Solifenacin 1mg/ml oral solution

• 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. Do not pass it onto 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 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

• 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 allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6).
• 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 ever had any of the above mentioned conditions before treatment with Solifenacin Succinate starts.

Talk to your doctor or pharmacist 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 (urinary retention) is much higher.
• 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 nervous disorder (autonomic neuropathy).
• if you suffer from any condition which results in alterations of your heart rhythm, especially an abnormality known as QT prolongation.

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).

Solifenacin Succinate is not to be used in children or adolescents under 18 years.

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.
• medicines, like metoclopramide and cisapride, which make the digestive system work faster. Solifenacin Succinate can reduce their effect.
• medicines, like ketoconazole, ritonavir, nelfinavir, itraconazole, 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 can be taken with or without food, depending on your preference.

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.

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.

If you have been told by your doctor that you have an intolerance to some sugars (such as liquid maltitol (E965)), contact your doctor before taking this medicinal product.

This medicine contains 0.2 mg sodium benzoate (E211) in each ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in new-born babies (up to 4 weeks old).

If you get Solifenacin Succinate in your eyes: If you get this medicine in your eyes, rinse and clean your eyes thoroughly with water.

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 orally with a glass of water. You can take this medicine before or after a meal. It can be taken with or without food, according to your preference.

The usual dose is 5 mg per day. If you need to take a dose of 5 mg, you should use the enclosed 5 ml oral syringe together with the enclosed adaptor to attach the syringe to the bottle. This helps you to take a dose from the bottle.

If your doctor told you to take 10 ml (10 mg) per day, you should use the enclosed 5 ml oral syringe together with the enclosed adaptor to attach the syringe to the bottle.

Instructions for Use:

• Open the bottle: press the cap and turn it anti clock wise (figure 1)
• Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is well fixed.
• Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure 5).
• Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C).
• Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).
• Close the bottle with the plastic screw cap.
• Empty the contents of the syringe into your mouth.
• Wash the syringe with water (figure 7).

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 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 this medicine your symptoms of overactive bladder 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 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.

• The active substance is solifenacin succinate. Each ml of oral solution contain 1 mg of Solifenacin Succinate, corresponding to 0.76 mg Solifenacin.
• The other ingredients are sodium benzoate (E211), sucralose (E955), liquid maltitol (E965), peppermint flavour, citric acid monohydrate (E330), purified water.

Solifenacin Succinate is a clear, colorless oral solution with peppermint flavour.

This medicine is supplied in 150 ml amber colored bottle with a tamper evident child resistant closure and a 5 ml oral syringe (graduated at every 0.5 ml equivalent to 0.5mg) with adaptor, packed in a carton.

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