Details for: PMS-TESTOSTERONE
Company: PHARMASCIENCE INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02322498 | PMS-TESTOSTERONE | TESTOSTERONE UNDECANOATE | 40 MG | CAPSULE | ORAL |
Summary Reports
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
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.
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:
- Visiting the Web page on Adverse Reaction
Reporting https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.htmlfor
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
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