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Details for: SANDOZ TAMSULOSIN

Company: SANDOZ CANADA INCORPORATED

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02319217SANDOZ TAMSULOSINTAMSULOSIN HYDROCHLORIDE0.4 MGCAPSULE (SUSTAINED-RELEASE)ORAL
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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 Sandoz Tamsulosin because you have lower urinary tract symptoms (LUTS) associated with a medical condition called benign prostatic hyperplasia or BPH.

What it does

Sandoz Tamsulosin 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

When it should not be used:

  • You should not use Sandoz Tamsulosin if you are allergic (hypersensitive) to tamsulosin or any of the other ingredients in Sandoz Tamsulosin capsules. Hypersensitivity may present itself 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 Sandoz Tamsulosin if you are taking ketoconazole (an antifungal used to treat fungal skin infection).
What the medicinal ingredient is

Tamsulosin hydrochloride

What the non-medicinal ingredients are

Each capsule contains (in alphabetical order) methacrylic acidethyl acrylate copolymer, microcrystalline cellulose, polyacrylate, polysorbate 80, purified water, sodium lauryl sulphate and talc.

Capsule shell contains (in alphabetic order): black iron oxide, gelatine, indigo carmine, red iron oxide, titanium dioxide, yellow iron oxide.

Capsule imprinting ink contains TekPrint SW-9008 Blank Ink (in alphabetical order): black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution. Opacode Black S-1-27794: Industrial methylated spirit 74 OP, Iron oxide black JPE, Isopropyl alcohol, N-butyl alcohol, Propylene glycol, Purified water, Shellac glaze – 47.5 % (22 % esterified) IN IMS 74 OP

What dosage form it comes in

Sustained-release capsules. Each capsule contains 0.4 mg tamsulosin hydrochloride.

Warnings and precautions

Rarely, fainting can occur during the use of Sandoz Tamsulosin, 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.

Sandoz Tamsulosin should not be used in women or children. BEFORE you use Sandoz Tamsulosin 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 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 surgery. A condition known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in association with tamsulosin during cataract and glaucoma surgery.
Sandoz Tamsulosin may cause dizziness. Do not drive or operate machinery or perform hazardous tasks for 12 hours after taking the initial dose of Sandoz Tamsulosin, or until you know how the medication affects you.

You must see your doctor regularly. While taking Sandoz Tamsulosin you must have regular checkups. Follow your doctor’s advice about when to have these checkups.
Interactions with this medication

Taking Sandoz Tamsulosin 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 Sandoz Tamsulosin. You should take one capsule (0.4 mg) following the same meal every day.

Do not chew or open Sandoz Tamsulosin capsules. These capsules are specially formulated to control the delivery of tamsulosin hydrochloride to the blood stream.

Do not share Sandoz Tamsulosin 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 Sandoz Tamsulosin capsules 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 Sandoz Tamsulosin.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

You may take your daily Sandoz Tamsulosin capsule 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 capsule as prescribed. Never take a double dose to make up for the forgotten capsule.

Side effects and what to do about them

Like all prescription drugs, Sandoz Tamsulosin may cause side effects. Side effects due to tamsulosin may include:

Common (1-10%):
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 (0.1-1%):
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- 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 Sandoz Tamsulosin.

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, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and call your doctor or pharmacist
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 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.

This is not a complete list of side effects. For any unexpected effects while taking Sandoz Tamsulosin, contact your doctor or pharmacist.
How to store

HDPE bottles: store at controlled room temperature (15-30°C), protect from heat and moisture.

Keep out of reach and sight of children

Reporting 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 three 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 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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

If you want more information about Sandoz Tamsulosin:

or by written request at:
110 rue de Lauzon

Boucherville, (QC), Canada
J4B 1E6

or by e-mail at :
medinfo@sandoz.com

This leaflet was prepared by Sandoz Canada Inc. The information in this leaflet is current up to the time of the last revision date shown below.

Last revised: October 22, 2019

Date modified: