Emselex 15 mg prolonged-release tablets

 

What is it and how is it used?

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).

What do you have to consider before using it?

Do not take Emselex if you are allergic hypersensitive to darifenacin or any of the other ingredients of Emselex. if you suffer from urinary retention inability to empty your bladder. if you have gastric retention problems emptying the contents of the stomach. if you suffer from uncontrolled narrow-angle glaucoma high pressure in the eyes with loss of eyesight that is not being adequately treated. if you have myasthenia gravis a disease marked by abnormal tiredness and weakness of selected muscles. if you have severe ulcerative colitis or toxic megacolon acute dilation of the colon due to complication of infection or inflammation. if you have severe liver problems. There are some medicines such as ciclosporin a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumathoid arthritis or atopic dermatitis, verapamil a medicine used to lower blood pressure, to correct hearth rhythm or to treat angina pectoris, antifungal medicines e.g. ketoconazole and itraconazole and some antiviral medicines e.g. ritonavir that must not be taken with Emselex.

Take special care with Emselex if you have autonomic neuropathy damage to the nerves that communicate between the brain and internal organs, muscles, skin, and blood vessels to regulate vital functions, including the heart rate, blood pressure and bowel function your doctor will have told you if you have this. if you have heartburn and belching. if you have difficulties in passing urine and a weak stream of urine. if you have severe constipation less than or equal to 2 bowel movements per week. if you have a digestive motility disorder. if you have an obstructive gastrointestinal disorder any obstruction of the passage of intestinal or gastric contents, such as narrowing of the pylorus, the lower part of the stomach your doctor will have told you if you have this. if you are taking medicinal products that can cause or worsen inflammation of the oesophagus such as oral bisphosphonates a class of medicinal products that prevent the loss of bone mass and are used to treat osteoporosis. if you are receiving treatment for narrow-angle glaucoma. if you have liver problems. if you have kidney problems. if you have heart diseases. If any of these apply to you, tell your doctor before you take Emselex.

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).

How is it used?

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.

What are possible side effects?

Like all medicines, Emselex can cause side effects, although not everybody gets them. The side effects caused by Emselex are usually mild and temporary.

These side effects may occur with certain frequencies, which are defined as follows very common affects more than 1 patient in 10 common affects 1 to 10 patients in 100 uncommon affects 1 to 10 patients in 1,000 rare affects 1 to 10 patients in 10,000 very rare affects less than 1 patient in 10,000 not known frequency cannot be estimated from the available data.

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.

How should it be stored?

Keep out of the reach and sight of children. Do not use after the expiry date which is stated on the carton. Keep the blister packs in the outer carton in order to protect from light. Do not use if the pack is damaged or shows signs of tampering.

What is it?

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.

What is it used for?

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.

How is it used?

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.

How does it work?

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.

How has it been studied?

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.

What benefits has it shown during the studies?

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.

What is the risk associated?

What is the risk associated with Emselex The most common side effects with Emselex seen in more than 1 patient in 10 are dry mouth and constipation. For the full list of all side effects reported with Emselex, see the Package Leaflet. Emselex should not be used in people who may be hypersensitive allergic to darifenacin or any of the other ingredients. It must not be used in patients with urinary retention difficulty passing urine gastric retention when the stomach does not empty properly uncontrolled narrow-angle glaucoma increased eye pressure even with treatment myasthenia gravis a disease causing muscle weakness severe liver problems severe ulcerative colitis severe inflammation of the gut causing ulcers and bleeding toxic megacolon a very serious complication of colitis. Emselex must not be taken by patients who are also taking medicines that are broken down in the same way as Emselex, such as protease inhibitors used to treat HIV infection, such as ritonavir, or ketoconazole or itraconazole used to treat fungal infections.

Why has it been approved?

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.

Further information

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.