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 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 allergic (hypersensitive) to Solifenacin succinate or any of the other ingredients of Solifenacin succinate.
• 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 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 succinate 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 Solifenacin succinate starts.
Warnings and precautions Talk to your doctor or pharmacist or nurse 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 is much higher (urinary retention).
• 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 Solifenacin succinate starts.
Before starting Solifenacin succinate, 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 succinate is not to be used in children or adolescents under 18 years.
Other medicines and Solifenacin succinate Please tell your doctor or pharmacist or nurse 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, as the effects and side effects of both medications could be increased.
• cholinergics, as they can reduce the effect of Solifenacin succinate.
• medicines, like metoclopramide and cisapride, which make the digestive system work faster. Solifenacin succinate 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 succinate 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 succinate 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 succinate with food and drink Solifenacin succinate can be taken with or without food, depending on your preference.
Pregnancy and breast-feeding and fertility You should not use < Product Name > if you are pregnant unless your doctor thinks it is necessary. Do not use Solifenacin succinate if you are breast-feeding as Solifenacin succinate 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 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 monohydrate If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
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 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.
The recommended dose is 5 mg per day, unless your doctor has told you to take 10 mg per day.
Use in children and adolescents Solifenacin succinate is not to be used in 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 product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Solifenacin succinate 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 succinate may cause the following other side effects:
Very common side effects (may affect more than 1 in 10 people)
• dry mouth
Common side effects (may affect up to one in ten people)
• blurred vision
• constipation, nausea, indigestion with symptoms such as abdominal fullness, abdominal pain, burping, nausea, and heartburn (dyspepsia), stomach discomfort
Uncommon side effects (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 side effects (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 side effects (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 (Torsade de Pointes), feeling your heartbeat, faster heartbeat
• 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:
Yellow Card Scheme
Website: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 storage conditions.
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 blister or carton after EXP. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that 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 to protect the environment.
What Solifenacin succinate contains The active substance is Solifenacin succinate
Each film-coated tablet contains 5 mg solifenacin succinate.
Each film-coated tablet contains 10 mg solifenacin succinate.
The other ingredients are:
Tablet core: Maize starch, Lactose monohydrate, Hypromellose (E464), Magnesium stearate
Film-coating: Hypromellose (E464), Macrogol, Talc (E553b), Titanium Dioxide (E171) and
Iron Oxide Yellow (E172) (only for 5 mg)
Iron Oxide Red (E172) (Only for 10 mg)
What Solifenacin succinate looks like and contents of the pack Solifenacin succinate 5 mg film-coated tablets are round, light yellow and marked with the code "390" on one side of the tablets.
Solifenacin succinate 10 mg film-coated tablets are round, light pink and marked with the code "391" on one side of the tablets.
Solifenacin succinate 5 mg and 10 mg film-coated tablets are supplied in blister packs of 10, 30, 50, 90 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Glenmark Pharmaceuticals Europe Limited
Laxmi House
2B Draycott Avenue
Kenton
Middlesex
HA3 0BU
United Kingdom
Manufacturer:
Zentiva s.a.
Bd. Theodor Pallady nr 50
032266 Bucuresti
Romania
This leaflet was last revised in 08/2017.
Glenmark Pharmaceuticals Europe Ltd
Address
Building 2, Croxley Park, Watford, WD18 8YA
Telephone
+44 (0)1923 202 950
Fax
+44 (0)1923 251137
Medical Information Direct Line
0800 458 0383
E-mail
[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.
Solifenacin succinate 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
The recommended dose is 5 mg solifenacin succinate once daily. If needed, the dose may be increased to 10 mg solifenacin succinate once daily.
Special Populations
Older people
No dosage adjustment is necessary for older people.
Patients with renal impairment
No dosage 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 dosage 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).
Patients treated with 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).
Pediatric population
Safety and effectiveness in children and adolescents below 18 years have not yet been established. Therefore, Solifenacin succinate should not be used in children and adolescents.
Method of administration
Solifenacin succinate should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.
- Hypersensitivity to the active substance or to any of the excipients listed in 6.1
- 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.
- 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/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 hypokalemia.
Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor overactivity.
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.
Patients with rare hereditary problems of galactose intolerance or glucose-galactose malabsorption should not take this medicinal product.
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 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 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 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 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.
Fertility
No fertility data are available.
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 only occasionally led 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 summary of adverse reactions
MedDRA system organ class
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)
Infections and infestations
Urinary tract infection
Cystitis
Psychiatric disorders
Hallucinations*
Confusional state*
Delirium*
Nervous system disorders
Somnolence
Dysgeusia
Dizziness,* Headache*
Eye disorders
Blurred vision
Dry eyes
Glaucoma*
Cardiac disorders
Electrocardiogram QT prolongation*
Torsades de Pointes*
Atrial fibrillation*
Palpitations*
Tachycardia*
Respiratory, thoracic and mediastinal disorders
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*
Skin and subcutaneous tissue disorders
Dry skin
Pruritus*, Rash*
Erythema multiforme*
Urticaria*, Angioedema*
Exfoliative dermatitis*
Renal and urinary disorders
Difficulty in micturition
Urinary retention
Renal impairment*
General disorders and administration site conditions
Fatigue
Peripheral oedema
Muscoloskeletal and connective tissue disorders
Muscular weakness*
Hepatobiliary disorders
Liver disorder*, Liver function test abnormal*
Metabolism and nutrition disorders
Decreased appetite*
Hyperkalaemia*
Immune system disorders
Anaphylactic reaction*
*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:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
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.
Management
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 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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