The active substance in Vesistad belongs to a group of medicines called anticholinergics. These medicines are used to reduce an overactive bladder. This allows you to wait longer before you need to go to the toilet and allows your bladder to store more urine.

Vesistad is used to treat the symptoms of a condition called overactive bladder syndrome. These symptoms include: a sudden and urgent need to urinate, a need to urinate very frequently, urine leakage caused by not being able to get to the toilet in time.

Do not take Vesistad:
– if you are unable to urinate or completely empty your bladder (urinary retention).
– if you have a severe stomach or intestinal disorder (including toxic megacolon, a
complication associated with ulcerative colitis).
– if you have a muscle disorder called myasthenia gravis, which can cause extreme weakness of certain muscles.
– if you have increased pressure inside the eyes, with gradual loss of vision (glaucoma).
– if you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6).
– if you are undergoing hemodialysis.
– if you have severe liver failure.
– if you have severe kidney failure or moderate liver failure AND at the same time you are taking medicines that can reduce the elimination of Vesistad from the body (for example, ketoconazole).
Your doctor or pharmacist will inform you if this was the case.

Please tell your doctor if you have or have ever had any of the above medical conditions before starting treatment with this medicine.

Talk to your doctor or pharmacist before using Vesistad.

Pregnancy and breastfeeding:
Do not take Vesistad if you are pregnant, unless your doctor considers it necessary. Do not take
Vesistad if you are breast-feeding, as solifenacin may pass into breast milk.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines:
Vesistad may cause blurred vision and sometimes drowsiness or tiredness. If you experience any of these side effects, do not drive or use machines.

Vesistad contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicine.

Instructions for correct use
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage:
The recommended dose is 5 mg per day, unless your doctor has told you to take 10 mg per day.

Method of administration:
The tablet should be swallowed whole with a glass of water. It can be taken with or without food, as preferred. Do not crush the tablets.

Use in children and adolescents:
Vesistad should not be used in children and adolescents under 18 years of age.

If you have any further questions on this medicine, ask your doctor or pharmacist.

- The active substance is solifenacin succinate.
Each Vesistad 5 mg film-coated tablet contains 5 mg solifenacin succinate, equivalent to 3.8 mg solifenacin.
Each Vesistad 10 mg film-coated tablet contains 10 mg solifenacin succinate, equivalent to 7.5 mg solifenacin.
- The other components are:
Core: lactose monohydrate, corn starch, hypromellose, magnesium stearate.
Film coating: hypromellose, titanium dioxide (E171), macrogol 8000, talc and iron oxide yellow (E172) iron oxide red (E172).

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

30 film-coated tablets