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Emselex (darifenacin hydrobromide) – Package leaflet - G04BD10

Updated on site: 06-Oct-2017

Medication nameEmselex
ATC CodeG04BD10
Substancedarifenacin hydrobromide
ManufacturerMerus Labs Luxco S.à R.L.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Emselex 7.5 mg prolonged-release tablets

Darifenacin

Read all of this leaflet carefully before you start taking this medicine.

-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 on to others. It may harm them, even if their symptoms are the same as yours.

-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.

In this leaflet:

1.What Emselex is and what it is used for

2.Before you take Emselex

3.How to take Emselex

4.Possible side effects

5.How to store Emselex

6.Further information

1.WHAT EMSELEX IS AND WHAT IT IS USED FOR

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).

2. BEFORE YOU TAKE EMSELEX

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. rheumatoid arthritis or atopic dermatitis), verapamil (a medicine used to lower blood pressure, to correct heart 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.

During treatment with Emselex, tell your doctor straight away and stop taking Emselex if you experience swelling of the face, lips, tongue and/or throat (signs of angioedema).

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),

antiviral medicines (e.g. nelfinavir and ritonavir),

antipsychotic medicines (e.g. thioridazine),

certain antidepressants (e.g. imipramine),

certain anticonvulsants (carbamazepine, barbiturates),

certain medicines used to treat heart problems (e.g. flecainide, verapamil and digoxin),

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).

3.HOW TO TAKE EMSELEX

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.

4.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

Dry mouth, constipation.

Common

Headache, abdominal pain, indigestion, feeling sick, dry eyes, nasal dryness.

Uncommon

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

Depressed mood/mood alterations, hallucination.

Reporting of side effects

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 national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5. HOW TO STORE EMSELEX

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.

6. FURTHER INFORMATION

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

Merus Labs Luxco S.à R.L. 26-28, rue Edward Steichen L-2540 Luxembourg

Manufacturer

Merus Labs Netherlands B.V.,

Alexander Battalaan 37

6221 CB Maastricht

The Netherlands

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

PACKAGE LEAFLET: INFORMATION FOR THE USER

Emselex 15 mg prolonged-release tablets

Darifenacin

Read all of this leaflet carefully before you start taking this medicine.

-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 on to others. It may harm them, even if their symptoms are the same as yours.

-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.

In this leaflet:

1.What Emselex is and what it is used for

2.Before you take Emselex

3.How to take Emselex

4.Possible side effects

5.How to store Emselex

6.Further information

1. WHAT EMSELEX IS AND WHAT IT IS USED FOR

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).

2. BEFORE YOU TAKE EMSELEX

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. rheumatoid arthritis or atopic dermatitis), verapamil (a medicine used to lower blood pressure, to correct heart 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.

During treatment with Emselex, tell your doctor straight away and stop taking Emselex if you experience swelling of the face, lips, tongue and/or throat (signs of angioedema).

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),

antiviral medicines (e.g. nelfinavir and ritonavir),

antipsychotic medicines (e.g. thioridazine),

certain antidepressants (e.g. imipramine),

certain anticonvulsants (carbamazepine, barbiturates),

certain medicines used to treat heart problems (e.g. flecainide, verapamil and digoxin),

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).

3. HOW TO TAKE EMSELEX

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.

4. 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

Dry mouth, constipation.

Common

Headache, abdominal pain, indigestion, feeling sick, dry eyes, nasal dryness.

Uncommon

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

Depressed mood/mood alterations, hallucination.

Reporting of side effects

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 national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5. HOW TO STORE EMSELEX

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.

6. FURTHER INFORMATION

What Emselex contains

-The active substance is darifenacin. Each tablet contains 15 mg darifenacin (as hydrobromide).

-The other ingredients are calcium hydrogen phosphate (anhydrous), hypromellose, magnesium stearate, polyethylene glycol, talc, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).

What Emselex looks like and contents of the pack

Emselex 15 mg prolonged-release tablets are round, convex light peach tablets and are debossed with “DF” on one side and “15” 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

Merus Labs Luxco S.à R.L. 26-28, rue Edward Steichen

L-2540 Luxembourg

Manufacturer

Merus Labs Netherlands B.V.,

Alexander Battalaan 37

6221 CB Maastricht

The Netherlands

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

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