Cipla Deferasirox
| Consumer Medicine Information (CMI) summary |
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
| 1. Why am I using Cipla Deferasirox? |
Cipla Deferasirox contains the active ingredient deferasirox. Cipla Deferasirox is used to treat a condition called iron overload and also used to treat patients who have iron overload associated with their thalassemia syndromes.
For more information, see Section 1. Why am I using Cipla Deferasirox? in the full CMI.
| 2. What should I know before I use Cipla Deferasirox? |
Do not use if you have ever had an allergic reaction to deferasirox or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Cipla Deferasirox? in the full CMI.
| 3. What if I am taking other medicines? |
Some medicines may interfere with Cipla Deferasirox and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
| 4. How do I use Cipla Deferasirox? |
- The dose depends on your body weight. Your doctor will calculate the dose you need and tell you how many tablets you need to take each day. Take the tablets once a day with either empty stomach or with a light meal.
- Follow all directions given to you by your doctor or pharmacist carefully.
More instructions can be found in Section 4. How do I use Cipla Deferasirox? in the full CMI.
| 5. What should I know while using Cipla Deferasirox? |
| Things you should do |
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| Things you should not do |
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| Driving or using machines |
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| Looking after your medicine |
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For more information, see Section 5. What should I know while using Cipla Deferasirox? in the full CMI.
| 6. Are there any side effects? |
Go to your nearest hospital if you experience: signs of allergic reaction, signs of severe skin reaction, sign of kidney problem or liver problems, ulcers, signs of gallstones, pancreatitis, blurred, cloudy or partial loss of vision, hearing disturbances.
You may experience common side effects such as headache, diarrhoea, constipation or indigestion, vomiting, nausea, pain in the abdomen, bloating, rash, itching, tiredness, swelling of arms or legs, sore muscles or joints and dizziness.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
Cipla Deferasirox
Active ingredients: Deferasirox (de FER a sir ox)
| Consumer Medicine Information (CMI) |
This leaflet provides important information about using Cipla Deferasirox. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Cipla Deferasirox.
Where to find information in this leaflet:
1. Why am I using Cipla Deferasirox?
2. What should I know before I use Cipla Deferasirox?
3. What if I am taking other medicines?
4. How do I use Cipla Deferasirox?
5. What should I know while using Cipla Deferasirox?
6. Are there any side effects?
7. Product details
| 1. Why am I using Cipla Deferasirox? |
Cipla Deferasirox contains an active substance called deferasirox. It is an iron chelator which is a medicine used to remove the excess iron from the body (also called iron overload). It traps to removes excess iron which is then excreted mainly in the stools.
Deferasirox attaches itself to the iron molecules to remove the excess iron from the body. This will help prevent iron-induced organ damage.
Cipla Deferasirox is used to treat a condition called iron overload, which happens when the body has too much iron. This can occur after repeated blood transfusions.
Cipla Deferasirox is also used to treat patients who have iron overload associated with their thalassemia syndromes, but who are not transfusion dependent. In patients with non-transfusion-dependent thalassemia syndromes, iron overload may develop over time due to increased absorption of dietary iron in response to low blood cell counts.
Over time, this excess iron can damage important organs such as the liver and heart.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
| 2. What should I know before I use Cipla Deferasirox? |
Warnings
Together with your doctor, you need to decide whether Cipla Deferasirox is right for you.
Do not use Cipla Deferasirox if:
- you have an allergy to deferasirox, the active ingredient, or to any of the other ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
If you develop a severe rash, or experience difficulty breathing and dizziness or swelling mainly of the face and throat (signs of severe allergic reaction) STOP taking Cipla Deferasirox immediately and tell your doctor straight away.
- you have severe kidney problems.
- you have low level of platelets or white blood cell counts.
- you have an advanced stage of myelodysplastic syndrome (MDS) or advanced cancer.
Check with your doctor if you:
- have allergies to any other medicines, foods, preservatives or dyes.
- have a low level of platelets or white blood cells in your blood test.
- have or have had any problems with your kidneys or liver.
Your doctor may want to take special precautions in this case.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Talk to your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
Cipla Deferasirox contains Lactose monohydrate
This medicine also contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), talk to your doctor before taking this medicine.
| 3. What if I am taking other medicines? |
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Cipla Deferasirox may interfere with each other. These include:
- ciclosporin, used in transplantation to prevent organ rejection or to treat rheumatoid arthritis or atopic dermatitis
- midazolam (a medicine used to sedate)
- simvastatin (medicines used to lower cholesterol)
- hormonal contraceptive agents (birth control medicines). Their effectiveness may be reduced while taking Cipla Deferasirox. Use additional contraception.
- certain painkillers or anti-inflammatory medicines (e.g. aspirin, ibuprofen, corticosteroids)
- oral bisphosphonates (medicines used to treat osteoporosis)
- anticoagulant medicines (medicines used to prevent or treat blood clotting)
- antacid preparations containing aluminium, which should not be taken at the same time of day as Cipla Deferasirox
- a medicine for type 2 diabetes called repaglinide
- certain medicines for epilepsy or sedation (phenytoin, phenobarbitone)
- a medicine for HIV called ritonavir
- a medicine for tuberculosis called rifampicin
- a medicine for cancer called paclitaxel
- a medicine used to remove bile acids called cholestyramine
- theophylline (used to treat respiratory diseases such as asthma).
- busulfan (used as treatment prior to bone marrow transplant)
Other medicines that are processed like theophylline in the body and your doctor should know about include: clozapine, cyclobenzaprine, imipramine, haloperidol, fluvoxamine, mexiletine, naproxen, olanzapine, riluzole, tacrine, tizanidine, zileuton and zolmitriptan.
Your doctor may need to test the level of some of these medicines in your blood. Your doctor will take these tests into consideration when deciding on the most suitable dose of these medicines for you.
You may need to take different medicines. Your doctor and pharmacist have more information.
If you have not told your doctor about any of these things, tell him/her before you start taking this medicine.
| 4. How do I use Cipla Deferasirox? |
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
Cipla Deferasirox is a different formulation of deferasirox dispersible tablet with the same active ingredient, deferasirox; however, the dose will change when switching between deferasirox dispersible tablet and Cipla Deferasirox.
How much to take Cipla Deferasirox
Cipla Deferasirox is to be taken every day.
This type of medicine must be taken every day to help remove the excess iron from your body.
The dose of Cipla Deferasirox is related to body weight for all patients. Your doctor will calculate the dose you need and tell you how many tablets to take each day.
The usual starting dose is 14 mg per kilogram body weight each day for patients receiving regular blood transfusions.
For patients NOT receiving regular blood transfusions, the usual starting dose is 7 mg per kilogram body weight.
A higher or lower starting dose may be recommended by your doctor based on your individual treatment needs.
Depending on your response, your doctor may increase the dose to a maximum 28 mg per kilogram body weight each day if you receive regular blood transfusions or 14 mg per kilogram body weight if you are NOT receiving regular blood transfusions.
How to take Cipla Deferasirox
- Take Cipla Deferasirox once a day, every day, at about the same time each day with some water.
- Take the tablets either on an empty stomach or with a light meal.
- The film-coated tablets should not be taken with a high fat meal.
- If you cannot swallow the tablets whole, you can crush them. Then sprinkle all of it onto soft food like yogurt or apple sauce (apple puree). You should then eat it all immediately. Do not keep any to have later.
Taking Cipla Deferasirox at the same time each day will help you remember when to take your tablets.
How long to take Cipla Deferasirox
Do not stop taking Cipla Deferasirox unless your doctor tells you to - even if you feel well.
This medicine helps to control your condition, but does not cure it. Therefore, you must take it every day. Continue taking the medicine as long as your doctor tells you to.
This medicine is not addictive.
If you forget to take Cipla Deferasirox
If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you use too much Cipla Deferasirox
If you think that you have used too much Cipla Deferasirox, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), or - contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you have taken too much Cipla Deferasirox, you may experience effects such as abdominal pain, nausea, vomiting, headache, diarrhoea and kidney or liver problems that can be serious.
| 5. What should I know while using Cipla Deferasirox? |
Things you should do
If you notice substantially reduced urine output, tell your doctor straight away.
This could be a sign of a problem with your kidneys.
Elderly patients should be monitored closely by their doctor.
Elderly patients may experience more side effects than younger patients and their doctor may adjust their dose.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor will do regular tests (blood, urine or Magnetic Resonance Imaging (MRI)) to make sure the medicine is working and to prevent unwanted side effects. Your doctor will also use these tests to decide when you should stop taking Cipla Deferasirox.
Your eyesight and hearing may be tested during treatment as a precautionary measure.
If you become pregnant while taking this medicine, tell your doctor immediately.
It may affect your developing baby. Your doctor will discuss the risks and benefits of continuing treatment in this case.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
Things you should not do
Do not give this medicine to anyone else, even if their condition seems similar to yours.
Do not use it to treat any other complaints unless your doctor tells you to.
Driving or using machines
Be careful driving, operating machinery or doing jobs that require you to be alert until you know how Cipla Deferasirox affects you.
This medicine may cause dizziness in some people. If you experience dizziness, do not drive, operate machinery or do anything else that could be dangerous. Children should be careful when riding bicycles or climbing trees.
Looking after your medicine
- Keep the medicine where children cannot reach it.
- Keep your medicine in the original container until it is time to take it.
- Store it in a cool, dry place, below 25°C.
- A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Follow the instruction in the carton on how to take care of your medicine properly.
Do not store it:
- in the bathroom or near a sink, or
- in the car or on window sills.
When to discard your medicine
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine you have left over.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not take Cipla Deferasirox after the expiry or “use by” date (EXP) printed in the blister pack or if the packaging is torn or shows signs of tampering.
| 6. Are there any side effects? |
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Cipla Deferasirox even if you do not think it is connected with the medicine.
Elderly patients may experience more side effects than younger patients.
Do not be alarmed by the following lists of side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.
STOP taking Cipla Deferasirox and seek medical help immediately if you or your child experience any of the following symptoms which may be signs of an allergic reaction:
- difficulty in breathing and swallowing
- swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised bumps
Less serious side effects
Tell your doctor or pharmacist if you notice any of the following and they worry you:
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
STOP taking Cipla Deferasirox and tell your doctor immediately if you notice any of the following:
| Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Some people may have other side effects not yet known or mentioned in this leaflet. Some of these side effects, for example, changes in kidney and liver function, can only be found when your doctor does tests from time to time to check your progress.
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
| 7. Product details |
This medicine is only available with a doctor's prescription.
What Cipla Deferasirox contains
| Active ingredient (main ingredient) |
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| Other ingredients (inactive ingredients) |
Tablet-coating:
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| Potential allergens | lactose monohydrate |
Do not take this medicine if you are allergic to any of these ingredients.
What Cipla Deferasirox looks like
Cipla Deferasirox 90 mg film-coated tablets: Light pink oval biconvex film-coated tablet, debossed with ‘C391’ on one side and plain on the other.
Cipla Deferasirox 180 mg film-coated tablets: Light pink oval biconvex film-coated tablet, debossed with ‘C392’ on one side and plain on the other.
Cipla Deferasirox 360 mg film-coated tablets: Light pink oval biconvex film-coated tablet, debossed with ‘C393’ on one side and plain on the other.
Cipla Deferasirox comes in packs of 30 film-coated tablets in blister packs.
Australian Registration Number
CIPLA DEFERASIROX deferasirox 90 mg tablet blister pack (AUST R 338094)
CIPLA DEFERASIROX deferasirox 180 mg tablet blister pack (AUST R 338095)
CIPLA DEFERASIROX deferasirox 360 mg tablet blister pack (AUST R 338142)
Who distributes Cipla Deferasirox
Cipla Australia Pty Ltd
Level 1, 132-136 Albert Road,
South Melbourne, VIC 3205.
drugsafety@Cipla.com
Toll Free number: 1800 569 074
This leaflet was prepared in April 2021.
Published by MIMS August 2021