The active substance of Solifenacin belongs to the group of anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This enables you to wait longer before having to go to the bathroom and increases the amount of urine that can be held by your bladder. Solifenacin is used to treat the symptoms of a condition called overactive bladder. These symptoms include: having a strong, sudden urge to urinate without prior warning, having to urinate frequently or wetting yourself because you could not get to the bathroom in time.
||•if you have an inability to pass water or to empty your bladder completely (urinary retention)
•if you have a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis)
•if you suffer from the muscle disease called myasthenia gravis, which can cause an extreme weakness of certain muscles
•if you suffer from increased pressure in the eyes, with gradual loss of eye sight (glaucoma)
•if you are allergic (hypersensitive) to solifenacin or any of the other ingredients of Solifenacin
•if you are undergoing kidney dialysis
•if you have severe liver disease
•if you suffer from severe kidney disease or moderate liver disease AND at the same time are being treated with medicines that may decrease the removal of Solifenacin from the body (for example, ketoconazole). Your doctor or pharmacist will have informed you if this is the case. Inform your doctor if you have or ever had any of the above mentioned conditions before treatment with Solifenacin starts.
|Drug Special Care
||•if you have trouble emptying your 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 you have some obstruction of the digestive system (constipation).
•if you are at risk of your digestive system slowing down (stomach and bowel movements). Your doctor will have informed you if this is the case.
•if you suffer from severe kidney disease.
•if you have moderate liver disease.
•if you have a stomach tear (hiatus hernia) or heartburn.
•if you have a nervous disorder (autonomic neuropathy).
Solifenacin is not to be used in children or adolescents under 18 years.
Inform your doctor if you have or ever had any of the above mentioned conditions before treatment with Solifenacin starts.
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 solifenacin succinate (Solifenacin). If angioedema occurs, solifenacin succinate (Solifenacin) should be discontinued immediately and appropriate therapy and/or measures should be taken. Before starting Solifenacin, your doctor will assess whether there are other causes for your need to pass urine frequently (for example heart failure (insufficient pumping power of the heart) or kidney disease). If you have a urinary tract infection, your doctor will prescribe you an antibiotic (a treatment against particular bacterial infections).
|Drug Drug Interactions
||Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important to inform your doctor if you are taking:
•other anticholinergic medicines, effects and side effects of both medications can be enhanced.
•cholinergics as they can reduce the effect of Solifenacin.
•medicines, like metoclopramide and cisapride,
which make the digestive system work faster. Solifenacin can reduce their effect.
•medicines, like ketoconazole, ritonavir, nelfinavir, intraconazole, verapamil and
diltiazem, which decrease the rate at which Solifenacin is broken down by the body
•medicines like rifampicin, phenytoin and carbamazepine, as they may increase the rate at which Solifenacin is broken down by the body.
•medicines such as bisphosphonates, that can cause or exacerbate inflammation of the gullet (oesophagitis).
|Drug Pregnancy Interaction
||You should not use Solifenacin if you are pregnant unless clearly necessary. Do not use Solifenacin
|Drug Breast feeding Interaction
||if you are breast-feeding as solifenacin may get into your breast milk.
Ask your doctor or pharmacist for advice before taking this medicine.
|Drug Machinery Interaction
||Solifenacin may cause blurred vision and sometimes sleepiness or tiredness. If you suffer from any of these side effects, do not drive or operate machinery.
|Drug More Information
||Solifenacin can be taken with or without food, depending on your preference.
|How to take the
||The usual dose is 5 mg per day, unless your doctor told you to take 10 mg per day.
||Always take Solifenacin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You should swallow the whole tablet with some liquid. It can be taken with or without food, according to your preference. Do not crush the tablets.
|Excess Drug Consumption
||If you have taken too much Solifenacin or if a child has accidentally taken Solifenacin, contact your 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).
|Forgot Drug Consumption
||If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time to take your next dose. Never take more than one dose per day. If you are in doubt, always consult your doctor or pharmacist.
|Stop Drug Consumption
||If you stop taking Solifenacin, your symptoms of overactive bladder may return or worsen. Always consult your doctor, if you are considering stopping the treatment.
|Common Drug Side Effects
• constipation, nausea, indigestion with symptoms such as abdominal fullness, abdominal pain, burping, nausea, and heartburn (dyspepsia), stomach discomfort
|Rare Drug Side Effects
||• 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)
|Very Rare Drug Side Effects
• changes in the electrical activity of the heart (ECG), irregular heartbeat (Torsade de Pointes)
• skin allergy that results in the swelling that occurs in the tissue just below the surface of the skin (angioedema).
|Drug Side Effects Symptoms
||•urinary tract infection, bladder infection
•impaired sense of taste (dysgeusia)
•dry (irritated) eyes
•dry nasal passages
•reflux disease (gastro-oesophageal reflux)
•difficulty in passing urine
•accumulation of fluid in the lower legs (oedema)
|How to Store the
|How to Store the Medicine
||There are no special precautions for storage. Keep out of the reach and sight of children. Do not use Solifenacin after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.