Contrave 8/90

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Bupropion hydrochloride 90mg equivalent to bupropion 78mg;  ;  ; Naltrexone hydrochloride 8mg equivalent to naltrexone 7.2mg;  

Available from:

iNova Pharmaceuticals (New Zealand) Limited

Pharmaceutical form:

Modified release tablet

Composition:

Active: Bupropion hydrochloride 90mg equivalent to bupropion 78mg     Naltrexone hydrochloride 8mg equivalent to naltrexone 7.2mg   Excipient: Colloidal silicon dioxide Crospovidone Cysteine hydrochloride monohydrate Disodium edetate Hyprolose Hypromellose Indigo carmine aluminium lake Lactose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry blue 85F90663

Prescription type:

Prescription

Therapeutic indications:

CONTRAVE 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: · >/= 30 kg/m2 (obese), or · >/= 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension). Treatment with CONTRAVE should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PCTFE/PVC with Al foil (starter pack) - 28 tablets - 30 months from date of manufacture stored at or below 25°C. Do not freeze. - Blister pack, PVC/PCTFE/PVC with Al foil - 112 tablets - 30 months from date of manufacture stored at or below 25°C. Do not freeze.

Authorization date:

2019-10-31

Patient Information leaflet

CONTRAVE
®
8/90
C
O
N
T
R
A
V
E
®
8
/
9
0
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING CONTRAVE?
Contrave contains the active ingredients naltrexone hydrochloride and
bupropion hydrochloride. Contrave is used in obese or
overweight adults to manage weight together with a reduced calorie
diet and physical exercise.
For more information, see Section 1. Why am I taking Contrave? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CONTRAVE?
Do not use if you have ever had an allergic reaction to Contrave or
any of the ingredients listed at the end of the CMI.
DO NOT TAKE CONTRAVE IF YOU ARE PREGNANT OR PLAN TO BECOME PREGNANT.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL
CONDITIONS, TAKE ANY OTHER MEDICINES OR ARE BREASTFEEDING OR INTEND TO
BREASTFEED.
For more information, see Section 2. What should I know before I take
Contrave? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Contrave and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE CONTRAVE?
Carefully follow all directions given by your doctor or other
healthcare professionals and never change the dose yourself.
•
The starting dose is one tablet once a day in the morning. The dose is
gradually increased over a four-week period.
•
Swallow the tablet whole with a glass of water. DO NOT CUT, CHEW OR
CRUSH THE TABLETS.
More instructions can be found in Section 4. How do I use Contrave? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CONTRAVE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Contrave.
•
Reduce the energy content of your diet and exercise regularly.
THINGS YOU
SHOULD NOT DO
•
Do not take any other me

Summary of Product characteristics

NEW ZEALAND DATA SHEET
CONTRAVE® 8/90
CONTRAVE 8/90
Page 1 of 22
1 PRODUCT NAME
CONTRAVE® 8 mg/90 mg modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg naltrexone hydrochloride, equivalent to 7.2
mg of naltrexone, and 90 mg
bupropion hydrochloride, equivalent to 78 mg of bupropion.
Excipient with known effect:
Each modified-release tablet contains 73.2 mg of lactose (see section
4.4). Contains sugars.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet.
Blue, biconvex, round tablet of 12.0-12.2 mm diameter debossed with
“NB-890” on one side.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
CONTRAVE 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:
•
≥ 30 kg/m
2
(obese), or
•
≥ 27 kg/m
2
to < 30 kg/m
2
(overweight) in the presence of one or more weight-related co-
morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled
hypertension).
Treatment with CONTRAVE should be discontinued after 16 weeks if
patients have not lost at least
5% of their initial body weight (see Section 5.1).
4.2
Dose and method of administration
_Adults: _
Upon initiating treatment, the dose should be escalated over a 4-week
period as follows:
MORNING DOSE
EVENING DOSE
WEEK 1
1 tablet
None
WEEK 2
1 tablet
1 tablet
WEEK 3
2 tablets
1 tablet
WEEK 4 - ONWARD
2 tablets
2 tablets
The maximum recommended daily dose of CONTRAVE is two tablets taken
twice daily (32 mg
naltrexone hydrochloride and 360 mg bupropion hydrochloride), which is
reached at the start of
week 4.
If a dose is missed, patients should not take an additional dose, but
take the prescribed next dose at
the usual time.
Patients may develop elevated blood pressure or heart rate during
CONTRAVE treatment. Blood
pressure and pulse should be measured prior to starting therapy with
CONTRAVE and should be
monitored at regular intervals consist