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Details for: PMS-TESTOSTERONE

Company: PHARMASCIENCE INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02322498PMS-TESTOSTERONETESTOSTERONE UNDECANOATE40 MGCAPSULEORAL
Search Reported Side Effects Report a Side Effect

Summary Reports

Summary Safety Review - Testosterone Replacement Products - Cardiovascular Risk

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

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

pms-TESTOSTERONE 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 non-medicinal ingredients are” in this section).
  • pms-TESTOSTERONE 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 non-medicinal ingredients are

Caprylic-capric Acid Tryglicerides.

Capsule shell: 2-ethoxyethanol, Ammonium Hydroxide, D&C Yellow #6, Glycerin, Lecithin, Pork Gelatin, Shellac Glaze, Simethicone, Sodium Methylparaben, Sodium Propylparaben Nipasol, Sorbitol Special Polyol and Titanium Dioxide.

What dosage form it comes in

Capsules: 40 mg of testosterone undecanoate.

Warnings and precautions

Serious Warnings and Precautions

The safety and efficacy have not been established for use of pms-TESTOSTERONE 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 pms-TESTOSTERONE.

Before using pms-TESTOSTERONE, 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 (pms-TESTOSTERONE 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.

Drug abuse and dependence:

pms-TESTOSTERONE 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 sideeffects.

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 pms-TESTOSTERONE 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 pms-TESTOSTERONE you may become dependent on it and you may get withdrawal symptoms when you take less or stop taking it suddenly. Do not abuse pms-TESTOSTERONE 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 pms-TESTOSTERONE include:

  • Insulin
  • Corticosteroids
  • Propranolol
  • Warfarin
  • Cyclosporine
Proper use of this medication

Never share your pms-TESTOSTERONE with anyone. Your doctor has prescribed pms-TESTOSTERONE 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, pms-TESTOSTERONE 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

If you think you have taken too much pms-TESTOSTERONE, contact your healthcare professional, 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, pms-TESTOSTERONE 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 cells relative to the total blood volume (haematocrit);
  • increased concentration of the red blood cell component that carries oxygen (haemoglobin);
  • 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 Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and seek immediate emergency medical attention
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 redcoloured 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 (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.    

This is not a complete list of side effects. For any unexpected effects while taking pms-TESTOSTERONE, contact your doctor or pharmacist.

How to store

Keep out of the reach and sight of children.

Store between 15°C 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 side effects associated with the use of health products to Health Canada by:

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

This document plus the full product monograph, prepared for health professionals can be obtained by contacting Pharmascience Inc. at 1-888-550-6060.

This leaflet was prepared by:
     Pharmascience Inc.
     Montréal, Québec
     H4P 2T4

www.pharmascience.com

Last revised: January 22, 2018

Date modified: