JEDOXRED 250 (DEFERASIROX DISPERSIBLE TABLETS 250MG)

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Buy It Now

Active ingredient:
DEFERASIROX
Available from:
Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.
INN (International Name):
DEFERASIROX
Units in package:
1 x 7 Tablets; 4 x 7 Tablets; 12 x 7 Tablets
Manufactured by:
MSN Laboratories Private Limited
Authorization number:
MAL20046128AZ

Documents in other languages

Patient Information leaflet Patient Information leaflet - Malay

28-02-2020

Consumer Medication Information Leaflet (RiMUP)

JEDOXRED 125 (Deferasirox Dispersible Tablets 125mg)

JEDOXRED 250 (Deferasirox Dispersible Tablets 250mg)

JEDOXRED 500 (Deferasirox Dispersible Tablets 500mg)

Deferasirox Dispersible Tablets 125mg, 250mg, 500mg

What is in this leaflet

1. What Jedoxred is used for

2. How Jedoxred works

3. Before you use Jedoxred

4. How to use Jedoxred

5. While you are using it

6. Side Effects

7. Storage and Disposal of Jedoxred

8. Product Description

9. Manufacturer and Product

Registration Holder

10. Date of Revision

What Jedoxred is used for

Jedoxred is used to treat chronic iron

overload in:

- adult patients and children aged 2

years and older who receive blood

transfusions for the treatment of

anemias;

- adult patients and children aged 10

years and older with thalassemia

syndromes who do not require regular

blood transfusions for the treatment

of anemia.

How Jedoxred works

Jedoxred is an iron chelating agent

which removes the excess iron from

the body (also called iron overload),

thereby reducing the risk of organ

damage caused by iron overload.

Before you use Jedoxred

- When you must not use it

If you are allergic (hypersensitive)

to deferasirox or any of the other

ingredients (in particular, lactose) of

Jedoxred listed in the section

“Product Description”.

If you have severe kidney disease.

If you have an advanced stage of

myelodysplastic syndrome (MDS) or

advanced cancer.

If you have low platelet count (<50

x 10

/L).

Pregnancy and lactation

Jedoxred is not recommended during

pregnancy unless clearly necessary. If

you are pregnant or think that you

may be, tell your doctor. Jedoxred

may decrease the effect of hormonal

contraceptives, and you may be at

risk of getting pregnant if you are

taking a hormonal contraceptive.

Breast-feeding is not recommended

during treatment with Jedoxred.

- Before you start to use it

Talk to your doctor or pharmacist if

you have:

severe heart problems (acute

cardiac failure).

ulcer or bleeding in the stomach or

intestines.

liver or kidney problems.

severe intolerance to lactose (milk

sugars). Jedoxred tablets contain

lactose.

visual (eye) problems.

hearing problems.

blood disorders (a low level of

platelets or white blood cell count).

skin problem.

- Taking other medicines

Please tell your doctor or pharmacist

if you are taking or have recently

taken any other medicines, including

non-prescription drugs (obtained

without a prescription), vitamins and

natural products. Some medicines

may interact with Jedoxred:

Antacids (medicines used to treat

heartburn) containing aluminum

should not be taken at the same time

of day as Jedoxred.

In particular tell your doctor if you

are taking any of the following:

cyclosporine (used in

transplantation to prevent graft

rejection or for any other condition)

simvastatin (used to lower

cholesterol)

hormonal contraceptive agents

(birth control medicines)

certain painkillers or anti-

inflammatory medicines (e.g.

acetylsalicylic acid, ibuprofen,

corticosteroids)

oral bisphosphonates (used to treat

osteoporosis)

anticoagulant medicines (used to

prevent or treat blood clotting)

repaglinide (used to treat diabetes)

rifampicin (used to treat

tuberculosis)

paclitaxel (used in cancer

treatment)

phenytoin, phenobarbital (used to

treat epilepsy)

ritonavir (used in the treatment of

HIV infection)

cholestyramine (used mainly to

lower cholesterol)

theophylline (used to treat

respiratory diseases such as asthma)

busulfan (used as treatment prior to

bone marrow transplant)

Consumer Medication Information Leaflet (RiMUP)

JEDOXRED 125 (Deferasirox Dispersible Tablets 125mg)

JEDOXRED 250 (Deferasirox Dispersible Tablets 250mg)

JEDOXRED 500 (Deferasirox Dispersible Tablets 500mg)

Deferasirox Dispersible Tablets 125mg, 250mg, 500mg

How to use Jedoxred

- How much to use

Always take Jedoxred exactly as your

doctor has told you. You should

check with your doctor or pharmacist

if you are not sure.

Usual dose:

For patients receiving regular blood

transfusion:

Initial dose: 10 mg, or 20 mg, or 30

mg per kg body weight daily.

Maximum dose: 40 mg per kg

body weight daily.

For patients with thalassemia

syndromes who do not require regular

blood transfusions:

Initial dose: 10 mg per kg body

weight daily.

Maximum dose: 20 mg per kg

body weight daily.

The daily dose will be adjusted

depending on how you respond to the

treatment.

Jedoxred dispersible tablets are

dispersed by stirring in a glass of

water or orange or apple juice (100 to

200 ml) until a fine suspension is

obtained. After the suspension has

been swallowed, any residue must be

re-suspended in a small volume of

water or juice and swallowed.

Dispersion in carbonated drinks or

milk is not recommended due to

foaming and slow dispersion,

respectively. The tablets must not be

chewed or swallowed whole.

- When to use it

Take Jedoxred once a day, every

day, at about the same time each day;

Must be taken on an empty

stomach;

Then wait at least 30 minutes

before eating the first meal of the day.

- How long to use it

Continue using Jedoxred for as long

as your doctor recommends.

- If you forget to use it

If you miss a dose, take it as soon as

you remember on that day. Take your

next dose as scheduled. Do not take a

double dose on the next day to make

up for the forgotten dose. Do not take

more than one dose on the same day.

- If you use too much (overdose)

If you have taken too much Jedoxred,

or if someone else accidentally takes

your tablets, contact your doctor or

go to the hospital or contact your

local poison control centre. Show

them the blister package of tablets.

Medical treatment may be necessary.

While you are using it

- Things you must do

Take your medicine exactly as your

doctor has told you. Tell all the

doctors, dentists and pharmacists

treating you that you are taking

Jedoxred.

Tell your doctor immediately if you

become pregnant while taking this

medication.

During treatment with Jedoxred, talk

to your doctor or pharmacist

immediately if you have:

Rash, red skin, pain, swelling or

blistering of the lips, eyes or mouth,

skin peeling, high fever and flu-like

symptoms and swollen lymph glands.

If you get these symptoms, your

doctor may stop your treatment

You should receive regular blood and

urine tests before and during

treatment with Jedoxred. You may

also be assessed by Magnetic

Resonance Imaging (MRI). These

will monitor the amount of iron in

your body (level of ferritin) to see

how well Jedoxred is working. The

tests will also monitor your kidney

function (blood level of creatinine,

presence of protein in the urine) and

liver function (blood level of

transaminases, bilirubin and alkaline

phosphatase). Your doctor will take

these tests into consideration when

deciding on the dose of Jedoxred

most suitable for you and will also

use these tests to decide when you

should stop taking Jedoxred.

Your eyesight and hearing will also

be tested before and periodically

during treatment as a precautionary

measure. The safety of Jedoxred

when administered with other iron

chelation therapy has not been

established.

- Things you must not do

Do not stop taking the medicine

unless advised by your doctor.

Do not take any new medicines

without consulting your doctor or

pharmacist.

Do not give Jedoxred to anyone else,

even if they have the same symptoms

or condition as you.

Consumer Medication Information Leaflet (RiMUP)

JEDOXRED 125 (Deferasirox Dispersible Tablets 125mg)

JEDOXRED 250 (Deferasirox Dispersible Tablets 250mg)

JEDOXRED 500 (Deferasirox Dispersible Tablets 500mg)

Deferasirox Dispersible Tablets 125mg, 250mg, 500mg

- Things to be careful of

Older people (age 65 years and

over):

Elderly patients may

experience more side effects than

younger patients. They should be

monitored closely by their doctor for

side effects that may require a dose

adjustment.

Children and adolescents (age 2

years to 16 years)

: Their growth and

development need to be monitored

during treatment with Jedoxred

Driving and using machines

This medicine may affect your ability

to drive or use machines. If the tablets

make you feel sick, dizzy or tired, or

give you a headache, do not drive or

use machines and contact your doctor

immediately.

Side effects

Like all medicines, Jedoxred can

cause side effects. Some side effects

are common.

Gastrointestinal disorders, such as

nausea, vomiting, diarrhea, pain in

the abdomen, bloating, constipation,

indigestion

Skin rash

Headache

Other side effects are uncommon.

Dizziness

Fever

Sore throat

Swelling of arms or legs

Change in the colour of the skin

Anxiety

Sleep disorder

Tiredness

Hearing loss

Vision change (early cataracts)

Ulcer and/or bleeding in the

stomach or intestine

Liver disorders

Traces of blood and/or protein in

the urine

Hair loss

You will have some blood tests while

taking Jedoxred. Your doctor will

look for any changes in kidney

function, liver function, or in blood

cell counts. Your doctor may also

want to test your eyesight and hearing

while you are taking Jedoxred. You

may notice other side effects not

listed in this leaflet. If you are

concerned with any side effect, or if

any side effect makes you feel

unwell, please tell you doctor or

pharmacist.

You may report any side effects or

adverse drug reactions directly to the

National Centre for Adverse Drug

Reaction Monitoring by visiting the

website npra.gov.my [Consumers

Reporting Side Effects to Medicines

(ConSERF) or Vaccines (AEFI)]

Storage and Disposal of Jedoxred

- Storage

Keep out of the reach and sight of

children. Store below 30°C.

- Disposal

Medicines should not be disposed of

via wastewater or household waste.

Ask your pharmacist how to dispose

of medicines no longer required.

These measures will help to protect

the environment.

Product Description

- What it looks like

Jedoxred 125: White to off-white,

round, flat, uncoated size 10mm

tablets, with debossing ‘D’ on one

side and ‘125’ on other side.

Jedoxred 250: White to off-white,

round, flat, uncoated size 12mm

tablets, with debossing ‘D’ on one

side and ‘250’ on other side.

Jedoxred 500: White to off-white,

round, flat, uncoated size 16mm

tablets, with debossing ‘D’ on one

side and ‘500’ on other side.

- Ingredients

- Active ingredient: Deferasirox

- Inactive ingredients: Cellulose

Microcrystalline, Crospovidone,

Sodium Lauryl Sulphate, Povidone

K30, Microcrystalline Cellulose,

Lactose monohydrate,

Croscarmellose sodium, Colloidal

silicon dioxide, Magnesium stearate

- MAL number:

Jedoxred 125: xxxxx

Jedoxred 250: xxxxx

Jedoxred 500: xxxxxxx

Manufacturer

MSN Laboratories Private Limited

Formulation Division, Unit-II,

Sy.No. 1277 & 1319 to1324,

Nandigama (Village & Mandal)

Rangareddy District-509228,

Telangana, India.

Consumer Medication Information Leaflet (RiMUP)

JEDOXRED 125 (Deferasirox Dispersible Tablets 125mg)

JEDOXRED 250 (Deferasirox Dispersible Tablets 250mg)

JEDOXRED 500 (Deferasirox Dispersible Tablets 500mg)

Deferasirox Dispersible Tablets 125mg, 250mg, 500mg

Product Registration Holder

Dr. Reddy's Laboratories Malaysia

Sdn. Bhd.

Unit 10-06, Level 10, Menara

MBMR, No. 1, Jalan Syed Putra,

58000 Kuala Lumpur, Malaysia

Date of revision

28/02/2020

Serial Number

NPRA (R2) 20/001

Similar products

Search alerts related to this product

View documents history

Share this information