Patient leaflet - SOLIFENACIN 10 MG FILM-COATED TABLETS
1. what solifenacin is and what it is used for
The active substance of Solifenacin belongs to the group of 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.
Solifenacin 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 solifenacin
Do not take Solifenacin:
- if you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6);
- 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 a 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 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.
Warnings and precautions
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).
Inform your doctor if you have or ever had any of the above mentioned conditions before treatment with Solifenacin starts.
Before starting the treatment, 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
Solifenacin is not to be used in children or adolescents under 18 years.
Other medicines and Solifenacin
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 (for stomach problems), which make the digestive system work faster. Solifenacin can reduce their effect.
- medicines like ketoconazole and itraconazole (for fungal infections), ritonavir and nelfinavir (for HIV), verapamil and diltiazem (for certain heart disorders), which decrease the rate at which Solifenacin is broken down by the body.
- medicines like rifampicin (an antibiotic), phenytoin (for seizures) and carbamazepine (for epilepsy), as they may increase the rate at which Solifenacin is broken down by the body.
- medicines such as bisphosphonates (used to prevent the loss of bone density), that can cause or exacerbate inflammation of the gullet (oesophagitis).
Solifenacin with food and drink
Solifenacin can be taken with or without food, depending on your preference.
Pregnancy and breast-feeding
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
Do not take Solifenacin if you are pregnant unless clearly necessary.
Do not take Solifenacin if you are breast-feeding as this medicine may get into your breast milk.
Driving and using machines
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.
Solifenacin contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. how to take solifenacin
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Instructions for proper use
Swallow the tablet whole, with some liquid. It can be taken with or without food, according to your preference. Do not crush the tablets.
The recommended dose is 5 mg per day, unless your doctor told you to take 10 mg per day.
If you take more Solifenacin than you should
If you have taken too many tablets or if a child has accidentally taken this medicine, 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 Solifenacin
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
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 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), inform your doctor or pharmacist immediately.
Angioedema (skin allergy that results in the swelling of the tissue just below the surface of the skin) with airway obstruction (difficulty in breathing) has been reported in some patients on solifenacin. If angioedema occurs, Solifenacin should be discontinued immediately and appropriate therapy and/or measures should be taken.
Solifenacin 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 heart beat
- 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 Yellow Card Scheme at:. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store solifenacin
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.
This medicinal product does not require any special storage conditions. After first opening of the HDPE bottles, the tablets can be used for up to 100 days. Keep the bottle tightly closed.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Solifenacin succinate film-coated tables contains
- The active substance is solifenacin succinate. Each film-coated tablet contains 5 mg or 10 mg of solifenacin succinate.
- The other ingredients are: lactose monohydrate, maize starch, hypromellose, magnesium stearate, opadry yellow 03F12967 – For 5 mg [hypromellose, talc, macrogol (8000), titanium dioxide (E171), iron oxide yellow (E172)] and opadry pink 03F14895 – For 10 mg [hypromellose, talc, macrogol, titanium dioxide (E171), iron oxide red (E172)].
What Solifenacin succinate film-coated tablets looks like and contents of the pack
Solifenacin succinate 5 mg film-coated tablets: Light yellow round shaped, film coated tablets debossed with „S5“ on one side and plain on other side.
Solifenacin succinate 10 mg film-coated tablets: Light pink, round shaped, film coated tablets debossed with „S10“ on one side and plain on other side.
Solifenacin succinate 5 mg and 10 mg film-coated tablets are available in packs of:
- Alu-Alu Dessicant Blister Pack – Pack sizes of 3, 5, 10, 20, 30, 50, 60, 90, 100 or 200 tablets per carton
- HDPE bottle pack – 30, 90 and 100 tablets