September 2, 2014
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Androderm

(testosterone patch)

DIN (Drug Identification Number)

02239653 ANDRODERM 12.2MG PATCH
02245972 ANDRODERM 24.3MG PATCH

What side effects are possible with Androderm?

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.

  • acne
  • aggressive behaviour
  • changes in sexual desire or drive
  • difficulty sleeping
  • dizziness
  • enlarged prostate
  • hair loss, thinning hair, or baldness
  • headache
  • mood changes
  • skin irritation where applied
  • weight gain

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

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

  • breast soreness or enlargement
  • depression
  • high blood pressure
  • problems with urination (change in frequency or colour, dribbling, pain or straining when urinating, weak urine stream, small urine amounts)
  • prolonged (more than 4 hours) or painful erections, or erections that happen too often
  • swelling of ankles and legs (for people with heart, liver, or kidney problems)
  • symptoms of liver problems, such as:
    • abdominal pain
    • dark urine
    • loss of appetite
    • nausea or vomiting
    • pale stools
    • yellow eyes or skin

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

  • symptoms of a serious allergic reaction, such as:
    • difficulty breathing
    • hives
    • rash
    • swollen face or throat

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 Androderm?

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

July 15, 2014

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

Blood tests: Your doctor may recommend that you have regular blood tests while using this medication to check whether the medication is working and whether you are having certain side effects. Also, the use of testosterone may interfere with a number of laboratory tests. Tell all health professionals administering these tests that you are using this medication.

Diabetes: This medication may affect blood sugar levels. If you have diabetes, monitor your blood sugar carefully while using this medication.

Heart disease: If you have heart disease, your doctor should monitor your condition closely while you are using this medication. Report any swelling in the feet and lower legs to a doctor immediately.

Kidney or liver disease: If you have kidney or liver disease, your doctor should monitor your condition closely while you are using this medication. Report any swelling in the feet and lower legs to a doctor immediately.

Skin irritation: If you continue to experience skin irritation, your doctor may recommend that you apply a corticosteroid cream to the skin under the patch. Ointments are not recommended, as they may reduce testosterone absorption by the body. Talk to your doctor to determine a treatment that is best for you.

Sleep disorders: Treatment with testosterone may cause sleep apnea (interruption of breathing during sleep) and high blood pressure for some people, especially those with risk factors such as being overweight or having a chronic lung disease.

Sperm counts: This medication may reduce sperm counts if high doses are used, or if it is used for a prolonged period.

Pregnancy and breast-feeding: This medication should not be used by women, especially pregnant or breast-feeding women. It may have unwanted effects on the developing child, including masculinization of female children.

Seniors: Seniors may have an increased risk for prostate enlargement and should be evaluated for prostate cancer before starting testosterone replacement therapy.

What other drugs could interact with Androderm?

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

  • adrenocorticotropic hormone (ACTH)
  • corticosteroids (e.g., prednisone, dexamethasone)
  • cyclosporine
  • medications used to treat diabetes (e.g., insulin)
  • propranolol
  • warfarin

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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