Silodosin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your doctor has prescribed SILODOSIN because you have a medical condition called benign prostatic hyperplasia (BPH). This only occurs in men.

What it does:

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 SILODOSIN if you:

• are allergic to silodosin or to any ingredient in SILODOSIN (see What the nonmedicinal ingredients are);
• take other alpha1-blockers for high blood pressure;
• take antifungal or HIV drugs such as ketoconazole, itraconazole (Sporanox®), ritonavir (Kaletra®, Norvir®);
• have severe liver problem; or
• have severe kidney problem.

What the medicinal ingredient is: Silodosin

What the nonmedicinal ingredients are:

Butylhydroxytoluene, Magnesium Aluminometasilicate, Magnesium Stearate, Mannitol, Pregelatinized Starch, Polysorbate 80. Capsules contain: Gelatin and Titanium Dioxide. The markings on the capsules are in black ink, which contains Shellac, Black Iron Oxide, Propylene Glycol, Potassium Hydroxide and Water.

What dosage forms it comes in:

4 mg capsules: 4 mg of silodosin.

8 mg capsules: 8 mg of silodosin.

WARNINGS AND PRECAUTIONS

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 SILODOSIN affects you.

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 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 SILODOSIN. Intraoperative Floppy Iris Syndrome (IFIS) has been reported during cataract surgery in some patients who take or have taken alpha1-blockers.

INTERACTIONS WITH THIS MEDICATION

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 SILODOSIN include:

• Alpha1-blockers for high blood pressure or prostate problems
• Certain anti-infection drugs such as ketoconazole, clarithromycin, itraconazole (Sporanox®) and ritonavir (Kaletra®, Norvir®)

PROPER USE OF THIS MEDICATION

Usual dose:

Follow your doctor’s instructions very carefully about how to take 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 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.

THEM

Like all prescription drugs, 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, 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 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 SILODOSIN.

This is not a complete list of side effects. For any unexpected effects while taking SILODOSIN, contact your doctor or pharmacist.

HOW TO STORE IT

SILODOSIN capsules should be stored at controlled room temperature (15°C to 30°C). Protect from light and moisture. Keep SILODOSIN out of reach and sight of children.

Reporting Side Effects

MORE INFORMATION

If you want more information about SILODOSIN:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Heath Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website https://sanis.com/products, or by calling 1-866-236-4076.

  Sanis Health Inc.

  1 President's Choice Circle

  Brampton, Ontario

  L6Y 5S5

Last revised: FEB 20, 2026