Resolor 2 mg film-coated tablets

Resolor belongs to a group of gut motility enhancing medicines (enterokinetics). It acts on the muscle wall of the gut, helping to restore the normal functioning of the bowel. The tablets are used for the treatment of chronic constipation in women in whom laxatives do not work well enough.

Not for use in men, children and adolescents younger than 18 years as Resolor has been insufficiently studied in these populations.

Do not take Resolor if you:

• are allergic (hypersensitive) to prucalopride or any of the other ingredients of Resolor,
• are on renal dialysis,
• 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.

Take special care with Resolor if you:

• suffer from severe kidney disease,
• suffer from severe liver disease,
• are currently under supervision by your doctor for a serious medical problem such as lung or heart disease, cancer or AIDS.

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.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking 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

Do not take Resolor if you are pregnant or if you intend to become pregnant unless your doctor advises you to do so.

When breast-feeding, prucalopride can pass into breast milk. Do not use Resolor while breastfeeding unless your doctor advises you to do so.

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.

Important information about some of the ingredients of Resolor

Resolor contains lactose monohydrate. 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 Resolor exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You must 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, 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 or liver disease.

Taking a higher dose than recommended will not make the product work better.

Resolor is only for adult women 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.

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, Resolor 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 frequency of possible side effects listed below is defined using the following convention:

• very common (affects more than 1 user in 10)
• common (affects 1 to 10 users in 100)
• uncommon (affects 1 to 10 users in 1,000)
• rare (affects 1 to 10 users in 10,000)
• very rare (affects less than 1 user in 10,000)
• not known (frequency cannot be estimated from the available data).

The following side effects have been reported very commonly: headache, feeling sick, diarrhoea and abdominal pain.

The following side effects have been reported commonly: dizziness, vomiting, disturbed digestion (dyspepsia), rectal bleeding, windiness, abnormal bowel sounds, increase in frequency of passing urine (pollakiuria), tiredness.

The following uncommon side effects have also been seen: loss of appetite, tremors, pounding heart, fever and weakness. If pounding heart occurs, please tell your doctor.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Resolor 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Resolor contains

The active substance is prucalopride.
One film-coated tablet of Resolor 1 mg contains 1 mg prucalopride (as prucalopride succinate). One film-coated tablet of Resolor 2 mg contains 2 mg prucalopride (as prucalopride succinate).

The other ingredients are:
Lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171), macrogol 3000. 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, biconvex, round shaped tablets marked ?PRU 1? on one side.
Resolor 2 mg film-coated tablets are pink, biconvex, 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 tablet.

Not all pack sizes may be marketed in your country.

Marketing authorisation holder

Shire-Movetis NV
Veedijk 58
B-2300 Turnhout
Belgium
Tel.: 008006683 8470

Manufacturer

Sanico NV
Veedijk 59
B-2300 Turnhout
Belgium

Janssen Cilag S.P.A.
Via C. Janssen

I-04010 Borgo San Michele (Latina)

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Ísland Shire Sweden AB Svärdvägen. 11D SE-182 33 Danderyd Svíjóð Tel 46 8 544 964 00 BelgiëBelgiqueBelgien LuxembourgLuxemburg Nederland Shire Belgium BVBA Lambroekstraat 5C B-1831 Diegem BelgiëBelgique TélTel 32 2 711 02 30

Italia Shire Italia S.p.A Corso Italia, 29 I-50123, Firenze Tel 39 055 288860 , eská Republika, Eesti, , K, Latvija, Lietuva, Magyarország, Malta, Österreich, Polska, România, Slovenija, Slovenská republika. Shire-Movetis NV Veedijk 58 1004 2300 Turnhout , Belgie, , Beija, Belgija, Belgium, Il-Belju, Belgicko TeTel 008006683 8470

Danmark Shire Sweden AB Svärdvägen. 11D SE-182 33 Danderyd Sverige Tlf 46 8 544 964 00 Norge Shire Sweden AB Svärdvägen. 11D SE-182 33 Danderyd Sverige Tel 46 8 544 964 00

Deutschland Shire Deutschland GmbH Friedrichstrasse 149 D-10117 Berlin Tel 49 30 206 582 0 Portugal Shire Pharmaceuticals Portugal Lda Avenida João Crisóstomo, 30-1 1050-127 Lisboa Tel 351 213 303 730

España Shire Pharmaceuticals Ibérica, S.L. Paseo Pintor Rosales, 44 Bajo Izda. E-28008 Madrid Tel 34 915 500 691 SuomiFinland Shire Sweden AB Svärdvägen. 11D SE-182 33 Danderyd Ruotsi Tel 46 8 544 964 00

France Shire France S.A. 88, rue du Dôme F-92514 Boulogne-Billancourt Cedex Tél 33 1 46 10 90 00 Sverige Shire Sweden AB Svärdvägen. 11D SE-182 33 Danderyd Tel 46 8 544 964 00

United Kingdom Shire Pharmaceuticals Ltd Hampshire International Business Park Chineham, Basingstoke Hampshire, RG24 8EP Tel 0800 055 6614 Ireland Shire Pharmaceuticals Ltd Hampshire International Business Park Chineham, Basingstoke Hampshire, RG24 8EP United Kingdom Tel 1800 818 016

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