1. what solifenacin succinate oral suspension is and what it is used for

The active substance of Solifenacin succinate oral suspension 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 oral suspension is used to:

• – treat the symptoms of a condition called overactive bladder in adults.

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.

• – treat a condition called neurogenic detrusor overactivity in children aged 2 to 18 years. Neurogenic detrusor overactivity is a condition in which involuntary bladder contractions occur due to a condition that you are born with or injury to the nerves which control the bladder. If left untreated, neurogenic detrusor overactivity may lead to damage to your bladder and/or kidneys.

Solifenacin succinate oral suspension is used to increase the amount of urine your bladder can hold and reduce urine leakage.

2. what you need to know before you take solifenacin succinate oral suspension

Do not take Solifenacin succinate oral suspension if you:

• – have an inability to pass water or to empty your bladder completely (urinary retention) and you do not practice clean intermittent catheterizati­on (CIC);

• – 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 allergic to solifenacin or any of the other ingredients of this medicine (listed in Section 6);

• – 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 oral suspension 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 oral suspension starts.

Warnings and precautions

Talk to your doctor or pharmacist before taking Solifenacin succinate oral suspension if you:

• – have trouble emptying your bladder (= bladder obstruction) or have difficulty in passing urine (e.g. a thin urine flow) and you do not practice clean intermittent catheterization (CIC). In such a case the risk of accumulation of urine in your 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 any condition which results in alterations of your heart rhythm, especially an abnormality known as QT prolongation;

• – 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 oral suspension starts.

Before starting Solifenacin succinate oral suspension, 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 oral suspension is not to be used in children under 2 years of age for treatment of neurogenic detrusor overactivity. Solifenacin succinate oral suspension is not to be used in children under 18 years of age for treatment of overactive bladder.

Other medicines and Solifenacin succinate oral suspension

Please tell your doctor or pharmacist if you are taking or have recently taken or might take 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 oral suspension.

• – medicines, like metoclopramide and cisapride, which make the digestive system work faster. Solifenacin succinate oral suspension can reduce their effect.

• – medicines, like ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil and diltiazem, which decrease the rate at which Solifenacin succinate oral suspension is broken down by the body

• – medicines like rifampicin, phenytoin and carbamazepine, as they may increase the rate at which Solifenacin succinate oral suspension is broken down by the body.

• – medicines such as bisphosphonates, that can cause or exacerbate inflammation of the gullet (oesophagitis).

Solifenacin succinate oral suspension with food and drink

Solifenacin succinate oral suspension oral suspension should not be taken together with food and/or other drinks than water. Take a glass of water after you have taken a dose. See Section 3. If you have taken accidently the suspension with food and/or drinks, you might experience a bitter taste and a feeling of numbness in your mouth.

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 oral suspension if you are pregnant unless clearly necessary.

Do not use Solifenacin succinate oral suspension if you are breast-feeding as solifenacin may get into your breast milk.

Driving and using machines

Solifenacin succinate oral suspension 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 oral suspension contains methyl parahydroxybenzoate and propyl parahydroxyben­zoate:

This may cause an allergic reaction (this might not happen straight away). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

Solifenacin succinate oral suspension contains propylene glycol: This medicine contains 20 mg propylene glycol in each ml which is equivalent to 200 mg/10 ml.

Solifenacin succinate oral suspension contains xylitol: This medicine contains 100 mg xylitol in each ml which is equivalent to 1000 mg/10 ml. Xylitol may have a laxative effect. Calorific value 2.4 kcal/g xylitol.

Solifenacin succinate oral suspension contains benzyl alcohol: This medicine contains 0.0002 mg benzyl alcohol in each ml which is equivalent to 0.002 mg/10 ml. Benzyl alcohol may cause allergic reactions.

Solifenacin succinate oral suspension contains sodium hydroxide: This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‚sodium-free‘.

If you get Solifenacin succinate oral suspension in your eyes: rinse and clean your eyes thoroughly with water.

3. how to take solifenacin succinate oral suspension

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

Take this medicine by mouth, once daily. You can take this medicine before or after a meal. Drink a glass of water after you have taken a Solifenacin succinate oral suspension dose. Do not take this medicine together with food and/or other drinks. If you have accidently taken the suspension with food and/or other drinks, you might experience a bitter taste and a feeling of numbness in your mouth.

Adults with overactive bladder

The usual dose is 5 mg (5 ml) per day, unless your doctor told you to take 10 mg (10 ml) per day. If you need to take a dose of 5 mg, you should use a 5 ml oral syringe. If you

170 mm

need to take a dose of 10 mg, you should use a 10 ml oral syringe.

Children and adolescents (age 2 to 18 years) with neurogenic detrusor overactivity

Your doctor will tell you which dose you/your child should take. Your doctor will calculate the correct dose for a patient depending on his or her body weight. Your pharmacist and doctor will tell you which syringe you should use. You should carefully follow their instructions.

How to take the Solifenacin succinate oral suspension dose using an oral syringe

Use the oral syringe and adaptor supplied with the pack to make sure you measure the right amount

• 1. Shake the bottle at least 20 times prior to each administration

• 2. Before first use of a bottle, remove the cap and attach the adaptor to the bottle according to the instructions by your pharmacist or healthcare provider

• 3. Insert the tip of the oral syringe into the adaptor until it is firmly in place

• 4. Carefully turn the bottle and syringe upside down

• 5. Pull back the plunger of the syringe to withdraw the amount prescribed by your doctor from the inverted bottle

• 6. Leave the syringe in place and turn the bottle upright, ensuring the plunger does not move. Gently remove the syringe from the adaptor and confirm the appropriate dose has been measured

• 7. Slowly dispense the oral suspension directly into the patient's mouth until all of the liquid medicine is given

• 8. In case of a press-in adaptor, leave the bottle adaptor in the neck of the bottle or follow the instructions by your pharmacist or healthcare provider

• 9. Close the bottle with the cap

• 10. Remove the plunger from the barrel of the syringe by gently pulling. Rinse the plunger and barrel with water and dry prior to storing the oral syringe

If you take more Solifenacin succinate oral suspension than you should

If you have taken too much Solifenacin succinate oral suspension or if a child has accidentally taken Solifenacin succinate oral suspension, 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), overexcitability, 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 oral suspension

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 oral suspension

If you stop taking Solifenacin succinate oral suspension, your symptoms of your underlying bladder disease 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.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Solifenacin succinate oral suspension and seek medical help immediately if you notice any of the following side effects:

If you experience an allergic attack (a sudden and rapid side effect consisting of generalized itching, hives, swelling, difficulty breathing and/or other allergic reactions, called anaphylaxis), or a severe skin reaction (e.g. blistering and peeling of the skin).

If you experience an 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). Angioedema has been reported in some patients on Solifenacin succinate oral suspension.

Solifenacin succinate oral suspension 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 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: r 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.

5. how to store solifenacin succinate oral suspension

Keep this medicine out of the sight and reach of children.

Do not use Solifenacin succinate oral suspension after the expiry date which is stated on the label, carton or bottle after EXP. The expiry date refers to the last day of that month.

Store this medicine in the original bottle in order to protect from light. This medicinal product does not require any special temperature storage conditions. After first opening of the bottle, the suspension can be stored for 30 days.

Discard any remaining medicine 30 days after opening the bottle.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other informationwhat solifenacin succinate oral suspension contains- the active substance is solifenacin succinate 1 mg per ml suspension.

• – The other ingredients are polacrilin potassium, methylparahydro­xybenzoate (E218), propylparahydro­xybenzoate (E216), propylene glycol (E1520), simethicone emulsion 30%, microcrystalline cellulose and carboxymethyl cellulose sodium, xylitol (E967), sucralose, orange flavour (consisting of maize maltodextrin, flavouring preparations, natural flavouring substances, flavouring substances and alpha-tocopherol (E307)), citric acid monohydrate, purified water.

What Solifenacin succinate oral suspension looks like and contents of the pack

Solifenacin succinate oral suspension is a white to off-white coloured aqueous, homogeneous suspension with an orange flavour.

Solifenacin succinate oral suspension is supplied in an amber polyethylene terephthalate (PET) bottle of 150 ml with child resistant tamper evident polypropylene closure, a 10 ml syringe and a syringe adaptor.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Glenmark Pharmaceuticals Europe Limited

Laxmi House, 2B Draycott Avenue, Kenton, Middlesex

HA3 0BU

United Kingdom

Manufacturer

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park, Croxley Green, Hertfordshire

WD18 8YA, United Kingdom

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56617 Vysoke Myto

Czech Republic

This leaflet was last revised in 03/2020

170 mm

need to take a dose of 10 mg, you should use a 10 ml oral syringe.

Children and adolescents (age 2 to 18 years) with neurogenic detrusor overactivity

Your doctor will tell you which dose you/your child should take. Your doctor will calculate the correct dose for a patient depending on his or her body weight. Your pharmacist and doctor will tell you which syringe you should use. You should carefully follow their instructions.

How to take the Solifenacin succinate oral suspension dose using an oral syringe

Use the oral syringe and adaptor supplied with the pack to make sure you measure the right amount

• 1. Shake the bottle at least 20 times prior to each administration

• 2. Before first use of a bottle, remove the cap and attach the adaptor to the bottle according to the instructions by your pharmacist or healthcare provider

• 3. Insert the tip of the oral syringe into the adaptor until it is firmly in place

• 4. Carefully turn the bottle and syringe upside down

• 5. Pull back the plunger of the syringe to withdraw the amount prescribed by your doctor from the inverted bottle

• 6. Leave the syringe in place and turn the bottle upright, ensuring the plunger does not move. Gently remove the syringe from the adaptor and confirm the appropriate dose has been measured

• 7. Slowly dispense the oral suspension directly into the patient's mouth until all of the liquid medicine is given

• 8. In case of a press-in adaptor, leave the bottle adaptor in the neck of the bottle or follow the instructions by your pharmacist or healthcare provider

• 9. Close the bottle with the cap

• 10. Remove the plunger from the barrel of the syringe by gently pulling. Rinse the plunger and barrel with water and dry prior to storing the oral syringe

If you take more Solifenacin succinate oral suspension than you should

If you have taken too much Solifenacin succinate oral suspension or if a child has accidentally taken Solifenacin succinate oral suspension, 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), overexcitability, 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 oral suspension

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 oral suspension

If you stop taking Solifenacin succinate oral suspension, your symptoms of your underlying bladder disease 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.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Solifenacin succinate oral suspension and seek medical help immediately if you notice any of the following side effects:

If you experience an allergic attack (a sudden and rapid side effect consisting of generalized itching, hives, swelling, difficulty breathing and/or other allergic reactions, called anaphylaxis), or a severe skin reaction (e.g. blistering and peeling of the skin).

If you experience an 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). Angioedema has been reported in some patients on Solifenacin succinate oral suspension.

Solifenacin succinate oral suspension 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 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: r 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.

5. how to store solifenacin succinate oral suspension

Keep this medicine out of the sight and reach of children.

Do not use Solifenacin succinate oral suspension after the expiry date which is stated on the label, carton or bottle after EXP. The expiry date refers to the last day of that month.

Store this medicine in the original bottle in order to protect from light. This medicinal product does not require any special temperature storage conditions. After first opening of the bottle, the suspension can be stored for 30 days.

Discard any remaining medicine 30 days after opening the bottle.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other informationwhat solifenacin succinate oral suspension contains- the active substance is solifenacin succinate 1 mg per ml suspension.

• – The other ingredients are polacrilin potassium, methylparahydro­xybenzoate (E218), propylparahydro­xybenzoate (E216), propylene glycol (E1520), simethicone emulsion 30%, microcrystalline cellulose and carboxymethyl cellulose sodium, xylitol (E967), sucralose, orange flavour (consisting of maize maltodextrin, flavouring preparations, natural flavouring substances, flavouring substances and alpha-tocopherol (E307)), citric acid monohydrate, purified water.