Vesicare

Solifenacin succinate.

The active substance is solifenacin succinate 5 mg or 10 mg.
Excipients/Inactive Ingredients: The other ingredients are maize starch, lactose, hypromellose (E464), magnesium stearate, macrogol, talc, titanium dioxide (E171) and iron oxide (E172).

The active substance of Vesicare belongs to the group of anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This enables the patient to wait longer before having to go to the bathroom and increases the amount of urine that can be held by the bladder.

Vesicare is used to treat the symptoms of condition called overactive bladder. These symptoms include: having a strong, sudden urge to urinate without prior warning, having to urinate frequently or wetting.

Instructions for proper use: Always take this medicine exactly as advised by the doctor. Check with the doctor or pharmacist if unsure.
The whole tablet should be swallowed with some liquid. It can be taken with or without food, according to the preference. Do not crush the tablets.
The usual dose is 5 mg per day, unless advised by the doctor to take 10 mg per day.
If the patient forgets to take Vesicare: If taking a dose at the usual time has been forgotten, take it as soon as remembered, unless it is time to take the next dose. Never take more than one dose per day. If in doubt, always consult the doctor or pharmacist.
If the patient stops taking Vesicare: If the patient stops taking Vesicare, the symptoms of overactive bladder may return or worsen. Always consult the doctor, if considering stopping the treatment.
For any further questions on the use of this product, ask the doctor or pharmacist.

If too much Vesicare has been taken or if a child has accidentally taken Vesicare, contact the doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and blurred vision, perceiving things that are not there (hallucinations), over-excitability, seizures (convulsions), difficulty breathing, elevated heart rate (tachycardia), accumulation of urine in the bladder (urinary retention) and dilated pupils (mydriasis).

The patient should not take Vesicare: if the patient has an inability to pass water or to empty the bladder completely (urinary retention); if the patient has a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis); if the patient suffers from the muscle disease called myasthenia gravis, which can cause an extreme weakness of certain muscles; if the patient suffers from increased pressure in the eyes, with gradual loss of eye sight (glaucoma); if the patient is allergic to solifenacin or any of the other ingredients of this medicine (listed in Description); if the patient is undergoing kidney dialysis; if the patient has severe liver disease; if the patient suffers from severe kidney disease or moderate liver disease and at the same time is being treated with medicines that may decrease the removal of Vesicare from the body (for example, ketoconazole) [The doctor or pharmacist will have informed the patient if this is the case].
The doctor should be informed if the patient has or ever had any of the previously mentioned conditions before treatment with Vesicare starts.

The patient should talk to the doctor or pharmacist before taking Vesicare: if the patient has trouble emptying the bladder (= bladder obstruction) or has difficulty in passing urine (e.g. a thin urine flow) [Risk of accumulation of urine in the bladder (urinary retention) is much higher]; if the patient has some obstruction of the digestive system (constipation); if the patient is at risk of the digestive system slowing down (stomach and bowel movements) [The doctor will have informed the patient if this is the case]; if the patient suffers from severe kidney disease; if the patient has moderate liver disease; if the patient has a stomach tear (hiatus hernia) or heartburn; if the patient has a nervous disorder (autonomic neuropathy).
Changes in the electrical activity of the heart (ECG) and irregular heartbeat (Torsade de Pointes) have been reported in patients with risk factors, such as pre-existing abnormal ECG and high levels of potassium.
The doctor should be informed if the patient has or ever had any of the previously mentioned conditions before treatment with Vesicare starts.
Anaphylactic reactions (the symptoms include hives, difficulty breathing, abdominal cramps, rapid heartbeat and feeling faint), which could be life threatening, have been reported in some patients taking VESICARE. If any of these symptoms are experienced, stop taking Vesicare and see the doctor immediately.
Angioedema (skin allergy that results in the swelling that occurs in the tissue just below the surface of the skin) with airway obstruction (difficulty in breathing) has been reported in some patients on Vesicare. If angioedema occurs, Vesicare should be discontinued immediately and appropriate therapy and/or measures should be taken.
Before starting Vesicare, the doctor will assess whether there are other causes for the need to pass urine frequently (for example heart failure (insufficient pumping power of the heart) or kidney disease). If the patient has a urinary tract infection, the doctor will prescribe an antibiotic (a treatment against particular bacterial infections).
Vesicare contains lactose: This medicine should not be used if the patient has a rare hereditary problem of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Driving and using machines: Vesicare may cause blurred vision and sometimes sleepiness or tiredness. If suffering from any of these side effects, do not drive or operate machinery.
Use in Children: Vesicare is not to be used in children or adolescents under 18 years.

Vesicare should not be used if the patient is pregnant unless clearly necessary. Do not use Vesicare if breast-feeding as solifenacin may get into the breast milk.
Ask the doctor or pharmacist for advice before taking this medicine.

Like all medicines, Vesicare can cause side effects, although not everybody gets them.
If an allergic attack, or a severe skin reaction (e.g. blistering and peeling of the skin) is experienced, the doctor or pharmacist must be informed immediately.
Vesicare may cause the following other side effects: Very common (may affect more than 1 in 10 people): dry mouth.
Common (may affect up to 1 in 10 people): blurred vision; constipation, nausea, indigestion with symptoms such as abdominal fullness, abdominal pain, burping, nausea, and heartburn (dyspepsia), stomach discomfort.
Uncommon (may affect up to 1 in 100 people): urinary tract infection, bladder infection; sleepiness; impaired sense of taste (dysgeusia); dry (irritated) eyes; dry nasal passages; reflux disease (gastro-oesophageal reflux); dry throat; dry skin; difficulty in passing urine; tiredness; accumulation of fluid in the lower legs (oedema).
Rare (may affect up to 1 in 1,000 people): lodging of a large amount of hardened stool in the large intestine (faecal impaction); build up of urine in the bladder due to inability to empty the bladder (urinary retention); dizziness, headache; vomiting; itching, rash.
Very rare (may affect up to 1 in 10,000 people): hallucinations, confusion; severe skin rash, itchiness and fever (erythema multiforme); allergic rash; skin allergy that results in the swelling that occurs in the tissue just below the surface of the skin (angioedema).
Not known (frequency cannot be estimated from the available data): anaphylactic reactions (hives, difficulty breathing, abdominal cramps, rapid heartbeat and feeling faint); decreased appetite; high levels of blood potassium which can cause abnormal heart rhythm; delirious state; increased pressure in the eyes; changes in the electrical activity of the heart (ECG), irregular heartbeat (Torsade de Pointes, atrial fibrillation), feeling the heartbeat, faster heartbeat; voice disorder; intestinal blockage; abdominal discomfort; liver disorder; severe skin scaling and redness, itching (exfoliative dermatitis); muscle weakness; renal disorder.
If any side effects occur, talk to the doctor or pharmacist. This includes any side effects not listed.

Tell the doctor or pharmacist if taking or have recently taken or might take other medicines.
It is especially important to inform the doctor if taking: other anticholinergic medicines, effects and side effects of both medications can be enhanced; cholinergics as they can reduce the effect of Vesicare; medicines, like metoclopramide and cisapride, which make the digestive system work faster [Vesicare can reduce their effect]; medicines, like ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil and diltiazem, which decrease the rate at which Vesicare is broken down by the body; medicines like rifampicin, phenytoin and carbamazepine, as they may increase the rate at which Vesicare is broken down by the body; medicines such as bisphosphonates, that can cause or exacerbate inflammation of the gullet (oesophagitis).
Vesicare with food and drink: Vesicare can be taken with or without food, depending on the preference.

Store at or below 30°C.

Drugs for Bladder & Prostate Disorders

G04BD08 - solifenacin ; Belongs to the class of urinary antispasmodics.

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