LENANGIO 10 CAPSULES 10 MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Lenalidomide Povidone Pre-mix (1:1) eqv to Lenalidomide

Available from:

ZYFAS PHARMA PTE LTD

ATC code:

L04AX04

Pharmaceutical form:

CAPSULE

Composition:

Lenalidomide Povidone Pre-mix (1:1) eqv to Lenalidomide 10 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Dr. Reddy’s Laboratories Ltd.

Authorization status:

ACTIVE

Authorization date:

2021-08-24

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LENANGIO
LENALIDOMIDE 5MG/10MG/15MG/25MG CAPSULES
_This medicine is subject to additional monitoring. This will allow
quick identification of new safety _
_information. _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist.

_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 Lenalidomide is and what it is used for
2. What you need to know before you use Lenalidomide
3. How to use Lenalidomide
4. Possible side effects
5. How to store Lenalidomide
6. Contents of the pack and other information
1. WHAT LENALIDOMIDE IS AND WHAT IT IS USED FOR
WHAT LENALIDOMIDE IS
Lenalidomide belongs to a group of medicines which affect how your
immune system works.
WHAT LENALIDOMIDE IS USED FOR
Lenalidomide is used in adults for Multiple myeloma
MULTIPLE MYELOMA
Multiple myeloma is a type of cancer which affects a certain kind of
white blood cell, called the
plasma cell. These cells collect in the bone marrow and divide,
becoming out of control. This can
damage the bones and kidneys.
Multiple myeloma generally cannot be cured. However, the signs and
symptoms can be greatly
reduced or disappear for a period of time. This is called a
‘response’.
Newly diagnosed multiple myeloma – in patients who have had a bone
marrow transplant
Lenalidomide is used on its own as maintenance therapy after patients
have recovered enough
following a bone marrow transplant.
Newly diagnosed multiple myeloma – in patients who cannot have a
bone marrow transplant
2
Lenalidomide is taken with other medicine:

an anti-inflam

Summary of Product characteristics

1
PRESCRIBING INFORMATION
LENANGIO
LENALIDOMIDE 5MG/10MG/15MG/25MG CAPSULES
COMPOSITION
LENANGIO 5
Each capsule contains:
Lenalidomide 5 mg (as 1:1 Premix with Povidone K-30).
White to off white colored powder filled in size ‘4’ hard gelatin
capsules with White opaque
colored cap imprinted ‘RDY’ with black ink and White opaque
colored body imprinted ‘5mg’ with
black ink.
LENANGIO 10
Each capsule contains:
Lenalidomide 10 mg (as 1:1 Premix with Povidone K-30).
White to off white colored powder filled in size ‘2’ hard gelatin
capsules with pale green colored
cap imprinted ‘RDY’ with black ink and pale yellow colored body
imprinted ’10mg’ with black
ink.
LENANGIO 15
Each capsule contains:
Lenalidomide 15 mg (as 1:1 Premix with Povidone K-30).
White to off white colored powder filled in size ‘1’ hard gelatin
capsules with blue colored cap
imprinted ‘RDY’ with black ink and white colored body imprinted
‘15mg’ with black ink.
LENANGIO 25
Each capsule contains:
Lenalidomide 25 mg (as 1:1 Premix with Povidone K-30).
White to off white colored powder filled in size ‘0’ hard gelatin
capsules with opaque white colored
cap imprinted ‘RDY’ with black ink and opaque white colored body
imprinted ‘25mg’ with black
ink.
LIST OF EXCIPIENTS:
Mannitol, Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium
Stearate, Hard Gelatin
Capsules shell
HARD GELATIN CAPSULES SHELL SIZE ‘4’:
2
Gelatin, Purified water, Titanium dioxide
HARD GELATIN CAPSULES SHELL SIZE ‘2’:
Gelatin, Purified water, FD & C BLUE 2, Iron Oxide Yellow, Titanium
dioxide
HARD GELATIN CAPSULES SHELL SIZE ‘1’:
Gelatin, Purified water, FD & C BLUE 2, Titanium dioxide
HARD GELATIN CAPSULES SHELL SIZE ‘0:
Gelatin, Purified water, Titanium dioxide
IMPRINTING INK
SW-9008 BLACK:
Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol,
Propylene Glycol, Strong Ammonia
solution, Black Iron Oxide, Potassium Hydroxide, Purified water
CLINICAL INFORMATION
INDICATIONS
Multiple myeloma
Lenalidomide as monother