What Resolor 1 mg is used for and how to use it
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Resolor 1 mg - Consumer Medicine Information

Manufacture: Shire, Inc.
Country: Belgium
Condition: Constipation, Chronic, Constipation
Class: Gastrointestinal agents
Form: Tablets
Ingredients: prucalopride, 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)

prucalopride

What Resolor is and What it is Used for

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.

What you Need to know Before you Take Resolor

Do not Take Resolor

  • if you are allergic to prucalopride or any of the other ingredients of this medicine (listed in section Contents of the pack and other information).
  • 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.

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 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.

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 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 (see below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: http://www.yellowcard.mhra.gov.uk/


Ireland

HPRA Pharmacovigilance Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971 Fax: +353 1 6762517

Website: http://www.hpra.ie

e-mail: medsafety@hpra.ie


Malta

ADR Reporting

Website: http://www.medicinesauthority.gov.mt/adrportal

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 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.

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 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

Shire Pharmaceuticals Ireland Limited

5 Riverwalk

Citywest Business Campus

Dublin 24

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

Luxembourg/Luxemburg

Nederland

Shire Belgium BVBA

België/Belgique/Belgien

Tél/Tel: +32 2 711 02 30

e-mail: medinfoeuceemea@shire.com

България, Česká republika, Eesti, Hrvatska,

Latvija, Lietuva, Magyarország, Polska,

Slovenská republika

Shire Pharmaceuticals Ireland

Ирландия, Irsko, Iirimaa, Irska, Īrija,

Airija, Írország, Irlandia, Írsko

Teл/Tel/Τηλ: 008006683 8470

e-mail: medinfoeuceemea@shire.com

Danmark

Shire Sweden AB

Sverige

Tlf: 8088 6962

e-mail: medinfoeuceemea@shire.com

Deutschland

Shire Deutschland GmbH

Tel: 0800 180 1627

e-mail: medinfoeuceemea@shire.com

Ελλάδα

Shire Hellas S.A

Τηλ.: +30 21 69 00 40 00

e-mail: medinfoeuceemea@shire.com

España

Shire Pharmaceuticals Ibérica, S.L.

Tel: +34 91 550 06 91

e-mail: medinfoeuceemea@shire.com

France

Shire France S.A.

Tél: +33 1 46 10 90 00

e-mail: medinfoeuceemea@shire.com

Κύπρος

Shire Hellas S.A

Ελλάδα

Τηλ.: +30 21 69 00 40 00

e-mail: medinfoeuceemea@shire.com

Malta

Vivian Corporation

Tel: +356 21320338

e-mail: medinfoeuceemea@shire.com

Norge

Shire Sweden AB

Sverige

Tlf: +46 8 544 964 00

e-mail: medinfoeuceemea@shire.com

Österreich

Shire Austria GmbH

Tel: +43 1 2051160 – 1051

e-mail: medinfoeuceemea@shire.com

Portugal

Shire Pharmaceuticals Portugal Lda

Tel.: + 351 213502130

e-mail: medinfoeuceemea@shire.com

România

Shire Pharmaceuticals Ireland Limited

Irlanda

Tel: 08008 95231

e-mail: medinfoeuceemea@shire.com

Slovenija

Shire Pharmaceuticals Ireland Limited

Irska

Tel: 0800 80607

e-mail: medinfoeuceemea@shire.com

Ireland

Shire Pharmaceuticals Ltd

United Kingdom

Tel: 1800 818 016

e-mail: medinfoeuceemea@shire.com

Ísland

Shire Sweden AB

Svíþjóð

Sími: +46 8 544 964 00

e-mail: medinfoeuceemea@shire.com

Italia

Shire Italia S.p.A

Tel: +39 02655 35001

e-mail: medinfoeuceemea@shire.com

Suomi/Finland

Shire Sweden AB

Ruotsi

Puh/Tel: +46 8 544 964 00

e-mail: medinfoeuceemea@shire.com

Sverige

Shire Sweden AB

Tel: +46 8 544 964 00

e-mail: medinfoeuceemea@shire.com

United Kingdom

Shire Pharmaceuticals Ltd

Tel: 0800 055 6614

e-mail: medinfoeuceemea@shire.com