Vesicare衛喜康

Vesicare

solifenacin

Manufacturer:

Astellas

Distributor:

Firma Chun Cheong
/
DKSH
Full Prescribing Info
Contents
Solifenacin succinate.
Description
The active ingredient is solifenacin succinate 5 mg or 10 mg.
Excipients/Inactive Ingredients: maize starch, lactose, hypromellose (E464), magnesium stearate, macrogol, talc, titanium dioxide (E171) and iron oxide (E172).
Action
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.
Indications/Uses
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.
Dosage/Direction for Use
Instructions for proper use: Always take this medicine exactly as advised by the doctor. Check with the doctor or pharmacist if not sure.
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 a dose is forgotten to take at the usual time, 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 further questions on the use of this product, ask the doctor or pharmacist.
Overdosage
If Vesicare is taken more than it should: If taken too much Vesicare 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).
Contraindications
Do not take Vesicare: If the patient has an inability to pass water or to empty the bladder completely (urinary retention).
Have a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis).
Suffers from the muscle disease called myasthenia gravis, which can cause an extreme weakness of certain muscles.
Suffers from increased pressure in the eyes, with gradual loss of eye sight (glaucoma).
Allergic to solifenacin or any of the other ingredients of this medicine (listed in Description).
Undergoing kidney dialysis.
Have severe liver disease.
Suffers from severe kidney disease or moderate liver disease AND at the same time are 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.
Inform the doctor if the patient has or ever had any of the previously mentioned conditions before treatment with Vesicare starts.
Special Precautions
Talk to the doctor or pharmacist before taking Vesicare: If having a trouble emptying the bladder (= bladder obstruction) or have difficulty in passing urine (e.g. a thin urine flow). Risk of accumulation of urine in the bladder (urinary retention) is much higher.
If having some obstruction of the digestive system (constipation).
If 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 suffering from severe kidney disease.
If having moderate liver disease.
If having a stomach tear (hiatus hernia) or heartburn.
If having 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.
Inform the doctor 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.
Use In Pregnancy & Lactation
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.
Side Effects
Like all medicines, Vesicare can cause side effects, although not everybody gets them.
If 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 1000 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.
Drug Interactions
Other medicines and Vesicare: The doctor or pharmacist must know if the patient is 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.
Storage
Store at or below 25°C.
ATC Classification
G04BD08 - solifenacin ; Belongs to the class of urinary antispasmodics.
Presentation/Packing
FC tab 5 mg (round, light yellow, marked with the company logo and the code "150" on the same side) x 30's. 10 mg (round, light pink, marked with the company logo and the code "151" on the same side) x 30's.
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