GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Tadalafil Capsules 5mg
B) Tadalafil Capsules 10mg
C) Tadalafil Capsules 20mg
D) Tadalafil Capsules 40mg
E) Tadalafil Capsules 60mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Tadalafil Capsules 5mg
Each Soft Gelatin Capsule Contains:
Tadalafil BP……………………………5mg
Excipients……………………………q.s
Colour: Ponceau 4 R

B) Tadalafil Capsules 10mg
Each Soft Gelatin Capsule Contains:
Tadalafil BP……………………………10mg
Excipients……………………………q.s
Colour: Sunset yellow FCF aluminium lake

C) Tadalafil Capsules 20mg
Each Soft Gelatin Capsule Contains:
Tadalafil BP……………………………20mg
Excipients……………………………q.s
Colour: Tartrazine

D) Tadalafil Capsules 40mg
Each Soft Gelatin Capsule Contains:
Tadalafil BP……………………………40mg
Excipients……………………………q.s
Colour: Brilliant blue lake

E) Tadalafil Capsules 60mg
Each Soft Gelatin Capsule Contains:
Tadalafil BP……………………………60mg
Excipients……………………………q.s
Colour: Carmoisine

THERAPEUTIC INDICATIONS:

Tadalafil Capsule use in treatment of Erectile dysfunction. It works by relaxing the blood vessels in your penis, thereby increasing blood flow into the penis on sexual stimulation. This helps you achieve and maintain a hard, erect penis suitable for sexual activity.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Do not take this medicine if you have severe heart or liver problems, have recently had a stroke or heart attack or if you have low blood pressure.
Do not use Sildenafil tablet if you have recently taken nitrates (medicines used in angina or chest pain).
WARNING: To be sold by retail on the prescription of an Endocrinologist/Psychiatrist and specialist only.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Keep in cool, dry & dark place. Protect from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.

Tadalafil Capsules 60mg Technical Specification:

Product Name:         Tadalafil Capsules                            
Brand Name: Generic
Strength: 5mg, 10mg, 20mg, 40mg, 60mg
Dosage Form: Capsule (Soft-gelatin)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Regulatory Documents: COA, MOA, COPP, FSC, Product Permission, Stability Studies, GMP
Therapeutic use: Erectile Dysfunction (ED), Phosphodiesterase Inhibitors (PDEI)
Indication: Tadalafil Capsules use in treatment of Erectile dysfunction. This helps you achieve and maintain a hard, erect penis suitable for sexual activity.
Storage: Store below 30°C. Keep in cool, dry & dark place. Protect from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Tadalafil Capsules 5mg
B) Tadalafil Capsules 10mg
C) Tadalafil Capsules 20mg
D) Tadalafil Capsules 40mg
E) Tadalafil Capsules 60mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Tadalafil Capsules 5mg
Each Soft Gelatin Capsule Contains:
Tadalafil BP……………………………5mg
Excipients……………………………q.s
Colour: Ponceau 4 R

B) Tadalafil Capsules 10mg
Each Soft Gelatin Capsule Contains:
Tadalafil BP……………………………10mg
Excipients……………………………q.s
Colour: Sunset yellow FCF aluminium lake

C) Tadalafil Capsules 20mg
Each Soft Gelatin Capsule Contains:
Tadalafil BP……………………………20mg
Excipients……………………………q.s
Colour: Tartrazine

D) Tadalafil Capsules 40mg
Each Soft Gelatin Capsule Contains:
Tadalafil BP……………………………40mg
Excipients……………………………q.s
Colour: Brilliant blue lake

E) Tadalafil Capsules 60mg
Each Soft Gelatin Capsule Contains:
Tadalafil BP……………………………60mg
Excipients……………………………q.s
Colour: Carmoisine

THERAPEUTIC INDICATIONS:

Tadalafil Capsule use in treatment of Erectile dysfunction. It works by relaxing the blood vessels in your penis, thereby increasing blood flow into the penis on sexual stimulation. This helps you achieve and maintain a hard, erect penis suitable for sexual activity.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Do not take this medicine if you have severe heart or liver problems, have recently had a stroke or heart attack or if you have low blood pressure.
Do not use Sildenafil tablet if you have recently taken nitrates (medicines used in angina or chest pain).

WARNING: To be sold by retail on the prescription of an Endocrinologist/Psychiatrist and specialist only.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Keep in cool, dry & dark place. Protect from light and moisture.
Dosage:  As directed by the Physician.

Attach dispensing label as per end country.