Deferiprone 500mg Capsules Taj Pharma-SmPC

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Deferiprone Capsules 500mg

this medicine should use effective birth control to prevent pregnancy.

Taj Pharma



If you are a woman, you may need to have

1. WHAT IS DEFERIPRONE

a negative pregnancy test before starting this

Deferiprone binds to iron and removes it from

treatment. Use effective birth control to

the bloodstream.

prevent pregnancy while you are using this

Deferiprone is used to treat iron overload caused

medicine and for at least 6 months after your

by blood transfusions in people with certain

last dose.

hereditary

red

blood

cell

disorders



If you are a man, use effective birth control

(thalassemia syndrome).

if your sex partner is able to get pregnant.

Deferiprone may also be used for purposes not

Keep using birth control for at least 3

listed in this medication guide.

months after your last dose.

Important Information



Tell your doctor right away if a pregnancy

Both men and women using deferiprone

occurs while either the mother or the father

should use effective birth control to prevent

is using deferiprone.

pregnancy. Women should keep using birth

You should not breastfeed while using this

control for at least 6 months after the last dose.

medicine, and for at least 2 weeks after your last

Men should keep using birth control for at least

dose.

3 months after the last dose.

Deferiprone is not approved for use by anyone

Stop using this medicine and call your doctor

younger than 18 years old.

right away if you have signs of infection such

3. HOW SHOULD I TAKE

as: fever, chills, body aches, flu symptoms, skin

DEFERIPRONE

sores, or sores in your mouth and throat.

Follow all directions on your prescription label

2. BEFORE TAKING THIS

and read all medication guides or instruction

MEDICINE

sheets. Your doctor may occasionally change

You should not use deferiprone if you are

your dose. Use the medicine exactly as directed.

allergic to it.

Deferiprone is usually taken 3 times per day.

Tell your doctor if you have ever had:

Take the first daily dose each morning, the



liver disease; or

second dose at mid-day, and the third dose in the



a weak immune system.

evening.

It is not known whether this medicine will harm

Measure

liquid

medicine

(oral

solution)

an unborn baby. Both men and women using

carefully. Use only the dose-measuring cup

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provided with the oral solution. Drink all of the

breathing; swelling of your face, lips, tongue, or

medicine in the measuring cup. Then add about

throat.

1 tablespoon of water to the cup, swirl gently

Serious and sometimes fatal infections may

and drink. Hand-wash the measuring cup after

occur during treatment with deferiprone. Stop

each use.

using deferiprone and call your doctor right

Take with food if deferiprone upsets your

away if you have signs of infection such as:

stomach.



fever, chills, body aches;

You will need frequent medical tests, and your



flu symptoms;

next dose may be delayed based on the results.



skin sores; or

Deferiprone doses are based on weight. Your



sores in your mouth and throat.

dose needs may change if you gain or lose

Further doses may be delayed until your

weight.

infection clears up.

Store

deferiprone tablets or liquid in

the

Deferiprone may cause your urine to turn a

original container at room temperature. Protect

reddish-brown color. This side effect is usually

from moisture, heat, and light. Keep the bottle

not harmful. Call your doctor if you also have

tightly closed when not in use.

upper

Throw away any liquid medicine not used within

or jaundice (yellowing of your skin or the

35 days after you first opened the bottle.

whites of your eyes).

What happens if I miss a dose?

Common side effects may include:

Take the medicine as soon as you can, but skip



nausea, vomiting, stomach pain;

the missed dose if it is almost time for your next



infections;

dose. Do not take two doses at one time.



joint pain; or

What happens if I overdose?



abnormal liver function tests.

What should I avoid while taking

Deferiprone dosing information

deferiprone?

Usual Adult Dose for Thalassemia:

Do not use other iron chelating medicines such

Initial dose: 25 mg/kg, orally, 3 times a day

as deferasirox (Exjade)

(total daily dose: 75 mg/kg)

or

deferoxamine

stomach

pain,

clay-colored

stools,

(Desferal), unless your doctor has told you to.

Maximum dose: 33 mg/kg, orally, 3 times a day

4. DEFERIPRONE SIDE

(total daily dose: 99 mg/kg) Comments:

EFFECTS

-Round dose to the nearest 250 mg (half tablet).

Get emergency medical help if you have signs of

an

allergic

reaction: hives;

difficult

-Tailor dose to patient response and therapeutic

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goals (maintenance or reduction of iron burden).

If you take any of the following medicines, take

-Approval based on reduction in serum ferritin;

your deferiprone dose 4 hours before or 4 hours

there are no trials showing a direct treatment

after you take the other medicine:

benefit (e.g. improved symptoms, functioning,



an antiacid that contains aluminum;

or survival).



a medicine or supplement that contains iron

-Safety and efficacy have not been established

(including ferric

for transfusional iron overload with other

citrate, Feosol, Fergon, Ferrocite,

chronic anemias.

Hemocyte, and others; or

Use: Treatment of transfusional iron overload due to thalassemia syndromes when current



vitamin or mineral supplements that contain iron or zinc.

chelation therapy is inadequate.

Avoid

taking

an

Initial dose: 25 mg/kg, orally, 3 times a day

containing milk thistle.

(total daily dose: 75 mg/kg)

Other drugs may affect deferiprone, including

Maximum dose: 33 mg/kg, orally, 3 times a day

prescription

(total daily dose: 99 mg/kg)

medicines, vitamins, and herbal products. Tell

Comments:

your doctor about all your current medicines and

-Round dose to the nearest 250 mg (half tablet).

any medicine you start or stop using.

-Tailor dose to patient response and therapeutic

Drug Interaction Classification

goals (maintenance or reduction of iron burden).

These classifications are only a guideline. The

-Approval based on reduction in serum ferritin;

relevance of a particular drug interaction to a

there are no trials showing a direct treatment

specific individual is difficult to determine.

benefit (e.g. improved symptoms, functioning,

Always consult your healthcare provider before

or survival).

starting or stopping any medication.

-Safety and efficacy have not been established

Major

and

herbal

supplement

over-the-counter

Highly clinically significant. Avoid

for transfusional iron overload with other

combinations; the risk of the

chronic anemias.

interaction outweighs the benefit.

Use: Treatment of transfusional iron overload

Moderate Moderately clinically significant.

due to thalassemia syndromes when current

Usually avoid combinations; use it

chelation therapy is inadequate.

only under special circumstances.

What other drugs will affect deferiprone?

Minor

Minimally clinically significant.

Minimize risk; assess risk and consider an alternative drug, take

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steps to circumvent the interaction

Time to Peak

risk and/or institute a monitoring plan.

1-2 hours

Unknown No interaction information available.

Half-Life Elimination 2 hours

Deferiprone alcohol/food interactions There is 1 alcohol/food interaction with

6. FURTHER INFORMATION

deferiprone

Remember, keep this and all other medicines out

Deferiprone disease interactions

of the reach of children, never share your

There are 2 disease interactions with

medicines with others, and use this medication

deferiprone which include:

only for the indication prescribed.



agranulocytosis/neutropenia

Always consult your healthcare provider to



hepatic impairment

ensure the information displayed on this page

5. PHARMACOLOGICAL PROPERTIES: Iron-chelating agent with affinity for ferric ion (iron III); binds to ferric ion and forms a 3:1 (deferiprone:iron) complex which is excreted in the urine. Has a lower affinity for other metals such as copper, aluminum, and zinc.

5.1 Pharmacokinetics Properties: Absorption Rapid Distribution 1.6 L/kg (in thalassemia patients) Metabolism Primarily by UGT 1A6; major metabolite (3-Oglucuronide) lacks iron-binding capacity Excretion Urine (75% to 90%; primarily as metabolite)

applies to your personal circumstances.

7. Manufactured in India by: TAJ PHARMACEUTICALS LTD. Mumbai, India Unit No. 214.Old Bake House, Maharashtra chambers of Commerce Lane, Fort, Mumbai - 400001 at:Gujarat, INDIA. Customer Service and Product Inquiries: 1-800-TRY-FIRST (1-800-222-434 & 1-800222-825) Monday through Saturday 9:00 a.m. to 7:00 p.m.

EST E-mail: tajgroup@tajpharma.com