Patient Leaflet Updated 22-Feb-2024 | Dexcel Pharma Ltd
Prucalopride 1 mg Film-coated Tablets and Prucalopride 2 mg Film-coated Tablets
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.
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
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.
Talk to your doctor before taking Prucalopride Film-coated Tablets.
Take special care with Prucalopride Film-coated Tablets and tell your doctor if you:
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.
Tell your doctor if you are taking, or have recently taken, or might take any other medicines.
Prucalopride Film-coated Tablets can be taken with or without food and drinks, at any time of the day.
Prucalopride Film-coated Tablets is not recommended for use during pregnancy.
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.
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.
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 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.
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.
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, 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, 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.
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.
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.
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).
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.
This leaflet was last revised in January 2024
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+44 (0) 1748 828 784
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