GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Tapentadol Hydrochloride Extended-Release Tablets 50mg (Nucyreta ER)
B) Tapentadol Hydrochloride Extended-Release Tablets 100mg (Nucyreta ER)
C) Tapentadol Hydrochloride Extended-Release Tablets 150mg (Nucyreta ER)
D) Tapentadol Hydrochloride Extended-Release Tablets 200mg (Nucyreta ER)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Tapentadol Hydrochloride Extended-Release Tablets 50mg
Each film coated Extended-Release tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol……….50mg
Excipients………………………………..q.s.
Colour: Titanium Dioxide IP

B) Tapentadol Hydrochloride Extended-Release Tablets 100mg
Each film coated Extended-Release tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol………….100mg
Excipients………………………………q.s.
Colour: Lake of quinoline yellow FCF

C) Tapentadol Hydrochloride Extended-Release Tablets 150mg
Each film coated Extended-Release tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol……………..150mg
Excipients………………………………………q.s.
Colour: Lake of Erythrosine

D) Tapentadol Hydrochloride Extended-Release Tablets 200mg
Each film coated Extended-Release tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol………..200mg
Excipients…………………………………q.s.
Colour: Ferric oxide yellow

THERAPEUTIC INDICATIONS:

Tapentadol tablets are used to treat moderate to severe acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed). Tapentadol extended-release tablets are used to treat severe neuropathic pain (pain caused by nerve damage) in people who have diabetes.

CAUTION & SCHEDULE:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store below 30 °C.
Protect from Light.
Dosage: As directed by the Physician.

Tapentadol Hydrochloride Extended-Release Tablets 100mg Technical Specification:

Product Name: Tapentadol Hydrochloride Extended-Release Tablets
Brand Name: NUCYRETA ER
Strength: 50mg, 100mg, 150mg, 200mg
Dosage Form: Tablets (Film coated Extended-Release)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Opioid Analgesic, Pain killer
Indication: Tapentadol tablets are used to treat moderate to severe acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed).
Storage: Store below 30 °C. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Tapentadol Hydrochloride Extended-Release Tablets 50mg (Nucyreta ER)
B) Tapentadol Hydrochloride Extended-Release Tablets 100mg (Nucyreta ER)
C) Tapentadol Hydrochloride Extended-Release Tablets 150mg (Nucyreta ER)
D) Tapentadol Hydrochloride Extended-Release Tablets 200mg (Nucyreta ER)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Tapentadol Hydrochloride Extended-Release Tablets 50mg
Each film coated Extended-Release tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol……….50mg
Excipients………………………………..q.s.
Colour: Titanium Dioxide IP

B) Tapentadol Hydrochloride Extended-Release Tablets 100mg
Each film coated Extended-Release tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol………….100mg
Excipients………………………………q.s.
Colour: Lake of quinoline yellow FCF

C) Tapentadol Hydrochloride Extended-Release Tablets 150mg
Each film coated Extended-Release tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol……………..150mg
Excipients………………………………………q.s.
Colour: Lake of Erythrosine

D) Tapentadol Hydrochloride Extended-Release Tablets 200mg
Each film coated Extended-Release tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol………..200mg
Excipients…………………………………q.s.
Colour: Ferric oxide yellow

THERAPEUTIC INDICATIONS:

Tapentadol tablets are used to treat moderate to severe acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed). Tapentadol extended-release tablets are used to treat severe neuropathic pain (pain caused by nerve damage) in people who have diabetes.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.

SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store below 30 °C.
Protect from Light.
Dosage: As directed by the Physician.