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

• if you are allergic to solifenacin succinate or any of the other ingredients of this medicine (listed in section 6).
• if you are unable 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 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 succinate 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 succinate starts.

Talk to your doctor or pharmacist before taking solifenacin succinate, 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.
• 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 succinate starts.

Before starting Solifenacin succinate, 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 succinate 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, as the 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 succinate can reduce their effect.
• medicines, like ketoconazole, itraconazole (medicines used to treat fungal infections), ritonavir, nelfinavir (medicines used to treat HIV infections) and verapamil, diltiazem (medicines used to treat high blood pressure and heart diseases). These medicines decrease the rate at which solifenacin succinate is broken down by the body.
• medicines like rifampicin (medicine used to treat tuberculosis and other bacterial infections) and phenytoin, carbamazepine (medicines used to treat epilepsy). These medicines 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).

If you are taking any other medicine, please ask your doctor if your medicine belongs to any of the above mentioned groups.

Solifenacin succinate 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 succinate if you are pregnant unless clearly necessary. Do not use Solifenacin succinate 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.

Always take this medicine exactly as your doctor or pharmacist has told you. 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.

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

If you have taken too much Solifenacin succinate or if a child has accidentally taken solifenacin succinate, 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 dose. If you are in doubt, always consult your doctor or pharmacist.

If you stop taking solifenacin succinate, 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 Yellow Card Scheme.

Website: 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

• Each Solifenacin succinate 5 mg film-coated tablets contains 5 mg of solifenacin succinate.
• Each Solifenacin succinate 10 mg film-coated tablets contains 10 mg of solifenacin succinate
• The other ingredients are lactose monohydrate, hydroxypropyl methylcellulose, magnesium stearate, HPMC 2910/Hypromellose (6mPas), titanium dioxide, triacetin, talc, iron oxide yellow (5 mg), iron oxide red (10 mg)

Solifenacin succinate 5 mg film-coated tablets are light yellow coloured, round shaped, biconvex film-coated tablets debossed with ‘S5’ on one side and plain on other side.

Solifenacin succinate 10 mg film-coated tablets are light pink coloured, round shaped, biconvex film-coated tablets debossed with ‘S10’ on one side and plain on other side.

Solifenacin succinate tablets are supplied in blister packs of 10, 20, 30, 50 and 90 tablets.

Not all pack sizes may be marketed.