Invokana 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Canagliflozin hemihydrate

Available from:

Napp Pharmaceuticals Ltd

ATC code:

A10BK02

INN (International Name):

Canagliflozin hemihydrate

Dosage:

100mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010203; GTIN: 5012674902417

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
INVOKANA 100 MG FILM-COATED TABLETS
INVOKANA 300 MG FILM-COATED TABLETS
canagliflozin
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Invokana is and what it is used for
2.
What you need to know before you take Invokana
3.
How to take Invokana
4.
Possible side effects
5.
How to store Invokana
6.
Contents of the pack and other information
1.
WHAT INVOKANA IS AND WHAT IT IS USED FOR
Invokana contains the active substance canagliflozin which belongs to
a group of medicines called
“blood-glucose lowering drugs.”
“Blood-glucose lowering drugs” are medicines used by adults to
treat type 2 diabetes.
This medicine works by increasing the amount of sugar removed from
your body in your urine. This
reduces the amount of sugar in your blood.
Invokana can be used by itself or along with other medicines you may
be using to treat your type 2
diabetes (such as metformin, insulin, a DPP-4 inhibitor [such as
sitagliptin, saxagliptin, or linagliptin],
a sulphonylurea [such as glimepiride or glipizide], or pioglitazone)
that lower blood sugar levels. You
may already be taking one or more of these to treat your type 2
diabetes.
It is also important to keep following advice about diet and exercise
given by your doctor or nurs

Summary of Product characteristics

OBJECT 1
INVOKANA 100 MG AND 300 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 14-Jun-2018 | Napp
Pharmaceuticals Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Invokana 100 mg film-coated tablets
Invokana 300 mg film-coated tablets
2. Qualitative and quantitative composition
Invokana 100 mg film-coated tablets
Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg
canagliflozin.
_Excipient(s) with known effect_
Each tablet contains 39.2 mg lactose.
Each tablet contains less than 1 mmol sodium (23 mg), and is
essentially sodium-free.
Invokana 300 mg film-coated tablets
Each tablet contains canagliflozin hemihydrate, equivalent to 300 mg
canagliflozin.
_Excipient(s) with known effect_
Each tablet contains 117.78 mg lactose.
Each tablet contains less than 1 mmol sodium (23 mg), and is
essentially sodium-free.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Invokana 100 mg film-coated tablets
The tablet is yellow, capsule-shaped, approximately 11 mm in length,
immediate-release and film-coated,
with “CFZ” on one side and “100” on the other side.
Invokana 300 mg film-coated tablets
The tablet is white, capsule-shaped, approximately 17 mm in length,
immediate-release and film-coated,
with “CFZ” on one side and “300” on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Invokana is indicated in adults aged 18 years and older with type 2
diabetes mellitus to improve
glycaemic control as:
Monotherapy
When diet and exercise alone do not provide adequate glycaemic control
in patients for whom the use of
metformin is considered inappropriate due to intolerance or
contraindications.
Add-on therapy
Add-on therapy with other glucose-lowering medicinal products
inc