Solifenacin

Overactive bladder occurs when the bladder muscles contract involuntarily, leading to a strong, sudden urge to urinate even when the bladder contains only a little bit of urine, or wetting yourself because you could not get to the bathroom in time.  

Solifenacin is used to treat the symptoms of an overactive bladder. The active ingredient solifenacin relaxes the bladder muscles. This enables you to wait longer before having to go to the bathroom, increases the amount of urine that can be held by your bladder and reduces the need to pass urine more often or urgently. 

Instructions for use are as follows: 

• The tablet should be swallowed whole with a drink. 
• Do not crush or chew the tablet. 
• The tablet can be taken with or without food. 

Dosage 

Solifenacin is available in two strengths: 5 mg and 10 mg. Your doctor will decide which strength is best for you. 

• The usual is dose is 5 mg per day, unless your doctor told you to take 10 mg per day. 

This medicine is not suitable for use in children under 18 years of age. 

Alcohol/driving 

This medicine does not interact with alcohol. 

Solifenacin may cause blurred vision and sometimes drowsiness or fatigue. If you suffer from any of these side effects, do not drive or operate machinery. 

Taken too much/forgot to take/stop taking Solifenacin 

If you have taken too many Solifenacin tablets or if a child has accidentally taken Solifenacin tablets, 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). 

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. Do not take a double dose to make up for a forgotten tablet. 

If you stop taking this medicine, your symptoms of overactive bladder may return or worsen. Always consult your doctor if you are considering stopping the treatment. 

Solifenacin is not suitable for everyone. Do not take this medicine if: 

• You are allergic any of the ingredients in this medicine (see section ‘What Solifenacin contains'). 
• You have an inability to pass water or to empty your bladder completely (urinary retention). 
• You have a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis). 
• You suffer from the muscle disease called myasthenia gravis, which can cause an extreme weakness of certain muscles. 
• You suffer from increased pressure in the eyes, with gradual loss of eyesight (glaucoma). 
• You are undergoing kidney dialysis. 
• You have severe liver disease. 
• 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 (e.g., 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. 

When should Solifenacin be used with caution? 

Talk to your doctor or pharmacist before taking using Solifenacin 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. 
• You have some obstruction of the digestive system (constipation). 
• 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. 
• You suffer from severe kidney disease. 
• You have moderate liver disease. 
• You have a stomach tear (hiatus hernia) or heartburn. 
• You have a nervous disorder (autonomic neuropathy). 

Inform your doctor if you have or ever had any of the above-mentioned conditions before treatment with Solifenacin starts.  

Before starting Solifenacin, your doctor will assess whether there are other causes for your need to pass urine frequently. 

Pregnancy and breastfeeding 

If you are pregnant or breastfeeding, think you may be pregnant, are planning to have a baby or breastfeeding, ask your doctor or pharmacist for advice before using this medicine. 

Other medicines and Solifenacin 

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products. 

Solifenacin can affect the way some medicines work and some medicines can have an effect on Solifenacin. For a list of these medicines, please see the package leaflet. Your doctor will have a list of medication that you should avoid mixing Solifenacin with. 

Like all medicines, this medicine can cause side effects, although some people may not experience any.  

If you experience an allergic attack, or a severe skin reaction (e.g., blistering and peeling of the skin or angioedema), you must inform your doctor or pharmacist immediately. See the package leaflet for more information. 

Solifenacin 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 and heartburn (dyspepsia), stomach discomfort. 

Uncommon (may affect up to 1 in 100 people): 

• Urinary infections, bladder infection (cystitis). 
• 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. 
• Fatigue. 
• Moisture accumulation in the lower limbs (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. 

This list is not exhaustive. For a complete list of possible side effects, see the package leaflet. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the package leaflet. 

The active substance is solifenacin succinate.  

• Solifenacin 5 mg: each film-coated tablet contains 5 mg solifenacin succinate. 
• Solifenacin 10 mg: each film-coated tablet contains 10 mg solifenacin succinate.