Details for: SANDOZ TAMSULOSIN
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02319217 | SANDOZ TAMSULOSIN | TAMSULOSIN HYDROCHLORIDE | 0.4 MG | CAPSULE (SUSTAINED-RELEASE) | ORAL |
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.
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.
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.
| 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) | ✔ | ||
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:
- Talk to your healthcare professional. Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website ( https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website (www.sandoz.ca), or by calling the manufacturer, Sandoz Canada Inc., at: 1-800-361-3062
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