Emselex 7.5 mg prolonged-release tablets

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).

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).

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.

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.

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 Emselex contains

• The active substance is darifenacin. Each tablet contains 7.5 mg darifenacin (as hydrobromide).
• The other ingredients are calcium hydrogen phosphate (anhydrous), hypromellose, magnesium stearate, polyethylene glycol, titanium dioxide (E171) and talc.

What Emselex looks like and contents of the pack

Emselex 7.5 mg prolonged-release tablets are round, convex white tablets and are debossed with ?DF? on one side and ?7.5? on the other.

The tablets are available in blister packs containing 7, 14, 28, 49, 56 or 98 tablets or in multipacks containing 140 (10x14) tablets. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Manufacturer

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany

If you have any questions about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma GmbH TélTel 49 911 273 0

Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Bayer Hungária Kft. Tel. 36 1 487 41 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Zambon Nederland B.V. Tel 31 33 45 04 371

Deutschland Bayer Vital GmbH Tel 49-0 214-3051348 Norge Novartis Norge AS Tlf 47 23 05 20 00

Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888

España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600

France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01

Ireland Novartis Ireland Limited Tel 353 1 260 12 55 Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 50

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakia s.r.o. Tel 421 2 5542 5439

Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 010 6133 200

357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00

Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370

Lietuva

Novartis Pharma Services Inc.
Tel: +370 5 269 16 50

This leaflet was last approved in