RESOLOR 2 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Resolor 1 mg film-coated tablets

Resolor 2 mg film-coated tablets

prucalopride

Read the entire package leaflet carefully before starting to take this medication 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Resolor and what is it used for
2. What you need to know before taking Resolor
3. How to take Resolor
4. Possible side effects
5. Storage of Resolor
6. Package contents and additional information

1. What is Resolor and what is it used for

Resolor contains the active substance prucalopride.

Resolor belongs to a group of medications that enhance intestinal motility (gastrointestinal prokinetics). It acts on the muscular wall of the intestine, helping to restore its normal function. Resolor is used to treat chronic constipation in adults for whom laxatives do not work completely.

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

2. What you need to know before taking Resolor

Do not take Resolor:

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

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

Warnings and precautions

Consult your doctor before starting to take Resolor.

Be particularly 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 a 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 package leaflet of the contraceptive pill you are taking.

Using Resolor with other medications

Tell your doctor if you are taking, have recently taken, or may take any other medication.

Taking Resolor with food and drinks

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

Pregnancy and breastfeeding

Resolor should not be used during pregnancy.

• If you are pregnant or plan 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. Breastfeeding is not recommended during treatment with Resolor. Consult your doctor about this.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Resolor contains lactose

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

3. How to take Resolor

Follow the instructions for administration of this medication contained in this package leaflet or as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Take Resolor every day for the time indicated by your doctor.

It is possible that your doctor may want to re-evaluate your condition and the benefit of continuing treatment after the first 4 weeks and at regular intervals thereafter.

The recommended dose of Resolor in 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 of age.

If you take more Resolor than you should

It is important to take the dose prescribed by your doctor. If you have taken more Resolor than you should, you may have diarrhea, headache, and/or nausea. In case of diarrhea, make sure to drink plenty of water.

If you forget to take Resolor

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

If you stop taking Resolor

If you stop taking Resolor, you may experience constipation again.

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

4. Possible side effects

Like all medications, Resolor can cause side effects, although not everyone will experience them. Side effects usually occur at the start of treatment and tend to disappear after a few days of continued treatment.

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

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

The following side effects have also been observed, although less frequently (may affect up to 1 in 100 people): tremors, palpitations, rectal bleeding, increased frequency of urination (pollakiuria: increased frequency of urinating), fever, and general malaise. Consult your doctor if you experience palpitations.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Resolor

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

Do not use this medication after the expiration date stated on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

Store in the original blister pack to protect from moisture.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Resolor

The active substance is prucalopride.

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

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

The other ingredients 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 red iron oxide (E172), yellow iron oxide (E172), and aluminum lake carmine indigo (E132).

Appearance of the product and package contents

Resolor 1 mg film-coated tablets are white to off-white, round tablets marked with "PRU 1" on one side.

Resolor 2 mg film-coated tablets are pink, round tablets marked with "PRU 2" on one side.

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

Not all pack sizes may be marketed.

Marketing authorization holder and 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

Date of the last revision of this package leaflet:

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu.