Prucalopride 2 mg film-coated tablets

• 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 their 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.

1. What Prucalopride is and what it is used for
2. What you need to know before you take Prucalopride
3. How to take Prucalopride
4. Possible side effects
5. How to store Prucalopride
6. Contents of the pack and other information

• 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.

Talk to your doctor before taking Prucalopride.

Take special care with Prucalopride 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.

Prucalopride film-coated tablets contain Isomalt (E 953):

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Tell your doctor if you are taking, or have recently taken, or might take any other medicines.

Prucalopride can be taken with or without food and drinks, at any time of the day.

Prucalopride 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 Prucalopride, to prevent pregnancy.
• If you do become pregnant during treatment with Prucalopride, tell your doctor.

When breastfeeding, prucalopride can pass into breast milk. Breastfeeding is not recommended during treatment with Prucalopride. Talk to your doctor about this.

Ask your doctor for advice before taking any medicine.

Prucalopride is unlikely to affect your ability to drive or use machines. However, sometimes Prucalopride may cause dizziness and tiredness, especially on the first day of treatment, and this may have an effect on driving and use of machines.

Prucalopride is only for adults and should not be taken by children and adolescents up to 18 years.

It is important to keep to the dose as prescribed by your doctor. If you have taken more Prucalopride 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.

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 Prucalopride your constipation symptoms may come back again.

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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is prucalopride.

One film-coated tablet of Prucalopride contains prucalopride succinate equivalent to 2 mg prucalopride.

The other ingredients are:

Tablet core

Microcrystalline cellulose (E 460 i); Isomalt (E 953); Sodium starch glycolate; Silica, colloidal anhydrous (E 551); Magnesium stearate (E 470 b)

Tablet coating

Hypromellose (E 464); Titanium dioxide (E 171); Macrogol; Talc (E 533 b)

Colourants

Iron oxide yellow (E 172)

Iron oxide red (E 172)

Indigo carmine aluminium lake (E 132)

Prucalopride 2 mg film-coated tablets are brown coloured, round, biconvex film-coated tablets debossed with ‘PRC’ on one side and ‘2’ on the other side. The average diameter of the tablets is 8.5 mm.

Prucalopride is available in packs of 7, 14, 28 or 84 film-coated tablets in aluminium/aluminium blister.

Prucalopride is available in packs of 7, 14, 28 or 84 film-coated tablets in clear- or opaque- PVC/PE/PVdC - aluminium blister.

Not all pack sizes may be marketed in your country.

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