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Prucalopride 1 mg Film-coated Tablets

Active Ingredient:
prucalopride succinate
Company:  
Dexcel Pharma Ltd See contact details
ATC code: 
A06AX05
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 22 Feb 2024
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL14017/0296.

{printer} Print patient leaflet as text only

Prucalopride 1 mg Film-coated Tablets and Prucalopride 2 mg Film-coated Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

Prucalopride 1 mg Film-coated Tablets

Prucalopride 2 mg Film-coated Tablets

prucalopride

The names of the products are Prucalopride 1 mg Film-coated Tablets and Prucalopride 2mg Film-coated tablets and they will be referred to as Prucalopride Film-coated Tablets throughout the leaflet.

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

1. What Prucalopride Film-coated Tablets is and what it is used for

Prucalopride Film-coated Tablets contains the active substance prucalopride.

Prucalopride Film-coated Tablets 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 Film-coated Tablets 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 Film-coated Tablets
Do not take Prucalopride Film-coated Tablets:
  • 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 Film-coated Tablets.

Take special care with Prucalopride Film-coated Tablets 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 Film-coated Tablets

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

Prucalopride Film-coated Tablets with food and drink

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

Pregnancy and breast-feeding

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

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

Ask your doctor for advice before taking any medicine.

Driving and using machines

Prucalopride Film-coated Tablets 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 Film-coated Tablets 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.

3. How to take Prucalopride Film-coated Tablets

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 Film-coated Tablets 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 Film-coated Tablets 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.

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

If you take more Prucalopride Film-coated Tablets than you should

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

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 Film-coated Tablets

If you stop taking Prucalopride Film-coated Tablets, 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 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 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 Film-coated Tablets

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.

This medicine does not require any special storage conditions.

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 Film-coated Tablets contains

The active substance is prucalopride.

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

One film-coated tablet of Prucalopride 2 mg Film-coated Tablets contains 2 mg prucalopride (as succinate).

The other ingredients are:

Lactose monohydrate (see section 2), microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 4000 and triacetin. The 2 mg tablet also contains iron oxide red (E172), FD&C Blue #2/Indigo carmine aluminium lake (E132) and iron oxide yellow (E172).

What Prucalopride Film-coated Tablets looks like and contents of the pack

Prucalopride 1 mg Film-coated Tablets are white to off-white, round biconvex, film-coated tablets debossed with “P1” on one side and no debossing on the other side.

Prucalopride 2 mg Film-coated Tablets are pink, round biconvex, film-coated tablets debossed with “P2” on one side and no debossing on the other side.

The tablets are packed in OPA/Alu/PVC blister strips sealed with aluminium foil. The blister strips are packed in cartons of 14, 28 or 84 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder
Dexcel®-Pharma Ltd.
7 Sopwith Way
Drayton Fields
Daventry
Northamptonshire
NN11 8PB
UK

Manufacturer
Combino Pharm Malta, Ltd
HF60 Hal Far Industrial Estate
Hal Far BBG 300
Malta

This leaflet was last revised in January 2024

V-000357

Dexcel Pharma Ltd
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Address
7, Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
WWW
http://www.dexcelpharma.com
Telephone
+44 (0)1327 312 266
Fax
+44 (0)1327 312 262
E-mail
[email protected]
Medical Information Direct Line
+44 (0) 1748 828 784
Medical Information e-mail
[email protected]
Out of Hours Telephone
+44 (0) 1748 828 784