Patient Medication Information: uses, side effects, how to take - Apo-Silodosin
ABOUT THIS MEDICATION
What the medication is used for:
Your doctor has prescribed APO-SILODOSIN because you have a medical condition called benign prostatic hyperplasia (BPH). This only occurs in men.
What it does:
APO-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 APO-SILODOSIN if you:
- are allergic to silodosin or to any ingredient in APO-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:
Isomalt, magnesium stearate, sodium starch glycolate. The size #4 and size #2 hard gelatin capsules contain gelatin and titanium dioxide. The size #4 and size #2 hard gelatin capsules are printed with black edible ink.
The complete composition for black edible ink is as follows:
| Ingredients | Percentage By weight |
| Butyl Alcohol-NF* | 1-3 % |
| Dehydrated Alcohol-USP* | 23-26 % |
| Iron Oxide Black–NF | 24-28 % |
| Isopropyl Alcohol-USP* | 1-3 % |
| Potassium Hydroxide | 0.05-0.1 % |
| Propylene Glycol-USP | 3-7 % |
| Purified Water-USP | 15-18 % |
| Shellac-NF | 24-27 % |
| Strong Ammonia Solution-NF | 1-2 % |
*Note that these components are evaporated off in the printing process and not found in the final product.
What dosage forms it comes in:
Hard gelatin capsules.
4 mg capsules contain 4 mg of silodosin.
WARNINGS AND PRECAUTIONS
APO-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 APO-SILODOSIN affects you.
APO-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 APO-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 APO-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
APO-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 APO-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 APO-SILODOSIN.
The recommended dosage is one capsules (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 APO-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 have taken too much APO-SILODOSIN, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all prescription drugs, APO-SILODOSIN may cause side effects. The most common side effect seen with APO-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, APO-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 APO-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 APO-SILODOSIN.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||||
|---|---|---|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |||||
| Only if severe | In all cases | ||||||
| Common | Dizziness Headache |
| |||||
| Uncommon | Fainting Lightheaded-ness 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 |
|
|
| |||
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist |
|---|
| Only if severe | In all cases |
|---|---|
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 APO-SILODOSIN, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15ºC - 30ºC. Protect from light and moisture.
Keep APO-SILODOSIN out of reach of children.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
MORE INFORMATION
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at:
1-800-667-4708
This leaflet can also be found at: http://www.apotex.ca/products.
Date of Revision: August 03, 2018