Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets (8mg/90mg) Technical Specification:

Product Name:Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets
Brand Name:Mysimtaj
Strength:8mg/90mg
Dosage Form:Film-coated Oral Tablets
Route of Administration:Via Oral Route
Packing:10s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antidepressant, Opioid antagonist
Indication: Naltrexone hydrochloride and Bupropion hydrochloride is a fixed combination of naltrexone, an opioid antagonist, and bupropion, an aminoketone antidepressant.
Storage:Store in cool & Dry place. Protect from light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets (8mg/90mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets (8mg/90mg)
    Each film-coated tablet contains:
    Naltrexone hydrochloride …………………8mg
    Equivalent to naltrexone ………………….7.2mg
    Bupropion hydrochloride …………………90mg
    Equivalent to bupropion …………………78mg
    Lactose……………………………. 73.2mg

THERAPEUTIC INDICATIONS:

Naltrexone hydrochloride and Bupropion hydrochloride is a fixed combination of naltrexone, an opioid antagonist, and bupropion, an aminoketone antidepressant, and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index.

CAUTION & WARNING:

CAUTION:  TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEWED OR CRUSHED.

WARNING: Both Naltrexone and Bupropion have been used clinically before but Mysimtaj is the first time they have been used together in one treatment.

Nearly half of all Mysimtaj users lost at least 5% of their total body weight.

Keep medicine out of reach and sight of children

*This medicinal product is subject to additional monitoring. ***For Weight Loss Use.

TAKE CHARGE OF YOUR HEALTH BY TAKING MEDICATION PROPERLY

STORAGE & DOSAGE:

STORAGE: Store in in cool & Dry place. Protect from light & moisture.

DOSAGE:
The normal regimen is as follows:
Week 1: one tablet each morning for one week.
Week 2: one tablet in the morning and one in the evening.
Week 3: two tablets in the morning and a single tablet in the evening.
Week 4: two tablets in the morning and two in the evening.

NOTE:

Mysimtaj is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥ 18 years)
With an initial Body Mass Index (BMI) of
≥ 30kg/m2 (obese), or
≥ 27kg/m2 to 30kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidemia, or controlled hypertension).

Mysimtaj should not be used by adults over 18 years old with a BMI of over 30 (or 27 if you have other health conditions like diabetes).
If do not lose 5% of your total body weight within 4 months of using the weight lose treatment Mysimtaj use should be stopped.

GENERIC NAME OF THE MEDICINAL PRODUCT:

Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets (8mg/90mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets (8mg/90mg)
Each film-coated tablet contains:
Naltrexone hydrochloride …………………8mg
Equivalent to naltrexone ………………….7.2mg
Bupropion hydrochloride …………………90mg
Equivalent to bupropion …………………78mg
Lactose……………………………. 73.2mg

THERAPEUTIC INDICATIONS:

Naltrexone hydrochloride and Bupropion hydrochloride is a fixed combination of naltrexone, an opioid antagonist, and bupropion, an aminoketone antidepressant, and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index.

CAUTION & WARNING:

CAUTION: TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEWED OR CRUSHED.
WARNING: Both Naltrexone and Bupropion have been used clinically before but Mysimtaj is the first time they have been used together in one treatment.
Nearly half of all Mysimtaj users lost at least 5% of their total body weight.
KEEP MEDICINE OUT OF REACH AND SIGHT OF CHILDREN
*This medicinal product is subject to additional monitoring. ***For Weight Loss Use.
TAKE CHARGE OF YOUR HEALTH BY TAKING MEDICATION PROPERLY

STORAGE & DOSAGE:

STORAGE: Store in in cool & Dry place.
Protect from light & moisture.
DOSAGE:
The normal regimen is as follows:
Week 1: one tablet each morning for one week.
Week 2: one tablet in the morning and one in the evening.
Week 3: two tablets in the morning and a single tablet in the evening.
Week 4: two tablets in the morning and two in the evening.
NOTE:
Mysimtaj is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥ 18 years)
With an initial Body Mass Index (BMI) of
≥ 30kg/m2 (obese), or
≥ 27kg/m2 to 30kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidemia, or controlled hypertension).
Mysimtaj should not be used by adults over 18 years old with a BMI of over 30 (or 27 if you have other health conditions like diabetes).
If do not lose 5% of your total body weight within 4 months of using the weight lose treatment Mysimtaj use should be stopped.