Patient Medication Information: uses, side effects, how to take - Sandoz Silodosin
What the medication is used for:
Your doctor has prescribed Sandoz Silodosin because you have a medical condition called benign prostatic hyperplasia (BPH). This only occurs in men.
What it does:
Sandoz Silodosin relaxes muscles in the prostate, bladder neck and base. This results in improved urine flow, and reduced BPH symptoms.
When it should not be used:
Do not use Sandoz Silodosin if you:
- are allergic to silodosin or to any ingredient in Sandoz Silodosin (see What the nonmedicinal ingredients are);
- take other alpha1-blockers for high blood pressure;
- take antifungal or HIV drugs such as ketoconazole, itraconazole, ritonavir;
- have severe liver problem; or
- have severe kidney problem.
What the medicinal ingredient is:
Silodosin
What the nonmedicinal ingredients are:
Gelatin, iron oxide black, magnesium stearate, mannitol, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium lauryl sulfate and titanium dioxide.
What dosage forms it comes in:
8 mg capsules contain 8 mg of silodosin.
4 mg capsules contain 4 mg of silodosin.
Sandoz Silodosin may lower blood pressure (postural hypotension), and may make you feel dizzy, especially when getting up from a lying or sitting position particularly if you are taking medications to lower blood pressure or have low blood pressure. In such cases, lie down until the symptoms have completely disappeared. Do not drive or operate machinery until you know how Sandoz Silodosin affects you.
Sandoz Silodosin is not indicated nor recommended for use in women and children.
Prostate cancer and BPH cause many of the same symptoms. Prior to starting Sandoz Silodosin, your doctor will examine you to rule out the presence of prostate cancer.
Tell your doctor or pharmacist, before using the medication, if:
- you suffer liver or kidneys problems;
- you have ever had a reaction to the ingredients of this medication; or
- you have had low blood pressure or signs of low blood pressure [fainting, dizziness] after taking another medicine.
If you will have eye surgery, you must inform your eye surgeon that you are currently using Sandoz Silodosin. Intraoperative Floppy Iris Syndrome (IFIS) has been reported during cataract surgery in some patients who take or have taken alpha1-blockers.
Sandoz Silodosin is broken down by specific enzymes in the liver. It is not known how combined use of drugs, or herbal products that are also broken down by the same enzymes, or grapefruit juice may influence the effectiveness or unwanted side effects of these drugs or herbal medicines.
Before using any prescription, over-the-counter medicines or herbal products, check with your doctor or your pharmacist.
Drugs that interact with Sandoz Silodosin include:
- Alpha1-blockers for high blood pressure or prostate problems
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
INTERACTIONS WITH THIS MEDICATION
- Certain anti-infection drugs such as ketoconazole, clarithromycin, itraconazole and ritonavir
Usual dose:
Follow your doctor’s instructions very carefully about how to take Sandoz Silodosin.
The recommended dosage is one capsule (8 mg) daily to be taken right after a meal, at the same time each day.
For those with moderate renal impairment, the recommended dosage is one capsule (4 mg) daily to be taken right after meal, at the same time each day.
If you stop taking Sandoz Silodosin for several days, you must check with your doctor before starting it again.
Overdose:
Overdose of silodosin may lead to low blood pressure and change in heart rate.
| If you think you, or a person you are caring for, have taken too much Sandoz Silodosin, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Like all prescription drugs, Sandoz Silodosin may cause side effects.
The most common side effect seen with silodosin is an orgasm with reduced or no semen. This side effect is reversible with discontinuation of the product. Other common side effects include dizziness, diarrhea, lightheadedness upon standing or sitting up abruptly, headache, swelling of the throat and nasal passages, and stuffy nose. Cases of itching, hives, shortness of breath, eosinophilic pneumonia (cough, fever, difficulty breathing), dry cough, swelling under the skin, peeling of skin, redness of skin, and swelling of the face have also been reported. If these side effects persist or become bothersome, please check with your physician or pharmacist.
As with other alpha-blockers, Sandoz Silodosin can cause a drop in blood pressure upon changing from a sitting to a standing position, especially when you start treatment. This may lead to fainting, dizziness, or lightheadedness, upon standing or sitting up abruptly. Be careful when driving, operating machinery, or when doing any dangerous activities until you know how Sandoz Silodosin affects you. This is important if you already have a problem with low blood pressure or take medicines to treat high blood pressure. If you begin to feel dizzy or lightheaded, lie down with your legs and feet up. If your symptoms do not improve call your doctor.
If you are undergoing cataract surgery or surgery because of cloudiness in your lens you should inform your ophthalmologist that you are taking Sandoz Silodosin.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
|---|---|---|---|---|---|---|
| Symptom / effect | Talk with your healthcare professional | Stop taking drug and get immediate medical help | ||||
| Only if severe | In all cases | |||||
| Common | ||||||
| Dizziness | ✓ | |||||
| Headache | ✓ | |||||
| Uncommon | ||||||
| Fainting | ✓ | |||||
Lightheadedness upon standing or sitting up abruptly | ✓ | |||||
| Liver disease or liver problems | ✓ | |||||
Allergic reactions (swollen tongue, Swollen throat) | ✓ | |||||
| Skin rash | ✓ | |||||
Red or purple discoloration of the skin caused by bleeding underneath the skin (known as purpura) | ✓ | |||||
Fast heart rate (tachycardia) | ✓ | |||||
| Rare | ||||||
| Feeling of rapid beating of the heart that may be more forceful (palpitation) | ✓ | |||||
This is not a complete list of side effects. For any unexpected effects while taking Sandoz Silodosin, contact your doctor or pharmacist.
PROPER USE OF THIS MEDICATION
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Store at room temperature (15°C to 30°C). Protect from light and moisture.
Keep out of reach and sight of children.
If you want more information about Sandoz Silodosin:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); Sandoz Canada Inc.’s website www.sandoz.ca, or by calling 1-800-361-3062.
®Registered trademark used under license by Sandoz Canada Inc. Boucherville, Québec J4B 1E6
Sandoz Canada Inc.
Boucherville, Québec
Canada J4B 1E6
medinfo@sandoz.com
Questions or concerns: 1-800-361-3062
Last Revised: May 14, 2021
HOW TO STORE IT
MORE INFORMATION
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.