Patient Medication Information: uses, side effects, how to take - Ava-Tamsulosin CR
ABOUT THIS MEDICATION
What the medication is used for:
Your doctor has prescribed Ava-Tamsulosin CR because you have lower urinary tract symptoms (LUTS) associated with a medical condition called benign prostatic hyperplasia or BPH.
What it does:
Ava-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 Ava-Tamsulosin CR if you are allergic (hypersensitive) to tamsulosin or any of the other ingredients in Ava-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).
What the medicinal ingredient is:
Tamsulosin Hydrochloride
What the important nonmedicinal ingredients are: Black iron oxide (E172), butylhydroxytoluene, carmine (E120), colloidal anhydrous silica, hydroxypropylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, quinoline yellow (E104), talc, titanium dioxide.
What dosage forms it comes in:
Controlled-release Tablets. Each tablet contains 0.4 mg tamsulosin hydrochloride.
WARNINGS AND PRECAUTIONS
Rarely, fainting can occur during the use of Ava-Tamsulosin CR tablet, 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.
Ava-Tamsulosin CR tablet should not be used in women or children.
BEFORE you use Ava-Tamsulosin CR tablet 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 have kidney problems;
if you have previously taken Ava-Tamsulosin
CR and became unwell;
if you are going to drive, operate machinery or perform hazardous tasks.
You must see your doctor regularly. While taking Ava-Tamsulosin CR tablet, you must have regular checkups. Follow your doctor’s advice about when to have these checkups.
If you are undergoing eye surgery because of cloudiness of the lens (cataract) please inform your eye specialist that you are using or have used Ava-Tamsulosin CR. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used. Ask your doctor whether or not you should temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens.
INTERACTIONS WITH THIS MEDICATION
Taking Ava-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 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 Ava-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 Ava-Tamsulosin CR tablets. These tablets are specially formulated to control the delivery of tamsulosin hydrochloride to the blood stream.
Do not share Ava-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:
Taking too many Ava-Tamsulosin CR tablets may lead to an unwanted decrease in blood pressure and an increase in heart rate, with feelings of faintness. Contact your doctor immediately if you have taken too much Ava-Tamsulosin CR.
For management of a suspected drug overdose, contact your regional Poison Control Centre.
Missed dose:
You may take your daily Ava-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 any medication, Ava-Tamsulosin CR may cause side effects.
Side effects due to Ava-Tamsulosin CR may include:
Common (1-10%):
Dizziness, particularly when getting up from a seated or lying position.
Some men may experience dizziness or fainting caused by a decrease in blood pressure after taking Ava-Tamsulosin CR. Although these symptoms are unlikely, you should avoid driving or hazardous tasks for 12 hours after the initial dose.
Uncommon (0.1-1%):
Headache, palpitations (a feeling of rapid beating of the heart that may be more forceful), reduced blood pressure 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), abnormal ejaculation. The latter means that semen does not leave the body via the urethra, but instead goes into the bladder. This phenomenon is harmless.
Rare (0.01-0.1%):
Rarely, fainting can occur during the use of Ava-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.
Sudden local swelling of the soft tissues of the body (e.g. the throat or tongue), difficulty breathing and/or itching and rash, often as an allergic reaction (angioedema). If you suspect such symptoms, call your doctor or go to an Emergency Room as soon as possible.
Very rare (<0.01%):
Priapism (painful prolonged unwanted erection for which immediate medical treatment is required).
There have been reports that tamsulosin hydrochloride sustained release capsules and similar medications have caused prolonged, painful 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. If you suspect such symptoms, call your doctor or go to an Emergency Room as soon as possible.
If you are undergoing eye surgery because of cloudiness of the lens (cataract) 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 Ava-Tamsulosin CR, contact your doctor or pharmacist immediately, so that these effects may be properly addressed.
| 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 | |||
| 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 the soft tissues of the body (e.g. the thorat 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 IT
Store at room temperature (15ºC - 30ºC).
Keep Ava-Tamsulosin CR and all medicines out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Report online at www.healthcanada.gc.ca/medeffect Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701D Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. 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 the sponsor, Avanstra Inc., at 1-855-708-3678.
or by e-mail, at :
medinfo@avanstra.com