Enablex (darifenacin hydrobromide) 28 Tablets

Active ingredient
Each film-coated tablet contains 7.5 mg darifenacin hydrobromide.

Excipients
Anhydrous calcium hydrogen phosphate, hypromellose, magnesium stearate, polyethylene glycol, talc, titanium dioxide (E171).

1. What is EMSELEX and what is it used for?

EMSELEX is a white, narrow, round, biconvex film coated tablet with "DF" on one side and "7.5" on the other side. Each film-coated tablet contains 7.5 mg darifenacin hydrobromide.

EMSELEX is presented in blister packages containing 28 film-coated tablets.

EMSELEX is used in the treatment of symptoms related to overactive bladder conditions such as sudden urge to go to the toilet, the need to go to the toilet frequently and / or inability to go to the toilet on time and diaper wetting (urinary incontinence due to sudden urinary incontinence).

Emselex belongs to a group of drugs called antimuscarinic drugs that relax the bladder muscles. This medicine allows you to hold your urine longer before going to the toilet and increases the amount of fluid your bladder can hold.

This product should be used under the supervision of a doctor.

If you have any questions about how Emselex works or why this medicine has been prescribed for you, consult your doctor.

2. How to use EMSELEX?

Instructions for proper use and dose / frequency of administration

• Follow your doctor's instructions carefully.

• Do not exceed the recommended dose. If you are not sure how much EMSELEX you should use, consult your doctor or pharmacist.

• EMSELEX is intended for use in adults (18 years of age and above). The recommended starting dose is 7.5 mg (1 film tablet) once a day. At least two weeks after the initial treatment, your doctor may increase your medication to 15 mg once a day, depending on your response and tolerability to Emselex.

• If you are using certain medications (eg some antibiotics, some antifungals or some antiviral drugs), do not take more than 7.5 mg per day. These drugs are listed above (see "Use with other drugs")

• Even if you do not see the effects of the medicine immediately, do not stop the treatment ahead of time. A certain period of time must pass for your bladder to adapt. Complete the treatment period indicated by your doctor. If you do not see any effect during this time, consult your doctor.

Application route and method

• Swallow the Emselex tablets once a day, at the same time every day, with a glass of water.

• Do not chew, split or break the tablets.
Different age groups

Use in children

Use in the elderly

Use in the elderly

EMSELEX can be used for people over 65 years of age. If you are over 65, use the same dose as other adults.

Special use cases

No dose adjustment is required in patients with renal insufficiency. Liver failure:

Emselex should be used with caution in patients with liver problems. Tell your doctor if you have any liver problems. Depending on the severity of your liver problem, your doctor will decide whether or how much to use Emselex.

Unless your doctor recommends otherwise follow these instructions. Do not forget to take your medicine on time.

If you have an impression that the effect of EMSELEX is too strong or too weak, talk to your doctor or pharmacist.

If you use more EMSELEX than you should

If you take too many tablets or if someone else has accidentally taken too much of your tablets, contact your doctor or hospital immediately. Also show your tablet box in your application. You may need medical attention.

If you have used more EMSELEX than you should use, talk to a doctor or pharmacist.

If you forgot to use EMSELEX

If you forget to take your medicine, take this dose as soon as you realize that you have forgotten and take the next dose at the usual time.

If you notice that you have forgotten to take your medicine and the time of the next dose is approaching, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

3. What are the possible side effects?

Like all medicines, there may be side effects in people who are sensitive to the substances contained in Emselex.

These side effects when using Emselex are usually mild to moderate and transient. The following side effects may occur as a result of using EMSELEX:

Side effects are listed as shown in the following categories: Very common: It can be seen in at least 1 of 10 patients.

Common: less than one in 10 patients, but more than one in 100 patients.

Uncommon: less than one in 100 patients, but more than one in 1,000 patients

visible.

: Less than one in 1,000 patients can be seen. : Less than one in 10,000 patients can be seen.

Rare Very rare

Unknown frequency: It can be seen in a small number of patients that cannot be determined from the available data. Very common:

Dry mouth,

Constipation,