How Emselex works
Emselex reduces the activity of an overactive bladder. This enables you to wait longer before you go to the toilet and it increases the amount of urine that your bladder can hold.
What Emselex can be used for
Emselex belongs to a class of medicines which relax the muscles of the bladder. It is used in adults for the treatment of the symptoms of overactive bladder conditions - such as a sudden urge to rush to the toilet, needing to go to the toilet frequently and/or not getting to the toilet in time and wetting yourself (urge incontinence).
Use in children (age below 18 years)
Emselex is not recommended for use in children.
Taking other medicines with Emselex
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is particularly important if you are taking any of the following as your doctor may need to adjust your dose of Emselex and/or the other product: certain antibiotics (e.g. erythromycin, clarithromycin and rifampicin), antifungal medicines (e.g. ketoconazole and itraconazole), antipsychotic medicines (e.g. thioridazine), certain antidepressants (e.g. imipramine), antiviral medicines (e.g. nelfinavir and ritonavir), certain anticonvulsants (carbamazepine, barbiturates), certain medicines used to treat heart problems (e.g. flecainide, verapamil and digoxin) and other antimuscarinic medicines (e.g. tolterodine, oxybutynin and flavoxate). Please also inform your doctor if you are taking products containing St John’s wort.
Taking Emselex with food and drink
Eating food has no effect on Emselex. Grapefruit juice may interact with Emselex. However, the adjustment of Emselex doses is not necessary.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant, tell your doctor. Emselex is not recommended during pregnancy.
If you are breast-feeding, ask your doctor for advice. Emselex should be taken with caution while breast-feeding.
Driving and using machines
Emselex may cause effects such as dizziness, blurred vision, trouble sleeping or drowsiness. If you have any of these symptoms whilst taking Emselex, consult your doctor for advice on changing the dose or considering an alternative treatment. You should not drive or use machines if you are affected by these symptoms. For Emselex, these side effects have been reported to be uncommon (see section 4).
Always take Emselex exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. If you have the impression that the effect of Emselex is too strong or too weak, talk to your doctor or pharmacist.
How much Emselex to take
The recommended starting dose, including for patients aged over 65 years, is 7.5 mg daily. Depending on your response to Emselex, your doctor may increase your dose to 15 mg daily, two weeks after starting therapy.
These doses are suitable for people with mild liver problems or people with kidney problems.
Take Emselex tablets once a day with water, at about the same time each day.
The tablet may be taken with or without food. Swallow the tablet whole. Do not chew, split or crush it.
How long to take Emselex
Your doctor will tell you how long your treatment with Emselex will last. Do not stop treatment early because you do not see an immediate effect. Your bladder will need some time to adapt. Finish the course of treatment prescribed by your doctor. If you have not noticed any effect by then, discuss it with your doctor.
If you take more Emselex than you should
If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, go to your doctor or hospital for advice immediately. When seeking medical advice, make sure that you take this leaflet and your remaining tablets with you to show them to the doctor. People who have taken an overdose may have dry mouth, constipation, headache, indigestion and nasal dryness. Overdose with Emselex may lead to severe symptoms requiring emergency treatment in hospital.
If you forget to take Emselex
If you forget to take Emselex at the usual time, take it as soon as you remember, unless it is the time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Emselex
It has been shown that taking all doses at the appropriate times can greatly increase the effectiveness of your medicine. Therefore, it is important to keep taking Emselex correctly, as described above. Do not stop taking Emselex until your doctor tells you to. You should not experience any effects when you stop treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Emselex can cause side effects, although not everybody gets them. The side effects caused by Emselex are usually mild and temporary.
Some side effects could be serious
Serious allergic reactions including swelling, mainly of the face and throat.
Other side effects Very common side effects
Dry mouth, constipation.
Common side effects
Headache, abdominal pain, indigestion, feeling sick, dry eyes.
Uncommon side effects
Fatigue, accidental injury, facial swelling, high blood pressure, diarrhoea, flatulence, inflammation of the mucous membrane of the mouth, increased liver enzymes, swelling, dizziness, sleeplessness, drowsiness, abnormal thinking, runny nose (rhinitis), cough, shortness of breath, dry skin, itching, rash, sweating, visual disturbance including blurred vision, taste disturbance, urinary tract disorder or infection, impotence, discharge and itching in the vagina, bladder pain, inability to empty your bladder.
Not known side effects
Depressed mood/mood alterations, hallucination.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Emselex is a medicine that contains the active substance darifenacin. It is available as round, prolonged-release tablets (white: 7.5 mg; light peach: 15 mg). ‘Prolonged-release’ means that darifenacin is released slowly from the tablet over a few hours.
Emselex is used in adults with overactive bladder syndrome. It is used to treat the urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and urgency (sudden urge to pass urine) that are associated with the syndrome.
The medicine can only be obtained with a prescription.
The recommended starting dose of Emselex is 7.5 mg once a day. For patients requiring greater symptom relief, the dose may be increased to 15 mg. The tablets can be taken with or without food. They should be swallowed whole with some liquid, and not chewed, divided or crushed.
The active substance in Emselex, darifenacin, is an anticholinergic medicine. It blocks a receptor called the ‘muscarinic M3 receptor’. In the bladder, this causes the muscles that push urine out of the bladder to relax. This leads to an increase in the capacity of the bladder and changes in the way the bladder contracts, resulting in fewer bladder contractions. This helps Emselex to prevent unwanted urination.
Emselex has been studied in four main studies in a total of 2,078 male and female patients with symptoms of overactive bladder. Emselex was used at various doses (from 3.75 mg to 30 mg a day) and compared with placebo (dummy treatment) or with tolterodine (another medicine used in this condition). The main measure of effectiveness was the change in the number of incontinence episodes per week.
When the results from all four studies were combined, Emselex was more effective in reducing the number of incontinence episodes than placebo. At the start of the studies, the patients had around 16 incontinence episodes per week. After 12 weeks of treatment, patients receiving Emselex 7.5 mg or 15 mg had 8.8 (68%) or 10.6 (77%) fewer episodes of incontinence per week, respectively, and patients receiving placebo had 7 or 7.5 (54 or 58%) fewer episodes per week.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Emselex showed an effectiveness similar to that of other anticholinergic medicines used in overactive bladder syndrome. The Committee decided that Emselex’s benefits are greater than its risks for the symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome. The Committee recommended that Emselex be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the European Union for Emselex to Novartis Europharm Limited on 22 October 2004. The marketing authorisation was renewed on 22 October 2009.