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DEFERIPRONE tablet


  1. What Is The Most Important Information I Should Know About Deferiprone Tablets?
  2. Stop Taking Deferiprone Tablets And Get Medical Help Right Away If You Develop Any Of These Symptoms Of Infection:
  3. It Is Not Known If Deferiprone Tablets Are Safe And Effective:
  4. Who Should Not Take Deferiprone Tablets?
  5. Before You Take Deferiprone Tablets, Tell Your Healthcare Provider If You:
  6. Especially Tell Your Healthcare Provider If You Take:
  7. How Should I Take Deferiprone Tablets?
  8. Deferiprone Can Cause Serious Side Effects, Including:
  9. Active Ingredients:
  10. Inactive Ingredients:
  11. Patient Information

What Is The Most Important Information I Should Know About Deferiprone Tablets? 

Deferiprone can cause serious side effects, including a very low white blood cell count in your blood. One type of white blood cell that is important for fighting infections is called a neutrophil. If your neutrophil count is low (neutropenia), you may be at risk of developing a serious infection that can lead to death. Neutropenia is common with deferiprone and can become severe in some people. Severe neutropenia is known as agranulocytosis. If you develop agranulocytosis, you will be at risk of developing serious infections that can lead to death.

Your healthcare provider should do a blood test before you start deferiprone and weekly during treatment to check your neutrophil count. If you develop neutropenia, your healthcare provider should check your blood counts every day until your white blood cell count improves.

Stop Taking Deferiprone Tablets And Get Medical Help Right Away If You Develop Any Of These Symptoms Of Infection: 

  • fever
  • sore throat or mouth sores
  • flu-like symptoms
  • chills and severe shaking

Deferiprone tablets are a prescription medicine used to treat people with thalassemia syndromes who have iron overload from blood transfusions, when current iron removal (chelation) therapy does not work well enough.

It Is Not Known If Deferiprone Tablets Are Safe And Effective: 

  • to treat iron overload due to blood transfusions in people with any other type of anemia that is long lasting (chronic)
  • in children
  • in people with severe liver problems

Who Should Not Take Deferiprone Tablets? 

Do not take deferiprone tablets if you are allergic to deferiprone or any of the ingredients in deferiprone tablets.

Before You Take Deferiprone Tablets, Tell Your Healthcare Provider If You: 

  • have liver problems
  • have any other medical conditions.
  • are pregnant or plan to become pregnant. Deferiprone can harm your unborn baby. You should avoid becoming pregnant while taking deferiprone. Tell your healthcare provider right away if you become pregnant or plan to become pregnant while taking deferiprone.
  • are breastfeeding or plan to breastfeed. It is not known if deferiprone passes into your breast milk. You and your healthcare provider should decide if you will take deferiprone or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins and herbal supplements.

Especially Tell Your Healthcare Provider If You Take: 

  • other medicines that can cause a lowering of your neutrophil count
  • antacids or mineral supplements that contain: iron, aluminum, and zinc.Allow at least 4 hours between taking deferiprone tablets and any of these products.

Ask your healthcare provider or pharmacist if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How Should I Take Deferiprone Tablets? 

  • Take deferiprone tablets exactly as prescribed by your healthcare provider. Do not change your dose of deferiprone unless your healthcare provider tells you to.
  • Your healthcare provider will tell you how many deferiprone tablets to take.
  • Deferiprone tablets are taken 3 times each day. Take your first dose in the morning, the second dose at mid-day, and third dose in the evening.
  • You can take deferiprone tablets with or without food.
  • Taking deferiprone with meals may help reduce nausea.
  • If you take too much deferiprone, call your healthcare provider.
  • If you do miss a dose take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and then continue with your regular schedule. Do not try to catch-up or take 2 doses at the same time to make up for a missed dose.

Deferiprone Can Cause Serious Side Effects, Including: 

  • Store deferiprone tablets at 20 C to 25 C (68 F to 77 F) [

Active Ingredients: 

deferiprone

Inactive Ingredients: 

colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel, 2624761

Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, 10532
Issued: October 2015
20872-1015-0

Patient Information 

SeeFDA-Approved Patient Labeling (Medication Guide)

  • Inform patients of the risks of developing agranulocytosis and instruct them to immediately interrupt therapy and report to their physician if they experience any symptoms of infection such as fever, sore throat or flu-like symptoms.
  • Advise patients that the amount of deferiprone prescribed is based on body weight and on the therapeutic goal (reduction or stabilization of the body iron load).
  • Advise patients to take the first dose of deferiprone in the morning, the second dose at midday, and the third dose in the evening. Clinical experience suggests that taking deferiprone with meals may reduce nausea. If a dose of this medicine has been missed, take as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not catch-up or double doses.
  • Advise patients to contact their physician in the event of overdose.
  • Inform patients that their urine might show a reddish/brown discoloration due to the excretion of the iron-deferiprone complex. This is a very common sign of the desired effect of deferiprone, and it is not harmful.
  • Counsel women of reproductive potential to avoid pregnancy while taking deferiprone. Advise patients to immediately notify their physician if they become pregnant, or if they plan to become pregnant during therapy.
  • Inform patients that they should not breast feed while taking deferiprone.

Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel, 2624761

Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, 10532
Issued: October 2015
20872-1015-0



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