Package leaflet: • If you are at risk of your digestive system Information for the user slowing down (stomach and bowel movements). Your doctor will have informed Solifenacin 5 mg you if this is the case. film-coated tablets • If you suffer from severe disease. • If you have moderate liver disease. Solifenacin 10 mg • If you have a stomach tear (hiatus hernia) or film-coated tablets heartburn. Solifenacin succinate • If you have a nervous disorder (autonomic neuropathy). Read all of this leaflet carefully before Children and adolescents you start taking this medicine because it Solifenacin is not to be used in children or contains important information for you. adolescents under 18 years. - Keep this leaflet. You may need to read it Inform your doctor if you have or ever had again. any of the above mentioned conditions before - If you have any further questions, ask your treatment with Solifenacin starts. doctor or pharmacist. - This medicine has been prescribed for you Before starting Solifenacin, your doctor will only. Do not pass it on to others. It may assess whether there are other causes for your harm them, even if their signs of illness are need to pass urine frequently (for example the same as yours. heart failure (insufficient pumping power of the - If you get any side effects talk to your doctor heart) or kidney disease). If you have a urinary or pharmacist. This includes any possible tract infection, your doctor will prescribe you side effects not listed in this leaflet. See an antibiotic (a treatment against particular section 4. bacterial infections). What is in this leaflet Other medicines and Solifenacin 1. What Solifenacin is and what it is used for Tell your doctor if you are taking, have recently 2. What you need to know before you take taken or might take any other medicines. Solifenacin It is especially important to inform your doctor if 3. How to take Solifenacin you are taking: 4. Possible side effects 5. How to store Solifenacin • Other medicines, effects 6. Contents of the pack and other information and side effects of both medications can be enhanced. 1. What Solifenacin is and what it is used • as they can reduce the effect for of Solifenacin. • Medicines, like metoclopramide and The active substance of Solifenacin belongs , which make the digestive system to the group of . These work faster. Solifenacin can reduce their medicines are used to reduce the activity of an effect. . This enables you to wait • Medicines, like , ritonavir, longer before having to go to the bathroom and nelfinavir, intraconazole, and increases the amount of urine that can be held , which decrease the rate at which by your bladder. Solifenacin is used to treat Solifenacin is broken down by the body the symptoms of a condition called overactive • Medicines like rifampicin, and bladder. These symptoms include: having a , as they may increase the strong, sudden urge to urinate without prior rate at which Solifenacin is broken down by warning, having to urinate frequently or wetting the body. yourself because you could not get to the • Medicines such as bisphosphonates, that bathroom in time. can cause or exacerbate inflammation of the gullet (oesophagitis). 2. What you need to know before you take Solifenacin Solifenacin with food, drink and Solifenacin can be taken with or without food, Do not take Solifenacin depending on your preference. • If you are allergic to solifenacin or any of the other ingredients of this medicine (listed in , breast-feeding and fertility section 6) You should not use Solifenacin if you are • If you have an inability to pass water or pregnant unless clearly necessary. Do not to empty your bladder completely (urinary use Solifenacin if you are breast-feeding as retention) solifenacin may get into your breast milk. • If you have a severe stomach or bowel If you are pregnant or breast-feeding, think condition (including toxic megacolon, a you may be pregnant or are planning to have a complication associated with ulcerative baby, ask your doctor or pharmacist for advice colitis) before taking this medicine. • If you suffer from the muscle disease called Driving and using machines myasthenia gravis, which can cause an Solifenacin may cause blurred vision and extreme weakness of certain muscles sometimes sleepiness or tiredness. If you suffer • If you suffer from increased pressure in from any of these side effects, do not drive or the eyes, with gradual loss of eye sight operate machinery. (glaucoma) lactose monohydrate • If you are undergoing kidney dialysis Solifenacin contains . If you have been told by your doctor that you • If you have severe liver disease have an intolerance to some sugars, contact • If you suffer from severe kidney disease or your doctor before taking this medicinal product moderate liver disease AND at the same time are being treated with medicines that 3. How to take Solifenacin may decrease the removal of Solifenacin from the body (for example ketoconazole). Always take this medicine exactly as your Your doctor or pharmacist will have doctor has told you. Check with your doctor or informed you if this is the case. pharmacist if you are not sure. Inform your doctor if you have or ever had You should swallow the whole tablet with some any of the above mentioned conditions before liquid. It can be taken with or without food, treatment with Solifenacin starts. according to your preference. Do not crush the Warnings and precautions tablets. Talk to your doctor or pharmacist before taking The recommended dose is 5 mg per day, Solifenacin unless your doctor told you to take 10 mg per • If you have trouble emptying your bladder day. (= bladder obstruction) or have difficulty in If you take more Solifenacin than you passing urine (e.g. a thin urine flow). Risk of should accumulation of urine in the bladder (urinary If you have taken too much Solifenacin retention) is much higher. If you have or if a child has accidentally taken some obstruction of the digestive system Solifenacin, contact your doctor or (constipation). pharmacist immediately. P1520766

Black A/s: 150 x 340 mm Symptoms of overdose may include: • liver disorder headache, dry mouth, dizziness, • muscle weakness drowsiness and blurred vision, • renal disorder perceiving things that are not there Reporting of side effects (hallucinations), over- excitability, If you get any side effects, talk to your doctor seizures (convulsions), difficulty or pharmacist. This includes any possible side breathing, elevated heart rate effects not listed in this leaflet. You can also (tachycardia), accumulation of urine report side effects directly via the Yellow Card in the bladder () and Scheme www.mhra.gov.uk/yellowcard or search dilated pupils (mydriasis). for MHRA Yellow Card in the Google Play or If you forget to take Solifenacin Apple App Store. By reporting side effects you If you forget to take a dose at the usual time, can help provide more information on the safety take it as soon as you remember, unless it is of this medicine. time to take your next dose. 5. How to store Solifenacin Do not take a double dose to make up for a forgotten dose. If you are in doubt, always Keep this medicine out of the sight and reach of consult your doctor or pharmacist. children. If you stop taking Solifenacin Do not use this medicine after the expiry date If you stop taking Solifenacin, your symptoms which is stated on the label, carton and bottle of overactive bladder may return or worsen. after EXP. The expiry date refers to the last day Always consult your doctor, if you are of that month. considering stopping the treatment. This medicine does not require any special If you have any further questions on the use of storage conditions. this medicine, ask your doctor or pharmacist. Do not throw away any medicines via 4. Possible side effects wastewater or household waste. Ask your pharmacist how to throw away medicines you Like all medicines, this medicine can cause side no longer use. These measures will help protect effects, although not everybody gets them. the environment. If you experience an allergic attack, or a severe 6. Contents of the pack and other skin reaction (e.g. blistering and peeling of information the skin), you must inform your doctor or pharmacist immediately. What Solifenacin contains - The active substance is solifenacin Angioedema (skin allergy that results in the succinate. swelling that occurs in the tissue just below Each film-coated tablet contains 5 mg of the surface of the skin) with airway obstruction solifenacin succinate. (difficulty in breathing) has been reported Each film-coated tablet contains 10 mg of in some patients on solifenacin succinate solifenacin succinate. (Solifenacin). The other ingredients are If angioedema occurs, solifenacin succinate Tablet core: Lactose monohydrate, maize (Solifenacin) should be discontinued starch, hypromellose (5 cp), silica colloidal immediately and appropriate therapy and/or anhydrous, magnesium stearate. measures should be taken. Tablet coating: Hypromellose (6 cp), Solifenacin may cause the following other side macrogol (PEG 4000), titanium dioxide (E effects: 171), talc, yellow iron oxide (E 172) (for 5 mg only), red iron oxide (E 172) (for 10 mg Very common (may affect more than 1 in only). 10 people) • dry mouth What Solifenacin looks like and contents of the pack Common (may affect up to 1 in 10 people) Film-coated tablet. • blurred vision Solifenacin 5 mg film-coated tablets: • constipation, nausea, indigestion with Light yellow colored, round shaped [diameter symptoms such as abdominal fullness, 7.6 mm], biconvex, film coated tablets, abdominal pain, burping, nausea, and debossed with ‘CC’ on one side and ‘31’ on the heartburn (dyspepsia), stomach discomfort other side. Uncommon (may affect up to 1 in 100 people) Solifenacin 10 mg film-coated tablets: • , bladder infection Light pink colored, round shaped [diameter: • sleepiness, impaired sense of taste 7.6 mm], biconvex, film coated tablets, (dysgeusia) debossed with ‘CC’ on one side and ‘32’ on the • dry (irritated) eyes other side. • dry nasal passages • reflux disease (gastro-oesophageal reflux), Solifenacin film-coated tablets are available dry throat in clear PVC- Aluminium foil blister pack and • dry skin white opaque round HDPE container closed • difficulty in passing urine with white opaque polypropylene stock ribbed • tiredness, accumulation of fluid in the lower closure. legs (oedema) Blister packs: 10, 30, 50, 60, 70, 90 and 200 film-coated tablets (may affect up to 1 in 1,000 people) Rare HDPE Packs: 100, 250 and 500 film-coated • lodging of a large amount of hardened stool tablets in the large intestine (faecal impaction) • build up of urine in the bladder due to Not all pack sizes may be marketed. inability to empty the bladder (urinary Marketing Authorisation Holder retention) Milpharm Limited • dizziness, headache Ares Block, Odyssey Business Park • vomiting West End Road • itching, rash Ruislip HA4 6QD Very rare (may affect up to 1 in 10,000 people) United Kingdom • hallucinations, confusion Manufacturer • allergic rash APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Not known (frequency cannot be estimated Birzebbugia, BBG 3000 from the available data) Malta • decreased appetite, high levels of blood potassium which can cause abnormal heart or rhythm Milpharm Limited • increased pressure in the eyes Ares Block, Odyssey Business Park • changes in the electrical activity of the heart West End Road (ECG), irregular heartbeat, feeling your Ruislip HA4 6QD heartbeat, faster heart beat United Kingdom • voice disorder This leaflet was last revised in 01/2019. 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