Details for: APO-TAMSULOSIN CR
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02362406 | APO-TAMSULOSIN CR | TAMSULOSIN HYDROCHLORIDE | 0.4 MG | TABLET (EXTENDED-RELEASE) | ORAL |
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 APO-TAMSULOSIN CR because you have lower urinary tract symptoms (LUTS) associated with a medical condition called benign prostatic hyperplasia or BPH.
What it does
APO-TAMSULOSIN CR acts by relaxing muscles in the prostate and bladder neck at the site of obstruction, resulting in improved urine flow, and reduced BPH symptoms.
BPH is an enlargement of the prostate gland. BPH is the most common cause of lower urinary tract symptoms (LUTS) in elderly males. After age 50, most men develop enlarged prostates. The prostate is located below the bladder. As the prostate enlarges, it may slowly restrict the flow of urine. This can lead to symptoms such as:
- frequent sleep interruption caused by a need to urinate;
- having a weak urinary stream;
- a sensation of not emptying your bladder completely after you finish urinating;
- pushing or straining to begin urination;
- stopping and starting again several times when urinating;
- urinating again less than 2 hours after you finish urinating;
- finding it difficult to postpone urination.
When it should not be used
- You should not use APO-TAMSULOSIN CR if you are allergic (hypersensitive) to tamsulosin or any of the other ingredients in APO-TAMSULOSIN CR. Hypersensitivity may present as sudden local swelling of the soft tissues of the body (e.g. the throat or tongue), difficult breathing and/or itching and rash (angioedema).;
- You should not use APO-TAMSULOSIN CR if you are taking ketoconazole (an antifungal used to treat fungal skin infections)
What the medicinal ingredient is
Tamsulosin Hydrochloride
What the non-medicinal ingredients are
citric acid, colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose 2208 and 2910, magnesium stearate, polyethylene glycol, sodium alginate and yellow ferric oxide.
What dosage form it comes in
Controlled-release Tablets. Each yellowish-brown, round, biconvex film-coated tablet, engraved “TA” over “0.4” on one side, and plain on the other side, contains 0.4 mg tamsulosin hydrochloride.
Warnings and precautions
Rarely, fainting can occur during the use of APO-TAMSULOSIN CR, as with other medicinal products of this type. At the first signs of dizziness or weakness you should sit or lie down until they have disappeared.
APO-TAMSULOSIN CR should not be used in women or children.
BEFORE you use APO-TAMSULOSIN CR talk to your doctor or pharmacist:
- if you suffer from severe liver problems;
- if you suffer from fainting due to reduced blood pressure when changing posture (going to sit or stand up);
- if you are allergic to sulfa drugs;
- if you have kidney problems;
- if you have previously taken tamsulosin hydrochloride and became unwell;
- if you are going to have eye surgery for cataract (cloudiness of the lens of the eye) and/or glaucoma (high pressure inside the eye), ask your doctor if you need to temporarily stop taking this medicine before your surgery. A condition known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in association with tamsulosin hydrochloride during cataract and glaucoma surgery.
APO-TAMSULOSIN CR may cause dizziness. Do not drive or operate machinery or perform a hazardous task for 12 hours after taking the initial dose of APO-TAMSULOSIN CR, or until you know how the medication affects you.
You must see your doctor regularly. While taking APO-TAMSULOSIN CR, you must have regular checkups. Follow your doctor’s advice about when to have these checkups.
Interactions with this medication
Taking APO-TAMSULOSIN CR with other medicines from the same class (alpha1- adrenoceptor blockers) may cause an unwanted decrease in blood pressure.
Please tell your doctor or pharmacist if you are taking or have recently taken cimetidine, ketoconazole, warfarin or any other medicines, including medicines obtained without a prescription.
Proper use of this medication
Usual dose
Follow your doctor’s advice about how to take APO-TAMSULOSIN CR. You should take one tablet (0.4 mg) once daily at the same time each day with or without food.
Do not crush or chew APO-TAMSULOSIN CR tablets. These tablets are specially formulated to control the delivery of tamsulosin hydrochloride to the blood stream.
Do not share APO-TAMSULOSIN CR with anyone else; it is prescribed only for you.
If you interrupt your treatment for several days or more, resume treatment after consulting with your physician.
Overdose
If you think you have taken too much APO-TAMSULOSIN CR, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose
You may take your daily APO-TAMSULOSIN CR tablet later the same day if you have forgotten to take it as recommended. If you have missed a day, just continue to take your daily tablet as prescribed. Never take a double dose to make up for the forgotten tablet.
Side effects and what to do about them
Like all prescription drugs, APO-TAMSULOSIN CR may cause side effects. Side effects due to APO-TAMSULOSIN CR may include:
Common (1 to 10%):
Abnormal ejaculation (ejaculation disorder). This means that semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.
Uncommon (0.1 to 1%):
Headache, reduced blood pressure (orthostatic hypotension) e.g. when getting up quickly from a seated or lying position sometimes associated with dizziness; runny or blocked nose (rhinitis), diarrhea, feeling sick and vomiting, constipation, weakness (asthenia), rashes, itching and hives (urticaria).
Rare (0.01 to 0.1%):
Fainting - at the first signs of dizziness or weakness you should sit or lie down until they have disappeared.
Allergic reaction (angioedema) – the symptoms include sudden local swelling of the soft tissues of the body (e.g. the throat or tongue), difficulty breathing and/or itching and rash.
Very rare (<0.01%):
Priapism (the painful prolonged unwanted erection of the penis), which is unrelieved by sexual intercourse or masturbation. This condition, if untreated, can lead to permanent inability to have an erection. Stevens-Johnson syndrome (a life-threatening skin disorder which can cause: rash, sores in the mouth, and sores on the body).
Not Known (frequency cannot be estimated from the available data);
Blurred vision or impaired vision, nose bleeds (epistaxis), serious skin rashes (erythema multiform, dermatitis exfoliative), dry mouth, increased sensitivity of the skin to light caused by APO-TAMSULOSIN CR.
If you are undergoing eye surgery because of cloudiness of the lens (cataract) or high pressure inside the eye (glaucoma) and are already taking or have previously taken tamsulosin hydrochloride, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure.
This is not a complete list of side effects. For any unexpected effects while taking APO-TAMSULOSIN CR, contact your doctor or pharmacist immediately, so that these effects may be properly addressed.
| Symptom/effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Dizziness, particularly when getting up from a seated or lying position | ✔ | ||
| Uncommon | |||
| Palpitations (feeling of rapid beating of the heart that may be more forceful) | ✔ | ||
| Rashes, itching and hives (urticaria) | ✔ | ||
| Reduced blood pressure e.g. when getting up quickly from a seated or lying position, sometimes associated with dizziness | ✔ | ||
| Rare | |||
| Fainting | ✔ | ||
| *Sudden local swelling of soft tissues of the body (e.g. the throat or tongue), difficulty breathing and/or itching and rash (angioedema) | ✔ | ||
| Very Rare | |||
| *Priapism (painful prolonged unwanted erection) | ✔ | ||
* If you suspect such symptoms, call your doctor or go to an Emergency Room as soon as possible.
How to store
Store at room temperature (15°C to 30°C).
Keep APO-TAMSULOSIN CR and all medicines out of 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.html) 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
If you want more information about APO-TAMSULOSIN CR:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last revised: November 21, 2019