Colselax contains the active substance prucalopride.

Colselax belongs to a group of medicines that increase intestinal motility (gastrointestinal prokinetics). It acts on the muscular wall of the intestine, helping to restore normal bowel function. Colselax is used to treat chronic constipation in adults where laxatives do not work well enough.

Not for use in children and adolescents under 18 years of age.

Do not take Colselax:
- if you are allergic to prucalopride or any of the other ingredients of this medicine (listed in section 6).
drug.

Talk to your doctor before taking Colselax.

Pregnancy and breastfeeding
Colselax is not recommended for use during pregnancy.
- Tell your doctor if you are pregnant or plan to become pregnant.
- While taking Colselax, use a reliable method of contraception to prevent pregnancy.
- If you become pregnant during treatment with Colselax, tell your doctor.

When you are breast-feeding, prucalopride may pass into your milk. Breast-feeding is not recommended for women while taking Colselax. Talk to your doctor about this.
Ask your doctor for advice before taking any medication.

Driving and using machines:
Colselax is unlikely to have any effect on the ability to drive or use machines. However, Colselax may sometimes cause dizziness and tiredness, especially on the first day of treatment.
These manifestations may have an effect on driving and using machines.

Colselax contains lactose:
If your doctor has told you that you have an intolerance to some sugars, please contact him before taking this medicine.

Always take this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Take Colselax every day for as long as your doctor has told you.

Your doctor may re-evaluate your health status and the benefit of continuing treatment after the first 4 weeks, and then at regular intervals.

The usual dose of Colselax for most patients is one 2 mg tablet once a day.

If you are over 65 years of age, or have severe liver disease, the starting dose is
one 1 mg tablet once a day, which your doctor may increase to 2 mg once a day if necessary.

Your doctor may also recommend a lower dose of one 1 mg tablet per day if you have severe kidney disease.

Using a higher dose than recommended will not result in a more intense effect of the
the medicine.

Colselax is for use in adults only, and should not be used in children and adolescents under 18 years of age.

- The active substance is prucalopride.
One film-coated tablet of Colselax 1 mg contains 1 mg prucalopride (as succinate).
One film-coated tablet of Colselax 2 mg contains 2 mg prucalopride (as succinate).
- The other components are:
lactose monohydrate (see section 2), microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 4000 and triacetin. The 2 mg tablet also contains red iron oxide (E172), indigo carmine (E132) and yellow iron oxide (E172).

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

28 film-coated tablets