Solifenacin succinate 5 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Solifenacin is and what it is used for
2. What you need to know before you take Solifenacin
3. How to take Solifenacin
4. Possible side effects
5. How to store Solifenacin
6. Contents of the pack and other information

• are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6).
• have an inability to pass water or to empty your bladder completely (urinary retention).
• have a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis).
• suffer from the muscle disease called myasthenia gravis, which can cause an extreme weakness of certain muscles.
• suffer from increased pressure in the eyes, with gradual loss of eye sight (glaucoma).
• are undergoing kidney dialysis.
• 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 (for example, ketoconazole). Your doctor or pharmacist will have informed you if this is the case.

Talk to your doctor or pharmacist before taking 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.
• have some obstruction of the digestive system (constipation).
• are at risk of your digestive system slowing down (stomach and bowel movements). Your doctor will have informed you if this is the case.
• suffer from severe kidney disease.
• have moderate liver disease.
• are being treated with medicines that may decrease the removal of solifenacin from the body (for example, ketoconazole).
• have a stomach tear (hiatus hernia) or heartburn.
• 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 (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).

Solifenacin is not to be used in children or adolescents under 18 years.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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, itraconazole, 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).

It can be taken with or without food, depending on your preference.

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

You should not use solifenacin if you are pregnant unless clearly necessary.

Do not use solifenacin if you are breast-feeding as solifenacin may get into your breast milk.

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.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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).

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.

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.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine

• The active substance is solifenacin succinate.
  Solifenacin 5 mg: Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8 mg solifenacin.
  Solifenacin 10 mg: Each tablet contains 10 mg solifenacin succinate, corresponding to 7.5 mg solifenacin.
• The other ingredients are:
  Core tablet: Maize starch pregelatinized; lactose monohydrate; cellulose, microcrystalline; hypromellose; magnesium stearate.
  Film coating: Macrogol 6000; talc; hypromellose; titanium dioxide (E171); Iron oxide yellow (E172) - Solifenacin 5 mg; Iron oxide red (E172) - Solifenacin 10 mg

Solifenacin 5 mg is a white to yellowish rounded biconvex film-coated tablet with a diameter of 8.0-8.2 mm.

Solifenacin 10 mg is a pinkish rounded biconvex film-coated tablet with a diameter of 10.0-10.2mm.

Solifenacin is supplied in blister packs of 10, 30, 50, 90 and 100 film-coated tablets.

Not all pack sizes may be marketed.