Urotel XL 4 Capsule

Urotel XL 4 Capsule is a prolonged-release oral capsule that contains tolterodine 4 mg in each capsule, as labelled. Tolterodine belongs to the antimuscarinic (anticholinergic) class of medicines. It is used to help control overactive bladder symptoms such as a sudden urge to urinate, frequent urination, and urge incontinence. Urotel XL 4 Capsule is designed to release the medicine slowly over time rather than all at once.

How it works: Tolterodine works by calming overactive bladder muscles, which helps reduce sudden urges and bladder spasms. The capsule form releases tolterodine gradually, so the effect is spread out through the day instead of peaking quickly.

Urotel XL 4 Capsule is a higher-strength, once-daily tolterodine capsule for people whose doctor has decided they need the 4 mg extended-release dose. Because it is a modified-release capsule, it is not the same as immediate-release tolterodine and should not be used as a substitute milligram-for-milligram without medical advice. A clinician may choose Urotel XL 4 Capsule when a lower dose was not enough or when once-daily extended release is preferred.

• Overactive bladder
• Urinary urgency
• Frequent urination
• Urge incontinence
• Bladder control symptoms

• Swallow Urotel XL 4 Capsule whole with water.
• Do not crush, chew, or open the capsule, because it is a prolonged-release form.
• Take it at the same time each day to help maintain steady effect.
• It may be taken with or without food.
• If you miss a dose, take the next dose at the usual time; do not take extra capsules to make up for a missed dose.
• Follow your prescriber’s directions exactly, since this is the 4 mg strength and may be too strong for some people.

Each Urotel XL 4 Capsule contains tolterodine 4 mg. For the extended-release capsule, the usual maximum dose is 4 mg once daily unless your doctor instructs otherwise. Your doctor decides the right dose based on your symptoms, other medicines, age, liver or kidney function, and how well you tolerate this higher-strength capsule.

Do not change your dose or stop the medicine without speaking to your doctor.

Common side effects of Tolterodine may include:

• Dry mouth, which may be more noticeable with the 4 mg strength
• Constipation
• Headache
• Dizziness
• Dry eyes or blurred vision
• Stomach discomfort or indigestion
• Sleepiness or fatigue

• Urotel XL 4 Capsule can worsen urinary retention, so it should be used carefully if you have trouble emptying your bladder.
• It may cause more dry mouth, constipation, or blurry vision at the 4 mg strength, especially at the start of treatment.
• Use caution if you have glaucoma, liver disease, kidney disease, heart rhythm problems, or myasthenia gravis.
• It can cause dizziness or sleepiness, so avoid driving or operating machinery until you know how it affects you.
• Alcohol may increase dizziness or drowsiness.
• Tell your doctor if you are older, since anticholinergic effects may be stronger or less well tolerated.
• Do not combine it with other medicines that have strong anticholinergic effects unless your doctor says it is safe.

• Ketoconazole, itraconazole, clarithromycin, and other strong CYP3A4 inhibitors may raise tolterodine levels.
• Other anticholinergic medicines can increase side effects such as dry mouth, constipation, and urinary retention.
• Some antidepressants and other medicines that affect heart rhythm may increase the risk of side effects.
• Cimetidine and certain other medicines may alter tolterodine exposure.
• Other bladder medicines or antispasmodics may add to anticholinergic effects.

Store Urotel XL 4 Capsule in its original strip or box at room temperature, away from moisture and heat, and keep it out of reach of children.