Solifenacin

Solifenacin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dry mouth
• constipation
• stomach pain
• upset stomach
• vomiting
• heartburn
• dry eyes
• blurred vision
• extreme tiredness

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• severe stomach pain
• constipation that lasts longer than 3 days
• painful or frequent urination
• bloody or cloudy urine
• back pain
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing

Solifenacin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

>10%

Dry mouth

Constipation

1-10%

Abdominal pain

Blurred vision

Constipation (with 5 mg)

Cough (with 10 mg)

Depression (with 5 mg)

Dizziness

Dry eyes

Dyspepsia

Edema (with 10 mg)

Fatigue

Hypertension (with 5 mg)

Influenza (with 5 mg)

Nausea

Pharyngitis (with 10 mg)

Urinary retention (with 10 mg)

Urinary tract infection

Vomiting (with 10 mg)

<1%

Cough (with 5 mg)

Depression (with 10 mg)

Dry eyes (with 5 mg)

Hypertension (with 10 mg)

Influenza (with 10 mg)

Lower-limb edema (with 5 mg)

Pharyngitis (with 5 mg)

Vomiting (with 5 mg)

Postmarketing Reports

General: Peripheral edema, hypersensitivity reactions (including angioedema with airway obstruction, rash, pruritus, urticaria, anaphylactic reaction)

Neurologic: Headache, confusion, hallucinations, delirium, somnolence

Cardiovascular: QT prolongation, torsades de pointes, atrial fibrillation, tachycardia, palpitations

Dermatologic: Exfoliative dermatitis, erythema multiforme

Hepatic: Liver disorders, mostly characterized by abnormal liver function test (LFT) results (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transpeptidase [GGT])

Renal: Renal impairment

Metabolic and nutritional: Decreased appetite, hyperkalemia

Musculoskeletal: Muscular weakness

Ophthalmologic: Glaucoma

Gastrointestinal (GI): Gastroesophageal reflux disease, ileus

Respiratory, thoracic, and mediastinal: Dysphonia

Solifenacin is part of the drug class:

• Drugs for urinary frequency and incontinence

• Take solifenacin exactly as your doctor tells you to take it.
• You should take 1 solifenacin tablet 1 time a day.
• You should take solifenacin with water and swallow the tablet whole.
• You can take solifenacin with or without food.
• If you miss a dose of solifenacin, begin taking solifenacin again the next day. Do not take 2 doses of solifenacin the same day.
• If you take too much solifenacin, call your doctor or go to the nearest hospital emergency room right away.

• Store solifenacin at 59°F to 86°F (15°C to 30°C). Keep the bottle closed.
• Safely throw away medicine that is out of date or that you no longer need.
• Keep solifenacin and all medicines out of the reach of children.  

Solifenacin reduces muscle spasms of the bladder and urinary tract.

Solifenacin is used to treat symptoms of overactive bladder, such as frequent or urgent urination, and incontinence (urine leakage).

Solifenacin may also be used for purposes not listed in this medication guide.

Take the missed dose on the same day you remember it. Take your next dose at the regular time the next day and stay on your once-daily schedule. Do not take extra medicine to make up the missed dose.

Do not take 2 doses on the same day.

Take solifenacin 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.

solifenacin 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 solifenacin with or without food.

Dosing

The dose of solifenacin 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 solifenacin. 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 (tablets):
  • To treat bladder problems:
    • Adults—At first, 5 milligrams (mg) as a single dose once a day. Your doctor may adjust your dose if needed. 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 solifenacin, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

• It is used to treat an overactive bladder.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take solifenacin or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to solifenacin. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

(sol i FEN a sin)

In elderly patients (65 to 80 years), Cmax, AUC, and half-life values were 20% to 25% higher.

Mild impairment (Child-Pugh class A): No dosage adjustment necessary; use with caution.

Moderate impairment (Child-Pugh class B): Maximum dose: 5 mg/day.

Severe impairment (Child-Pugh class C): Use is not recommended.

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Applies to solifenacin: oral tablet

Along with its needed effects, solifenacin 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 while taking solifenacin:

• Bladder pain
• bloody or cloudy urine
• chills
• decrease in the frequency of urination
• decrease in urine volume
• difficult, burning, or painful urination
• difficulty in passing urine (dribbling)
• fever
• frequent urge to urinate
• painful urination
• swelling of the lower legs
• unusual tiredness or weakness

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• chest pain or discomfort
• fainting
• irregular heartbeat recurrent
• irregular or slow heart rate
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• rapid weight gain
• shortness of breath
• tingling of the hands or feet
• unusual weight gain or loss

Some side effects of solifenacin 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:

• Acid or sour stomach
• belching
• body aches or pain
• congestion
• cough
• diarrhea
• discouragement
• feeling sad or empty
• general feeling of discomfort or illness
• headache
• heartburn
• hoarseness
• indigestion
• irritability
• joint pain
• lack of appetite
• loss of interest or pleasure
• lower back or side pain
• muscle aches and pains
• nervousness
• pounding in the ears
• runny nose
• shivering
• slow or fast heartbeat
• sore throat
• stomach discomfort, upset, or pain
• sweating
• tender, swollen glands in the neck
• tiredness
• trouble concentrating
• trouble with sleeping
• trouble with swallowing
• upper abdominal or stomach pain
• voice changes

• Hives or welts
• itching
• redness of the skin
• skin rash

Applies to solifenacin: oral tablet

Gastrointestinal

Very common (10% or more): Dry mouth (up to 28%), constipation (up to 13%)
Common (1% to 10%): Nausea, dyspepsia, upper abdominal pain, vomiting
Uncommon (0.1% to 1%): Gastroesophageal reflux disease, dry throat, flatulence, throat irritation, eructation, thirst
Rare (less than 0.1%): Colonic obstruction, fecal impaction
Postmarketing reports: Ileus[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, cough, sinusitis, bronchitis
Uncommon (0.1% to 1%): Nasal dryness
Postmarketing reports: Dysphonia[Ref]

Psychiatric

Common (1% to 10%): Depression
Postmarketing reports: Confusion, hallucinations, delirium, somnolence[Ref]

Ocular

Common (1% to 10%): Blurred vision, dry eyes
Very rare (less than 0.01%): Glaucoma[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, urinary retention
Uncommon (0.1% to 1%): Cystitis, suprapubic pain, bladder pain, micturition urgency[Ref]

Cardiovascular

Common (1% to 10%): Lower limb edema, hypertension
Uncommon (0.1% to 1%): Syncope, chest tightness, hot flushes
Postmarketing reports: Peripheral edema, QT prolongation, Torsade de Pointes, atrial fibrillation, tachycardia, palpitations, atrial fibrillation[Ref]

Dermatologic

Uncommon (0.1% to 1%): Dry skin
Rare (0.01% to 0.1%): Pruritus, rash
Very rare (less than 0.01%): Erythema multiforme, urticaria, angioedema, exfoliative dermatitis[Ref]

Immunologic

Common (1% to 10%): Influenza[Ref]

Metabolic

Very rare (less than 0.01%): Decreased appetite, hyperkalemia[Ref]

Hypersensitivity

Very rare (less than 0.01%): Hypersensitivity reactions (including angioedema with airway obstruction, rash, pruritus, urticaria, and anaphylactic reaction)[Ref]

Other

Common (1% to 10%): Fatigue[Ref]

Renal

Very rare (less than 0.01%): Renal impairment[Ref]

Hepatic

Postmarketing reports: Abnormal liver function tests, AST (aspartate aminotransferase), ALT (alanine aminotransferase), GGT (gamma-glutamyl transferase)[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain
Uncommon (0.1% to 1%): Neck pain
Postmarketing reports: Muscular weakness[Ref]

Nervous system

Common (1% to 10%): Dizziness, insomnia
Uncommon (0.1% to 1%): Dysgeusia
Rare (0.01% to 0.1%): Headache
Postmarketing reports: Headache, tremors[Ref]

Some side effects of solifenacin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Animal studies have failed to reveal evidence of embryotoxicity or teratogenicity when exposed to 1.2 times the maximum recommended human dose (30 mg/kg/day). Reduced fetal body weight has been observed in mice when exposed to 3.6 times the maximum recommended human dose (100 mg/kg). An increase incidence in cleft palate has been reported in mice exposed to 7.9 the maximum recommended human dose (250 mg/kg). There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comment: -This drug has been shown to cross the placenta in pregnant animals.