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 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.
Solifenacin succinate 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 succinate: • 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 succinate from the body (for example, ketoconazole). Your doctor or pharmacist will have informed you if this is the case.
Tell your doctor if you have or have 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 Solifenacin succinate
• 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 (e.g. 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).
Tell your doctor if you have or have ever had any of the above mentioned conditions before treatment with Solifenacin succinate starts.
Before starting Solifenacin succinate, your doctor will check 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 an antibiotic (a treatment against particular bacterial infections).
Other medicines and Solifenacin succinate Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is especially important to tell your doctor if you are taking:
• other anticholinergic medicines. The effects and side effects of both medications can be increased.
• cholinergic medicines as they can reduce the effect of Solifenacin succinate.
• medicines, such as metoclopramide and cisapride, which make the digestive system work faster. Solifenacin succinate can reduce their effect.
• medicines such as ketoconazole and itraconazole (antifungals), ritonavir and nelfinavir (used to treat HIV), verapamil and diltiazem (used to treat heart conditions or high blood pressure), may decrease the rate at which Solifenacin succinate is broken down by the body
• medicines such as rifampicin (an antibacterial), phenytoin and carbamazepine (used to treat epilepsy), may increase the rate at which Solifenacin succinate is broken down by the body.
• medicines such as bisphosphonates (used to treat osteoporosis), may cause or worsen inflammation of the gullet (oesophagitis).
Solifenacin succinate with food and drink Solifenacin succinate can be taken with or without food.
Pregnancy and breast-feeding You should not take Solifenacin succinate if you are pregnant unless your doctor has told you to.
Do not take Solifenacin succinate if you are breast-feeding as solifenacin may get into your breast milk.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines Solifenacin succinate 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 succinate 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 take this medicine.
Instructions for proper use Adults
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. Do not crush the tablets.
The recommended dose is 5 mg per day, unless your doctor told you to take 10 mg per day.
For appropriate dosing solifenacin succinate 5mg tablets may be available.
Children and adolescents
Solifenacin succinate is not to be given to children or adolescents under 18 years.
If you take more Solifenacin succinate than you should If you have taken too much Solifenacin succinate 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 Solifenacin succinate 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.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Solifenacin succinate If you stop taking Solifenacin succinate, 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.
Serious side effects Stop taking this medicine and contact your doctor immediately if you experience any of the following:
• a severe allergic attack (skin rash; swollen eyes, lips, hands and feet; swelling of the mouth, throat or tongue, which can cause breathing and swallowing difficulties), or a severe skin reaction (e.g. blistering and peeling of the skin)
• angioedema (skin allergy that results in swelling in the tissue just below the surface of the skin) with airway obstruction (difficulty in breathing)
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, pharmacist or nurse. 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.
Do not use this medicine after the expiry date which is stated on the carton, bottle and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 succinate contains • The active substance is solifenacin succinate 10 mg
• The other ingredients are: lactose anhydrous, hypromellose (E464), maize starch, magnesium stearate (E470b), macrogol (E1521), titanium dioxide (E171), talc (E553b) and ferric oxide Red (E172).
What Solifenacin succinate looks like and contents of the pack Solifenacin succinate 10 mg film-coated tablets are light pink colored film-coated round biconvex tablets embossed with code 'RK76' on one side and plain on other side. The tablets are about 7.5 mm long.
Solifenacin succinate tablets are available in PVC/PVDC blister pack and 40 ml HDPE bottle pack.
Pack sizes in blisters
30, 50, 90 or 100 tablets
Pack sizes in bottles
30, 50, 90 or 100 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands
Manufacturers: Terapia SA
124 Fabricii Street
400 632 Cluj-Napoca
Romania
Or
Alkaloida Chemical Company Zrt.
Kabay János u. 29
Tiszavasvári
H-4440
Hungary
Or
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Netherlands: Solifenacinesuccinaat SUN
Germany: SOLIFENACIN BASICS
Spain: Solifenacina SUN
Poland: SILAMIL
United Kingdom: Solifenacin succinate
This leaflet was last revised in May 2024.
V005
Ranbaxy (UK) Limited a Sun Pharmaceutical Company
Address
6-9 The Square, Stockley Park, Uxbridge, UB11 1FW, UK
Telephone
+44 (0) 208 848 8688
Medical Information Direct Line
+44 (0) 208 848 5052
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http://www.sunpharma.com
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[email protected]
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Solifenacin succinate 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 succinate 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 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 succinate 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.
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.
For appropriate dosing solifenacin succinate 5mg tablets may be available.
Paediatric population
The safety and efficacy of solifenacin succinate in children have not yet been established. Therefore, Solifenacin succinate should not be used in children.
Patients with 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).
Patients with 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 succinate 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).
Method of administration
Solifenacin succinate should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.
Solifenacin is contraindicated in patients with urinary retention, severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma and in patients at risk for these conditions.
- Patients hypersensitive to the active substance or to any of the excipients listed in 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).
Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with solifenacin succinate. If urinary tract infection is present, an appropriate antibacterial therapy should be started.
Solifenacin succinate 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/gastro-oesophageal 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 succinate can be determined after 4 weeks at the earliest.
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 succinate 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 gastro-intestinal 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 succinate 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 contra-indicated 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, carbamazepin).
Effect of solifenacin on the pharmacokinetics of other medicinal products
Oral Contraceptives
Intake of solifenacin succinate showed no pharmacokinetic interaction of solifenacin on combined oral contraceptives (ethinylestradiol/levonorgestrel).
Warfarin
Intake of solifenacin succinate did not alter the pharmacokinetics of R-warfarin or S-warfarin or their effect on prothrombin time.
Digoxin
Intake of solifenacin succinate showed no effect on the pharmacokinetics of digoxin.
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.
Breast-feeding
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 succinate should therefore be avoided during breast-feeding.
Since solifenacin, like other anticholinergics may cause blurred vision, and, uncommonly, somnolence and fatigue (see section 4.8. undesirable effects), the ability to drive and use machines may be negatively affected.
Summary of the safety profile
Due to the pharmacological effect of solifenacin, Solifenacin succinate 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 succinate 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 succinate completed the full study period of 12 weeks treatment.
Tabulated list of adverse reactions
MedDRA system organ class
Very common
≥1/10
Common
≥1/100, <1/10
Uncommon
≥1/1000, <1/100
Rare
≥ 1/10000, <1/1000
Very rare
<1/10,000
Not known (cannot be estimated from the available data)
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
Torsade de Pointes*
Electrocardiogram QT prolonged*
Atrial fibrillation*
Palpitations*
Tachycardia*
Respiratory, thoracic and mediastinal disorders
Nasal dryness
Dysphonia*
Gastrointestinal disorders
Dry mouth
Constipation
Nausea
Dyspepsia
Abdominal pain
Gastro-oesophageal 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 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, website www.mhra.gov.uk/yellowcard.
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 hospitalization.
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 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 succinate 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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