Nefopam Hydrochloride Tablets 30mg Technical Specification:

Product Name:Nefopam Hydrochloride Tablets 30mg
Brand Name:Generic
Strength:20mg, 30mg
Dosage Form:Tablets (Film coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Analgesic, Painkiller
Indication: Nefopam is a painkiller. It treats moderate pain, for example after an operation or a serious injury, dental pain, joint pain and muscle pain, or pain from cancer.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Nefopam Hydrochloride Tablets 20mg
  • Nefopam Hydrochloride Tablets 30mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Nefopam Hydrochloride Tablets 20mg
    Each film coated tablet contains:
    Nefopam Hydrochloride…………..20mg
    Excipients………………………………..q.s.
    Colours: Titanium Dioxide USP-NF
  • Nefopam Hydrochloride Tablets 30mg
    Each film coated tablet contains:
    Nefopam Hydrochloride…………..30mg
    Excipients…………………………………q.s.
    Colours: Yellow oxide of iron

THERAPEUTIC INDICATIONS:

Nefopam is indicated for the relief of acute and chronic pain, including post-operative pain, dental pain, musculo-skeletal pain, acute traumatic pain and cancer pain.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from Light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end county.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Nefopam Hydrochloride Tablets 20mg
B) Nefopam Hydrochloride Tablets 30mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Nefopam Hydrochloride Tablets 20mg
Each film coated tablet contains:
Nefopam Hydrochloride…………..20mg
Excipients………………………………..q.s.
Colours: Titanium Dioxide USP-NF

B) Nefopam Hydrochloride Tablets 30mg
Each film coated tablet contains:
Nefopam Hydrochloride…………..30mg
Excipients…………………………………q.s.
Colours: Yellow oxide of iron


THERAPEUTIC INDICATIONS:

Nefopam is indicated for the relief of acute and chronic pain, including post-operative pain, dental pain, musculo-skeletal pain, acute traumatic pain and cancer pain.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from Light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.