Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - resolor

Document Subject

Generated Narrative: MedicinalProductDefinition mpff7e41e620a058f62e199d7b81a017a6

identifier: http://ema.europa.eu/identifier/EU/1/09/581/001 (28 tablets)

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Resolor 1 mg film-coated tablets.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-ff7e41e620a058f62e199d7b81a017a6

identifier: http://ema.europa.eu/identifier/EU/1/09/581/001 (28 tablets)

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - resolor

Attesters

What is in this leaflet

1. What Resolor is and what it is used for
2. What you need to know before 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

Resolor contains the active substance prucalopride. Resolor belongs to a group of gut motility enhancing medicines (gastrointestinal prokinetics). 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 constipation in adults in whom laxatives do not work well enough. Not for use in children and adolescents younger than 18 years.

Do not take Resolor:

if you are allergic to prucalopride or any of the other ingredients of this 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 colitis or toxic megacolon/megarectum. Warnings and precautions Talk to your 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 under supervision by a doctor 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 use of an extra method of contraception is recommended. See the instructions in the patient leaflet of the contraceptive pill you are taking. Other medicines and Resolor Tell your doctor if you are taking, or have recently taken, or might take any other medicines. Resolor with food 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 reliable method of 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 treatment with 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 Resolor may cause dizziness and tiredness, 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 taking this medicine.

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 long as your doctor prescribes it. The doctor may want to reassess your condition and the benefit of continued treatment after the first 4 weeks 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 day if needed. Your doctor may also recommend a lower dose of one 1 mg tablet daily if you have severe kidney disease. Taking a higher dose than recommended will not make the product work better. Resolor is only for adults and 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. If 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 or pharmacist.

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 few days 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 up 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 heart, 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 listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Resolor contains The active substance is prucalopride. One film-coated tablet of Resolor 1 mg contains 1 mg prucalopride (as succinate). One film-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, hypromellose, triacetin, titanium dioxide (E171), macrogol. The 2 mg tablet also contains iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132). What Resolor looks like and contents of the pack Resolor 1 mg film-coated tablets are white to off-white round shaped tablets 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) containing 7 tablets. Each pack contains 7x1, 14x1, 28x1 or 84x1 film-coated tablets. Not all pack sizes may be marketed in your country. Marketing Authorisation Holder Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50-58 Baggot Street Lower Dublin 2 D02 HWIreland Manufacturer Sanico NV Veedijk B-2300 Turnhout Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Takeda Belgium NV T l/Tel: +32 2 464 06 medinfoEMEA@takeda.com Lietuva Takeda, UAB Tel: +370 521 09 medinfoEMEA@takeda.com

.: +359 2 958 27 medinfoEMEA@takeda.com Luxembourg/Luxemburg Takeda Belgium NV T l/Tel: +32 2 464 06 medinfoEMEA@takeda.com esk republika Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 medinfoEMEA@takeda.com Magyarorsz g Takeda Pharma Kft. Tel.: +36 1 270 7medinfoEMEA@takeda.com Danmark Takeda Pharma A/S Tlf: +45 46 77 10 medinfoEMEA@takeda.com Malta Drugsales Ltd Tel: +356 21419safety@drugsalesltd.com Deutschland Takeda GmbH Tel: +49 (0)800 825 3medinfoEMEA@takeda.com Nederland Takeda Nederland B.V. Tel: +31 20 203 5medinfoEMEA@takeda.com Eesti Takeda Pharma AS Tel: +372 6177 medinfoEMEA@takeda.com Norge Takeda AS Tlf: +47 800 800 medinfoEMEA@takeda.com

akeda . . T : +30 210 6387medinfoEMEA@takeda.com sterreich Takeda Pharma Ges.m.b.H. Tel: +43 (0) 800-20 80 medinfoEMEA@takeda.com Espa a Takeda Farmac utica Espa a S.A. Tel: +34 917 90 42 medinfoEMEA@takeda.com Polska Takeda Pharma Sp. z o.o. Tel.: +48223062medinfoEMEA@takeda.com France Takeda France SAS T l: + 33 1 40 67 33 medinfoEMEA@takeda.com Portugal Takeda Farmac uticos Portugal, Lda. Tel: + 351 21 120 1medinfoEMEA@takeda.com Hrvatska Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 medinfoEMEA@takeda.com Rom nia Takeda Pharmaceuticals SRL Tel: +40 21 335 03 medinfoEMEA@takeda.com Ireland Takeda Products Ireland Ltd Tel: 1800 937 medinfoEMEA@takeda.com Slovenija Takeda Pharmaceuticals farmacevtska dru ba d.o.o. Tel: + 386 (0) 59 082 medinfoEMEA@takeda.com sland Vistor hf. S mi: +354 535 7medinfoEMEA@takeda.com Slovensk republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 medinfoEMEA@takeda.com Italia Takeda Italia S.p.A. Tel: +39 06 502medinfoEMEA@takeda.com Suomi/Finland Takeda Oy Puh/Tel: 0800 774 medinfoEMEA@takeda.com

A.POTAMITIS MEDICARE LTD : +357 22583a.potamitismedicare@cytanet.com.cy Sverige Takeda Pharma AB Tel: 020 795 medinfoEMEA@takeda.com Latvija Takeda Latvia SIA Tel: +371 67840medinfoEMEA@takeda.com United Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 (0) 2830 640 medinfoEMEA@takeda.com This leaflet was last revised in . Detailed information on this medicine is available on the European Medicines Agency web site: