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

• if you have an inability 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 allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6),
• 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 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 starts.

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,
• if you have some obstruction of the digestive system (constipation),
• if 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,
• if you suffer from severe kidney disease,
• if you have moderate liver disease,
• if you have a stomach tear (hiatus hernia) or heartburn,
• if you have a nervous disorder (autonomic neuropathy).

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

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).

Tell your doctor 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).

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

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.

Ask your doctor or pharmacist for advice before taking this medicine.

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 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 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 succinate 5 mg Film-coated Tablets: each film-coated tablet contains 5 mg of solifenacin succinate corresponding to 3.8 mg of solifenacin.
  Solifenacin succinate 10 mg Film-coated Tablets: each film-coated tablet contains 10 mg of solifenacin succinate corresponding to 7.5 mg of solifenacin.
• The other ingredients are:
  Tablet core: lactose monohydrate, hypromellose (E464), magnesium stearate (E572).
  Tablet coating:
  Solifenacin succinate 5 mg Film-coated Tablets: Opadry yellow (hypromellose (E464), titanium dioxide (E171), triacetin (E1518), talc (E553b), iron oxide yellow (E172)).
  Solifenacin succinate 10 mg Film-coated Tablets: Opadry pink (hypromellose (E464), titanium dioxide (E171), triacetin (E1518), talc (E553b), iron oxide red (E172)).

Solifenacin succinate 5 mg Film-coated Tablets: 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: light pink coloured, round shaped, biconvex film-coated tablets debossed with ‘S10’ on one side and plain on other side.

Tablets are packed in PVC/PVdC-Al blister in carton box.

Pack size: 10, 20, 30, 50, 60, 90, 100 and 200 film-coated tablets.

Not all pack sizes may be marketed.

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