TADALAFIL TAB 20,25,50,100MG

Product Details
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Name Of Product(Genric Name) :

TADALAFIL TAB 20,25,50,100MG

Product Description :

TADALAFIL ORAL JELLY

20 mg / 25 mg / 50 mg / 100 mg

1. COMPOSITION

Each sachet/container contains:

  • Tadalafil — 20 mg / 25 mg / 50 mg / 100 mg

  • Suitable pharmaceutical excipients — q.s.

2. PHARMACEUTICAL FORM

Oral Jelly.

3. THERAPEUTIC CLASS

Phosphodiesterase Type-5 (PDE5) Inhibitor.

4. INDICATIONS

Tadalafil is indicated for the treatment of erectile dysfunction in adult men when sexual stimulation is present.

5. CONTRAINDICATIONS

  • Hypersensitivity to Tadalafil or any component of the formulation.

  • Concomitant use with organic nitrates or nitric oxide donors, including recreational nitrates (“poppers”), because of the risk of significant hypotension.

  • Concomitant use with guanylate cyclase stimulators such as riociguat.

  • Patients for whom sexual activity is inadvisable because of their cardiovascular condition.

  • Do not use in patients with severe hepatic impairment unless specifically advised by a physician.

6. DRUG INTERACTIONS

Tadalafil may interact with:

  • Organic nitrates and nitric oxide donors — contraindicated.

  • Alpha-blockers and antihypertensive medicines — may increase the risk of hypotension.

  • Potent CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir — may increase tadalafil exposure.

  • Other PDE5 inhibitors or treatments for erectile dysfunction — concomitant use is not recommended.

  • Alcohol — excessive consumption may increase the risk of dizziness and a fall in blood pressure.

7. ADMINISTRATION

Take orally as directed by a physician.

For erectile dysfunction, tadalafil is generally taken at least 30 minutes before anticipated sexual activity. The effect may persist for up to 36 hours.

  • Sexual stimulation is required for tadalafil to be effective.

  • Do not take more than one dose in a 24-hour period unless specifically prescribed.

  • Do not exceed the prescribed dose.

  • The oral jelly may be taken with or without food.

  • Do not use concurrently with nitrate medicines.

Important: The 25 mg, 50 mg and 100 mg strengths should only be used where specifically approved/prescribed according to the applicable regulatory requirements.

8. STORAGE

Store below 25°C, protected from excessive heat, moisture and direct sunlight.
Keep the container/sachet tightly closed until use.
Keep out of reach of children.
Do not use after the expiry date.

Market : international export

Private Label : Available

Registration Support : Available

Regulatory documents : Available on request


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