Package Leaflet: Information for the User

Resolor 1 mg Film-Coated Tablets

Resolor 2 mg Film-Coated Tablets

prucaloprida

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours, as it may harm them.

• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Resolor contains the active ingredient prucalopride.

Resolor belongs to a group of medicines that enhance intestinal motility (gastrointestinal prokinetics). It acts on the intestinal muscle wall, helping to restore normal functioning. Resolor is used for the treatment of chronic constipation in adults in whom laxatives do not work properly.

It should not be used in children or adolescents under 18 years old.

Do not take Resolor:

• if you are allergic to prucalopride or any of the other ingredients in this medicine (listed in section 6),
• if you are on renal dialysis,

• if you have a perforation or obstruction of the intestinal wall, if you have severe inflammation of the intestinal tract, such as Crohn's disease, ulcerative colitis, or toxic megacolon/megarectum.

Warnings and precautions

Consult your doctor before starting to take Resolor.

Be especially careful with Resolor and inform your doctor:

• if you have severe kidney disease,
• if you have severe liver disease,

• if you are currently under medical supervision due to a serious medical condition such as lung or heart disease, mental health or nervous system problems, cancer, AIDS, or hormonal disorder.

If you have severe diarrhea, it is possible that the contraceptive pill may not work properly, so it is recommended to use an additional contraceptive method. Read the instructions in the contraceptive pill package insert that you are taking.

Use of Resolor with other medicines

Inform your doctor if you are taking, have taken recently, or may need to take any other medicine.

Resolor with food and drinks

Resolor can be taken with or without food and drinks at any time of the day.

Pregnancy and breastfeeding

Resolor is not recommended during pregnancy.

• If you are pregnant or intend to become pregnant, consult your doctor.
• Use an effective contraceptive method while taking Resolor to avoid pregnancy.
• If you become pregnant during treatment with Resolor, consult your doctor.

During breastfeeding, prucalopride may pass into breast milk. Resolor is not recommended during breastfeeding. Consult your doctor about this.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

It is unlikely that Resolor will affect your ability to drive or operate machines. However, Resolor may cause dizziness and fatigue, especially on the first day of treatment, which may affect your ability to drive and operate machines.

Resolor contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Follow exactly the administration instructions for this medication contained in this leaflet or those indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Take Resolor every day for the time indicated by your doctor.

Your doctor may wish to re-evaluate your condition and the benefit of continuing treatment after the first 4 weeks and then at regular intervals.

The recommended dose of Resolor for most patients is one 2 mg tablet once a day.

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

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

You will not get better results by taking higher doses than recommended.

Resolor should only be used in adults and should not be used in children or adolescents under 18 years old.

If you take more Resolor than you should

It is essential to take the dose prescribed by your doctor. If you have taken more Resolor than you should, you may experience diarrhea, headaches, and/or nausea. If you have diarrhea, make sure to drink enough water.

If you forgot to take Resolor

Do not take a double dose to make up for the missed doses. Simply take the next dose at the usual time.

If you interrupt treatment with Resolor

If you interrupt treatment with Resolor, you may experience constipation again.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Resolor may produce adverse effects, although not everyone will experience them. Adverse effects primarily occur at the beginning of treatment and usually disappear after a few days of continued treatment.

The following adverse effects have been reported frequently (may affect more than 1 in 10 people): headache, nausea, diarrhea, and abdominal pain.

The following adverse effects have been reported frequently (may affect up to 1 in 10 people): decreased appetite, dizziness, vomiting, digestive alteration (dyspepsia), flatulence, abnormal intestinal sounds, fatigue.

Additionally, the following adverse effects have been observed infrequently (may affect up to 1 in 100 people): tremors, palpitations, rectal bleeding, increased frequency of urination (polyuria: increased frequency of urinating), fever, and general discomfort. Consult your doctor if palpitations occur.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

Store in the original blister pack to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Resolor

The active principle is prucalopride.

A Resolor film-coated tablet 1 mg contains 1 mg of prucalopride (as succinate).

A Resolor film-coated tablet 2 mg contains 2 mg of prucalopride (as succinate).

The other components are:

Lactose monohydrate (see section 2), microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171), macrogol. The 2 mg tablet also contains iron oxide red (E172), iron oxide yellow (E172), and aluminium lake carmine indigo (E132).

Appearance of the product and contents of the container

Resolor 1 mg film-coated tablets are white to off-white, round, marked with “PRU 1” on one face.

Resolor 2 mg film-coated tablets are pink, round, marked with “PRU 2” on one face.

Resolor is presented in aluminium/aluminium perforated blisters (with calendar printed) containing 7 tablets. Each pack contains 7 x 1, 14 x 1, 28 x 1 or 84 x 1 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorisation holder and responsible manufacturer

Shire Pharmaceuticals Ireland Limited

Block 2 Miesian Plaza

50 – 58 Baggot Street Lower

Dublin 2

D02 HW68

Ireland

Manufacturer

Sanico NV

Veedijk 59

B-2300 Turnhout

Belgium

Last revision date of this leaflet:

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