Resolor 2 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Resolor 1 mg film-coated tablets
Resolor 2 mg film-coated tablets
prucalopride
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Resolor is and what it is used for
- What you need to know before taking Resolor
- How to take Resolor
- Possible side effects
- How to store Resolor
- Contents of the pack and other information
1. What Resolor is and what it is used for
Resolor contains the active substance prucalopride.
Resolor belongs to a group of medicines that enhance intestinal motility (gastrointestinal prokinetics). It acts on the intestinal muscular wall, helping to restore normal bowel function. Resolor is used for the treatment of chronic constipation in adults where laxatives are not fully effective.
It must not be used in children and adolescents under 18 years of age.
2. What you need to know before starting Resolor
Do not take Resolor:
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if you are allergic to prucalopride or to any of the other ingredients of this medicine (listed in section 6),
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if you are on renal dialysis,
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if you have intestinal perforation or obstruction of the intestinal wall, or if you have severe inflammation of the gastrointestinal tract, such as Crohn's disease, ulcerative colitis, or toxic megarectum/toxic megacolon.
Warnings and precautions
Talk to your doctor before starting Resolor.
Be especially careful with Resolor and inform your doctor:
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if you have severe kidney disease,
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if you have severe liver disease,
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if you are currently under medical supervision for a serious medical condition such as lung or heart disease, mental or nervous system disorders, cancer, AIDS, or a hormonal disorder.
If you have severe diarrhoea, your oral contraceptive may not work properly; therefore, it is recommended to use an additional contraceptive method. Read the instructions in the leaflet of the oral contraceptive you are taking.
Taking Resolor with other medicines
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.
Taking Resolor with food and drink
Resolor can be taken with or without food and drink, at any time of day.
Pregnancy and breastfeeding
Resolor is not recommended during pregnancy.
- If you are pregnant or planning to become pregnant, consult your doctor.
- Use an effective method of contraception 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 medicine.
Driving and using machines
It is unlikely that Resolor will affect your ability to drive or operate machinery. However, Resolor may sometimes cause dizziness and fatigue, especially on the first day of treatment, which could affect your ability to drive or use machines.
Resolor contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Resolor
Follow exactly the instructions for use of this medicine provided in this leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist again. Take Resolor every day for the length of 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 subsequently at regular intervals.
The recommended dose of Resolor in most patients is one 2 mg tablet once daily.
If you are over 65 years of age or have severe liver disease, the initial dose is one 1 mg tablet once daily, which your doctor may increase to 2 mg daily if considered necessary.
Your doctor may also recommend a lower dose of one 1 mg tablet daily if you have severe renal disease.
You will not achieve better results by taking higher doses than recommended.
Resolor should only be used in adults and must not be used in children or adolescents under 18 years of age.
If you take more Resolor than you should
It is important that you take the dose prescribed by your doctor. If you have taken more Resolor than you should, you may experience diarrhoea, headache and/or nausea. If you have diarrhoea, make sure you drink enough water.
If you forget to take Resolor
Do not take a double dose to make up for missed doses. Simply take the next dose at your usual time.
If you stop taking Resolor
If you stop treatment with Resolor, your constipation may return.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Resolor may cause adverse effects, although not everyone experiences them. Adverse effects occur mainly at the beginning of treatment and usually disappear after a few days while continuing treatment.
The following adverse effects have been reported very frequently (may affect more than 1 in 10 people): headache, nausea, diarrhoea, and abdominal pain.
The following adverse 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 adverse effects have also been observed uncommonly (may affect up to 1 in 100 people): tremor, palpitations, rectal bleeding, increased frequency of urination (pollakiuria: increased frequency of urination), fever, and malaise. Consult your doctor if you experience palpitations.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Resolor
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the carton after EXP. The expiry date is the last day of the month indicated.
Store in the original blister pack to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Resolor
The active substance is prucalopride.
One Resolor 1 mg film-coated tablet contains 1 mg of prucalopride (as succinate).
One Resolor 2 mg film-coated tablet contains 2 mg of prucalopride (as succinate).
The other components are:
Monohydrate lactose (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 indigo carmine aluminium lake (E132).
Appearance of the product and contents of the pack
Resolor 1 mg film-coated tablets are white to off-white, round, film-coated tablets marked with “PRU 1” on one side.
Resolor 2 mg film-coated tablets are pink, round, film-coated tablets marked with “PRU 2” on one side.
Resolor is available in single-dose aluminum/aluminum blisters (with calendar embossed) containing 7 tablets. Each pack contains 7 x 1, 14 x 1, 28 x 1 or 84 x 1 film-coated tablets.
Only certain 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
Date of the most recent revision of this leaflet:
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.