Patient Medication Information: uses, side effects, how to take - Teva-Tamsulosin
ABOUT THIS MEDICATION
Please read this leaflet before you start taking TEVA-TAMSULOSIN (tamsulosin hydrochloride). Also, read it each time you renew your prescription, just in case new information has been added. Remember, this leaflet does not take the place of careful discussions with your doctor. You and your doctor should discuss TEVA-TAMSULOSIN when you start taking your medication and at regular checkups.
TEVA-TAMSULOSIN is for use by men only.
What the medication is used for:
Your doctor has prescribed TEVA-TAMSULOSIN (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:
TEVA-TAMSULOSIN 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 take TEVA- TAMSULOSIN (tamsulosin) if you are allergic to tamsulosin or any of the non-medicinal ingredients.
What the medicinal ingredient is:
Tamsulosin Hydrochloride
What the nonmedicinal ingredients are:
Glyceryl monostearate, methacrylic acid copolymer, microcrystalline cellulose, polysorbate, talc and triethyl citrate. Capsule shell contains: FD&C Blue No. 2, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. Capsule imprinting ink contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.
What dosage forms it comes in:
0.4 mg sustained-release capsules.
WARNINGS AND PRECAUTIONS
What you need to know while taking TEVA-TAMSULOSIN
You must see your doctor regularly. While taking TEVA-TAMSULOSIN (tamsulosin hydrochloride), 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 TEVA-TAMSULOSIN (tamsulosin hydrochloride). 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 under going eye surgery because of a cloudy lens.
INTERACTIONS WITH THIS MEDICATION
TEVA-TAMSULOSIN (tamsulosin hydrochloride) interacts with other drugs. Always tell your doctor about other medical conditions you have or any medicines you are taking. This means medicines you bought for yourself as well as medicines on prescription. Your doctor or pharmacist will know if it is safe to take TEVA-TAMSULOSIN as well.
Interactions with herbal products have not been established.
PROPER USE OF THIS MEDICATION
Usual dose:
Follow your doctor's advice about how to take TEVA-TAMSULOSIN. You should take it approximately 30 minutes following the same meal every day.
Do not crush, chew, or open capsules of TEVA-TAMSULOSIN Sustained-release Formulation. These capsules are specially formulated to control the delivery of tamsulosin HCl to the blood stream.
Overdose: If you take too many TEVA-TAMSULOSIN capsules at once, tell your doctor or emergency physician immediately.
Missed Dose: If you miss a dose of TEVA-TAMSULOSIN, skip the missed dose and go back to your regular dosing schedule. Do IMPORTANT: PLEASE READ
Page 27 not double doses.
If you interrupt your treatment for several days or more, resume
treatment at one capsule/day, after consulting with your physician.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
You should discuss side effects with your doctor before taking TEVA-TAMSULOSIN and anytime you think you are having a side effect.
Like all prescription drugs, TEVA-TAMSULOSIN may cause side effects. Side effects due to 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 TEVA-TAMSULOSIN.
Some men may experience dizziness or fainting caused by a decrease in blood pressure after taking TEVA-TAMSULOSIN. 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.
Extremely rarely tamsulosin 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 taking or have taken TEVA-TAMSULOSIN (tamsulosin hydrochloride), you should inform your surgeon. TEVA-TAMSULOSIN (tamsulosin hydrochloride) 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, or ejaculatory problems | T | ||
| Uncommon | Prolonged painful erection of the penis | T | T | |
This is not a complete list of side effects. For any unexpected effects while taking TEVA-TAMSULOSIN, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15-30°C).
Keep TEVA-TAMSULOSIN and all medicines out of reach of children.
Do not share TEVA-TAMSULOSIN with anyone else even if his symptoms are similar to yours; it was prescribed only for you.
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 0701D
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 by contacting Teva Canada Limited.
at: 1-800-268-4127 ext. 5005 (English); 1-877-777-9117 (French) or druginfo@tevacanada.com
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9