea

Alcohol Use

Large amounts of alcohol may increase the risk of:

• Dizziness

• Low blood pressure

• Fainting

Limit alcohol consumption while using this medication.

Driving and Operating Machinery

Some users may experience:

• Dizziness

• Visual disturbances

Use caution when driving or operating machinery after taking the product.

Possible Side Effects

Common Side Effects (≥1%)

• Headache

• Facial flushing

• Indigestion

• Heartburn

• Nasal congestion

• Dizziness

Less commonly:

• Back pain

• Muscle pain

Uncommon Side Effects (<1%)

• Visual disturbances

• Increased sensitivity to light

• Mild changes in color perception

• Palpitations

• Blood pressure changes

• Skin rash

• Allergic reactions

Rare but Serious Side Effects

Seek immediate medical attention if you experience:

• Sudden hearing loss

• NAION-related vision loss

• Severe hypotension

• Priapism

• Severe allergic reactions:

• Difficulty breathing

• Swelling of throat or face

Drug Interactions

Absolute Contraindications

Do not combine with:

Nitrates

• Nitroglycerin

• Isosorbide medications

Riociguat

(A pulmonary hypertension medication)

Use With Caution

Alpha-blockers

Examples:

• Tamsulosin

Maintain appropriate separation time (usually at least 6 hours).

Strong CYP3A4 inhibitors

Including:

• Ketoconazole

• Ritonavir

• Clarithromycin

These drugs may significantly increase Vardenafil levels.

Antihypertensive medications

Blood pressure should be monitored.

Use in Special Populations

Elderly Patients (≥65 years)

Drug clearance may decrease.

A lower starting dose may be considered.

Liver Impairment

Moderate liver impairment:

• Start with 5mg

• Maximum 10mg

Severe liver impairment:

Not recommended.

Kidney Impairment

Mild to moderate:

No dose adjustment usually required.

Severe renal impairment:

Start with a lower dose.

Children and Adolescents

Not recommended.

Pregnancy and Breastfeeding

Not applicable.

This medicine is intended only for adult males.

Pharmacological Action

Vardenafil is a:

PDE5 (Phosphodiesterase Type 5) inhibitor

Mechanism of Action:

Vardenafil blocks the PDE5 enzyme in penile tissue, enhancing the:

Nitric Oxide (NO) – cGMP pathway

This leads to:

• Relaxation of smooth muscle

• Increased blood flow into the penis

• Improved erectile response during sexual stimulation

Pharmacokinetics

Absorption:

Rapidly absorbed after oral administration.

Peak Concentration:

Approximately:

30–120 minutes

Bioavailability:

Approximately 15%

Protein Binding:

Approximately 95%

Metabolism:

Primarily through:

Liver CYP3A4 enzyme pathway

Half-life:

Approximately:

4–5 hours

Elimination:

• Feces: approximately 61%

• Urine: approximately 28%

Storage Conditions

• Store in a sealed package.

• Protect from light.

• Store below 30°C.

• Keep out of reach of children.

Packaging

Aluminum composite sachets.

Each sachet contains approximately 10g oral jelly.

Important Information Before Purchasing Sexual Health Products

Important:
Male oral erectile dysfunction medications require sexual stimulation to work. They do not automatically produce an erection.

When using medicines containing:

• Sildenafil

• Vardenafil

• Tadalafil

• Avanafil

• Dapoxetine

some users may experience limited response.

Treatment effectiveness varies between individuals due to:

• Individual metabolism

• Cardiovascular health

• Underlying diseases

• Psychological factors

• Drug sensitivity

If the expected effect is not achieved, users should not increase the dose, change medication, or continue long-term self-medication without medical advice.

Consult a qualified urologist or healthcare professional for proper evaluation and treatment adjustment.

Product Specifications

Product Name: Valif Oral Jelly 20mg
Generic Name: Vardenafil Oral Jelly
Active Ingredient: Vardenafil Hydrochloride
Dosage Form: Oral Jelly
Package: 7 sachets per box
Manufacturer: Ajanta Pharma Ltd

Indication:
For the treatment of male erectile dysfunction (ED).

Dosage:

• One sachet (20mg) before sexual activity.

• Take approximately 25–60 minutes before intercourse.

• Maximum one dose per day.

• Requires sexual stimulation to produce an effect.