Sandoz Fesoterodine Fumarate: Uses, Side Effects and Dosage

What is Sandoz Fesoterodine Fumarate used for?

Sandoz Fesoterodine Fumarate 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 Sandoz Fesoterodine Fumarate work?

Sandoz Fesoterodine Fumarate 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 Sandoz Fesoterodine Fumarate?

Medicinal ingredient: Fesoterodine fumarate

Non-medicinal ingredients: Fumaric acid, glycerol dibehenate, hypromellose (methocel K4M and K100M premium CR), hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose, pullulan, talc. The film coating contains the following inactive ingredients: Lecithin (soya), macrogol/PEG, FD&C blue #2/ indigo carmine aluminum lake, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide.

Sandoz Fesoterodine Fumarate comes in the following dosage forms:

• Sandoz Fesoterodine Fumarate 4 mg extended-release tablets (light blue, oval, biconvex, film-coated tablets debossed with I11 on one side and plain on other side)
• Sandoz Fesoterodine Fumarate 8 mg extended-release tablets (blue oval, biconvex, film-coated tablets debossed with I17 on one side and plain on other side)

Do not use Sandoz Fesoterodine Fumarate 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 Sandoz Fesoterodine Fumarate or any of its ingredients. For a complete list, see What are the ingredients in Sandoz Fesoterodine Fumarate?
• You are allergic to lactose, peanuts or soya.
• 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 Sandoz Fesoterodine Fumarate. 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 a rare hereditary problem of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption. Sandoz Fesoterodine Fumarate contains lactose.
• 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.
• Have a family history of soya intolerance. Sandoz Fesoterodine Fumarate contains soya lecithin.

Other warnings you should know about:

Angioedema and Allergic Reactions: Sandoz Fesoterodine Fumarate 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 Sandoz Fesoterodine Fumarate and see your healthcare professional right away.

Driving and Operating Machinery: Until you know how Sandoz Fesoterodine Fumarate 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 Sandoz Fesoterodine Fumarate 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 Sandoz Fesoterodine Fumarate:

• Other drugs similar to Sandoz Fesoterodine Fumarate (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 Sandoz Fesoterodine Fumarate:

• Take Sandoz Fesoterodine Fumarate as instructed by your healthcare professional. Do not increase, decrease or stop taking Sandoz Fesoterodine Fumarate without first talking to your healthcare professional.
• Take Sandoz Fesoterodine Fumarate with liquid and swallow the tablet whole. Sandoz Fesoterodine Fumarate 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 Sandoz Fesoterodine Fumarate is 8 mg.
• Your healthcare professional may give you the lower 4 mg dose of Sandoz Fesoterodine Fumarate if you have certain medical conditions.
• Based on how you respond to Sandoz Fesoterodine Fumarate 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 Sandoz Fesoterodine Fumarate?

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

• Dry mouth. If you experience dry mouth after taking Sandoz Fesoterodine Fumarate, 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 food
  • 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 or pharmacist right away if you have any bothersome or unusual effects while taking Sandoz Fesoterodine Fumarate.

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 at controlled room temperature at 15 – 25°C. Protect from moisture.

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

Keep out of reach and sight of children.

If you want more information about Sandoz Fesoterodine Fumarate:

• 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 [www.sandoz.ca], or by calling 1-800-361-3062.

Last Revised: November 28, 2024