What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 47848/0023.


Prucalopride 1mg film-coated tablets

Package leaflet: Information for the patient

Prucalopride 1 mg film-coated tablets

Prucalopride succinate

Read all of this leaflet carefully before you start taking this medicine because it contains 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 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.

What is in this leaflet

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

1. What Prucalopride is and what it is used for

Prucalopride contains the active substance prucalopride.

Prucalopride 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.

Prucalopride 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.

2. What you need to know before you take Prucalopride

Do not take Prucalopride

  • 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 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.

Other medicines and Prucalopride

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

Prucalopride with food and drink

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

Pregnancy and breast-feeding

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 breast-feeding, prucalopride can pass into breast milk. Breast-feeding is not recommended during treatment with Prucalopride. Talk to your doctor about this.

Ask your doctor for advice before taking any medicine.

Driving and using machines

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.

3. How to take Prucalopride

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 Prucalopride 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 Prucalopride 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.

Use in children and adolescents

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

If you take more Prucalopride than you should

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.

If you forget to take Prucalopride

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

If you stop taking Prucalopride your constipation symptoms may come back again.

If you have any further questions on the use of this medicine, ask your doctor or 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 few days with continued treatment.

The following side effects have been reported:

Very common: may affect more than 1 in 10 people

  • headache,
  • feeling sick,
  • diarrhoea,
  • abdominal pain.

Common: may affect up to 1 in 10 people

  • decreased appetite,
  • dizziness,
  • vomiting,
  • disturbed digestion (dyspepsia),
  • windiness,
  • abnormal bowel sounds,
  • tiredness.

Uncommon: 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 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.

5. How to store Prucalopride

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.

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.

6. Contents of the pack and other information

What Prucalopride contains

The active substance is prucalopride.

One film-coated tablet of Prucalopride 1 mg contains 1 mg prucalopride (as 1.321 mg of prucalopride succinate).

The other ingredients are:

Tablet core

Microcrystalline cellulose; Isomalt; Sodium starch glycolate (Type A); Silica, colloidal anhydrous;

Magnesium stearate

Tablet coating

Hypromellose; Titanium dioxide (E171); Macrogol (6000); Talc

Colourants

Iron oxide yellow (E172) (2 mg film-coated tablets)

Iron oxide red (E172) (2 mg film-coated tablets)

Indigo carmine aluminium lake (E132) (2 mg film-coated tablets)

What Prucalopride looks like and contents of the pack

Prucalopride 1 mg film-coated tablets are white coloured, round, biconvex film-coated tablets debossed with ‘PRC’ on one side and ‘1’ on the other side. The average diameter of the tablets is 6.0 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 blister.

Not all pack sizes may be marketed in your country.

Marketing authorisation holder and Manufacturer

Marketing authorisation holder

axunio Pharma GmbH
Van-der-Smissen-Straße 1
22767 Hamburg
Germany

Manufacturer

Pharmacare Premium Ltd.
HHF 003
Hal Far Industrial Estate
Birzebbugia BBG 3000
Malta

This medicinal product is authorized in the Member States of the EEA under the following names:

Germany: Prucaloprid axunio 1 mg Filmtabletten

Prucaloprid axunio 2 mg Filmtabletten

United Kingdom: Prucalopride 1 mg film-coated tablets

Prucalopride 2 mg filmcoated tablets

This leaflet was last revised in March 2021.

B-V01