7.5 mg prolonged-release tablets are Darifenacin

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Emselex is and what it is used for 
2. What you need to know before taking Emselex 
3. How to take Emselex 
4. Possible side effects 
5. How to store emselex 6. Contents of the pack 
and other ingredients information

1. What Emselex is and what it is used for

How Emselex works

Emselex attenuates the increased activity of the bladder. This allows you to wait longer before going to the toilet and it also increases the amount of urine that the bladder can hold.

What Emselex can be used for

Emselex belongs to a group of medicines that relax the muscles in the bladder. It is used in adults to treat the symptoms of an overactive bladder characterized by conditions such as – a sudden urge to go to the toilet, need to go to the toilet often, and/or not have time to go to the toilet in time and to leak urine (urge incontinence).

2. What you need to know before taking Emselex

Do not take Emselex:

  • if you are allergic to darifenacin or any of the other ingredients of this medicine (listed in section 6).
  • if you suffer from urinary retention (inability to empty your bladder).
  • if you have ventricular retention (problems with emptying the stomach contents).
  • If you suffer from untreated glaucoma ( glaucoma ) with a narrow chamber angle(untreated high pressure in the eyes with loss of vision).
  • if you have myasthenia gravis (a disease characterized by abnormal fatigue and weakness in some muscles).
  • if you have severe ulcerative colitis or toxic megacolon ( acute enlargement of the colon due to complication associated with infection or inflammation ).
  • if you have severe liver problems.
  • There are certain medicines such as ciclosporin (a medicine used in transplantation to prevent organ rejection or other diseases such as rheumatoid arthritis or severe dermatitis), verapamil (a medicine used to lower blood pressure, to adjust the heart rhythm, or to treat angina, antifungals (eg ketoconazole and itraconazole) and certain antiviral medicines (eg ritonavir) that must not be taken with Emselex.

Warnings and caution

Talk to your doctor before taking Emselex

  • if you have autonomic neuropathy (damage to the nerves responsible for communication between the brain and internal organs, muscles, skin, and blood vessels to regulate vital functions, including heart rhythm, blood pressure, and bowel function) – your doctor has informed you about this.
  • if you have heartburn and belching.
  • if you have difficulty emptying your bladder and the urine flow is weak.
  • if you have severe constipation (2 or fewer bowel movements per week).
  • if you have indigestion.
  • if you have an obstructive gastrointestinal disease (obstruction in the passage of intestinal or gastric contents, such as narrowing of pyrosis, lower abdomen) – your doctor has informed you about this.
  • if you are taking medicines that can cause or worsen the inflammation of the esophagus such as oral bisphosphonates (a group of medicines that prevent the loss of bone mass and are used to treat osteoporosis ).
  • if you get treatment for glaucoma ( glaucoma ) with a narrow chamber angle.
  • if you have liver problems.
  • if you have kidney problems.
  • if you have heart disease.

If any of the above apply to you, talk to your doctor before taking Emselex.

Tell your doctor immediately and stop taking Emselex if you experience swelling of the face, lips, tongue, and/or throat during treatment with Emselex (may be a symptom of angioedema ).

Children and young people

Emselex is not recommended for children and adolescents (<18 years).

Other medicines and Emselex

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are taking any of the following medicines as your doctor may need to adjust the dose of one of Emselex and/or the other medicine:

  • certain antibiotics (eg erythromycin, clarithromycin, and rifampicin),
  • antifungal agents (eg ketoconazole and itraconazole),
  • antiviral agents (eg nelfinavir and ritonavir),
  • drugs for psychosis (eg thioridazine),
  • certain antidepressants (eg imipramine),
  • certain antiepileptic drugs (carbamazepine, barbiturates ),
  • certain medicines to treat heart problems (eg flecainide, verapamil, and digoxin ),
  • other antimuscarinic drugs (eg tolterodine, oxybutynin, and flavoxate).

Also, tell your doctor if you are taking products that contain St. John’s wort.

Emselex with food and drink

Food intake does not affect Emselex. Grapefruit juice can affect Emselex. However, does one of Emselex does not need to be changed

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Emselex is not recommended during pregnancy.

Emselex should be taken with caution when breast-feeding.

Driving and using machines:

Emselex can cause effects such as dizziness, blurred vision, sleep disturbances, and drowsiness. If you get any of these symptoms while taking Emselex, talk to your doctor for advice on changing the dose or any alternative treatment. You should not drive or use machines if you experience these symptoms. These side effects have been reported to be less common in Emselex (see section 4).

3. How to take Emselex

How much Emselex to take

Always take Emselex exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. If you have the impression that the effect of Emselex is too strong or too weak, talk to your doctor or pharmacist.

The recommended starting dose, even for patients over 65 years of age, is 7.5 mg daily. Depending on how you respond to this dose your doctor may increase the dose one to 15 mg daily two weeks after starting treatment.

The doses listed above are suitable for people with mild liver problems and people with kidney problems.

Take the Emselex tablets once daily with water, at about the same time of day.

The tablets can be taken regardless of the meal. Swallow the tablet whole. The tablets must not be chewed, divided, or crushed.

How long does Emselex take?

Your doctor will tell you how long the treatment with Emselex should last. Do not stop treatment prematurely just because you do not get an immediate effect. Your bladder will need some time to adjust. Complete the treatment prescribed by your doctor. If you have not seen any effect of the tablets, discuss it with your doctor.

If you take more Emselex than you should

If you have taken more tablets than you have been prescribed, or if someone else has taken your tablets by mistake, contact your doctor or hospital immediately for advice. Bring this leaflet and remaining tablets to show to your doctor when you seek advice. People who have taken an overdose can get dry mouth, constipation, headaches, indigestion, and dry nose. Overdose with Emselex can lead to serious symptoms which require emergency care in a hospital.

If you forget to take Emselex

If you forget to take Emselex at the usual time, take the tablet as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Emselex

If all doses are taken at the recommended times, it has been shown that the effect of the medicine can increase greatly. Therefore, it is important to take Emselex correctly, as described above. Do not stop taking Emselex until your doctor tells you to. You should not get any side effects when the treatment is stopped.

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 of Emselex are usually mild and transient.

Some side effects can be serious

Severe allergic reactions including swelling, mainly of the face and throat.

Other side effects ar

Very common (may affect more than 1 in 10 people)

Dry mouth, constipation.

Common (may affect up to 1 in 10 people)

Headache, abdominal pain, indigestion, nausea, dry eyes, dry nose.

Uncommon (may affect up to 1 in 100 people)

Fatigue, accidental injury, facial swelling, high blood pressure, diarrhea, flatulence, inflammation of the oral mucosa, increased liver enzymes, swelling, dizziness, insomnia, drowsiness, abnormal thinking, runny nose ( rhinitis ), cough, shortness of breath, dry skin, pruritus, skin rash, sweating, blurred vision including blurred vision, taste changes, urinary tract problems or infection, impotence, discharge and itching from the vagina, pain in the bladder, inability to empty the bladder.

No known frequency (cannot be calculated from the available data)

Decreased mood/mood changes, hallucinations.

5. How to store emselex

– Keep this medicine out of the reach and sight of children.

– Use before the expiry date which is stated on the carton and blister. The expiration date is the last day of the specified month.

– Store the blister pack in the outer carton. Sensitive to light.

– Do not use the packaging if it is damaged or appears to have been broken.

– Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures are intended to protect the environment.

6. Contents of the packaging and other information

Content declaration

– 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 the medicine looks like and the contents of the pack

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

The tablets are supplied in pressure packs containing 7, 14, 28, 49, 56, or 98 tablets or in multiple packs consisting of 140 (10×14) tablets. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Merus Labs Luxco S.á RL

26-28, rue Edward Steichen

L-2540 Luxembourg

Tel: + 352 26 37 58 78

Manufacturer

Merus Labs Netherlands BB

Alexander Battalion 37

6221 CB Maastrict

Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Norgine Danmark A / S

Tel: +46 (0) 8 223 050

Muhammad Nadeem

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