Jamp Silodosin: Uses, Side Effects and Dosage

What the medication is used for:

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

What it does:

JAMP 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 JAMP Silodosin if you:

• are allergic to silodosin or to any ingredient in JAMP Silodosin (see What the non-medicinal ingredients are);
• take other alpha-1 blockers for high blood pressure;
• take antifungal or HIV drugs such as ketoconazole, itraconazole (Sporanox^®), ritonavir (Kaletra^®, Norvir^®);
• have severe liver problems; or
• have severe kidney problems.

What the medicinal ingredient is:

Silodosin

What the non-medicinal ingredients are:

FD&C Blue No. 1 Aluminum Lake (in 8 mg capsules only), gelatin, iron oxide yellow, magnesium stearate, mannitol, pregelatinized starch, propylene glycol, shellac, sodium lauryl sulfate and titanium dioxide.

What dosage forms it comes in:

Hard gelatin capsules.

8 mg capsules contain 8 mg of silodosin. 4 mg capsules contain 4 mg of silodosin.

JAMP 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 JAMP Silodosin affects you.

JAMP 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 JAMP 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 kidney 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 JAMP Silodosin. Intraoperative Floppy Iris Syndrome (IFIS) has been reported during cataract surgery in some patients who take or have taken alpha-1 blockers.

JAMP 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 JAMP Silodosin include:

• Alpha-1 blockers for high blood pressure or prostate problems

• Certain anti-infection drugs such as ketoconazole, clarithromycin, itraconazole (Sporanox^®) and ritonavir

  (Kaletra^®, Norvir^®).

INTERACTIONS WITH THIS MEDICATION

WARNINGS AND PRECAUTIONS

ABOUT THIS MEDICATION

Usual dose:

Follow your doctor’s instructions very carefully about how to take JAMP 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 a meal, at the same time each day.

If you stop taking JAMP 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.

Like all prescription drugs, JAMP Silodosin may cause side effects.

The most common side effect seen with JAMP 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, JAMP 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 JAMP 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 JAMP Silodosin.

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

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

PROPER USE OF THIS MEDICATION

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

JAMP Silodosin capsules should be stored at controlled room temperature (15-30°C). Protect from light and moisture.

Keep out of reach and sight of children.

Reporting Side Effects

If you want more information about JAMP 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 Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-866-399-9091.

JAMP Pharma Corporation

1310 rue Nobel

Boucherville, Quebec

J4B 5H3, Canada

Last Prepared: July 10, 2023

MORE INFORMATION

HOW TO STORE IT