Pronunciation:

soe-li-FEN-a-sin SUX-i-nate

Brand Names:

• Vesicare
• VESIcare LS

Dosage Forms:

• Suspension
• Tablet

Classifications:

Therapeutic—

Urinary Antispasmodic

Pharmacologic—

Solifenacin

Uses of This Medicine:

Solifenacin is used to treat bladder problems, including neurogenic detrusor overactivity and symptoms of an overactive bladder, such as incontinence (loss of bladder control), a strong need to urinate right away, or a frequent need to urinate. It works on the muscles of the bladder to increase the amount of urine your bladder can hold and prevent them from causing incontinence.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of solifenacin oral liquid in children 2 years of age and older. Safety and efficacy have not been established in children younger than 2 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of solifenacin tablets in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of solifenacin oral liquid in geriatric patients.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of solifenacin tablets in the elderly. However, elderly patients are more sensitive to effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Fluconazole
• Itraconazole
• Ketoconazole
• Levoketoconazole
• Mesoridazine
• Nelfinavir
• Pimozide
• Piperaquine
• Posaconazole
• Potassium Citrate
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Alfuzosin
• Amantadine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Buprenorphine
• Bupropion
• Buserelin
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Codeine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Etrasimod
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Ivabradine
• Ivosidenib
• Lapatinib
• Lefamulin
• Lenvatinib
• LetibotulinumtoxinA-wlbg
• Leuprolide
• Levofloxacin
• Lofexidine
• Lopinavir
• Lumefantrine
• Macimorelin
• Mefloquine
• Methacholine
• Methadone
• Methotrimeprazine
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nafarelin
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Oliceridine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxycodone
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Pimavanserin
• Pipamperone
• Pitolisant
• Ponesimod
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Revefenacin
• Ribociclib
• Risperidone
• Scopolamine
• Secretin Human
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sorafenib
• Sotalol
• Sufentanil
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telavancin
• Tetrabenazine
• Tiotropium
• Tolterodine
• Toremifene
• Tramadol
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zotepine
• Zuclopenthixol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Glaucoma, narrow-angle and controlled or
• Heart rhythm problem (eg, QT prolongation), history of or
• Stomach or bowel problems (eg, constipation) or
• Urinary blockage—Use with caution. May make these conditions worse.

• Glaucoma, narrow-angle and uncontrolled or
• Liver disease, severe or
• Stomach problems (eg, gastric retention) or
• Urinary problems (eg, urinary retention)—Should not be used in patients with these conditions.

• Kidney disease, severe or
• Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for side effects.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Swallow the tablet whole with water. Do not crush, break, or chew it. You may take it with or without food.

To use the oral liquid:

• Shake the bottle well just before taking each dose.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• It is best to drink water or milk after taking this medicine. Do not take it at the same with food or other drinks, as it may cause a bitter taste.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (suspension):
  • For neurogenic detrusor overactivity:
    • Children 2 years of age and older—Dose is based on body and must be determined by your doctor:
      • Weighing more than 60 kilograms (kg)—At first, 5 milliliters (mL) once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 10 mL per day.
      • Weighing more than 45 to 60 kg—At first, 4 mL once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 8 mL per day.
      • Weighing more than 30 to 45 kg—At first, 3 mL once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 6 mL per day.
      • Weighing more than 15 to 30 kg—At first, 3 mL once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 5 mL per day.
      • Weighing 9 to 15 kg—At first, 2 mL once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 4 mL per day.
    • Children younger than 2 years of age or weighing less than 9 kg—Use and dose must be determined by your doctor.
• For oral dosage form (tablets):
  • For symptoms of an overactive bladder:
    • Adults—At first, 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 10 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of the oral liquid and it is less than 12 hours from your regular schedule, take the dose as soon as you can. If you miss a dose and it is more than 12 hours, skip the missed dose and go back to your regular dosing schedule.

If you miss a dose of the tablet, skip the missed dose and go back to your regular dosing schedule.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Dispose any unused oral liquid 28 days after first opening the bottle.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

Solifenacin may cause serious types of allergic reactions called angioedema and anaphylaxis, which may be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, or chest tightness while you are using this medicine.

This medicine may cause some people to become dizzy, drowsy, or have blurred vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke.

This medicine may cause constipation. Call your doctor if you get severe stomach pain or become constipated for 3 or more days.

This medicine may cause dry mouth. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Constipation

stomach pain

Less common

Bladder pain

bloody or cloudy urine

blurred vision

chills

decrease in the frequency of urination

decrease in urine volume

difficult, burning, or painful urination

dizziness

dry eyes

fever

frequent urge to urinate

headache

lower back or side pain

nervousness

pounding in the ears

slow or fast heartbeat

swelling of the lower legs

unusual tiredness or weakness

Incidence not known

Bloating or swelling of the face, arms, hands, lower legs, or feet

body aches or pain

chest pain or discomfort

confusion

cough

decreased or increased sweating

diarrhea

discouragement

dry skin

fainting

feeling sad or empty

general feeling of discomfort or illness

hives or welts, itching, skin rash

hoarseness

irregular heartbeat recurrent

irritability

joint pain

lack of appetite

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of interest or pleasure

muscle aches and pains

redness of the skin

runny or stuffy nose

seeing, hearing, or feeling things that are not there

shivering

sore throat

tender, swollen glands in the neck

tingling of the hands or feet

trouble concentrating

trouble with sleeping

trouble with swallowing

unusual weight gain or loss

voice changes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Dry mouth

Less common

Acid or sour stomach

belching

heartburn

indigestion

nausea

stomach discomfort or upset

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.