Apo-Fesoterodine: Uses, Side Effects and Dosage

What is APO-FESOTERODINE used for?

APO-FESOTERODINE is used to treat the symptoms of an overactive bladder in adults. Symptoms of an overactive bladder can include any of the following or combination of the following:

• having to urinate often
• having a strong need to urinate right away
• leaking or wetting accidents due to a strong need to urinate

How does APO-FESOTERODINE work?

APO-FESOTERODINE works by helping to relax the muscles of the bladder. This helps to relieve many of the symptoms of an overactive bladder.

What are the ingredients in APO-FESOTERODINE?

Medicinal ingredient: Fesoterodine fumarate

Non-medicinal ingredients: Colloidal silicon dioxide, glyceryl behenate, hypromellose, indigotine AL lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

APO-FESOTERODINE comes in the following dosage forms:

Extended-release tablets:

• 4 mg (light blue colored, oval-shaped biconvex, film coated tablet engraved with “APO” on one side and “F4” on other side)
• 8 mg (blue colored, oval-shaped biconvex, film coated tablet engraved with “APO” on one side and “F8” on other side)

Do not use APO-FESOTERODINE if:

• You are not able to completely empty your bladder (urinary retention).
• You have delayed or slow emptying of the contents in your stomach (gastric retention).
• You have an eye problem called uncontrolled narrow-angle glaucoma which leads to an increase of the pressure inside the eyeball.
• You are allergic to APO-FESOTERODINE or any of its ingredients. For a complete list, see What are the ingredients in APO-FESOTERODINE?
• You are allergic to medicines that contain tolterodine (Detrol® or Detrol® LA).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-FESOTERODINE. Talk about any health conditions or problems you may have, including if you:

• Have or have had problems with your heart, such as:

  • abnormal increases in heart rate or rhythm (arrhythmia), or
  • ischemic heart disease, or
  • heart failure
• Take medicines, such as ketoconazole, itraconazole, miconazole, clarithromycin and cimetidine.
• Have stomach problems affecting passage and digestion of food.
• Have severe constipation.
• Have gastrointestinal obstruction disorders (e.g. pyloric stenosis).
• Have problems emptying your bladder or if you have weak urine stream.
• Have liver problems.
• Have myasthenia gravis (a chronic autoimmune neuromuscular disease which causes muscle weakness).
• Are receiving treatment for an eye problem called narrow-angle glaucoma.
• Have kidney problems.

• Are pregnant, or trying to become pregnant.

• Are breastfeeding your child.

Other warnings you should know about:

Angioedema and Allergic Reactions: APO-FESOTERODINE can cause:

• angioedema (swelling of face or tongue, difficulty breathing) and
• severe allergic reactions (hives, trouble breathing, abdominal cramps, rapid heartbeat and feeling faint).

If you experience any of these symptoms, stop taking APO-FESOTERODINE and see your healthcare professional right away.

Driving and Operating Machinery: Until you know how APO-FESOTERODINE affects you, do not drive or operate a vehicle or potentially dangerous machinery, especially when you first start treatment, or when your dose is changed. Taking APO-FESOTERODINE can cause side effects such as:

• blurred vision,
• dizziness, and
• drowsiness.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with APO-FESOTERODINE:

• Other drugs similar to APO-FESOTERODINE (antimuscarinic/anticholinergic)
• Drugs to treat fungal infections (such as, fluconazole, ketoconazole, miconazole or itraconazole)
• Drugs to treat ulcers or gastroesophageal reflux disease (GERD) (such as cimetidine)
• Drugs to treat bacterial infections (such as erythromycin, clarithromycin)
• Drugs to treat some types of cancer (such as vinblastine)
• Drugs to treat depression
• Antipsychotics (drugs to stabilize thinking and behavior)

How to take APO-FESOTERODINE:

• Take APO-FESOTERODINE as instructed by your healthcare professional. Do not increase, decrease or stop taking APO-FESOTERODINE without first talking to your healthcare professional.
• Take APO-FESOTERODINE with liquid and swallow the tablet whole. APO-FESOTERODINE should not be chewed, divided, or crushed.

Remember: This medication is for YOU. Never give it to others. It may harm them even if their symptoms are the same as yours.

Usual Adult dose:

• The usual starting dose is 4 mg once daily.
• The maximum daily dose for APO-FESOTERODINE is 8 mg.
• Your healthcare professional may give you the lower 4 mg dose of APO-FESOTERODINE if you have certain medical conditions.
• Based on how you respond to APO-FESOTERODINE upon your response and tolerability, your healthcare professional may increase your dose to 8 mg once daily.

Overdose:

Some of the signs of an overdose could be:

• Dry mouth
• Constipation
• Dry eyes
• Seeing or believing things that are not there (hallucinations)
• Feeling excited
• Convulsions
• Trouble breathing
• Fast heart rate
• Dilated pupils
• Problems emptying your bladder.

Missed Dose:

If you miss taking your dose, take it as soon as you remember. But if it is almost time for you to take the next dose, skip the missed dose and just take it at your usual time. Do not take two doses at the same time to make up for the dose that you missed.

What are possible side effects from using APO-FESOTERODINE?

These are not all the possible side effects you may have when taking APO-FESOTERODINE. If you experience any side effects not listed here, tell your healthcare professional.

• Dry mouth. If you experience dry mouth after taking APO-FESOTERODINE, there are a few ways that might help relieve the symptoms:

  • Carry a bottle of water and sip a little bit throughout the day or suck on ice chips to provide moisture.
  • Chew sugarless gum or suck on sugarless hard candy to stimulate saliva production.
  • Avoid eating salty or spicy foods.
  • Avoid drinking carbonated, caffeinated and alcoholic beverages.
  • Avoid using mouth rinses that contain alcohol, as they may dry out the mouth.
  • Use a humidifier at night.
  • Ask your healthcare professional to recommend an over-the-counter saliva substitute or oral lubricant.
• Constipation
• Upset stomach
• Nausea
• Urinary tract infection
• Upper respiratory tract infection
• Dry eyes
• Painful urination
• Difficulty emptying your bladder
• Dry throat, throat numbness, swelling and soreness
• Swelling of your lower legs and hands
• Skin rash
• Blurred vision
• Dizziness
• Headache
• Cough
• Back pain
• Abdominal pain
• Trouble sleeping
• Drowsiness
• Confusion
• Heart palpitations
• Hypersensitivity reactions
• Hives, itching
• Reduced sense of touch, temperature and pain (numbness)

Check with your healthcare professional right away if you have any bothersome or unusual effects while taking APO-FESOTERODINE.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store between 15°C - 25°C. Protect from light and moisture.

You should not use your medication after the expiration date printed on the label.

Keep out of reach and sight of children.

If you want more information about APO-FESOTERODINE:

• 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); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last Revised: JAN 07, 2025

®All brands referenced herein are the property of their respective owners