Solifenacin succinate 1 mg/ml oral suspension

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

1. What Solifenacin succinate oral suspension is and what it is used for
2. What you need to know before you take Solifenacin succinate oral suspension
3. How to take Solifenacin succinate oral suspension
4. Possible side effects
5. How to store Solifenacin succinate oral suspension
6. Contents of the pack and other information

• 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.

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).

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.

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 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.

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.

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.

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.

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 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), 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 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, your symptoms of your underlying bladder disease may return or worsen. Always consult your doctor, if you are considering stopping the treatment.

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: 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.

• 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.

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

Manufacturer