August 1, 2014
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Temodal

(temozolomide)

DIN (Drug Identification Number)

02241095 TEMODAL 100MG CAPSULE
02241094 TEMODAL 20MG CAPSULE
02241096 TEMODAL 250MG CAPSULE
02241093 TEMODAL 5MG CAPSULE
02312794 TEMODAL 140MG CAPSULE
02321262 TEMODAL 100MG/VIAL POWDER FOR SOLUTION

What side effects are possible with Temodal?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • blurred vision
  • bruising or bleeding
  • changes in taste perception
  • constipation
  • diarrhea
  • dizziness
  • drowsiness
  • fever and other signs of infection (such as chills or cough)
  • hair loss
  • headache
  • lack of energy
  • loss of appetite or weight
  • nausea and vomiting
  • rash
  • tiredness
  • weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • burning, prickling, or tingling sensations in the hands or feet
  • confusion or memory problems
  • rash with skin swelling, including on the palms of the hands and soles of the feet (if you are not having difficulty breathing)
  • signs of infection (fever, chills, cough, sore throat)
  • pain, bruising, irritation, itching, warmth, swelling, or redness at the injection site
  • pneumonia (symptoms such as cough that does not go away, or trouble breathing and fever)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • seizures
  • signs of an allergic reaction (such as difficulty breathing, hives, or swelling of the face or throat)
  • signs of bleeding (such as easy bruising, bleeding gums, nosebleeds, vomiting blood, blood in the urine, dark tarry stools)
  • swelling of the hands or feet with shortness of breath

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Temodal?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

May 7, 2014

Health Canada has issued new restrictions concerning the use of Temodal (temozolomide). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Birth defects: Temozolomide can have genotoxic effects, meaning that it may damage the genetic material contained in sperm. This could lead to birth defects. If you are a man being treated with temozolomide, you should not father a child during treatment and for up to 6 months after treatment.

Blood disorders: This medication can cause the levels of certain blood cells to drop. This may lead to problems with blood clotting, the immune system, or the transport of oxygen through the body. Contact your doctor immediately if you develop a fever, chills, easy bruising, paleness, or bleeding (symptoms may include black and tarry stools, blood in the urine, or cuts that won't stop bleeding) while taking this medication. Your doctor will arrange periodic blood testing to monitor various blood components.

Kidney or liver disease: The safety and effectiveness of using this medication have not been established for people with kidney or liver problems. You should be closely monitored by your doctor if you have kidney or liver problems.

Male infertility: Irreversible infertility may result from treatment with temozolomide. Therefore, men who may want to father a child in the future should seek advice on cryoconservation (freezing for long-term storage) of sperm prior to starting treatment.

Pneumocystis carinii pneumonia (PCP): If you are taking temozolomide daily along with radiation, your doctor will prescribe medication to help prevent a serious form of pneumonia called Pneumocystis carinii pneumonia (PCP). People who take temozolomide daily along with radiation may be at a higher risk of developing PCP.

Vomiting: Nausea and vomiting are very common with temozolomide treatment. Antinausea medications taken before or after taking temozolomide may be recommended.

Pregnancy: This medication may harm the baby if used during pregnancy. Women should avoid becoming pregnant while taking this medication. Use effective birth control while using this medication and for 6 months after stopping the medication. Tell your doctor immediately if you become pregnant.

Breast-feeding: It is not known if temozolomide passes into breast milk. It is recommended that women should stop breast-feeding while taking this medication.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: People over the age of 70 are more likely to experience a decrease in white blood cell counts or platelet cells. This can affect their body's ability to fight infection or their blood's ability to clot.

What other drugs could interact with Temodal?

There may be an interaction between temozolomide and any of the following:

  • other cancer medications
  • valproic acid

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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