Resolor
Italy
Table of Contents
Patient Information Leaflet: Information for the User
Resolor 1 mg film-coated tablets, 2 mg film-coated tablets
prucalopride
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
- Keep this leaflet. 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 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 improve intestinal motility (gastrointestinal prokinetics).
It acts on the muscular wall of the intestine, helping to restore normal bowel function. Resolor is used for the treatment of chronic constipation in adults in whom laxatives do not work adequately.
Do not use in children and 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 to any of the other ingredients of this medicine (listed in section 6),
- if you are undergoing renal dialysis,
- if you have intestinal wall perforation or obstruction, severe inflammation of the gastrointestinal tract, such as Crohn's disease, ulcerative colitis, or toxic megacolon/megarectum.
Warnings and precautions
Talk to your doctor before taking Resolor.
Be especially cautious 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 for a serious health condition, such as heart or lung disease, a mental or nervous system disorder, cancer, AIDS, or a hormonal disorder.
In case of severe diarrhoea, oral contraceptive pills may not work properly: you are advised to use an additional effective contraceptive method. See the instructions contained in the leaflet of the contraceptive pill you are taking.
Other medicines and Resolor
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
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.
- Inform your doctor if you are pregnant or planning to become pregnant.
- Use a reliable contraceptive method during treatment with Resolor to avoid pregnancy.
- If you become pregnant during treatment with Resolor, inform your doctor.
Prucalopride may pass into breast milk during breastfeeding. Breastfeeding is not recommended during treatment with Resolor. Consult your doctor about this.
Ask your doctor for advice before taking any medicine.
Driving and using machines
It is unlikely that Resolor will affect your ability to drive or use machines. However, in some cases Resolor may cause dizziness and fatigue, especially on the first day of treatment, which could affect your ability to drive or operate machinery.
Resolor contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
3. How to take Resolor
Take this medicine exactly as described in this leaflet or as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Continue taking Resolor every day for the duration prescribed by your doctor.
Your doctor may wish to reassess your condition and the benefit of long-term treatment after the first 4 weeks and subsequently at regular intervals.
The usual dose of Resolor for most patients is one 2 mg tablet once daily.
If you are over 65 years of age or have severe liver disease, the starting dose is one 1 mg tablet once daily. If necessary, your doctor may increase the dose to 2 mg once daily.
Your doctor may also recommend the lower dose of one 1 mg tablet once daily if you have severe renal impairment.
Taking a higher dose than recommended will not increase the effectiveness of the medicine.
Resolor is indicated only for adults and must not be taken by children or adolescents under 18 years of age.
If you take more Resolor than you should
It is important to follow the dose prescribed by your doctor. If you have taken more Resolor than prescribed, you may experience diarrhea, headache and/or nausea. If you have diarrhea, make sure you drink enough water.
If you forget to take Resolor
Do not take a double dose to make up for the missed tablet. Take the next dose at the usual time.
If you stop taking Resolor
If you stop taking Resolor, constipation symptoms may return.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects occur mainly at the beginning of treatment and usually disappear within a few days of continued treatment.
The following side effects have occurred very commonly (may affect more than 1 in 10 people): headache, nausea, diarrhoea, and abdominal pain.
The following side effects have occurred commonly (may affect up to 1 in 10 people): loss of appetite, dizziness, vomiting, digestive disorders (dyspepsia), flatulence, abnormal intestinal rumbling (borborygmi), fatigue.
The following uncommon side effects have also been reported (may affect up to 1 in 100 people): tremors, palpitations, rectal bleeding, increased frequency of urination (pollakiuria), fever, and feeling unwell. If you experience palpitations, inform your doctor.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store 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 the carton after
Exp. The expiry date refers to the last day of that month.
Store in the original blister packaging to protect from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.
6. Package Contents and Other Information
What Resolor Contains
The active substance is prucalopride.
One Resolor 1 mg film-coated tablet contains 1 mg prucalopride (as succinate).
One Resolor 2 mg film-coated tablet contains 2 mg 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), indigo carmine aluminium lake (E132).
Description of the Appearance of Resolor and Contents of the Pack
Resolor 1 mg film-coated tablets are round, white to off-white tablets, marked “PRU 1” on one side.
Resolor 2 mg film-coated tablets are round, pink tablets, marked “PRU 2” on one side.
Resolor is available in perforated unit-dose aluminum/aluminum blister packs (calendar packs) containing 7 tablets. Each package contains 7x1, 14x1, 28x1 or 84x1 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 HW68
Ireland
Manufacturer
Sanico NV
Veedijk 59
B-2300 Turnhout
Belgium
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Takeda Belgium NV Takeda, UAB
Tél/Tel: +32 2 464 06 11 Tel: +370 521 09 070
[email protected] [email protected]
България Luxembourg/Luxemburg
Такеда България ЕООД Takeda Belgium NV
Тел.: +359 2 958 27 36 Tél/Tel: +32 2 464 06 11
[email protected] [email protected]
Česká republika Magyarország
Takeda Pharmaceuticals Czech Republic s.r.o. Takeda Pharma Kft.
Tel: +420 234 722 722 Tel.: +36 1 270 7030
[email protected] [email protected]
Danmark Malta
Takeda Pharma A/S Drugsales Ltd
Tlf: +45 46 77 10 10 Tel: +356 21419070
[email protected] [email protected]
Deutschland Nederland
Takeda GmbH Takeda Nederland B.V.
Tel: +49 (0)800 825 3325 Tel: +31 20 203 5492
[email protected] [email protected]
Eesti Norge
Takeda Pharma AS Takeda AS
Tel: +372 6177 669 Tlf: +47 800 800 30
[email protected] [email protected]
Ελλάδα Österreich
Takeda ΕΛΛΑΣ Α.Ε. Takeda Pharma Ges.m.b.H.
Tηλ: +30 210 6387800 Tel: +43 (0) 800-20 80 50
[email protected] [email protected]
España Polska
Takeda Farmacéutica España S.A. Takeda Pharma Sp. z o.o.
Tel: +34 917 90 42 22 Tel.: +48223062447
[email protected] [email protected]
France Portugal
Takeda France SAS Takeda Farmacêuticos Portugal, Lda.
Tél: +33 1 40 67 33 00 Tel: +351 21 120 1457
[email protected] [email protected]
Hrvatska România
Takeda Pharmaceuticals Croatia d.o.o. Takeda Pharmaceuticals SRL
Tel: +385 1 377 88 96 Tel: +40 21 335 03 91
[email protected] [email protected]
Ireland Slovenija
Takeda Products Ireland Ltd Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: 1800 937 970 Tel: +386 (0) 59 082 480
[email protected] [email protected]
Ísland Slovenská republika
Vistor hf. Takeda Pharmaceuticals Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 (2) 20 602 600
[email protected] [email protected]
Italia Suomi/Finland
Takeda Italia S.p.A. Takeda Oy
Tel: +39 06 502601 Puh/Tel: 0800 774 051
[email protected] [email protected]
Κύπρος Sverige
A.POTAMITIS MEDICARE LTD Takeda Pharma AB
Τηλ: +357 22583333 Tel: 020 795 079
[email protected] [email protected]
Latvija United Kingdom (Northern Ireland)
Takeda Latvia SIA Takeda UK Ltd
Tel: +371 67840082 Tel: +44 (0) 2830 640 902
[email protected] [email protected]
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.