Patient Medication Information: uses, side effects, how to take - Andriol

ABOUT THIS MEDICATION

What the medication is used for:

Your doctor has prescribed this medicine because your body is not making enough testosterone. The medical term for this condition is hypogonadism. Your doctor will confirm this by blood testosterone measurements and also clinical symptoms such as inability to get or maintain an erection (impotence), infertility, low sex drive, tiredness, depressive moods, or bone loss caused by low hormone levels.

What it does:

Andriol^®is absorbed from the gut and delivers testosterone to your blood stream.

When it should not be used:

If you have or it is suspected that you have prostate or
breast cancer.
If you have difficulty in urinating due to an enlarged
prostate.
Known allergy to any of its components (see “What the
important non-medicinal ingredients are” in this section).
Andriol^®should NOT be used by women. Pregnant and
breast feeding women are especially at risk. Testosterone may cause harm to your unborn baby.

What the medicinal ingredient is:

Testosterone undecanoate

What the important nonmedicinal ingredients are:

Castor oil, propylene glycol monolaurate, gelatin, glycerin and Sunset Yellow (E110, FD&C Yellow no. 6).

What dosage forms it comes in:

Each capsule contains 40 mg of testosterone undecanoate.

WARNINGS AND PRECAUTIONS

The safety and efficacy have not been established for use of Andriol^®in children under 18 years of age and therefore should not be used in this population.

There is very little information from clinical trials with testosterone in the older male (over 65 years of age) to support safe use for a long period of time.

You should not use testosterone in an attempt to reduce weight

and increase muscle, or improve athletic performance as it may cause serious health problems.

You should not use testosterone to treat sexual dysfunction or male infertility.

Your doctor will measure testosterone blood levels before and during your treatment. Based on the blood test results, your doctor may adjust the dose of Andriol^®.

Before using Andriol^®, talk to your doctor or pharmacist if you:

have difficulty urinating due to an enlarged prostate. Older patients may have a higher risk of developing an enlarged prostate or prostate cancer;
have prostate cancer (confirmed or suspected);
have liver, kidney or heart disease;
have high blood pressure (hypertension);
have diabetes (Andriol^®may affect blood sugar levels);
have breathing problems during sleep (sleep apnea);
are on a low salt diet or low sugar diet;
have allergies;
have breast cancer;
are bedridden;
have swelling of face, hands, feet or lower legs
have heart or blood vessel problems or a history of these problems such as heart attacks, stroke, or blood clot in the lungs or legs..

Andriol^®contains Sunset Yellow which may cause allergic reactions.

Drug abuse and dependence

Andriol^®contains testosterone which is a controlled substance under schedule G of the Food and Drugs Act.

Your doctor should check your progress at regular visits in order to make sure this medicine does not cause unwanted side-effects.

Any male adolescent patient receiving androgens for delayed puberty should have bone development checked every six months.

Always take this medicine exactly as your doctor or pharmacist has told you. You can get serious side effects if you take too much of it on its own or with other drugs similar to Andriol^®called anabolic androgenic steroids (AAS). These include heart and blood vessel problems which can lead to death, liver problems and mental health problems. If you abuse Andriol^®you may become dependent on it and you may get withdrawal symptoms when you take less or stop taking it suddenly. Do not abuse Andriol alone or with other drugs called AAS because you can get serious side effects.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist if you are taking or have recently taken any other drugs or herbal products (St. John’s Wort), even those without a prescription.

Drugs that may interact with Andriol^®include:

Insulin
Corticosteroids
Propranolol
Warfarin
Cyclosporine

PROPER USE OF THIS MEDICATION

Never share your Andriol^®with anyone. Your doctor has prescribed Andriol^®specifically for your needs. It is essential that you take it exactly as your doctor has prescribed.

Usual dose:

Usually, the dosage is 3-4 capsules daily during the first 2-3 weeks. Subsequent dosage (1-3 capsules daily) should be based on the clinical effect obtained during the first weeks of therapy.

To ensure adequate absorption, Andriol^®must be taken with a meal. Swallow the capsules whole without chewing, using some water or other fluid.

Take half of the daily dose in the morning and the other half in the evening, if dose consists of more than one capsule. If the daily dose is an uneven number of capsules, take the larger number in the morning.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose, do not double your next dose the next day to catch up. Resume your normal dosing the next day.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, Andriol^®can have side effects. The following side effects have been reported for products containing testosterone:

increased prostatic specific antigen (PSA);
enlarged prostate (benign prostatic hyperplasia);
increase in the number of red blood cells (the cells which
carry the oxygen in your blood);
increase in the percentage of red blood calls relative to the
total blood volume (haematocrit);
increased concentration of the red blood cell component that
carries oxygen (haemogloblin)’
acne;
change in mood, depression;
prolonged or painful erection;
sleep disturbances caused by breathing problems;
aggression or aggressive behaviour;
- breast enlargement and breast pain;
- loss of hair and baldness;
- high blood pressure;
- weight gain;
- headache, dizziness;
- increased or irregular heart rate, blood clot in the lungs or the legs.

	SERIOUS SIDE EFFECTS, HOW OFTEN THEY
	HAPPEN AND WHAT TO DO ABOUT THEM
Symptom/effect			Talk with your doctor or pharmacist		Stop taking drug and call your doctor or pharmacist
			Only if severe	In all cases
Uncommon		Liver problems with symptoms such as nausea or vomiting, vomiting of blood, yellow eyes or skin.			√
		Swelling of feet or lower legs in patients with heart, kidney or liver damage.		√
		Flushing or redness of skin or any changes in skin colour.		√
		Skin rash or itching; hives.	√
		Black, tarry, or light-coloured stools; dark coloured urine.		√
		Purple or red-coloured spots on body or inside the mouth or nose.		√
		Sore throat and/or fever.	√
		Abdominal or stomach pain (continuing); pain, tenderness, or swelling in the upper abdominal or stomach area.	√
		Loss of appetite (continuing); unpleasant breath odour	√

	SERIOUS SIDE EFFECTS, HOW OFTEN THEY
	HAPPEN AND WHAT TO DO ABOUT THEM
Symptom/effect (continuing). Confusion; dizziness, headache (frequent or continuing); mental depression. Feeling of discomfort (continuing). Shortness of breath. Unusual bleeding; unusual tiredness. Erections that are too frequent or continue for too long or too painful; frequent urge to urinate Heart attack and stroke.		Talk with your doctor or pharmacist		Stop taking drug and call your doctor or pharmacist
			√
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This is not a complete list of side effects. For any unexpected effects while taking Andriol^®, contact your doctor or pharmacist.

HOW TO STORE IT

Keep out of the reach and sight of children.

Store between 15 and 30°C. Protect from light and moisture. Do not refrigerate. Keep the blister in the outer carton. Do not keep outdated medicine or medicine no longer needed. Be sure that any

discarded medicine is out of the reach of children.

REPORTING SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to Helath Canada by:

Visiting the Web page on Adverse Reaction Reporting
(http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

Also, you can report any suspected adverse reactions associated with the use of health products to Merck Canada Inc. by one of the following 2 ways:

Call toll-free at 1-800-567-2594
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1--877-428-8675, or
- Mail to: Merck Canada Inc.
  Medical Information Center
  16750 route Transcanadienne Kirkland, QC H9H 4M7

This document plus the full product monograph, prepared for health professionals can be found at: www.merck.ca or by contacting the sponsor, Merck Canada Inc. at: 1-800-567-2594.

Last revised: November 10, 2017

® Registered trademark of N.V. Organon. Used under license.

Rx or OTC	Prescription (Rx)?
DIN	00782327
Schedule(s)	CONTROLLED DRUGS (CDSA IV)
Active ingredient(s)	Testosterone undecanoate 40 MG
Dosage form(s)	Capsule
Route(s) of administration	Oral
Drug class (WHO ATC)	G Genito urinary system and sex hormones G03 Sex hormones and modulators of the genital system G03B Androgens G03BA 3-oxoandrosten (4) derivatives G03BA03 Testosterone
Company	MERCK CANADA INC
Current status	Cancelled Post Market
Current status date	January 29, 2018

Andriol: Uses, Side Effects and Dosage