What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL35533/0140 .


Solifenacin succinate 5mg/10mg film-coated tablets

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Solifenacin succinate 5mg film-coated tablets

Solifenacin succinate 10mg film-coated tablets

Solifenacin succinate

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

  • 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.

What is in this leaflet

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

1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR

The active substance solifenacin succinate belongs to the group of medicines called anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This enables you to wait longer before having to go to the bathroom and increases the amount of urine that can be held by your bladder.

This medicine is used to treat the symptoms of a condition called overactive bladder. These symptoms include: having a strong, sudden urge to urinate without prior warning, having to urinate frequently or wetting yourself because you could not get to the bathroom in time.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE

Do not take this medicine

  • 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 succinate 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 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine

  • 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).

Inform your doctor if you have or ever had any of the above conditions before treatment with solifenacin succinate starts.

Before you start taking this medicine, 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).

Children and adolescents

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

Other medicines and solifenacin succinate

Tell your doctor or pharmacist if you are taking or 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 medicines can be enhanced.
  • cholinergics as they can reduce the effect of solifenacin succinate.
  • medicines like metoclopramide and cisapride which make the digestive system work faster. This medicine can reduce their effect.
  • medicines like ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil and diltiazem which decrease the rate at which this medicine is broken down by the body.
  • medicines like rifampicin, phenytoin and carbamazepine, as they may increase the rate at which this medicine is broken down by the body.
  • medicines such as bisphosphonates, that can cause or exacerbate inflammation of the gullet (oesophagitis).

This medicine with food and drink

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

Pregnancy and breast-feeding

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

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

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

Driving and using machines

This medicine may cause blurred vision and sometimes sleepiness or tiredness. If you suffer from any of these side effects, do not drive or operate machinery.

This medicine contains lactose

If you have been told by your doctor that you have a rare hereditary problem of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption you should not use this medicine.

3. HOW TO TAKE THIS MEDICINE

Instructions for proper use

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

If you take more solifenacin succinate than you should

If you have taken too much of this medicine 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 this medicine

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 this medicine

If you stop taking this medicine, your symptoms of overactive bladder may return or worsen.

Always consult your doctor if you are considering stopping the treatment.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience an allergic attack, or a severe skin reaction (e.g. blistering and peeling of the skin), you must inform your doctor or pharmacist immediately.

Angioedema (skin allergy that results in swelling that occurs in the tissue just below the surface of the skin) with airway obstruction (difficulty in breathing) has been reported in some patients on solifenacin succinate. If angioedema occurs, solifenacin succinate should be discontinued immediately and appropriate therapy and/or measures should be taken.

This medicine may cause the following other side effects:

Very common (may affect more than 1 in 10 people)

  • dry mouth

Common (may affect up to 1 in 10 people)

  • blurred vision
  • constipation, nausea, indigestion with symptoms such as abdominal fullness, abdominal pain, burping, nausea, and heartburn (dyspepsia), stomach discomfort

Uncommon (may affect up to 1 in 100 people)

  • urinary tract infection, bladder infection
  • sleepiness, impaired sense of taste (dysgeusia)
  • dry (irritated) eyes
  • dry nasal passages
  • reflux disease (gastro-oesophageal reflux), dry throat
  • dry skin
  • difficulty in passing urine
  • tiredness, accumulation of fluid in the lower legs (oedema)

Rare (may affect up to 1 in 1,000 people)

  • lodging of a large amount of hardened stool in the large intestine (faecal impaction)
  • build up of urine in the bladder due to inability to empty the bladder (urinary retention)
  • dizziness, headache
  • vomiting
  • itching, rash

Very rare (may affect up to 1 in 10,000 people)

  • hallucinations, confusion
  • allergic rash

Not known (frequency cannot be estimated from the available data)

  • decreased appetite, high levels of blood potassium which can cause abnormal heart rhythm
  • increased pressure in the eyes
  • changes in the electrical activity of the heart (ECG), irregular heartbeat, feeling your heartbeat, faster heartbeat
  • voice disorder
  • liver disorder
  • muscle weakness
  • renal disorder

Reporting of side effects

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 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.

5. HOW TO STORE THIS MEDICINE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

There are no special precautions for storage.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What this medicine contains

The active substance is solifenacin succinate.

The other ingredients are maize starch, lactose monohydrate, hypromellose, magnesium stearate, silica colloidal anhydrous, propyl gallate, polyethylene glycol, talc, titanium dioxide (E171) and iron oxide red (E172).

5mg tablets only: iron oxide yellow (E172).

What this medicine looks like and contents of the pack

Solifenacin succinate film-coated tablets are available in two strengths:

5mg tablets are pink coloured, round, biconvex, film-coated tablets marked with “5” on one side.

10mg tablets are red-brown coloured, round, biconvex, film-coated tablets marked with “10” on one side.

Available in pack sizes of 10, 20, 30, 50, 90, 100 film-coated tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aspire Pharma Limited
Unit 4
Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom

Manufacturer(s)

Delorbis Pharmaceuticals Limited
17 Athinon Street
Ergates Industrial Area
Ergates
Lefkosia
2643
Cyprus

Or

Medis International a.s.
Production plant Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic

This leaflet was last revised in 08/2018.

1010466 - P1.6