Emselex (Darifenacin) modified-release tablets

Talk to your doctor before taking 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 a condition where one or more organs in your abdomen has moved up into your
chest through a hole in your diaphragm, causing you to get heartburn and belch a lot.
• 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 urinary tract infection or other kidney problems.
• if you have an overactive muscle that controls the emptying of the bladder which may cause accidental passing of urine (a condition called detrusor hyperreflexia) – your doctor will tell you
if you are suffering from this condition.
• 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)

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.

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.

Like all medicines, this medicine 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

Not known (frequency cannot be estimated from the available data)

Serious allergic reactions including swelling, mainly of the face and neck (angioedema).

Other side effects

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, feeling sick, dry eyes, nasal dryness.

Uncommon (may affect up to 1 in 100 people)

Fatigue, accidental injury, facial swelling, high blood pressure, diarrhoea, flatulence, ulceration of the
mucous membrane of the mouth, increased liver enzymes (this shows abnormal functioning of the
liver), swelling including swelling of the hands, ankles or feet, 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 (frequency cannot be estimated from the available data)

Depressed mood/mood alterations, hallucination