Patient Medication Information: uses, side effects, how to take - Mylan-Tamsulosin
ABOUT THIS MEDICATION
What the medication is used for:
Your doctor has prescribed MYLAN-TAMSULOSIN because you have a medical condition called benign prostatic hyperplasia or BPH. This occurs only in men.
MYLAN-TAMSULOSIN is for use by men only.
What is BPH?
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 than 2 hours after you finish urinating; finding it difficult to postpone urination;
frequent sleep interruption caused by a need to urinate.
What it does:
MYLAN-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 use MYLAN-TAMSULOSIN if you are allergic to tamsulosin or any component of the MYLAN-TAMSULOSIN sustained-release formulation (see ‘What the important non-medicinal ingredients are’ listed below).
What the medicinal ingredient is:
tamsulosin hydrochloride
What the important non-medicinal ingredients are:
Non-medicinal ingredients (in alphabetical order): indigo carmine – FD&C Blue 2, iron oxide black, iron oxide red, iron oxide yellow, gelatin, methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30 per cent (contains polysorbate 80 and sodium laurilsulfate), microcrystalline cellulose (Grade 101), purified water, talc, titanium dioxide, triethylcitrate.
Capsule imprinting ink contains (in alphabetical order): black
iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.
What dosage forms it comes in:
Sustained – Release Capsules. Each capsule contains 0.4 mg tamsulosin hydrochloride.
WARNINGS AND PRECAUTIONS
Before you use MYLAN-TAMSULOSIN, tell your doctor or pharmacist:
If you suffer from fainting due to reduced blood pressure. If you suffer from severe liver problems.
If you have kidney problems.
If you have or ever had prostate cancer.
What you need to know while taking MYLAN-TAMSULOSIN:
You must see your doctor regularly. While taking MYLAN-TAMSULOSIN, 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 MYLAN-TAMSULOSIN. 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 cloudy lens.
You should avoid driving or hazardous tasks for 12 hours after the initial dose or after your doctor recommends an increase in dose.
INTERACTIONS WITH THIS MEDICATION
Drug that may interact with MYLAN-TAMSULOSIN include warfarin, cimetidine and alpha-adrenergic blocking agents (alfuzosin, doxazosin, prazosin, terazosin).
Tell your doctor and pharmacist what prescription and non-prescription medications, vitamins, nutritional supplements and herbal products that you are taking.
PROPER USE OF THIS MEDICATION
Do not share MYLAN-TAMSULOSIN with anyone else; it was prescribed only for you.
Usual dose:
The recommended dose for MYLAN-TAMSULOSIN is 0.4 mg once daily.
Follow your doctor’s advice about how to take MYLAN-TAMSULOSIN. You should take it approximately 30 minutes following the same meal every day.
If you discontinued or interrupt your treatment for several days or more, resume treatment at one capsule/day, after consulting
with your doctor.
Do not crush, chew, or open capsules of MYLAN-TAMSULOSIN Sustained-release Formulation. These capsules are specially formulated to control the delivery of tamsulosin HCl to the blood stream.
Overdose:
You should take MYLAN-TAMSULOSIN as prescribed by your doctor. If you suspect that you took too many capsules, contact your doctor.
Missed Dose:
If a dose of this medication has been missed, it should be taken as soon as possible. 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 dosage.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all prescription drugs, MYLAN-TAMSULOSIN may cause side effects. Side effects due to MYLAN-TAMSULOSIN may include dizziness, weakness/loss of strength (asthenia), headache, runny nose, heart palpitations (feeling of heart beating fast), ejaculatory problems, nausea, diarrhoea, vomiting, constipation, rashes, itching and hives. In some cases side effects may decrease or disappear while the patient continues to take MYLAN-TAMSULOSIN.
Some men may experience dizziness or fainting caused by a decrease in blood pressure after taking MYLAN-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, MYLAN-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 MYLAN-TAMSULOSIN, you should inform your surgeon. MYLAN-TAMSULOSIN 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.
You should discuss side effects with your doctor before taking MYLAN-TAMSULOSIN and anytime you think you are having a side effect.
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 pharmac ist | ||||||||
| Only if severe | In all cases | |||||||||
| Common | Dizziness/ lighheadedness upon rising | √ | ||||||||
| Abnormal ejaculation | √ | |||||||||
| Uncommon | Headache | √ | ||||||||
| Heart palpitations | √ | |||||||||
| Weakness/loss of strength (asthenia) | √ | |||||||||
| Itchiness | √ | |||||||||
| Hives | √ | |||||||||
| Serious and Rare | Fainting | √ | ||||||||
| Swelling of the face, eyes, lips, tongue and/or throat, hands or feet (angioedema). | √ | |||||||||
| Very Rare | Prolonged painful erection of penis | √ | ||||||||
This is not a complete list of side effects. For any unexpected effects while taking MYLAN-TAMSULOSIN, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15-30°C).
Keep MYLAN-TAMSULOSIN and all medicines out of 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 by contacting the sponsor, Mylan Pharmaceuticals ULC, at: 1-800-575-1379.
Mylan Pharmaceuticals ULC
85 Advance Road
Toronto, Ontario
M8Z 2S6
Date of preparation: June 3, 2009