Patient Medication Information: uses, side effects, how to take - Uflo
ABOUT THIS MEDICATION
What the medication is used for:
Your doctor has prescribed UFlo (tamsulosin hydrochloride) because you have a medical condition called benign prostatic hyperplasia or BPH. This occurs only in men.
BPH is an enlargement of the prostate gland. 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:
- 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 that 2 hours after you finish urinating;
- finding it difficult to postpone urination;
- frequent sleep interruption caused by a need to urinate.
What it does:
UFlo (tamsulosin hydrochloride) acts by relaxing muscles in the prostate and bladder neck at the site of the obstruction, resulting in improved urine flow, and reduced BPH symptoms.
When it should not be used:
Do not use UFlo if you are allergic to tamsulosin or to any ingredient in the formulation or component of the container (see What the important non-medicinal ingredient are).
What the medicinal ingredient is:
tamsulosin hydrochloride
What the important nonmedicinal ingredients are: Eudragit L30 D55*, Eudragit L 100-55*, Magnesium Stearate, Microcrystalline Cellulose, Sodium Hydroxide, Talc, Titanium Dioxide, Triacetin, Gelatin, Sunset Yellow, Ponceau 4R, Brilliant Blue, Quinolene Yellow, Yellow Iron Oxide, Carmoisine, Activated Charcoal, Shellac. (*contains methacrylic acid - ethyl acrylate copolymer and may contain suitable surface active agents such as polysorbate 80 and sodium dodecyl sulphate)
What dosage forms it comes in:
UFlo is available as sustained release capsules containing 0.4 mg tamsulosin hydrochloride.
WARNINGS AND PRECAUTIONS
UFlo (tamsulosin hydrochloride) is for use by men only.
BEFORE you use UFlo (tamsulosin hydrochloride):
$ You should know that tamsulosin hydrochloride 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.
$ Tell your doctor or pharmacist if you have any allergies to this drug or its ingredients or components of the container.
$ Tell your doctor or pharmacist if you have or have ever had prostate cancer, liver disease or kidney disease.
If you are undergoing eye surgery due to cloudiness of the lens (cataract), please inform your eye specialist that you are using or have used UFlo (tamsulosin hydrochloride). The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used. Ask your doctor whether you should temporarily stop or continue taking this medicine when undergoing eye surgery because of a cloudy lens.
While taking UFlo (tamsulosin hydrochloride), you may experience dizziness or fainting. You should practice caution while driving, operating machinery or performing hazardous tasks. If you think you are having a side effect tell your doctor or pharmacist. (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM)
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with UFlo (tamsulosin hydrochloride) include: warfarin, cimetidine, and other alpha-adrenergic blocking agents such as alfuzosin, doxazosin, prazosin and terazosin.
PROPER USE OF THIS MEDICATION
Usual dose:
Follow your doctor's advice about how to take UFlo (tamsulosin hydrochloride). You should take it approximately 30 minutes following the same meal every day.
Do not crush, chew, or open capsules of UFlo (tamsulosin hydrochloride) sustained-release formulation. These capsules are specially formulated to control the delivery of tamsulosin
Page 28 of 28 hydrochloride to the blood stream.
You must see your doctor regularly. While taking UFlo, you must have regular checkups. Follow your doctor’s advice about when to have these checkups.
If you interrupt your treatment for several days or more, resume treatment at one capsule/day, after consulting with your doctor.
Overdose:
It is important to follow the instructions from your doctor or pharmacist. If you or someone have taken more than the recommended dose at once contact your doctor or nearest hospital emergency department immediately.
Missed Dose:
If a dose of this medication is missed, it should be taken as soon as possible. This will help to keep a constant amount of medication in the blood. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double doses.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects due to UFlo (tamsulosin hydrochloride) may include dizziness, insomnia, runny nose, or ejaculatory problems. In some cases side effects may decrease or disappear while the patient continues to take UFlo.
Some men may experience dizziness or fainting caused by a decrease in blood pressure after UFlo (tamsulosin hydrochloride). Although these symptoms are unlikely, you should avoid driving or hazardous tasks for 12 hours after the initial dose or after your doctor recommends an increase in dose.
If you are undergoing eye surgery because of cloudiness of the lens (cataract), and are taking or have taken UFlo (tamsulosin hydrochloride), you should inform your surgeon. UFlo may cause your pupil to dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure. By warning your surgeon in advance, he will be able to use a slightly different technique to make the surgery easier.
| 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 Insomnia Runny nose Ejaculatory problems | √ √ | √ | |
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Talk with your doctor or pharmacist | ||||
| Uncommon | Prolonged, painful erection of the penis. | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking UFlo (tamsulosin hydrochloride) contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15 - 30ºC).
Keep out of the reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at: www.tritonpharma.ca or by contacting the sponsor, Triton Pharma Inc. at: 1.866.429.9707
Last revised:
September 10, 2009