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How does it work?

This medicine contains the active ingredient solifenacin succinate, which is a type of medicine called an anticholinergic (or antimuscarinic) muscle relaxant. It works by relaxing the involuntary muscle that is found in the wall of the bladder.

The muscle in the wall of the bladder is called the detrusor muscle. It can sometimes contract in uncontrollable spasms, and this is often referred to as having an overactive bladder. The overactive detrusor muscle can increase in the number of times you need to pass urine, or cause uncontrollable urges to pass urine, or involuntary leakage of urine (urinary incontinence).

Solifenacin works by relaxing the detrusor muscle in the wall of the bladder. It does this by blocking receptors called cholinergic (or muscarinic) receptors that are found on the surface of the muscle cells. This prevents a natural body chemical called acetylcholine from acting on these receptors.

Normally when acetylcholine acts on these receptors, it causes the detrusor muscle to contract and the bladder to empty. By blocking acetylcholine, solifenacin helps the muscle in the bladder wall to relax. This reduces unstable, involuntary contractions of the bladder, and thereby increases the capacity of the bladder to hold urine. In turn, this reduces the need to pass urine.

It may take at least four weeks of treatment for this medicine to become fully effective.

What is it used for?

Increased need to pass urine (urinary frequency), uncontrollable urges to pass urine (urinary urgency) and involuntary leakage of urine (urinary incontinence) due to an overactive bladder

Warning!

This medicine may cause blurred vision, fatigue and sleepiness, which may affect your ability to perform potentially hazardous tasks. If affected you should avoid driving or operating machinary.

The safety and efficacy of this medicine have not been established in children and it is therefore not recommended for children.

Use with caution in

Decreased kidney function

Decreased liver function

Blockage of the outflow of urine from the bladder

Obstruction of the stomach or intestines

Risk of decreased muscle contraction in the muscles of the stomach or intestines

Gastro-oesophageal reflux disease

People taking medicines that can cause or worsen reflux oesophagitis, eg bisphosphonates such as alendronate

Hiatus hernia

Disorder of the involuntary nervous system, usually causing weakness and numbness (autonomic neuropathy)

Not to be used in

Difficulty in passing urine (urinary retention)

Abnormal muscle weakness (myasthenia gravis)

Closed angle glaucoma

Severe disorders of the stomach or intestines

Sudden expansion of the large intestine seen in advanced ulcerative colitis or Crohn's disease (toxic megacolon)

Severely decreased liver function

People having haemodialysis for kidney failure

People with severely decreased kidney function or moderately decreased liver function who are taking ketoconazole, itraconazole, ritonavir or nelfinavir

Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

Breastfeeding

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this medicine in pregnancy has not been established. It should therefore be used with caution during pregnancy, and only if the benefits to the mother outweigh any risks to the foetus. Seek medical advice from your doctor.

It is not known if this medicine passes into breast milk, therefore it should be avoided by breastfeeding mothers. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Dry mouth

Constipation

Nausea

Indigestion

Abdominal pain

Blurred vision

Sleepiness

Gastro-oesophageal reflux

Taste disturbance

Urinary tract infection

Dry eyes

Fatigue

Ankle swelling due to fluid retention

Dry nose or throat

Dry skin

Difficulty passing urine

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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