Product Name: Apcalis Oral Jelly 20mg

Drug Information

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

Ingredients

Active Ingredient:
Tadalafil 20mg

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

Indications

Apcalis Oral Jelly is used for the treatment of:

Male Erectile Dysfunction (ED)

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

Dosage and Administration

Recommended Dose

Take one sachet (20mg) as needed.

Recommended Timing

Take approximately:

30 minutes to 1 hour before sexual activity.

Maximum Dose

• Do not exceed 20mg per day.

• Do not take more than once within 24 hours.

Administration Method

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

• No water is required.

• Can be taken with or without food.

• A high-fat meal may slightly delay the onset of action.

Onset of Action

Usually begins within:

30–60 minutes

Duration of Effect

The effect may last up to:

36 hours

Because of its long duration, tadalafil is sometimes called the:

“Weekend Pill.”

Important Note

Tadalafil requires sexual stimulation to work.

It does not automatically cause an erection.

Do not combine with nitrate medications, such as:

• Nitroglycerin

• Isosorbide mononitrate

as this may cause a potentially life-threatening drop in blood pressure.

Contraindications

Apcalis Oral Jelly should not be used in the following situations:

1. Use of Nitrate Medications

Patients taking any form of nitrate medication for angina or heart disease must not use tadalafil.

Examples:

• Nitroglycerin

• Isosorbide mononitrate

• Isosorbide dinitrate

2. Allergy

Do not use if allergic to:

• Tadalafil

• Any ingredient in the formulation

3. Severe Cardiovascular Disease

Including:

• Heart attack within the previous 6 months

• Stroke within the previous 6 months

• Unstable angina

• Severe heart failure

4. Severe Blood Pressure Abnormalities

Avoid use in cases of:

• Severe hypotension
  (systolic blood pressure <90 mmHg)

• Uncontrolled hypertension
  (systolic blood pressure >170 mmHg or diastolic blood pressure >100 mmHg)

5. Eye Disorders

Including:

• Hereditary retinal disorders such as retinitis pigmentosa

• History of non-arteritic anterior ischemic optic neuropathy (NAION)

6. Severe Liver or Kidney Disease

Patients with severe liver or kidney impairment should only use tadalafil after medical evaluation and possible dose adjustment.

Warnings and Precautions

1. For Adult Men Only

This product is intended only for adult males.

Not suitable for:

• Women

• Children

2. Not for Recreational Use

Tadalafil should not be used for recreational sexual enhancement.

Unnecessary use may increase health risks.

3. Prolonged Erection (Priapism)

If an erection lasts:

More than 4 hours

seek emergency medical attention immediately.

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

4. Hearing Problems

Rare cases of:

• Sudden hearing loss

• Ringing in the ears (tinnitus)

have been reported.

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

5. Vision Changes

Possible temporary effects include:

• Blurred vision

• Changes in color perception

• Difficulty distinguishing blue and green colors

6. Alcohol Use

Alcohol may increase the blood-pressure-lowering effect of tadalafil.

Excessive alcohol consumption may increase the risk of:

• Dizziness

• Low blood pressure

• Fainting

Avoid heavy drinking while using this medication.

7. Product Quality Warning

Products obtained through unofficial channels may carry risks, including:

• Incorrect ingredients

• Contamination

• Unlisted active substances

• Incorrect dosage information

Always purchase medicines from reliable and legally authorized sources.

Common Side Effects

Most side effects are mild and temporary.

Common reactions include:

• Headache (most common)

• Indigestion

• Heartburn

• Back pain

• Muscle pain

• Nasal congestion

• Facial flushing

• Dizziness

• Visual disturbances

These symptoms usually decrease as the body adapts to the medication.

Rare but Serious Side Effects

Seek medical attention immediately if you experience:

• Sudden hearing loss

• Vision loss related to NAION

• Severe low blood pressure

• Abnormal heart rhythm

• Heart attack symptoms

• Severe allergic reactions:

• Skin rash

• Itching

• Difficulty breathing

Drug Interactions

Absolute Contraindications

Do not combine tadalafil with:

Nitrates

Examples:

• Nitroglycerin

• Isosorbide medications

Guanylate Cyclase Stimulators

Example:

• Riociguat

Use With Caution

Alpha-blockers

Examples:

• Terazosin

May increase the risk of low blood pressure.

Strong CYP3A4 Inhibitors

Examples:

• Ketoconazole

• Ritonavir

May increase tadalafil blood levels.

Antihypertensive Drugs

May enhance blood-pressure-lowering effects.

Blood pressure monitoring may be required.

Use in Special Populations

Elderly Patients (≥65 years)

No routine dose adjustment is required.

However, elderly patients may be more sensitive to side effects.

Liver Impairment

Moderate liver impairment:

Maximum dose:

10mg per day

Severe liver impairment:

Not recommended.

Kidney Impairment

For severe renal impairment:

(CrCl <30 mL/min)

Maximum recommended dose:

10mg every other day

Pregnancy and Breastfeeding

Not applicable.

This medication is intended only for adult males.

Pharmacological Action

Tadalafil is a selective:

Phosphodiesterase Type 5 (PDE5) inhibitor

Mechanism of Action

Tadalafil enhances the:

Nitric Oxide (NO) – cGMP pathway

by inhibiting PDE5 enzymes in penile tissue.

This results in:

• Relaxation of smooth muscle

• Increased blood flow into the penis

• Improved erectile response during sexual stimulation

Pharmacokinetics

Absorption

Rapidly absorbed after oral administration.

Peak Plasma Concentration

Approximately:

2 hours (Tmax)

Half-life

Approximately:

17.5 hours

This contributes to its long duration of action.

Metabolism

Mainly metabolized by:

Liver CYP3A4 enzyme

Elimination

• Feces: approximately 61%

• Urine: approximately 36%

Storage Conditions

• Store in a sealed package.

• Protect from light.

• Store below 25°C in a dry place.

• Keep out of reach of children.

Packaging

Aluminum composite sachets.

Each sachet contains approximately 10g oral jelly.

Individual sachet packaging.

Important Information Before Purchasing Sexual Health Products

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

When using medications containing:

• Sildenafil

• Vardenafil

• Tadalafil

• Avanafil

• Dapoxetine

some users may experience reduced response.

The effectiveness of these medicines varies between individuals due to:

• Metabolism differences

• Cardiovascular condition

• Underlying diseases

• Psychological factors

• Individual sensitivity to medication

If the expected effect is not achieved:

• Do not increase the dose yourself.

• Do not switch medicines randomly.

• Do not continue long-term unsupervised use.

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

Product Specifications

Product Name: Apcalis Oral Jelly

Generic Name: Tadalafil Oral Jelly

Active Ingredient:
Tadalafil 20mg per sachet

Dosage Form:
Oral Jelly

Package:
7 sachets per box

Manufacturer:
Ajanta Pharma Ltd

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

Dosage Instructions

Recommended Dose:
One sachet (20mg) as needed.

Administration Time:
Approximately 30 minutes to 1 hour before sexual activity.

Maximum Dose:
Once daily only. Do not exceed 20mg per day.

Method of Use:
Squeeze directly into the mouth. No water required.

May be taken with or without food.

A high-fat meal may slightly delay the onset of action.

Onset of Effect:
Usually within 30–60 minutes.