Solifenacin Succinate 5 Mg Film-Coated Tablets
10 mm 10 mm
E
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8
5 mm
Package leaflet: Information for the patient
Solifenacin succinate 5 mg film-coated tablets Solifenacin succinate 10 mg film-coated tablets
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 in this medicine is Solifenacin succinate 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.
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 are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• 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 from the body (for example, ketoconazole). Your doctor or pharmacist will have informed you if this is the case.
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).
Children and adolescents
This medicine 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 this medicine starts.
Before starting 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).
Taking other medicines
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, 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, intraconazole, 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).
Taking 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 breastfeeding as solifenacin may get into your breast milk.
Ask your doctor or pharmacist for advice before taking any 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 an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take this medicine
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. 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 of this medicine than you should
If you or your child accidentally takes more of this medicine than you should, talk to a doctor straight away. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and blurred vision, perceiving things that are not there (hallucinations),
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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. Do not take a double dose to make up for a forgotten dose.
If you stop taking this medicine
Do not stop taking your tablets unless your doctor tells you to. If you stop taking this medicine, your symptoms of overactive bladder may return or worsen. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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. By reporting side effects, you can help provide more information on the safety of this medicine.
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage conditions
• Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
• 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.
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 the 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.
Very common (may affect more than 1 in 10 people)
• Dry mouth.
Common (may affect up to 1 to 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
What this medicine contains
• The active substance is solifenacin succinate 5 mg or 10 mg.
• The other ingredients are maize starch, lactose, hypromellose (E464), pregelatinised starch, magnesium stearate, macrogol, talc, titanium dioxide (E171) and iron oxide yellow (E172). Additionally 10mg tablets contain iron oxide red (E172).
What this medicine looks like and contents of the pack
• 5 mg: Light yellow, round, biconvex film-coated tablets.
• 10 mg: Light pink, round, biconvex film-coated tablets with score line on one side and plain on the other.
• This medicine is available in packs of 3, 5, 10, 20, 30, 50, 60, 90, 100 or 200 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922 Fax : 0044 (0)1442 873717
E-mail: info@bristol-labs.co.uk
Solifenacin succinate 5 mg film-coated tablets; PL 17907/0542 Solifenacin succinate 10 mg film-coated tablets; PL 17907/0543
This leaflet was last revised in September 2016
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
V4 19-09-16 D0
130 mm