SOLIFENACIN SUCCINATE 5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

1. What Solifenacin Succinate is and what it is used for

2. What you need to know before you take Solifenacin Succinate

3. How to take Solifenacin Succinate

4. Possible side effects

5. How to store Solifenacin Succinate

6. Contents of the pack and other information

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What Solifenacin Succinate is and what it is used for

The active substance of 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.

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.

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What you need to know before you take Solifenacin Succinate

Do not take Solifenacin Succinate if you:

• are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6)
• have an inability to pass water or to empty your bladder completely (urinary retention)
• have a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis)
• suffer from the muscle disease called myasthenia gravis, which can cause an extreme weakness of certain muscles
• suffer from increased pressure in the eyes, with gradual loss of eye sight (glaucoma)
• are undergoing kidney dialysis
• have severe liver disease
• 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 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 (i.e. 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
• have some obstruction of the digestive system (constipation)
• are at risk of your digestive system slowing down (stomach and bowel movements). Your doctor will have informed you if this is the case
• suffer from severe kidney disease
• have moderate liver disease
• have a stomach tear (hiatus hernia) or heartburn
• have a nervous disorder (autonomic neuropathy).

Inform your doctor if you have or 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 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, effects and side effects of both medications can be enhanced
• 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, ritonavir, nelfinavir, intraconazole, verapamil and diltiazem, which decrease the rate at which Solifenacin Succinate is broken down by the body
• medicines like rifampicin, phenytoin and carbamazepine, as 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).

Solifenacin Succinate with food

Solifenacin Succinate can be taken with or without food, depending on your preference.

Pregnancy and breast-feeding

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.

You should not use Solifenacin Succinate if you are pregnant unless clearly necessary. Do not use Solifenacin Succinate if you are breast-feeding as solifenacin may get into your breast milk.

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 use this medicine.

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How to take Solifenacin Succinate

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 5 mg per day, unless your doctor told you to take 10 mg per day.

You should swallow the whole tablet with some liquid. It can be taken with or without food, according to your preference. Do not crush the tablets.

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).

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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.

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.

Possible side effects

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.

Solifenacin Succinate 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
• 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 1000 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 (Torsade de Pointes), 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 theYellow Card Scheme Website: 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.

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How to store Solifenacin Succinate

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 after EXP. The expiry date refers to the last day of that month.

Blisters

This medicine does not require any special storage conditions.

Bottles

This medicine does not require any special temperature storage conditions.

Keep the bottle tightly closed in order to protect from moisture.

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.

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Contents of the pack and other information

What Solifenacin Succinate contains

The active ingredient is solifenacin succinate.

Each film-coated tablet contains either 5 mg or 10 mg solifenacin succinate, corresponding to either 3.8 mg or 7.5 mg solifenacin. The exact amount is shown on the carton.

The other ingredients are:

Tablet core

Microcrystalline cellulose, povidone, crospovidone, lactose, silica colloidal anhydrous, magnesium stearate.

Tablet coating

Solifenacin Succinate 5 mg: polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol 3350, talc (E553b), iron oxide yellow (E172).

Solifenacin Succinate 10 mg: polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol 3350, talc (E553b), carmine (E120), iron oxide red (E172), iron oxide yellow (E172).

What Solifenacin Succinate looks like and contents of the pack

Solifenacin Succinate 5 mg are light yellow to yellow, round standard convex, film-coated tablet, diameter 8 mm, debossed with “S5” on one side of the tablet and plain on the other side of the tablet.

Solifenacin Succinate 10 mg are light pink to pink, round standard convex, film-coated tablet, diameter 8 mm, debossed with “S10” on one side of the tablet and plain on the other side of the tablet.

The tablets are packed in

• Aluminium – Aluminium blister packs.
• Polymer blister packs.

Teva Pharmaceuticals Europe B.V

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Approvals

REG0243186

Version 0.1

Approved

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