Rivaroxaban Sandoz

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Rivaroxaban 15mg;  

Available from:

Sandoz New Zealand Limited

Dosage:

15 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Rivaroxaban 15mg   Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry orange 04F530006 Sodium laurilsulfate

Prescription type:

Prescription

Therapeutic indications:

Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/aluminium - 28 dose units - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2020-01-30

Patient Information leaflet

RIVAROXABAN SANDOZ
®
1
RIVAROXABAN SANDOZ
®
_rivaroxaban _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Rivaroxaban Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Rivaroxaban
Sandoz against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT RIVAROXABAN
SANDOZ IS USED FOR
The active substance is rivaroxaban.
It belongs to a group of medicines
called
_anticoagulants_
. It works by
inhibiting the blood clotting protein
called Factor Xa, thus reducing the
tendency of blood to form clots.
Rivaroxaban Sandoz has been
prescribed to you for one of the
following uses:
•
Prevention of blood clots in your
veins after a hip or knee
replacement operation because
after an operation you are at an
increased risk of getting blood
clots.
•
Prevention of blood clots in your
brain (stroke) and/or other blood
vessels in your body if you have a
form of irregular heart rhythm
called non-valvular atrial
fibrillation
•
Treatment of blood clots in the
veins of your legs (deep vein
thrombosis, DVT) and clots in
your lung (pulmonary embolism,
PE) and to prevent blood clots
from re-occurring in your legs
and/or lungs.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Rivaroxaban Sandoz for another
reason.
Rivaroxaban Sandoz is a prescription
medicine. It should only be used in
adults under medical supervision.
BEFORE YOU TAKE
RIVAROXABAN SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE RIVAROXABAN SANDOZ IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
rivaroxaban
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:

Summary of Product characteristics

200831-rivaroxaban-sandoz-ds
Page 1 of 39
NEW ZEALAND DATA SHEET
1.
RIVAROXABAN SANDOZ
®
Rivaroxaban Sandoz
®
10 mg film-coated tablets
Rivaroxaban Sandoz
®
15 mg film-coated tablets
Rivaroxaban Sandoz
®
20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Rivaroxaban Sandoz 10 mg film-coated tablet contains 10 mg
rivaroxaban.
Each Rivaroxaban Sandoz 15 mg film-coated tablet contains 15 mg
rivaroxaban.
Each Rivaroxaban Sandoz 20 mg film-coated tablet contains 20 mg
rivaroxaban
Excipient with known effect:
_Lactose monohydrate._
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Rivaroxaban Sandoz 10 mg tablets are approximately 6 mm, peach
colored, round, biconvex film-
coated tablets marked with "10" on one side.
Rivaroxaban Sandoz 15 mg tablets are approximately 6 mm, light orange
colored, round, biconvex
film-coated tablets marked with "15" on one side.
Rivaroxaban Sandoz 20 mg tablets are approximately 7 mm, orange
colored, round, biconvex film-
coated tablets marked with "20" on one side.
4.
CLINICAL PARTICULARS
T
HERAPEUTIC INDICATIONS
Rivaroxaban Sandoz is indicated for
•
Prevention of venous thromboembolism (VTE) in adult patients
undergoing elective
hip or knee replacement surgery.
•
Prevention of stroke and systemic embolism in adult patients with
non-valvular atrial
fibrillation with one or more risk factors, such as congestive heart
failure, hypertension,
age ≥ 75 years, diabetes mellitus, prior stroke or transient
ischaemic attack.
•
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE)
and for the
prevention of recurrent DVT and pulmonary embolism (see section 4.4
Special
warnings and precautions for use for haemodynamically unstable PE
patients).
D
OSE AND METHOD OF ADMINISTRATION
DOSE
_VTE PREVENTION IN TOTAL HIP AND KNEE REPLACEMENT _
The recommended dose of Rivaroxaban Sandoz for VTE prevention in major
orthopaedic surgery
of the lower limbs (elective total hip or knee replacement) is a 10 mg
tablet taken on