Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
The active substance of Solifenacin belongs to the group 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.
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.
DO NOT take Solifenacin • if you are unable 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 have ever had any of the above mentioned conditions before treatment with this medicine 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 disorder of the nervous system called autonomic neuropathy
Inform your doctor if you have or have ever had any of the above mentioned conditions before treatment with this medicine 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).
Children and adolescents Solifenacin is not to be used in children or adolescents under 18 years.
Package leaflet: Information for the user Solifenacin 5 mg film-coated tablets Solifenacin 10 mg 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
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 could be increased. Please ask your doctor if your medicine belongs to this group • cholinergics, as they can reduce the effect of solifenacin. Please ask your doctor if your medicine belongs to this group • medicines, like metoclopramide and cisapride, which make the digestive system work faster. Solifenacin can reduce their effect • medicines, like ketoconazole, itraconazole (medicines used to treat fungal infections), ritonavir, nelfinavir (medicines used to treat HIV infections) and verapamil, diltiazem (medicines used to treat high blood pressure and heart diseases). These medicines decrease the rate at which solifenacin is broken down by the body • medicines like rifampicin (medicine used to treat tuberculosis and other bacterial infections) and phenytoin, carbamazepine (medicines used to treat epilepsy). 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). Please ask your doctor if your medicine belongs to this group
Solifenacin 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 solifenacin if you are pregnant unless your doctor thinks it is necessary. Do not use this medicine if you are breast-feeding as solifenacin may pass into your breast milk.
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.
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.
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.
Dosage The recommended dose is 5 mg per day, unless your doctor has told you to take 10 mg per day.
Method of administration You should swallow the tablet whole with some liquid, e.g. a glass of water. It can be taken with or without food, according to your preference. Do not crush the tablets.
Use in children and adolescents Solifenacin is not to be used in children or adolescents under 18 years.
If you take more Solifenacin than you should If you have taken too much solifenacin 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. Do not take a double dose to make up for a forgotten dose. If you are in doubt, always consult your doctor or pharmacist.
If you stop taking Solifenacin 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking solifenacin and seek medical help immediately if you notice any of the following side effects • allergic attack, or a severe skin reaction (e.g. blistering and peeling of the skin) • 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.
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 • acid reflux (gastrooesophageal 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 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.
This medicinal product does not require any special temperature storage conditions. Store in original package in order to protect from humidity.
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 and blister after EXP. The expiry date refers to the last day of that month.
Do not use this medicine if the pack is damaged or shows signs of tampering.
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.
What Solifenacin contains
The active substance is solifenacin succinate
Solifenacin 5mg film-coated tablets: Each film-coated tablet contains 5 mg solifenacin succinate equivalent to 3.8 mg solifenacin.
The other ingredients are Tablet core Lactose monohydrate, Maize starch, Hypromellose, Magnesium stearate
Film-coating Hypromellose, Titanium Dioxide (E171), Macrogol 8000, Talc and Iron Oxide Yellow (E172)
Solifenacin 10mg film-coated tablets: Each film-coated tablet contains 10 mg solifenacin succinate equivalent to 7.5 mg solifenacin.
The other ingredients are Tablet core Lactose monohydrate, Maize starch, Hypromellose, Magnesium stearate
Film-coating Hypromellose, Titanium Dioxide (E171), Macrogol 8000, Talc and Iron Oxide Red (E172)
What Solifenacin looks like and contents of the pack
Solifenacin 5mg film-coated tablets: Round, light yellow, biconvex film-coated tablets.
Solifenacin 10mg film-coated tablets: Round, light pink, biconvex film-coated tablets.
Solifenacin film-coated tablets are supplied in blister packs of 10, 20, 30, 40, 50, 60, 80, 90, 100, 105, 120, 150, 180 and 200 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder STADA, Linthwaite, Huddersfield, HD7 5QH, UK
Manufacturer STADA M&D SRL, Str. Trascăului, nr. 10, Municipiul Turda, Județul Cluj, 401135, Romania
This leaflet was revised in March 2024.
93572262405 GB 1372358
Solifenacin 10 mg Film-Coated Tablets comes as tablet containing 10mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Solifenacin 10 mg Film-Coated Tablets is solifenacin succinate.
Medicines with the same active substance, strength and form include: Vesicare 10mg film-coated tablets, Solifenacin 10 mg film-coated tablets, Solifenacin succinate 10 mg Film-coated Tablets. In total there are 11 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Solifenacin 10 mg Film-Coated Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Solifenacin is indicated in adults for symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.
Posology Adults, including the elderly The recommended dose is 5 mg solifenacin succinate once daily. If needed, the dose may be increased to 10 mg solifenacin succinate once daily. Renal impairment No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance > 30 ml/min). Patients with severe renal impairment (creatinine clearance ≤ 30 ml/min) should be treated with caution and receive no more than 5 mg once daily (see section 5.2). Hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child-Pugh score of 7 to 9) should be treated with caution and receive no more than 5 mg once daily (see section 5.2). Potent inhibitors of cytochrome P450 3A4 The maximum dose of solifenacin should be limited to 5 mg when treated simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors e.g. ritonavir, nelfinavir, itraconazole (see section 4.5). Paediatric population The safety and efficacy of solifenacin in children and adolescents below 18 years have not yet been established. Therefore, solifenacin should not be used in children and adolescents. Method of administration Solifenacin should be taken orally and should be swallowed whole with liquids. It can be taken with or without food. <summary id="CONTRAINDICATIONS" data-evt="smpcSectionOpen"
• Solifenacin is contraindicated in patients with urinary retention, severe gastrointestinal condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma and in patients at risk for these conditions. • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Patients undergoing haemodialysis (see section 5.2). • Patients with severe hepatic impairment (see section 5.2). • Patients with severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole (see section 4.5). <summary id="CLINICAL_PRECAUTIONS" data-evt="smpcSectionOpen"
Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with solifenacin. If urinary tract infection is present, an appropriate antibacterial therapy should be started. Solifenacin should be used with caution in patients with: • clinically significant bladder outflow obstruction at risk of urinary retention • gastrointestinal obstructive disorders • risk of decreased gastrointestinal motility • severe renal impairment (creatinine clearance ≤ 30 ml/min; see section 4.2 and 5.2) and doses should not exceed 5 mg for these patients • moderate hepatic impairment (Child-Pugh score of 7 to 9; see section 4.2 and 5.2) and doses should not exceed 5 mg for these patients • concomitant use of a potent CYP3A4 inhibitor, e.g. ketoconazole (see 4.2 and 4.5) • hiatus hernia/gastroesophageal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis. • autonomic neuropathy QT prolongation and torsade de pointes have been observed in patients with risk factors, such as pre-existing long QT syndrome and hypokalaemia. Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor overactivity. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Angioedema with airway obstruction has been reported in some patients on solifenacin succinate. If angioedema occurs, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken. Anaphylactic reaction has been reported in some patients treated with solifenacin succinate. In patients who develop anaphylactic reactions, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken. The maximum effect of solifenacin can be determined after 4 weeks at the earliest. <summary id="INTERACTIONS" data-evt="smpcSectionOpen"
Pharmacological interactions Concomitant medication with other medicinal products with anticholinergic properties may result in more pronounced therapeutic effects and undesirable effects. An interval of approximately one week should be allowed after stopping treatment with solifenacin before commencing other anticholinergic therapy. The therapeutic effect of solifenacin may be reduced by concomitant administration of cholinergic receptor agonists. Solifenacin can reduce the effect of medicinal products that stimulate the motility of the gastrointestinal tract, such as metoclopramide and cisapride. Pharmacokinetic interactions In vitro studies have demonstrated that at therapeutic concentrations, solifenacin does not inhibit CYP1A1/2, 2C9, 2C19, 2D6, or 3A4 derived from human liver microsomes. Therefore, solifenacin is unlikely to alter the clearance of drugs metabolised by these CYP enzymes. Effect of other medicinal products on the pharmacokinetics of solifenacin Solifenacin is metabolised by CYP3A4. Simultaneous administration of ketoconazole (200 mg/day), a potent CYP3A4 inhibitor, resulted in a two-fold increase of the AUC of solifenacin, while ketoconazole at a dose of 400 mg/day resulted in a three-fold increase of the AUC of solifenacin. Therefore, the maximum dose of solifenacin should be restricted to 5 mg when used simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors (e.g. ritonavir, nelfinavir, itraconazole) (see section 4.2). Simultaneous treatment of solifenacin and a potent CYP3A4 inhibitor is contraindicated in patients with severe renal impairment or moderate hepatic impairment. The effects of enzyme induction on the pharmacokinetics of solifenacin and its metabolites have not been studied as well as the effect of higher affinity CYP3A4 substrates on solifenacin exposure. Since solifenacin is metabolised by CYP3A4, pharmacokinetic interactions are possible with other CYP3A4 substrates with higher affinity (e.g. verapamil, diltiazem) and CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine). Effect of solifenacin on the pharmacokinetics of other medicinal products Oral Contraceptives Intake of solifenacin showed no pharmacokinetic interaction of solifenacin on combined oral contraceptives (ethinylestradiol/levonorgestrel). Warfarin Intake of solifenacin did not alter the pharmacokinetics of R-warfarin or S-warfarin or their effect on prothrombin time. Digoxin Intake of solifenacin showed no effect on the pharmacokinetics of digoxin. <summary id="PREGNANCY" data-evt="smpcSectionOpen"
Pregnancy
No clinical data are available from women who became pregnant while taking solifenacin. Animal studies do not indicate direct harmful effects on fertility, embryonal/foetal development or parturition (see section 5.3). The potential risk for humans is unknown. Caution should be exercised when prescribing to pregnant women.
Breastfeeding
No data on the excretion of solifenacin in human milk are available. In mice, solifenacin and/or its metabolites was excreted in milk, and caused a dose dependent failure to thrive in neonatal mice (see section 5.3). The use of solifenacin should therefore be avoided during breastfeeding.
Since solifenacin, like other anticholinergics may cause blurred vision and, uncommonly, somnolence and fatigue (see section 4.8), the ability to drive and use machines may be negatively affected.
a. Summary of the safety profile Due to the pharmacological effect of solifenacin, it may cause anticholinergic undesirable effects of (in general) mild or moderate severity. The frequency of anticholinergic undesirable effects is dose related. The most commonly reported adverse reaction with solifenacin was dry mouth. It occurred in 11 % of patients treated with 5 mg once daily, in 22 % of patients treated with 10 mg once daily and in 4 % of placebo-treated patients. The severity of dry mouth was generally mild and did only occasionally lead to discontinuation of treatment. In general, medicinal product compliance was very high (approximately 99 %) and approximately 90 % of the patients treated with solifenacin completed the full study period of 12 weeks treatment. b. Tabulated list of adverse reactions Frequency Very common ≥ 1/10 Common ≥ 1/100 to > 1/10 Uncommon ≥ 1/1,000 to > 1/100 Rare ≥ 1/10,000 to > 1/1,000 Very rare > 1/10,000 Not known (cannot be estimated from the available data) MedDRA system organ class Infections and infestations Urinary tract infection, Cystitis Immune system disorders Anaphylactic reaction* Metabolism and nutrition disorders Decreased appetite*, Hyperkalaemia* Psychiatric disorders Hallucinations *, Confusional state* Delirium* Nervous system disorders Somnolence, Dysgeusia Dizziness,* Headache* Eye disorders Blurred vision Dry eyes Glaucoma* Cardiac disorders Torsades de Pointes*, Electrocardiogram QT prolonged*, Atrial fibrillation*, Palpitations*, Tachycardia* Respiratory, thoracic and mediastinal Nasal dryness Dysphonia* Gastrointestinal disorders Dry mouth Constipation, Nausea, Dyspepsia, Abdominal pain Gastroesophageal reflux diseases, Dry throat Colonic obstruction, Faecal impaction, Vomiting* Ileus*, Abdominal discomfort* Hepatobiliary disorders Liver disorder*, Liver function test abnormal* Skin and subcutaneous tissue disorders Dry skin Pruritus*, Rash* Erythema multiforme*, Urticaria*, Angioedema* Exfoliative dermatitis* Musculoskeletal and connective tissue disorders Muscular weakness* Renal and urinary disorders Difficulty in micturition Urinary retention Renal impairment* General disorders and administration site conditions Fatigue, Peripheral oedema * observed in post-marketing Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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. <summary id="OVERDOSE" data-evt="smpcSectionOpen"
Symptoms
Overdosage with solifenacin succinate can potentially result in severe anticholinergic effects. The highest dose of solifenacin succinate accidentally given to a single patient was 280 mg in a 5 hour period, resulting in mental status changes not requiring hospitalisation.
Treatment
In the event of overdose with solifenacin succinate, the patient should be treated with activated charcoal. Gastric lavage is useful if performed within 1 hour, but vomiting should not be induced.
As for other anticholinergics, symptoms can be treated as follows:
• Severe central anticholinergic effects such as hallucinations or pronounced excitation: treat: with physostigmine or carbachol.
• Convulsions or pronounced excitation: treat with benzodiazepines.
• Respiratory insufficiency: treat with artificial respiration.
• Tachycardia: treat with beta-blockers.
• Urinary retention: treat with catheterisation.
• Mydriasis: treat with pilocarpine eye drops and/or place patient in a dark room.
As with other antimuscarinics, in case of overdosing, specific attention should be paid to patients with known risk for QT-prolongation (i.e. hypokalaemia, bradycardia and concurrent administration of medicinal products known to prolong QT-interval) and relevant pre-existing cardiac diseases (i.e. myocardial ischaemia, arrhythmia, congestive heart failure).
Ask anything about Solifenacin 10 mg Film-Coated Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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