Resolor – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Resolor, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you start taking this m edicine because it cont ains important information for you .
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others . It may harm them, even if the ir signs of illness are the same as yours.
- If you get any side effects , talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet .See section 4.
What is i n this leaflet 1. What Resolor is and what it is used for 2. What you need to know b efore you take Resolor 3. How to take Resolor 4. Possible side effects 5. How to store Resolor 6. Contents of the pack and other information
ℹ️ 1. What Resolor is and what it is used for
Resolor con tains the active substa nce pruc alopride.
Resolor belongs to a group of gut motility enhancing medicines ( gastrointestinal prokinetic s). It acts on the muscle wall of the gut, helping to restore the normal functioning of the bowel. Resolor is used for the treatment of chronic co nstipati on in adult sin whom laxatives do not work well enough.
Not for use in children and adolescents younger than 18 years.
⚠️ 2. What you need to know before you take Resolor
Do not take Resolor
- if you are allergic to prucaloprid e or any of the other i ngredien ts ofthis medicine (listed in section 6).
- if you are on renal dialysis,
- if you suffer from perforation or obstruction of the gut wall, severe inflammation of the intestinal tract, such as Crohn’s disease, ulcerative coli tis or toxic megacolon/ megarect um.
Warnings and precautions
Talk to you r doctor before taking Resolor.
Take special care with Resolor and tell your doctor if you:
- suffer from severe kidney disease,
- suffer from severe liver disease,
- are currently un der supervision by adoctor for a serious medical problem such as lung or heart disease, nervous system or mental health problems, cancer ,AIDS or a hormonal disorder .
If you have very bad diarrhoea, the contraceptive pill may not work properly and the us e of an extra method of contrac eption is recommended. See the instructions in the patient leaflet of the contraceptive pill you are taking.
32Other medicines and Resolor Tell your doctor if you are taking ,or have recently taken ,or might take any other med icines .
Resolor with f ood and drink Resolor can be taken with or without food and drinks, at any time of the day.
Pregnancy and breast -feeding Resolor is not recommended for use during pregnancy.
- Tell your doctor if you are pregnant or planning to become pregnant.
- Use a reliab le metho dof contraception while you’re taking Resolor, to prevent pregnancy.
- If you do become pregnant during treatment with Resolor, tell your doctor.
When breast -feeding, prucalopride can pass into breast milk. Breast -feeding is not recommended during treatmen twith Resolor. Talk to your doctor about this.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Resolor is unlikely to affect your ability to drive or use machines. However, sometimes Resol or may cause dizziness and tire dness, especially on the first day of treatment, and this may have an effect on driving and use of machines.
Resolor contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before tak ing this medicine.
💊 3. How to take Resolor
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 Resolor every day for as lon g as your doctor prescribes it.
The doctor may want to reassess your condition and the benefit of continued treatment after the first 4weeks and thereafter at regular intervals.
The usual dose of Resolor for most patients is one 2 mg tablet once a day.
If you are older than 65 years 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 d ay if needed.
Your doctor may also recommend a lower dose of one 1 mg tablet daily if you have se vere kidney disease.
Taking a hi gher dose than recommended will not make the product work better.
Resolor is only for adult sand should not be taken by children and adolescents up to 18 years.
If you take more Resolor than you should
It is important to keep to the dose as prescribed by your doctor. If you have taken more Resolor than you should, it is possible that you will get diarrhoea, headache and/or nausea. In case of diarrhoea, make sure that you drink enough water.
If you forget to take Resolor
Do not take a double dose to make up for a forgotten tablet. Just take your next dose at the usual time.
33If you stop taking Resolor If you stop taking Resolor, your constipation symptoms may come back again.
If you have any further questions on the use of this medicine, ask your doctor o r pharmacist.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects mostly occur at the start of treatment and usually disappear within a fe wdays with continued treatment.
The following side effects have been reported very commonly ( may affect more than 1 in 10 people) : headache, feeling sick , diarrhoea and abdominal pain.
The following side effects have been reported commonly ( may affect u p to 1 in 10 people) : decreased appetite, dizziness, vomiting, disturbed digestion (dyspepsia), windiness, abnormal bowel sounds, tiredness.
The following uncommon side effects have also been seen ( may affect up to 1 in 100 people) : tremors, pounding hea rt,rectal bleeding, increase in frequency of passing urine (pollakiuria), fever and feeling unwell. If pounding heart occurs, please tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not li sted in this leaflet. You can also report side effects directly via the national reporting system listed in Append ix 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 which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Store in the original blister package in order to protect from mo isture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no long er use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What Resolor contains
The active substance is prucalopride.
One film -coated tablet of Resolor 1 mg contains 1 mg prucalopride (as succinate).
One fil m-coated tablet of Resolor 2 mg contains 2 mg prucalopride (as succinate).
The other ingredients are:
Lactose monohydrate (see section 2) , microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hypromel lose, triacetin, titanium dioxide (E171), macrogol. The 2 mg tablet also contains iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132).
34What Resolor looks like and contents of the pack Resolor 1 mg film -coated tablets are white to off -white round shaped t ablets marked “PRU 1” on one side.
Resolor 2 mg film -coated tablets are pink round shaped tablets marked “PRU 2” on one side.
Resolor is provided in aluminium/aluminium perforated unit dose blister (calendar marked) conta ining 7tablets. Each pack contai ns 7×1, 14×1, 28×1 or 84×1 film-coated tablet s.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder
Takeda Pharmaceuticals International AG Ireland Branch Block 2Miesian Plaza 50-58 Baggot Street Lower Dublin 2 D02 HW 68 Ireland
Manufacturer
Sanico NV Veedijk 59 B-2300 Turnhout Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Taked a Belgium NV Tél/Tel: +32 2 464 06 11 [email protected] Takeda, UAB Tel: +370 521 09 070 [email protected] България Такеда България ЕООД Тел.: +359 2 958 27 36 [email protected] Luxembourg/Luxemburg Takeda Belgium NV Tél/Tel: +32 2 464 06 11 medinfoEMEA@ takeda.com Česká republika Takeda Pharmaceuticals Czech Republic s.r.o.
Tel: +420 234 722 722 [email protected]ág Takeda Pharma Kft.
Tel.: +36 1 270 7030 [email protected] Danmark Takeda Pharma A/S Tlf: +45 46 77 10 10 medinfoEME [email protected] Drugsales Ltd Tel: +356 21419070 [email protected] Deutschland Takeda GmbH Tel: +49 (0)800 825 3325 [email protected] Takeda Nederland B.V.
Tel: +31 20 203 5492 medinfoEMEA@taked a.com Eesti Takeda Pharma AS Tel:+372 6177 6 69 [email protected] Takeda AS Tlf: +47 800 800 30 [email protected] 35Ελλάδα Τakeda ΕΛΛΑΣ Α .Ε.
Tηλ: +30 210 6387800 [email protected]Österreich Takeda Pharma Ges.m.b.H.
Tel: +43 (0) 800 -20 80 50 [email protected] España Takeda Farmacéutica España S.A .
Tel: +34 917 90 42 22 [email protected] Taked a Pharma Sp. z o.o.
Tel.: +48223062447 [email protected] France Takeda France SAS Tél:+ 33 1 40 67 33 00 [email protected] Takeda Farmacêuticos Portugal, Lda.
Tel: + 351 21 120 1457 [email protected] Hrvatska Takeda Phar maceu ticals Croatia d.o.o.
Tel: +385 1 377 88 96 [email protected]ânia Takeda Pharmaceuticals SRL Tel: +40 21 335 03 91 medinfo [email protected] Ireland Takeda Products Ireland Ltd Tel: 1800 937 970 [email protected] Takeda Pharma ceuti cals farmacevtska družba d.o.o.
Tel: + 386 (0) 59 082 480 [email protected] Ísland Vistor hf.
Sími: +354 535 7000 [email protected]á republika Takeda Pharmaceuticals Slovakia s.r.o.
Tel: +421 (2) 20 602 600 [email protected] Italia Takeda Italia S.p.A.
Tel: +39 06 502601 [email protected]/Finland Takeda Oy Puh/Tel: 0800 774 051 [email protected] Κύπρος A.POTAMITIS MEDICARE LTD Τηλ: +357 22583333 [email protected] Takeda Pharma AB Tel: 020 795 079 [email protected] Latvija Takeda Latvia SIA Tel: +371 67840082 [email protected] Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 (0) 2830 640 902 [email protected] This leaflet was last revised in.
Detailed info rmation on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/ .
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Resolor (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/09/581).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.