5 mg and 10 mg film-coated tablet (tablet)
solifenacin succinate
What Vesicare is and what it is used for
The active ingredient in Vesicare belongs to the drug group anticholinergics. These drugs suppress the overactivity of the bladder. Urinary urges become fewer and weaker and the ability to hold urine improves.
Vesicare is used to treat overactive bladder. Symptoms of an overactive bladder include frequent bladder emptying, urges, and difficulty holding urine (urinary incontinence).
The solifenacin contained in Vesicare may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Vesicare
Do not take Vesicare:
- if you have difficulty urinating or completely emptying the bladder when urinating ( urinary retention )
- if you have any serious gastrointestinal disease (including toxic megacolon, a condition that can occur in some cases in association with ulcerative colitis )
- if you have myasthenia gravis (a muscle disease with weakness in certain muscles)
- if you have uncontrolled glaucoma ( glaucoma ) with a narrow chamber angle (increased pressure and pain in the eye)
- if you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6)
- if you are undergoing dialysis
- if you have severe liver disease
- if you have severe kidney disease or moderately impaired liver function AND if you simultaneously use medicines that can reduce the breakdown of Vesicare in the body (e.g. ketoconazole ). Your doctor or pharmacist will inform you if this is the case.
Tell your doctor if you have or have had any of the above conditions before starting Vesicare treatment.
Warnings and precautions
Talk to your doctor or pharmacist before taking Vesicare.
- if you have difficulty emptying your bladder or urinating (e.g. have a weak stream of urine). The risk of urine accumulating in the bladder ( urinary retention ) is then much greater.
- if you have problems from the gastrointestinal tract causing difficulty in emptying the bowels (constipation)
- if you belong to a risk group where the digestive organs may start to work more slowly (stomach and bowel movements). If you belong to this risk group, you have been told by your doctor.
- if you have severely impaired kidney function
- if you have impaired liver function
- if you have a hernia in the upper stomach mouth ( hiatus hernia) and/or problems with heartburn.
- if you have a nerve disease (autonomic neuropathy ).
Children and young people
Vesicare should not be used by children and adolescents under 18 years of age.
Tell your doctor if you have or have had any of the above conditions before starting Vesicare treatment.
Before starting Vesicare treatment, your doctor will assess whether there are other causes of your urge to urinate (eg heart failure or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic medicine.
Other medicines and Vesicare
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
You must tell your doctor if you are taking:
- other anticholinergic drugs, effects and side effects of both drugs can be enhanced
- cholinergic medicines, as they can reduce the effect of Vesicare
- medicines such as metoclopramide and cisapride, which can make the gastrointestinal tract work faster. Vesicare can reduce the effect of these medicines.
- medicines containing ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, or diltiazem, as they may reduce the rate at which Vesicare is broken down in the body.
- medicines containing rifampicin, phenytoin, and carbamazepine as they may increase the rate at which Vesicare is broken down in the body.
- medicines such as bisphosphonates, which can cause or increase inflammation in the esophagus ( oesophagitis ).
Vesicare with food and drink
It does not matter if Vesicare is taken with or without food.
Pregnancy and breastfeeding
Vesicare should not be used during pregnancy unless necessary.
Vesicare can be excreted in breast milk. Therefore, do not use Vesicare if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving ability and use of machinery
Vesicare can affect the eye’s ability to judge distance, which must be taken into account at times when heightened attention is required, e.g. when driving. Drowsiness and fatigue may occur in rare cases, which should also be taken into account.
You are always responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Vesicare contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
How to use Vesicare
Instructions for proper use
Always take Vesicare as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The usual dose is 5 mg daily. If necessary, your doctor can increase the dose up to 10 mg daily.
The tablets should be swallowed whole with liquid. The tablets can be taken with or without food.
If you have taken too much Vesicare
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Symptoms of overdose can be headache, dry mouth, dizziness, drowsiness, and visual effects, hallucinations, mood effects (overactivity), tremors (convulsions), breathing difficulties, increased heart rhythm (palpitations), accumulation of urine in the bladder ( urinary retention ) and enlarged pupils ( mydriasis ).
If you forget to take Vesicare:
If you forget to take the tablet, you can take it later the same day. If it is already time for the next dose, continue according to the normal dosage. Do not take a double dose to make up for a missed tablet. If you are unsure, always consult a doctor or pharmacist.
If you stop taking Vesicare
If you stop taking Vesicare, symptoms of overactive bladder may return or worsen. Always contact your doctor if you are considering stopping treatment.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, Vesicare can cause side effects, although not everybody gets them.
If you have an allergic attack or a serious skin reaction (eg blisters and peeling of the skin), you must tell your doctor or pharmacist immediately.
Angioedema ( allergy with skin involvement; swelling of tissue closest to the surface of the skin) with difficulty breathing has been reported in some patients using Vesicare. Stop taking Vesicare and contact your doctor immediately if you experience any of the following symptoms ( angioedema )
- swelling of the face, tongue, or throat,
- difficulty swallowing,
- hives and difficulty breathing.
Vesicare may cause the following other side effects:
Very common (may affect more than 1 in 10 users):
- dry mouth.
Common (may affect up to 1 in 10 users):
- blurred vision,
- constipation, nausea, indigestion ( dyspepsia ), and stomach pain.
Uncommon (may affect up to 1 in 100 users):
- urinary tract infections, cystitis,
- sleepiness, altered taste perception,
- dry (irritated) eyes,
- dryness of the nasal mucosa,
- heartburn, dry throat,
- dry skin,
- difficulty throwing water,
- fatigue, fluid swelling in arms and legs.
Rare (may affect up to 1 in 1,000 users):
- sluggish stomach and hard stools,
- difficulties in completely emptying the bladder when urinating,
- dizziness, headache,
- vomiting,
- itching, rash.
Very rare (may affect up to 1 in 10,000 users):
- hallucinations, confusion
- allergic skin rashes.
Frequency not known (cannot be estimated from available data):
- decreased appetite, high level of potassium in the blood which can cause abnormal heart rhythm,
- high eye pressure,
- changes in the electrical activity of the heart ( ECG ), irregular heartbeat, feeling your heartbeats, faster heartbeat,
- voice problem,
- liver disease,
- muscle weakness,
- kidney disease.
How to store Vesicare
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after EXP. The expiration date is the last day of the specified month.
No special storage instructions. After the can packaging is opened, the tablets are stable for 6 months. Close the jar well.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
Vesicare 5 mg:
- The active substance is 5 mg solifenacin succinate, which corresponds to 3.8 mg solifenacin.
- Other ingredients are corn starch, lactose monohydrate, hypromellose, magnesium stearate, macrogol 8000, talc, titanium dioxide (E 171), and yellow iron oxide (E 172).
Vesicare 10 mg:
- The active substance is 10 mg solifenacin succinate, which corresponds to 7.5 mg solifenacin.
- Other ingredients are corn starch, lactose monohydrate, hypromellose, magnesium stearate, macrogol 8000, talc, titanium dioxide (E 171), and red iron oxide (E 172).
Appearance and package sizes of the medicine
Vesicare 5 mg is a round, light yellow tablet marked with “150” on the same side.
Vesicare 10 mg is a round, light red tablet marked with “151” on the same side.
Vesicare tablets are supplied in blister packs of 3, 5, 10, 20, 30, 50, 60, 90, 100, or 200 tablets. Vesicare tablets are also supplied in HDPE cans, with a PP cap, of 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Astellas Pharma a/s
Arne Jacobsen’s Allé 15
2300 Copenhagen S
Denmark
Manufacturer
Astellas Pharma Europe BV
Sylviusweg 62
2333 BE Leiden
Netherlands
Information provided by
Astellas Pharma AB
Box 21046
200 21 Malmö
This medicine is approved in the European Economic Area under the names:
Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Iceland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Great Britain, Hungary, and Austria: Vesicare
Italy: Venice
Ireland: Vesitirim
Germany: Vesikur